S HARE W ITH W OMEN INTRAUTERINE DEVICES INTRAUTERINE DEVICES What is An Intrauterine Device? An intrauterine device (IUD) is anything that is placed inside the uterus (womb) to prevent pregnancy. ...
Wang, K; Cheng, Y; Yang, H; Tang, Y H; Jiang, J; Ji, F; Li, L B; Wu, S C
To compare the effectiveness of medicated γ intrauterine device (IUD) and medicated genefix IUD inserted immediately after abortion. A multicenter clinical trail was performed for the study from Mar. 2012 to Jan. 2013. Totally 840 women who volunteered to participate were randomly allocated to γ-group (medicated γ IUD) or genefix-group (medicated genefix IUD) immediately after abortion. While 464 abortion women who had not used IUD or steroids contraceptive methods were chosen as control group. The effectiveness of the IUD were followed up for 1 year. All women were required to record the number of vaginal bleeding days and blood volume of vaginal bleeding within 3 months after abortion. At the 12(th) month, the expulsion was the most common reason for termination. The expulsion rates of genefix-group and γ-group were 2.48/100 women years and 3.12/100 women years, respectively (P>0.05). For the expulsion reasons, IUD moving down could account for more than seventy percent. The removal rate for IUD usage of two IUD groups were almost equal (3.91/100 women years verus 4.35/100 women years), the differences were not statistically significant (P>0.05). At the 90(th) day after abortion, comparing with control group, the bleeding and (or) spotting days of genefix-group and γ-group extended by 3.9 and 2.6 days respectively, the differences had statistical significance between the three groups (P0.05). The insertion of medicated genefix IUD and medicated γ IUD immediately after abortion is safe, feasible, has slight side effects and could be effective contraception.
The aim of this chapter is to review the worldwide use of intrauterine devices (IUDs) for contraception and the long-term contraceptive efficacy and safety of copper-bearing IUDs. The TCu380A and Multiload Cu375 have a very low failure rate (0.2-0.5%) over 10 years. The main concerns of the use of IUDs are risk of pelvic inflammatory diseases and increased menstrual blood loss and irregular bleeding. Factors associated with an increase in risk of pelvic inflammatory diseases are discussed. Preventive measures can be taken with careful screening of eligible IUD users, technical training and adequate service facilities for provision of IUDs. Levonorgestrel-releasing IUDs have the benefit of reducing menstrual blood loss in addition to high contraceptive efficacy. The copper IUD is the most effective method for emergency contraception. It can prevent over 95% of unwanted pregnancies within 5 days of unprotected intercourse. Copyright 2002 Elsevier Science Ltd.
Zapata, Lauren B; Jatlaoui, Tara C; Marchbanks, Polly A; Curtis, Kathryn M
Potential barriers to intrauterine device (IUD) use include provider concern about difficult insertion, particularly for nulliparous women. This study aims to evaluate the evidence on the effectiveness of medications to ease IUD insertion on provider outcomes (i.e., ease of insertion, need for adjunctive insertion measures, insertion success). We searched the PubMed database for peer-reviewed articles published in any language from database inception through February 2016. We included randomized controlled trials (RCTs) that examined medications to ease interval insertion of levonorgestrel-releasing IUDs and copper T IUDs. From 1855 articles, we identified 15 RCTs that met our inclusion criteria. Most evidence suggested that misoprostol did not improve provider ease of insertion, reduce the need for adjunctive insertion measures or improve insertion success among general samples of women seeking an IUD (evidence Level I, good to fair). However, one RCT found significantly higher insertion success among women receiving misoprostol prior to a second IUD insertion attempt after failed attempt versus placebo (evidence Level I, good). Two RCTs on 2% intracervical lidocaine as a topical gel or injection suggested no positive effect on provider ease of insertion (evidence Level I, good to poor), and one RCT on diclofenac plus 2% intracervical lidocaine as a topical gel suggested no positive effect on provider ease of insertion (evidence Level I, good). Limited evidence from two RCTs on nitric oxide donors, specifically nitroprusside or nitroglycerin gel, suggested no positive effect on provider ease of insertion or need for adjunctive insertion measures (evidence Level I, fair). Overall, most studies found no significant differences between women receiving interventions to ease IUD insertion versus controls. Among women with a recent failed insertion who underwent a second insertion attempt, one RCT found improved insertion success among women using misoprostol versus
Gyasi-Sarpong, Christian Kofi; Maison, Patrick Opoku Manu; Morhe, Emmanuel; Aboah, Ken; Appiah, Kwaku Addai-Arhin; Azorliade, Roland; Baah-Nyamekye, Kofi; Otu-Boateng, Kwaku; Amoah, George; Antwi, Isaac; Frimpong-Twumasi, Benjamin; Arthur, Douglas
Background Intrauterine contraceptive device is the most common method of reversible contraception in women. The intrauterine contraceptive device can perforate the uterus and can also migrate into pelvic or abdominal organs. Perforation of the urinary bladder by an intrauterine contraceptive device is not common. In West Africa, intravesical migration of an intrauterine contraceptive device has been rarely reported. In this report, we present a case of an intrauterine contraceptive device mi...
Stephen Searle, E
Intrauterine contraception is used by about 100 million women worldwide, making it the most popular form of fertility regulation. In UK community contraception clinics, however, long-acting reversible contraception has increased to 28% of users, and intrauterine contraception accounts for only 8% of methods used by women accessing these services. Potential exists to increase uptake of these more effective methods. In this chapter, we review the clinical advantages, disadvantages and cost-effectiveness of intrauterine contraception. We discuss the management of complications along with advice for trainers, and briefly consider issues in developing countries. Copyright © 2014 Elsevier Ltd. All rights reserved.
Diken, Adem I; Yalçınkaya, Adnan; Aksoy, Eray; Yılmaz, Seyhan; Çağlı, Kerim
Primary Raynaud's phenomenon may be insistent in patients under medical therapy, and intrauterine devices may be an unnoticed reason in these patients. Fluctuations in female sex hormone status were reported to be associated with the emergence of primary Raynaud's phenomenon symptoms. The use of intrauterine devices was not reported to be associated with Raynaud's phenomenon previously. Intrauterine device may stimulate vascular hyperactivity regarding hormonal or unknown mechanisms that result in Raynaud's phenomenon. We present a postmenopausal patient who complained of primary Raynaud's phenomenon symptoms and had recovery after the removal of her copper intrauterine device. © The Author(s) 2014 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
Rovati, Marco; Raveglia, Federico; Baisi, Alessandro; De Simone, Matilde; Cioffi, Ugo
Extrauterine translocation of intrauterine device (IUD) to peritoneal cavity is an uncommon event, moreover the ovarian embedding of a transmigrated IUD is very rare, and only two previous cases have been reported in the literature. We present a single case treated with laparoscopy. The aims of this study were to focus attention on the utility of preoperative computed tomography in planning the best surgical approach and to describe the two-port technique. © 2016 Japan Society of Obstetrics and Gynecology.
Aruna Nigam; Ratna Biswas; Archana Mishra
Aruna Nigam, Ratna Biswas, Archana MishraDepartment of Obstetrics and Gynaecology, Lady Hardinge Medical College, New Delhi, IndiaAbstract: Intrauterine contraceptive device (IUCD) migration subsequent to uterine wall perforation is an uncommon but serious complication. Three cases of misplaced IUCD at three different sites, ie, posterior fornix, rectal wall, and mesoappendix, are reported. An IUCD thread coming through the posterior fornix is reported in the literature for the first time.Key...
Mejia Restrepo, Jorge; Lopez, Juan Esteban; Aldana Sepulveda, Natalia; Ruiz Zabaleta, Tania; Mazzaro Mauricio
Intrauterine devices have been used for over 40 years, and they constitute the most widely accepted method of contraception among women because of the low rates of complications and low cost. Although uncommon, with the growing use of multidetector CT penetrated and migrated intrauterine devices have become a more common incidental finding. In some cases, intrauterine devices migrate to adjacent viscera, in particular the bladder and bowel and may give rise to symptoms. Consequently tomographic localization and characterization are essential for treatment planning.
Gyasi-Sarpong, Christian Kofi; Maison, Patrick Opoku Manu; Morhe, Emmanuel; Aboah, Ken; Appiah, Kwaku Addai-Arhin; Azorliade, Roland; Baah-Nyamekye, Kofi; Otu-Boateng, Kwaku; Amoah, George; Antwi, Isaac; Frimpong-Twumasi, Benjamin; Arthur, Douglas
Intrauterine contraceptive device is the most common method of reversible contraception in women. The intrauterine contraceptive device can perforate the uterus and can also migrate into pelvic or abdominal organs. Perforation of the urinary bladder by an intrauterine contraceptive device is not common. In West Africa, intravesical migration of an intrauterine contraceptive device has been rarely reported. In this report, we present a case of an intrauterine contraceptive device migration into the urinary bladder of a 33 year old African woman at the Komfo Anokye Teaching Hospital, Kumasi, Ghana. A 33 year old African woman presented with persistent urinary tract infection of 7 months duration despite appropriate antibiotic treatments. An abdominal ultrasonography revealed a urinary bladder calculus which was found to be an intrauterine contraceptive device on removal at cystoscopy. She got pregnant whilst having the intrauterine contraceptive device in place and delivered at term. The presence of recurrent or persistent urinary tract infection in any woman with an intrauterine contraceptive device should raise the suspicion of intravesical migration of the intrauterine contraceptive device.
Phillips, Sharon J; Hofler, Lisa G; Modest, Anna M; Harvey, Lara F B; Wu, Lily H; Hacker, Michele R
Studies conflict on whether the duration of use of the copper intrauterine device is longer than that of the levonorgestrel intrauterine device, and whether women who continue using intrauterine devices differ from those who discontinue. We sought to assess continuation rates and performance of levonorgestrel intrauterine devices compared with copper intrauterine devices over a 5-year period. We performed a retrospective cohort study of 1164 individuals who underwent intrauterine device placement at an urban academic medical center. The analysis focused on a comparison of continuation rates between those using levonorgestrel intrauterine device and copper intrauterine device, factors associated with discontinuation, and intrauterine device performance. We assessed the differences in continuation at discrete time points, pregnancy, and expulsion rates using χ 2 tests and calculated hazard ratios using a multivariable Cox model. Of 1164 women who underwent contraceptive intrauterine device insertion, 956 had follow-up data available. At 2 years, 64.9% of levonorgestrel intrauterine device users continued their device, compared with 57.7% of copper intrauterine device users (P = .11). At 4 years, continuation rates were 45.1% for levonorgestrel intrauterine device and 32.6% for copper intrauterine device (P intrauterine device and 23.8% for copper intrauterine device (P = .33). Black race, primiparity, and age were positively associated with discontinuation; education was not. The hazard ratio for discontinuation of levonorgestrel intrauterine device compared with copper intrauterine device >4 years was 0.71 (95% confidence interval, 0.55-0.93) and >5 years was 0.82 (95% confidence interval, 0.64-1.05) after adjusting for race, age, parity, and education. Copper intrauterine device users were more likely to experience expulsion (10.2% copper intrauterine device vs 4.9% levonorgestrel intrauterine device, P intrauterine device vs 0.1% levonorgestrel intrauterine
Changes in the use of intrauterine devices (IUDs) for contraception in China in the past 10 years are reviewed. Replacement of the inert stainless steel ring with copper-bearing IUDs was an essential decision to improve the efficacy of the IUDs. The most commonly used, TCu380A, TCu220C and MLCu375, and those developed in China, such as the uterine-shaped UCu300 IUD and gamma Cu380 IUD, are reviewed. Studies of MLCu375 and TCu380A for emergency contraception revealed a highly effective method, which could prevent over 96% of unwanted pregnancies. Use of levonorgestrel-releasing system provides both contraceptive and therapeutic effects in the treatment of menorrhagia.
Haddad, Lisa B; Feldacker, Caryl; Jamieson, Denise J; Tweya, Hannock; Cwiak, Carrie; Bryant, Amy G; Hosseinipour, Mina C; Chaweza, Thomas; Mlundira, Linly; Kachale, Fanny; Stuart, Gretchen S; Hoffman, Irving; Phiri, Sam
To determine medical eligibility for contraceptive use, contraceptive preference, and acceptance of a copper intrauterine device (IUD) among a cohort of HIV-infected women receiving antiretroviral therapy (ART). All HIV-infected women who received ART and sought contraceptive services at the Lighthouse clinic, an integrated HIV/ART clinic in Lilongwe, Malawi, between August and December 2010 were invited to participate in a structured interview. Eligibility and preference for the following contraceptive methods were assessed: combined hormonal contraceptives, progestogen-only pills, copper IUD, injectable depot medroxyprogesterone acetate (DMPA), and contraceptive implants. The final sample included 281 women; five were pregnant. The remaining 276 women were eligible for at least three contraceptive methods, with 242 (87.7%) eligible for all five methods evaluated. After counseling, 163 (58.0%) selected DMPA and 98 (34.9%) selected an IUD as their preferred contraceptive method. Regardless of their method of choice, 222 (79.0%) women agreed to have an IUD placed on the same day. Most methods of contraception are safe for use by HIV-infected women. Approximately 80% of the women were willing to receive an IUD. Efforts must be made to increase education about, and access to, long-acting reversible methods that may be acceptable and appropriate contraceptive options for HIV-infected women. Copyright © 2014 International Federation of Gynecology and Obstetrics. All rights reserved.
We present a case of successful laparoscopic retrieval of a perforated intrauterine device (Lippes loop). The Lippes loop was inserted after manual intrauterine adhesiolysis as a treatment of uterine synaechia presenting as secondary amenorrhoea of 20 months duration. The uterine perforation in this patient did not occur at ...
Semra Oruç Koltan
Full Text Available The intrauterine device (IUD is a widely used, highly effective method of birth control. Uterine perforation is a rare yet serious complication and is usually seen during insertion of the IUD. A regular examination is necessary for follow-up. We present a patient with an IUD that had perforated the cervix. The diagnosis was made during routine gynecological examination, and the patient was treated in a timely manner before any complications such as ectopic pregnancy, intrauterine pregnancy, infection or irreversible harm to the cervix arose. This case stresses the importance of regular visits to maintain health and diagnose possible adverse effects of intrauterine contraceptive methods.
Ganer, Hadas; Levy, Amalia; Ohel, Iris; Sheiner, Eyal
To investigate pregnancy outcome in patients who conceived with an intrauterine contraceptive device. A retrospective study comparing the pregnancy outcome of women with retained intrauterine device (n = 98), patients after intrauterine device removal in early pregnancy (n = 194), and pregnancies without an intrauterine device (n = 141,191) was performed. A significant linear association was documented among the 3 groups and adverse outcomes such as preterm delivery (18.4% in the retained intrauterine device, 14.4 % in removed intrauterine device, and 7.3% in the no-intrauterine device group; P intrauterine device, 4.1% in removed intrauterine device and 0.7% in the no-intrauterine device group; P intrauterine device was found as an independent risk factor for both preterm delivery and chorioamnionitis in multivariable models. Women conceiving with an intrauterine device are at increased risk for adverse obstetric outcomes, whereas the risk is higher for pregnancies with retained intrauterine device compared with early intrauterine device removal.
Gabriel O. Igberase
Full Text Available The aim of the study is to show that long standing forgotten intrauterine device contributes to infertility, reporting three cases presented at Central Hospital Warri, Nigeria, a government tertiary health center. Three cases of forgotten intrauterine contraceptive device (IUCD contributing to infertility were seen. Two were inserted for contraceptive reasons while one was inserted while being managed for uterine synechae. Health care providers should ensure proper documentation of all procedures carried out, adequate counseling which should include taking an informed consent and also ensuring both short and long term follow up of their clients. Also all patients being evaluated for infertility and clients with past history of intrauterine device must have a speculum examination and ultrasound scan carried out.
Kurdoglu, Zehra; Ceylan, Kadir; Kurdoglu, Mertihan; Guler, Ayse; Sahin, Hanim Guler
Background. Uterine perforation and transvesical migration of an intrauterine device are rare complications. Case. A 28-year-old woman who had an intrauterine device was admitted to our outpatient clinic with complaints of amenorrhea lasting 5 weeks and pelvic pain lasting a year. Transvaginal ultrasonography revealed embedding of the intrauterine device in the bladder. The misplaced device was removed by laparotomy. Conclusion. The followup of intrauterine device localization with transvaginal ultrasonography is essential for early detection of possible serious complications. PMID:20811600
Veldhuis, H.M.; Vos, A.G.; Lagro-Janssen, A.L.M.
OBJECTIVES: The intrauterine device (IUD) is still related to pelvic inflammatory disease (PID), pregnancy, expulsion, perforation and menstrual problems, particularly in nulliparous women. We aimed to study the complications and symptoms of the intrauterine device in general practice, particularly
Background: Intrauterine contraceptive device (IUCD) is one of the reversible methods of contraception. Its use has increased steadily worldwide. However, some women reject it based on presumed complications associated with its use. Aim: To determine the complications reported by women, action taken on the ...
Davies, Amanda; Fleming, Charlotte
Expulsion of an intrauterine device (IUD) occurs in about 1 in 20 women and expulsion may not be noticed by the user. Current guidance recommends that users are instructed to check regularly for their threads. This is the first study to explore the reality of how women feel about checking their threads and the details surrounding how frequently checks are done. One hundred consecutive IUD users were interviewed regarding their type of device, duration of use, frequency of thread checking, prompts for checking and reasons for not checking. Only 23% checked their threads regularly and 51% had never done so. The most common reason for not checking was forgetting about it. Despite being advised to do so, the majority of users do not check their threads at all and fewer than one-quarter of them check regularly. We propose that advice offered about thread checking should be given less emphasis and suggested more for user reassurance.
Salma, Umme; Xue, Min; Md Sayed, Ali Sheikh; Xu, Dabao
The primary purpose of this paper is to assess the efficacy of the use of the intrauterine device (IUD) as an adjunctive treatment modality, for intrauterine adhesions (IUAs). All eligible literatures were identified by electronic databases including PubMed, Scopus, and Web of Science. Additional relevant articles were identified from citations in these publications. There were 28 studies included for a systematic review. Of these, 5 studies were eligible for meta-analysis and 23 for qualitative assessment only. Twenty-eight studies related to the use of IUDs as ancillary treatment following adhesiolysis were identified. Of these studies, 25 studies at least one of the following methods were carried out as ancillary treatment: Foley catheter, hyaluronic acid gel, hormonal therapy, or amnion graft in addition to the IUD. There was one study that used IUD therapy as a single ancillary treatment. In 2 studies, no adjunctive therapy was used after adhesiolysis. There was a wide range of reported menstrual and fertility outcomes which were associated with the use of IUD combined with other ancillary treatments. At present, the IUD is beneficial in patients with IUA, regardless of stage of adhesions. However, IUD needs to be combined with other ancillary treatments to obtain maximal outcomes, in particular in patients with moderate to severe IUA. PMID:25254212
Full Text Available The primary purpose of this paper is to assess the efficacy of the use of the intrauterine device (IUD as an adjunctive treatment modality, for intrauterine adhesions (IUAs. All eligible literatures were identified by electronic databases including PubMed, Scopus, and Web of Science. Additional relevant articles were identified from citations in these publications. There were 28 studies included for a systematic review. Of these, 5 studies were eligible for meta-analysis and 23 for qualitative assessment only. Twenty-eight studies related to the use of IUDs as ancillary treatment following adhesiolysis were identified. Of these studies, 25 studies at least one of the following methods were carried out as ancillary treatment: Foley catheter, hyaluronic acid gel, hormonal therapy, or amnion graft in addition to the IUD. There was one study that used IUD therapy as a single ancillary treatment. In 2 studies, no adjunctive therapy was used after adhesiolysis. There was a wide range of reported menstrual and fertility outcomes which were associated with the use of IUD combined with other ancillary treatments. At present, the IUD is beneficial in patients with IUA, regardless of stage of adhesions. However, IUD needs to be combined with other ancillary treatments to obtain maximal outcomes, in particular in patients with moderate to severe IUA.
Trignol-Viguier, N; Blin, E; Marret, H
Intra-uterine device (IUD) is one of the birth control methods, which is available for nulliparous women, even though misconceptions still remain in medical or popular opinion. Only 1.3 % of nulliparous have a IUD as contraception in France while it is the second methods used by all women, after pill. The best contraception is the one chosen by women; however, the choice for a nulliparous of an IUD may be really difficult, despite the increasing number of women wishing to use it. Long-acting reversible contraceptives utilization, including IUD, is probably one of the issues to decrease the unintended pregnancies. An exhaustive and clear information about IUD is necessary to allow an informed and real choice. This prescription must consider contraindications and medical conditions for safe insertion, especially to avoid infection by screening STD (Chlamydia trachomatis and Nesseria gonorrhoeae) in nulliparous womeneffected with usual precautions and short or SL IUD preferred. Even if side effects such as expulsion, pelvic pains or dysmenorrhea are more frequent by nulliparous, IUD is a first intention choice for contraception to be consider, that women could obtain easily, including in emergency contraception situation. Copyright © 2014 Elsevier Masson SAS. All rights reserved.
Full Text Available Background. Uterine perforation and transvesical migration of an intrauterine device are rare complications. Case. A 28-year-old woman who had an intrauterine device was admitted to our outpatient clinic with complaints of amenorrhea lasting 5 weeks and pelvic pain lasting a year. Transvaginal ultrasonography revealed embedding of the intrauterine device in the bladder. The misplaced device was removed by laparotomy. Conclusion. The followup of intrauterine device localization with transvaginal ultrasonography is essential for early detection of possible serious complications.
Patil, Eva; Bednarek, Paula H
Placement of an intrauterine device (IUD) immediately after a first or second trimester surgical abortion is safe and convenient and decreases the risk of repeat unintended pregnancy. Immediate postabortion IUD placement is not recommended in the setting of postprocedure hemorrhage, uterine perforation, infection, or hematometra. Otherwise, there are few contraindications to IUD placement following surgical abortion. Sexually transmitted infection screening should follow US Centers for Disease Control and Prevention guidelines. No additional antibiotics are needed beyond those used for the abortion. Placing immediate postabortion IUDs makes highly-effective long-acting reversible contraception more accessible to women. Copyright © 2015 Elsevier Inc. All rights reserved.
Baker, William D; Pierce, Stuart R; Mills, Anne M; Gehrig, Paola A; Duska, Linda R
To assess the endometrial response rates to treatment with the levonorgestrel intrauterine device in post-menopausal women with atypical hyperplasia/endometrial intraepithelial neoplasia and grade 1 endometrioid (AH/EC) endometrial carcinoma who are not surgical candidates. Chart review was undertaken of patients with AH/EC who underwent levonorgestrel intrauterine device insertion by a gynecologic oncologist within two academic health systems between 2002 and 2013. When available, tissue blocks were evaluated with immunohistochemical staining for progesterone receptor expression. A total of 41 patients received treatment for AH/EC with the levonorgestrel intrauterine device. Follow up sufficient to assess response occurred in 36 women (88%). Complete response was documented in 18 of 36 women (50%), no response in 8 patients (22%), partial response in 3 women (8%) and progression of disease in 7 patients (19%). Four of 18 patients with complete response (22%) later experienced relapse of hyperplasia or cancer. Four patients (10%) died during the study period: none had evidence of metastatic disease and 1 of the 4 woman died of perioperative complications following hysterectomy for stage I disease. Patients responding to treatment had significantly lower progesterone receptor expression on post-treatment biopsies. Intrauterine levonorgestrel is a viable treatment option for post-menopausal women with AH/EC who are poor candidates for standard surgical management. The response rate in this series is similar to published reports in premenopausal patients and includes cases of disease recurrence following conversion to benign endometrium. Copyright © 2017 Elsevier Inc. All rights reserved.
Kimble-Haas, S L
The worldwide popularity and usage of intrauterine devices (IUDs) plummeted in the 1970s, when grim reports of septic abortions and pelvic inflammatory disease were published. Although the Dalkon Shield ultimately was determined to be the culprit for these problems, the reputation of all IUDs was damaged, and their popularity spiraled downward. The stigma continues, despite the proven safety and efficacy of newer IUDs, particularly the ParaGard T 380A and the Progestasert, which are now the only two IUDs approved for use in the United States. This article will review how the IUD works and will focus on dispelling the misconceptions surrounding its use. Rigid patient-selection guidelines and strict aseptic insertion techniques can provide safe, long-term, cost-effective, and highly efficacious contraception for monogamous women. Practitioners who follow these guidelines should not fear prescribing IUDs as a contraceptive device in the appropriate female population.
This study aimed to evaluate the feasibility of conducting a randomized controlled trial of postpartum intrauterine device insertion and to demonstrate that the postpartum intrauterine device is acceptable to women. Women attending prenatal care at a maternity hospital in Lilongwe, Malawi were recruited into a trial ...
Chai, Wei; Zhang, Wenlei; Jia, Guifeng; Cui, Miao; Cui, Lifeng
Abstract Rationale: Displacement of an intrauterine contraceptive device (IUD) is a rare and serious complication of IUD insertion. Theoretically, it can migrate to anywhere in the pelvic and abdominal cavity. However, it is not usual for an IUD to migrate to the bladder. Patient concerns: In this case report, we reported a patient with chronic urinary symptoms caused by the migration of an IUD into the bladder. The displacement of the IUD led to contraception failure and IUD retention in the bladder for 5 years. Diagnoses: Pelvic ultrasonography (US), radiography, and cystoscopy examinations confirmed the migration of IUD in bladder. Interventions: The patient underwent cystoscopy. Outcomes: The MCu IUD was successfully removed without any complications. Lessons: Our study demonstrated that a missing IUD should be followed up and removed early to avoid possible serious complications. PMID:28984781
Full Text Available Objective: To investigate a level of knowledge about intrauterine device between females who were examined in our gynecology department. Metods: The study was conducted at Gynecology and Obstetric Department of Bakirkoy Dr. Sadi Konuk Teaching and Research Hospital between August 2012-November 2012. The study were included 189 patients who accepted to participate. For collecting data; a form of questionnaire was used which has gived information about the intrauterine device (IUD and status of socio-demographic characteristics of the patients. The questionnaire were administered by the researchers in a separate room as a face-to-face interviews. SPSS 20.0 (SPSS Inc, Chicago, IL, USA program was used for statistical analysis. Results: The mean age of the women in the study was 31.1 ± 9.9. 44.7% of women were not using any modern contraceptive method. IUD utilization rate was 3.2%. 1.6% of women had never heard IUD, %76.1 women heard copper IUD. 42% of respondents gave the wrong answer to IUD inserted into ovaries. Conclusion: The IUD which is a cheap, does not require patient compliance, and has high efficacy. In this study, we were not found a statisfically significant difference for answers to questions in patients with different socio-demographic characteristics. The main result of the study was; among all parcipitians ,even health care workers there was an important disability about level of knowledge for IUD. It is great importance the whole society, including health professionals must train about family planning. [Cukurova Med J 2013; 38(3.000: 440-445
Full Text Available Anita L Nelson,1 Natasha Massoudi2 1Department of Obstetrics and Gynecology, Los Angeles BioMedical Research Institute at Harbor-UCLA Medical Center, David Geffen School of Medicine at UCLA, Torrance, CA, USA; 2American University of the Caribbean School of Medicine, Cupecoy, Sint Maarten Abstract: Many more women in the US today rely upon intrauterine devices (IUDs than in the past. This increased utilization may have substantially contributed to the decline in the percentage of unintended pregnancies in the US. Evidence-based practices have increased the number of women who are medically eligible for IUDs and have enabled more rapid access to the methods. Many women enjoy freedom to use IUDs without cost, but for many the impact of the Affordable Care Act has yet to be realized. Currently, there are three hormonal IUDs and one copper IUD available in the US. Each IUD is extremely effective, convenient, and safe. The newer IUDs have been tested in populations not usually included in clinical trials and provide reassuring answers to older concerns about IUD use in these women, including information about expulsion, infection, and discontinuation. On the other hand, larger surveillance studies have provided new estimates about the risks of complications such as perforation, especially in postpartum and breastfeeding women. This article summarizes significant features of each IUD and provides a summary of the differences to aid clinicians in the US and other countries in advising women about IUD choices. Keywords: copper intrauterine device, levonorgestrel intrauterine systems, noncontraceptive benefits, same-day/quick start initiation, safety, bleeding patterns, placement pain, medical eligibility
Neumann, Dana A; Graversen, Joseph A; Pugh, Suzanne K
The intrauterine device is a popular form of long-acting reversible contraception. Although generally safe, one of the most serious complications of intrauterine device use is uterine perforation. Risk factors for perforation include position of the uterus, force exerted during intrauterine device insertion, postpartum period, and breastfeeding. This case is important and needs to be reported because it highlights the need to assess risk factors for uterine perforation. It adds to the medical literature because it examines the relationship between position of the uterus and the location of uterine perforation. This case report is unusual in that it describes the mechanism and specific location of uterine perforation in relation to the position of the uterus. We present a case of an intrauterine device found in the omentum of a 30-year-old white postpartum woman with a significantly retroverted uterus after the intrauterine device threads were not visualized on speculum examination during a 6-week placement check. The intrauterine device was located and removed via laparoscopy without complication. This case report will be of interest to women's health practitioners because it illustrates the importance of identifying patients with risk factors for uterine perforation, examining the relationship between uterine position and location of perforation. This is especially significant because the true incidence of perforation may be higher than the numbers reported in the literature. There is no specific diagnostic code for uterine perforation and it is unlikely that retrospective studies can accurately identify all cases.
Rowlands, Sam; Oloto, Emeka; Horwell, David H
Uterine perforation is an uncommon complication of intrauterine device insertion, with an incidence of one in 1,000 insertions. Perforation may be complete, with the device totally in the abdominal cavity, or partial, with the device to varying degrees within the uterine wall. Some studies show a positive association between lactation and perforation, but a causal relationship has not been established. Very rarely, a device may perforate into bowel or the urinary tract. Perforated intrauterine devices can generally be removed successfully at laparoscopy. PMID:29386934
Full Text Available Piotr Zolnierczyk, Krzysztof Cendrowski, Wlodzimierz Sawicki Department of Obstetrics, Gynecology and Oncology, 2nd Faculty of Medicine, Medical University of Warsaw, Warsaw, Poland Abstract: This report describes the case of a 29-year-old patient, female (nulliparous who had an intrauterine device (IUD inserted in 2010 and who has had no gynecological control since then (for 4 years. After this time, the asymptomatic patient had a gynecological appointment, during which a doctor did not find the strings of IUD in the speculum. Ultrasound examination did not reveal the presence of the IUD in the uterine cavity, which led to the suspicion of its presence outside the uterus. The patient was referred to a hospital, where she underwent ultrasound and X-ray examination of the pelvis that confirmed the presence of the IUD outside the uterus. Laparoscopy was performed during which the IUD was localized as being embedded in the omentum. It was removed by performing a resection of a part of the omentum with inflammatory infiltration. The patient was discharged home on the second postoperative day in a good condition. This case confirms the need for gynecological control and ultrasound examination shortly after insertion. An ultrasound or/and X-ray is mandatory in any case of absence of IUD strings previously visible in the vagina, if the patient did not observe its expulsion. Keywords: intrauterine device, myometrium, IUD threads, uterine cavity, ultrasound examination
Ortiz, M E; Croxatto, H B; Bardin, C W
The major effect of all intrauterine devices (IUD) is to induce a local inflammatory reaction in the endometrium whose cellular and humoral components are released into the uterine cavity. This inflammatory reaction has a variable effect on the reproductive strategy of the species studied. For example, this foreign body reaction can be localized within the uterus of rodents; and in farm animals it can have striking extrauterine effects. Thus, the action of IUDs in humans cannot be discerned from animals. In humans, copper ions released from Cu-IUDs enhance the inflammatory response and reach concentrations in the luminal fluids of the genital tract that are toxic for spermatozoa and embryos. In women using the IUD, the entire genital tract seems affected, at least in part, because of luminal transmission of the fluids that accumulates in the uterine lumen. This affects the function or viability of gametes, decreasing the rate of fertilization and lowering the chances of survival of any embryo that may be formed, even before it reaches the uterus. Studies on the recovery of eggs from women using IUDs and from women not using contraception show that embryos are formed in the tubes of IUD users at a much lower rate compared with nonusers. This is believed to be the major action of IUDs. Therefore, the common belief that the major mechanism of action of IUDs in women is through destruction of embryos in the uterus (i.e., abortion) is not supported by the available evidence. In Cu-IUD users, it is likely that few spermatozoa reach the distal segment of the fallopian tube, those that encounter an egg may be in poor condition. Thus, the few eggs that are fertilized have little chance for development and their possibility for survival in the altered tubal milieu become worse as they approach the uterine cavity.
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Contraceptive intrauterine device (IUD) and... Gynecological Therapeutic Devices § 884.5360 Contraceptive intrauterine device (IUD) and introducer. (a) Identification. A contraceptive intrauterine device (IUD) is a device used to prevent pregnancy. The device is...
In conclusion, more effort should be directed to counseling for adherence to the IUD use to ensure longer duration of use. Provision of the levonorgestrel intrauterine system which reduces bleeding and dysmenorrhoea, in our clinic may increase the continuation rate of IUD. Key words; IUD, duration of use, discontinuation, ...
Goldthwaite, Lisa M; Sheeder, Jeanelle; Hyer, Jennifer; Tocce, Kristina; Teal, Stephanie B
An intrauterine device placed immediately following a delivery can serve as an effective and safe contraceptive strategy in the postpartum period. There is limited evidence that the levonorgestrel intrauterine system may have a higher rate of expulsion compared to the copper intrauterine device; however, rates of expulsion for these 2 intrauterine device types have not been compared directly. We sought to compare expulsion rates by 12 weeks' postpartum for the levonorgestrel intrauterine system and copper intrauterine device. We enrolled women who received postplacental intrauterine devices at 2 urban hospitals. Eligible women were ≥18 years old, English- or Spanish-speaking, with singleton vaginal delivery at ≥35 weeks' gestation. Intrauterine devices were inserted within 10 minutes of placental delivery by trained providers using ring forceps or the operator's hand. Intrauterine device location was evaluated via abdominal ultrasound at 24-48 hours' postpartum, and via transvaginal ultrasound 6 and 12 weeks later, categorizing position of the intrauterine device at the fundus, below the fundus but above the internal os, any part of the intrauterine device below the internal os (partial expulsion), or no intrauterine device visualized. Outcomes included intrauterine device expulsion and method continuation. We used multivariable logistic regression to identify factors associated with expulsion. We enrolled 123 women ages 18-40 years. Of these, 68 (55%) initiated levonorgestrel intrauterine system and 55 (45%) initiated copper intrauterine device. Groups were similar except more copper intrauterine device users were Hispanic (66% vs 38%) and fewer were primiparous (16% vs 31%). Among the 96 (78%) with 12-week follow-up, expulsion was higher for levonorgestrel intrauterine system users (21/55 or 38%) than for copper intrauterine device users (8/41 or 20%) (odds ratio, 2.55; 95% confidence interval, 0.99-6.55; P = .05). At 24 hours' postpartum, there was no
Eichengreen, Courtney; Landwehr, Haley; Goldthwaite, Lisa; Tocce, Kristina
A 27-year-old woman presented for routine examination 1 year after intrauterine device (IUD) placement; strings were not visualized. The device was found to be penetrating through the rectal mucosa. It was removed easily through the rectum during an examination under anesthesia. Perforated IUDs with rectal involvement require thoughtful surgical planning to optimize outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.
Ozgu-Erdinc, A Seval; Tasdemir, Ufuk Goker; Uygur, Dilek; Aktulay, Ayla; Tasdemir, Nicel; Gulerman, H Cavidan
This study aimed to compare the outcome of pregnancies with retained or removed intrauterine devices (IUDs) and the effect of IUD location on pregnancy outcome. In a retrospective cohort study, we searched 27,578 records of women who had CuT380 IUD inserted, and 144 pregnancies with IUD were analyzed. IUDs were removed from 114 patients and retained for 30 patients. The combined risk of adverse pregnancy outcomes (miscarriage, intrauterine fetal death, intrauterine growth retardation, preterm birth and preterm premature rupture of membranes) was 36.8% in the IUD-removed group and 63.3% in the IUD-retained group [p<.01; relative risk (RR)=2.0; 95% confidence interval (CI) 1.3-3.3]. Newborns of the IUD-retained women had significantly lower Apgar scores and significantly higher admission rate to the neonatal intensive care unit (p=.01; RR=10.8; 95% CI 1.04-111.6 and p<.01; RR=4.5; 95% CI 1.5-12.9, respectively). There were more miscarriages and adverse pregnancy outcome when the IUD was retained (16.9% vs. 66.7%) in patients with an IUD in low-lying position (p<.01; RR=3.9; 95% CI 1.8-8.6). Women who conceived with an IUD in place and chose to continue the pregnancy without removing the IUD need close follow-up, as there appears to be higher risk of adverse pregnancy and neonatal outcome. Furthermore, when the IUD is retained in the low-lying position, there is increased risk of miscarriage and adverse pregnancy outcome compared to removal of the IUD. Future randomized controlled studies are needed to determine the outcome of pregnancies with retained or removed IUD. In this study, we have evaluated the IUD location and its effect on pregnancy outcome in women with a retained or removed IUD. This study is the first to investigate the relationship between IUD location and pregnancy outcome in women who conceived with an IUD. We need evidence from a collaborative multicenter randomized trial to answer the question of whether the IUD should be removed in case of
Caddy, Sheila; Yudin, Mark H; Hakim, Julie; Money, Deborah M
Intrauterine devices provide an extremely effective, long-term form of contraception that has the benefit of being reversible. Historically, the use of certain intrauterine devices was associated with increased risk of pelvic inflammatory disease. More recent evidence suggests that newer devices do not carry the same threat; however, certain risk factors can increase the possibility of infection. To review the risk of infection with the insertion of intrauterine devices and recommend strategies to prevent infection. The outcomes considered were the risk of pelvic inflammatory disease, the impact of screening for bacterial vaginosis and sexually transmitted infections including chlamydia and gonorrhea; and the role of prophylactic antibiotics. Published literature was retrieved through searches of PubMed, Embase, and The Cochrane Library on July 21, 2011, using appropriate controlled vocabulary (e.g., intrauterine devices, pelvic inflammatory disease) and key words (e.g., adnexitis, endometritis, IUD). An etiological filter was applied in PubMed. The search was limited to the years 2000 forward. There were no language restrictions. Grey (unpublished) literature was identified through searching the web sites of national and international medical specialty societies. The quality of evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventative Health Care (Table). Recommendations 1. All women requesting an intrauterine device should be counselled about the small increased risk of pelvic inflammatory disease in the first 20 days after insertion. (II-2A) 2. All women requesting an intrauterine device should be screened by both history and physical examination for their risk of sexually transmitted infection. Women at increased risk should be tested prior to or at the time of insertion; however, it is not necessary to delay insertion until results are returned. (II-2B) 3. Not enough current evidence is available
Rowe, Patrick; Farley, Tim; Peregoudov, Alexandre; Piaggio, Gilda; Boccard, Simone; Landoulsi, Sihem; Meirik, Olav
To compare rates of unintended pregnancy, method continuation and reasons for removal among women using the 52-mg levonorgestrel (daily release 20 microg) levonorgestrel IUD (LNG-IUD) or the copper T 380A (TCu380A) intrauterine device. This was an open-label 7-year randomized controlled trial in 20 centres, 11 of which in China. Data on 1884 women with interval insertion of the LNG-IUD and 1871 of the TCu380A were analysed using life tables with 30-day intervals and Cox proportional hazards models. The cumulative 7-year pregnancy rate of the LNG-IUD was 0.5 (standard error 0.2) per 100, significantly lower than 2.5 (0.4) per 100 of the TCu380A, cumulative method discontinuation rates at 7 years were 70.6 (1.2) and 40.8 (1.3) per 100, respectively. Dominant reasons for discontinuing the LNG-IUD were amenorrhea (26.1 [1.3] per 100) and reduced bleeding (12.5 [1.1] per 100), particularly in Chinese women and, for the TCu380A, increased bleeding (9.9 [0.9] per 100), especially among non-Chinese women. Removal rates for pain were similar for the two intrauterine devices (IUDs). Cumulative rates of removal for symptoms compatible with hormonal side effects were 5.7 (0.7) and 0.4 (0.2) per 100 for the LNG-IUD and TCu380A, respectively, and cumulative losses to follow-up at 7 years were 26.0 (1.4) and 36.9 (1.3) per 100, respectively. The LNG-IUD and the TCu380A have very high contraceptive efficacy, with the LNG-IUD significantly higher than the TCu380A. Overall rates of IUD removals were higher among LNG-IUD users than TCu380A users. Removals for amenorrhea appeared culturally associated. The 52-mg LNG-IUD and the TCu380A have very high contraceptive efficacy through 7 years. As an IUD, the unique side effects of the LNG-IUD are reduced bleeding, amenorrhea and symptoms compatible with hormonal contraceptives. Copyright © 2016. Published by Elsevier Inc.
Wildemeersch, Dirk; Goldstuck, Norman; Hasskamp, Thomas; Jandi, Sohela; Pett, Ansgar
Background Long-acting reversible contraceptive (LARC) methods, including intrauterine devices (IUDs) and the contraceptive implant, are considered the best methods for preventing unintended pregnancies, rapid repeat pregnancy, and abortion in young women. An opinion paper of 2012 by the American College of Obstetricians and Gynecologists recommends Mirena and Paragard for use in nulliparous and adolescent women. However, these IUDs are not designed for young women and are not optimal as they often lead to early discontinuation. Objective This article was written with the objective to respond to the urgent need to improve intrauterine contraception as it is likely that the objectives of LARC will not be met without significant improvement of IUD design. Anatomical variations in size and shape of the uterus are not sufficiently considered, producing harm and suffering, which often lead to early removal of the IUD. Proposed problem solving The article describes why IUDs should be revisited to meet the challenge of LARC and proposes how to solve these problems. The opinion statement presented here may be considered provocative but is based on hundreds of women with IUD problems who consult or are referred to the practices of the authors of this article due to the disproportion between the IUD and their small uterine cavity. The solution is simple but requires a revision of the current design of IUDs. One-dimensional (longitudinal) IUDs are likely to be the first option. Framed devices with shortened transverse arm and IUDs which adapt to the width of the given uterus are viewed as second best. Conclusion One of the reasons of the high unintended pregnancy rate in the USA may be the paucity of suitable IUDs. Also, the legal climate in the USA seems to be a problem for developers as many lawsuits have recently been reported. Clinical studies conducted in young nulliparous and adolescent women suggest that IUDs that fit well in the uterine cavity, like a shoe, result in
Full Text Available Dirk Wildemeersch,1 Norman Goldstuck,2 Thomas Hasskamp,3 Sohela Jandi,4 Ansgar Pett4 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Department of Obstetrics and Gynaecology, Faculty of Medicine and Health Sciences, Stellenbosch University and Tygerberg Hospital, Western Cape, South Africa; 3GynMünster, Münster, 4Gynecological Outpatient Clinic, Berlin, Germany Background: Long-acting reversible contraceptive (LARC methods, including intrauterine devices (IUDs and the contraceptive implant, are considered the best methods for preventing unintended pregnancies, rapid repeat pregnancy, and abortion in young women. An opinion paper of 2012 by the American College of Obstetricians and Gynecologists recommends Mirena and Paragard for use in nulliparous and adolescent women. However, these IUDs are not designed for young women and are not optimal as they often lead to early discontinuation. Objective: This article was written with the objective to respond to the urgent need to improve intrauterine contraception as it is likely that the objectives of LARC will not be met without significant improvement of IUD design. Anatomical variations in size and shape of the uterus are not sufficiently considered, producing harm and suffering, which often lead to early removal of the IUD. Proposed problem solving: The article describes why IUDs should be revisited to meet the challenge of LARC and proposes how to solve these problems. The opinion statement presented here may be considered provocative but is based on hundreds of women with IUD problems who consult or are referred to the practices of the authors of this article due to the disproportion between the IUD and their small uterine cavity. The solution is simple but requires a revision of the current design of IUDs. One-dimensional (longitudinal IUDs are likely to be the first option. Framed devices with shortened transverse arm and IUDs which adapt to the width of the given
AJRH Managing Editor
Department of Obstetrics and Gynecology, University of North Carolina at Chapel Hill, Chapel Hill, NC1; UNC Project,. Lilongwe, Malawi2 ... Keywords: Intrauterine Device, IUD, Africa, Malawi, Sub-Saharan Africa, Qualitative Research. Résumé ... factors affecting method choice include individuals' knowledge and beliefs as.
Context: Intrauterine contraceptive devices (IUDs) are commonly used reversible methods of contraception. The CuT 380A is recommended for use for 10 years but common observation has shown that they are removed much earlier than the recommended duration of use. Methodology: A retrospective study of all clients ...
Alfuhaid, T. [Dept. of Medical Imaging, Univ. Health Centre and Mount Sinai Hospital, Toronto General Hospital, Toronto, Ontario (Canada); Reinhold, C. [Radiology, Gastroenterology and Gynecology, McGill Univ. Health Centre, Montreal General Hospital, Montreal, Quebec (Canada)
Pelvic actinomycosis is a rare disease that may complicate longstanding intrauterine device (IUD) use. Its timely recognition is crucial to minimize morbidity and avoid the erroneous diagnosis of malignancy with subsequent, unnecessary surgery. We describe a case of pelvic actinomycosis. The role of magnetic resonance imaging (MRI) in recognizing this infectious disease process is stressed. (author)
Background Missing intrauterine contraceptive device (IUCD) is a known complication of IUCD use. Objective To examine the methods of diagnosis and Management modalities of missing IUCD at the University of Nigeria Teaching Hospital, Enugu. Materials and Method This was a retrospective review of the records of all ...
Background: Use of modern contraceptive methods has been shown to reduce unwanted pregnancy, high parity and maternal mortality. Intrauterine contraceptive devices which are among the safest and most effective reversible contraceptives available, are particularly suitable for women in developing countries as they ...
The copper intrauterine device (IUD) is a safe, long-acting, and effective method of contraception that is under-utilized in many countries, including Malawi. A unique cohort of women who had enrolled in a trial of postpartum IUD use one year earlier gave insights into reasons for using, discontinuing, or not using the IUD.
Modern Copper Intrauterine Devices [Cu IUDs] are extremely safe, highly effective, long acting yet rapidly reversible contraceptives. They are also very cost effective and suitable for use by a wide range of women, including nulliparous as well as HIV infected women. Despite a large body of scientific evidence attesting to its ...
Peleg, David; Latta, Richard
A woman with a viable intrauterine 12-week pregnancy and an intraabdominal levonorgestrel-releasing intrauterine device had the device successfully removed under local anesthesia. The pregnancy continued without complication. The decision to remove an intraabdominal levonorgestrel-releasing intrauterine device during pregnancy remains controversial. Copyright © 2013 Mosby, Inc. All rights reserved.
Dina, Blair; Peipert, Leah J; Zhao, Qiuhong; Peipert, Jeffrey F
Intrauterine devices have been gaining popularity for the past 2 decades. Current data report that >10% of women who use contraception are using an intrauterine device. With intrauterine device is one of the most effective forms of long-acting reversible contraception, yet evidence shows that fear of pain during intrauterine device placement deters women from choosing an intrauterine device as their contraceptive method. The objective of this analysis was to estimate the association between anticipated pain with intrauterine device placement and experienced pain. We also assessed other factors associated with increased discomfort during intrauterine device placement. We hypothesized that patients with higher levels of anticipated pain would report a higher level of discomfort during placement. We performed a secondary analysis of the Contraceptive CHOICE Project. There were 9256 patients enrolled in Contraceptive CHOICE Project from the St. Louis region from 2007-2011; data for 1149 subjects who came for their first placement of either the original 52-mg levonorgestrel intrauterine system or the copper intrauterine device were analyzed in this study. Patients were asked to report their anticipated pain before intrauterine device placement and experienced pain during placement on a 10-point visual analog scale. We assessed the association of anticipated pain, patient demographics, reproductive characteristics, and intrauterine device type with experienced pain with intrauterine device placement. The mean age of Contraceptive CHOICE Project participants in this subanalysis was 26 years. Of these 1149 study subjects, 44% were black, and 53% were of low socioeconomic status. The median expected pain score was 5 for both the levonorgestrel intrauterine system and the copper intrauterine device; the median experienced pain score was 5 for the levonorgestrel intrauterine system and 4 for the copper intrauterine device. After we controlled for parity, history of
Rahnemai-Azar, Amir A; Apfel, Tehilla; Naghshizadian, Rozhin; Cosgrove, John Morgan; Farkas, Daniel T
The intrauterine device (IUD) is a popular family planning method worldwide. Some of the complications associated with insertion of an IUD are well described in the literature. The frequency of IUD perforation is estimated to be between 0.05 and 13 per 1000 insertions. There are many reports of migrated intrauterine devices, but far fewer reports of IUDs which have penetrated into the small intestine. Herein we report a case of perforated intrauterine device embedded in the small intestine. By using a wound protector retraction device, and fashioning the anastomosis extra-corporeally, we were able to more easily perform this laparoscopically. This left the patient with a quicker recovery, and a better cosmetic result. IUD perforation into the peritoneal cavity is a known complication, and necessitates close follow-up. Most, if not all, should be removed at the time of diagnosis. In the majority of previously reported cases, removal was done through laparotomy. Even in cases where removal was attempted laparoscopically, many were later converted to laparotomy. Surgeons should be aware of different techniques, including using a wound protector retraction device, in order to facilitate laparoscopic removal.
Kathpalia, S K; Singh, M K; Grewal, D S
Intrauterine contraceptive device is a popular and effective method of contraception. It can be inserted either as an interval procedure or after abortion or delivery. Threads are attached to the vertical limb so that the user can find out the location of the device. Sometimes the threads are not palpable by the user; this study was conducted to find out the reasons for inability to palpate the threads. The retrospective study was conducted over a period of eight years; 110 female patients who complained of inability to feel the threads were included in the study. In most of the cases the device was in the right place. In four cases the device could not be felt on uterine sounding; this could have been due to subendometrial placement of the device. There was no case of perforation by the device. Inability to feel the threads is a common complaint by the patients who are using intrauterine contraceptive device. In most of the cases the device was in correct position and could be localized by clinical examination. Ultrasonography can help in localization of the device; if used at the time of insertion it can confirm proper insertion and location of the device. This will reassure the client and the health care providers.
Nelson, Anita L; Massoudi, Natasha
Many more women in the US today rely upon intrauterine devices (IUDs) than in the past. This increased utilization may have substantially contributed to the decline in the percentage of unintended pregnancies in the US. Evidence-based practices have increased the number of women who are medically eligible for IUDs and have enabled more rapid access to the methods. Many women enjoy freedom to use IUDs without cost, but for many the impact of the Affordable Care Act has yet to be realized. Currently, there are three hormonal IUDs and one copper IUD available in the US. Each IUD is extremely effective, convenient, and safe. The newer IUDs have been tested in populations not usually included in clinical trials and provide reassuring answers to older concerns about IUD use in these women, including information about expulsion, infection, and discontinuation. On the other hand, larger surveillance studies have provided new estimates about the risks of complications such as perforation, especially in postpartum and breastfeeding women. This article summarizes significant features of each IUD and provides a summary of the differences to aid clinicians in the US and other countries in advising women about IUD choices. PMID:29386944
Bilgehan, Fatma; Dilbaz, Berna; Karadag, Burak; Deveci, Canan Dura
The aim of this study was to compare the safety, bleeding pattern, effects, side-effects, complications and 6-month continuity rates of levonorgestrel-bearing intrauterine system (LNG-IUS) with conventional copper intrauterine device (Cu-IUD) inserted immediately after voluntary termination of pregnancy up to 10 weeks of gestation. One hundred women who underwent voluntary pregnancy termination and preferred IUD insertion as a contraceptive method after counseling were enrolled. The patients were randomly allocated to Cu-IUD or LNG-IUS and followed up at 10 days, and at 1, 3 and 6 months. The expulsion rates, continuation rates, side-effects, and bleeding patterns were compared. Fifty women in the Cu-IUD group and 44 women in the LNG-IUS group were followed up. The continuity and expulsion rate for Cu-IUD and LNG-IUS at the end of 6 months was 74%, 12%, and 75%, 11.3%, respectively. In LNG-IUS users, the incidence of amenorrhea and the number of spotting days were higher and hemoglobin increased throughout the follow-up period. The side-effects related to both methods were not different from interval insertions. Immediate post-abortion intrauterine contraception with Cu-IUD or LNG-IUS is a safe, reliable method. The incidence of side-effects is similar, and there is only a slightly higher rate of expulsion but an acceptable rate of method continuation. © 2015 Japan Society of Obstetrics and Gynecology.
Thompson, Kirsten M J; Rocca, Corinne H; Stern, Lisa; Morfesis, Johanna; Goodman, Suzan; Steinauer, Jody; Harper, Cynthia C
US unintended pregnancy rates remain high, and contraceptive providers are not universally trained to offer intrauterine devices and implants to women who wish to use these methods. We sought to measure the impact of a provider training intervention on integration of intrauterine devices and implants into contraceptive care. We measured the impact of a continuing medical education-accredited provider training intervention on provider attitudes, knowledge, and practices in a cluster randomized trial in 40 US health centers from 2011 through 2013. Twenty clinics were randomly assigned to the intervention arm; 20 offered routine care. Clinic staff participated in baseline and 1-year surveys assessing intrauterine device and implant knowledge, attitudes, and practices. We used a difference-in-differences approach to compare changes that occurred in the intervention sites to changes in the control sites 1 year later. Prespecified outcome measures included: knowledge of patient eligibility for intrauterine devices and implants; attitudes about method safety; and counseling practices. We used multivariable regression with generalized estimating equations to account for clustering by clinic to examine intervention effects on provider outcomes 1 year later. Overall, we surveyed 576 clinic staff (314 intervention, 262 control) at baseline and/or 1-year follow-up. The change in proportion of providers who believed that the intrauterine device was safe was greater in intervention (60% at baseline to 76% at follow-up) than control sites (66% at both times) (adjusted odds ratio, 2.48; 95% confidence interval, 1.13-5.4). Likewise, for the implant, the proportion increased from 57-77% in intervention, compared to 61-65% in control sites (adjusted odds ratio, 2.57; 95% confidence interval, 1.44-4.59). The proportion of providers who believed they were experienced to counsel on intrauterine devices also increased in intervention (53-67%) and remained the same in control sites (60
Turok, David K; Leeman, Lawrence; Sanders, Jessica N; Thaxton, Lauren; Eggebroten, Jennifer L; Yonke, Nicole; Bullock, Holly; Singh, Rameet; Gawron, Lori M; Espey, Eve
Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast-feeding outcomes. This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast-feeding outcomes. We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast-feed, spoke English or Spanish, were aged 18-40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4-12 weeks' postpartum. Prespecified exclusion criteria included delivery feeding. We conducted per-protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent-to-treat analysis. We powered the study for the primary outcome, breast-feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast-feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70-86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76-91%). The 5% difference in breast-feeding continuation at 8 weeks between the
Eggebroten, Jennifer L; Sanders, Jessica N; Turok, David K
In-hospital placement of intrauterine devices and contraceptive implants following vaginal and cesarean delivery is increasingly popular and responds to maternal motivation for highly effective postpartum contraception. Immediate postpartum intrauterine device insertion is associated with higher expulsion than interval placement, but emerging evidence suggests that the levonorgestrel intrauterine device may have a higher expulsion rate than the copper intrauterine device. This study evaluated in-hospital provision, expulsion, and 6-month continuation of immediate postpartum copper T380 intrauterine devices, levonorgestrel intrauterine devices, and contraceptive implants. We offered enrollment in this prospective observational trial to women presenting to the University of Utah labor and delivery unit from October 2013 through February 2016 who requested an intrauterine device or implant for postpartum contraception during prenatal care or hospitalization at the time of delivery. Following informed consent, participants completed questionnaires prior to hospital discharge and at 3 and 6 months postpartum. Data on expulsions at 6 months were validated by chart abstraction. During the study period, 639 patients requested a postpartum intrauterine device or implant and 350 patients enrolled in prospective follow-up prior to discharge from the hospital. Among enrollees, 325 (93%) received their preferred contraceptive device prior to hospital discharge: 88 (27%) copper intrauterine device users, 123 (38%) levonorgestrel intrauterine device users, and 114 (35%) implant users. Participants predominantly were Hispanic (90%), were multiparous (87%), reported a household income device recipients (89%) completed follow-up. Among levonorgestrel intrauterine device users 17% reported expulsions relative to 4% of copper intrauterine device users. The adjusted hazard ratio for expulsion was 5.8 (confidence interval, 1.3-26.4). There was no statistically significant difference in
Sonalkar, Sarita; Kapp, Nathalie
Given new research on postpartum placement of levonorgestrel and copper intrauterine devices (IUDs), our objective was to update a prior systematic review of the safety and expulsion rates of postpartum IUDs. We searched MEDLINE, CENTRAL, LILACS, POPLINE, Web of Science, and ClinicalTrials.gov databases for articles between the database inception until July 2013. We included studies that compared IUD insertion time intervals and routes during the postpartum period. We used standard abstract forms and the United States Preventive Services Task Force grading system to summarise and assess the quality of the evidence. We included 18 articles. New evidence suggests that a levonorgestrel releasing-intrauterine system (LNG-IUS) insertion within 48 hours of delivery is safe. Postplacental insertion and insertion between 10 minutes and 48 hours after delivery result in higher expulsion rates than insertion 4 to 6 weeks postpartum, or non-postpartum insertion. Insertion at the time of caesarean section is associated with lower expulsion rates than postplacental insertion at the time of vaginal delivery. This review supports the evidence that insertion of an intrauterine contraceptive within the first 48 hours of vaginal or caesarean delivery is safe. Expulsion rates should be further studied in larger randomised controlled trials.
Kaislasuo, Janina; Heikinheimo, Oskari; Lähteenmäki, Pekka; Suhonen, Satu
To assess the relationship of preinsertion vaginal ultrasound assessment and menstrual and gynecologic history as predictors of difficult or painful intrauterine device insertion in nulligravid women. Nulligravid women seeking contraception were invited to participate in this nonrandomized study and given the choice between the levonorgestrel-releasing intrauterine system or a copper-releasing intrauterine device. All 165 enrolled women were interviewed and a pelvic examination, including vaginal ultrasonography, was performed before insertion. Insertion difficulties and pain intensity were recorded and assessed against uterine measurements and background characteristics. Most insertions were assessed as easy (n=144 [89.4%]) and only two (1.2%) failed. Most women had uterine measurements smaller than the studied devices. Odds for difficulties at insertion decreased with every increasing millimeter in total uterine length (odds ratio [OR] 0.86, 95% confidence interval [CI] 0.78-0.96, P=.006) and cervical length (OR 0.85, 95% CI 0.74-0.97, P=.02) and similarly with every decreasing degree of (straighter) flexion angle (OR 0.96, 95% CI 0.94-0.99, P=.005). No absolute threshold measurements could be determined. Still, the majority of insertions in small and flexed uteri were uneventful. Severe insertion pain was common (n=94 [58.4%]). Severe dysmenorrhea was the only predictor of insertion pain (OR 8.16 95% CI 2.56-26.02, P<.001). Ultrasonographic evaluation does not give additional information compared with clinical pelvic examination and sound measure. Although smaller uterine length measurements and steeper flexion angle more often predicted difficulties, the majority of insertions were uneventful in women with small measures. Dysmenorrhea was the only predictor of pain. ClinicalTrials.gov, www.clinicaltrials.gov, NCT01685164. II.
Kallat, Adil; Ibrahimi, Ahmed; Fahsi, Otheman; El Sayegh, Hachem; Iken, Ali; Benslimane, Lounis; Nouini, Yassine
The intrauterine device (IUD) is the most common contraceptive method used in the world. Transuterine migration is a rare complication, accounting for 1/350 - 1/10000 insertions in the literature. We report the case of a 40-year old patient, who had had an IUD insertion 12-year before, presenting with pelvic and right lower back pain associated with intermittent hematuria and burning during urination. Radiological assessment showed calcific deposits on intra bladder IUD. The patient underwent cystostomy, without any difficulty, allowing stone and IUD extraction. A urinary catheter was left in place for 5 days and then withdrawn. The postoperative course was uneventful.
Abdulwahab-Ahmed, Abdullahi; Ogunleye, Oluwagbemiga Olabisi
Intravesical migration of intrauterine contraceptive device (IUCD) is rare. Early diagnosis of this rare entity is difficult because of its non-specific manifestations and very low index of suspicion. We present this case of bladder stone following intravesical migration of IUCD found to have been missing since insertion 10 years earlier. Lower abdominal discomfort and a missing vaginal string may be the only pointer to this unfortunate event in the immediate post insertion period. It is pertinent to consider the possibility of an intravesical migration of a missing IUCD in a patient presenting with lower abdominal discomfort, urinary frequency, and missing IUCD string on vaginal examination. PMID:24470853
A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study.
Lin, Xiaona; Wei, Minling; Li, T C; Huang, Qiongxiao; Huang, Dong; Zhou, Feng; Zhang, Songying
To compare the efficacy of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of the adhesion reformation after hysteroscopic adhesiolysis for Asherman's syndrome. Retrospective cohort study of 107 women with Asherman's syndrome who were treated with hysteroscopic division of intrauterine adhesions. After hysteroscopic adhesiolysis, 20 patients had intrauterine balloon inserted, 28 patients had intrauterine contraceptive device (IUD) fitted, 18 patients had hyaluronic acid gel instilled into the uterine cavity, and 41 control subjects did not have any of the three additional treatment measures. A second-look hysteroscopy was performed in all cases, and the effect of hysteroscopic adhesiolysis was scored by the American Fertility Society classification system. Both the intrauterine balloon group and the IUD group achieved significantly (Pintrauterine balloon or intrauterine device is more effective than the use of hyaluronic acid gel in the prevention of intra-uterine adhesion reformation. Crown Copyright © 2013. Published by Elsevier Ireland Ltd. All rights reserved.
Averbach, Sarah H; Ma, Yifei; Smith-McCune, Karen; Shiboski, Stephen; Moscicki, Anna B
Previous studies have shown a decrease in cervical cancer associated with intrauterine device use. It has been hypothesized that intrauterine device use may alter the natural history of human papillomavirus infections, preempting development of precancerous lesions of the cervix and cervical cancer, but the effect of intrauterine devices on the natural history of human papillomavirus infection and subsequent development of cervical cancer is poorly understood. The purpose of this study was to evaluate the association between intrauterine device use and cervical high-risk human papillomavirus acquisition and clearance. This is a prospective cohort study conducted from October 2000 through June 2014 among 676 sexually active young women and girls enrolled from family planning clinics in San Francisco, CA. Data were analyzed using a Cox proportional hazards model, including time-varying indicators of intrauterine device use, and adjusting for fixed and time-dependent predictor variables. A total of 85 women used an intrauterine device at some time during follow-up. Among 14,513 study visits, women reported intrauterine device use at 505 visits. After adjusting for potential behavioral confounders, there was no association between intrauterine device use and human papillomavirus acquisition (hazard ratio, 0.50; 95% confidence interval, 0.20-1.23; P = .13) or clearance of human papillomavirus infection (hazard ratio, 1.44; 95% confidence interval, 0.76-2.72; P = .26). Current intrauterine device use is not associated with acquisition or persistence of human papillomavirus infection. Intrauterine device use is safe among women and girls with human papillomavirus infections and at risk for human papillomavirus acquisition. Intrauterine device use may play a role further downstream in the natural history of cervical cancer by inhibiting the development of precancerous lesions of the cervix in human papillomavirus-infected women, or enhancing clearance of established
Fulkerson Schaeffer, Sandy; Gimovsky, Alexis C; Aly, Hany; Mohamed, Mohamed A
Pregnancy with intrauterine device in place is rare and there are limited data that exist regarding associated perinatal outcomes. The objective of this study is to determine the association between presence of an intrauterine device during pregnancy and spontaneous abortion, induced abortion, and preterm or small for gestational age delivery outcomes. The National Inpatient Sample database was analyzed for the years 2010 and 2011. Maternal records with an intrauterine device in situ during delivery were identified using International Classification of Diseases, Ninth Revision, diagnostic codes. Primary outcome was incidence of spontaneous abortion. Secondary outcomes were incidence of induced abortion, preterm delivery, and small for gestational age. Data were analyzed using Chi-square and Fisher's exact tests to calculate odds ratios (ORs) of abortion in association with intrauterine device in situ during pregnancy. Maternal birth records were further analyzed for adverse neonatal outcomes using logistic regression models, controlling for possible confounding variables. The data included 8,597,284 maternal birth records; 0.02% with an intrauterine device in situ. Patients with an intrauterine device in situ experienced a higher frequency of the pregnancy ending in spontaneous abortion (OR: 7.15; 95% confidence interval (CI): 5.06-10.09; p intrauterine device in place. Adjusted odds ratio for preterm delivery among women with an intrauterine device in situ was 2.04 (95% CI: 1.71-2.43; p intrauterine device, and adjusted odds ratio for delivery of a small for gestational age infant among intrauterine device cohort was 0.56 (95% CI: 0.34-0.92; p = .022), after controlling for associated demographic and clinical variables. The presence of an intrauterine device in situ during pregnancy was associated with increased spontaneous and induced abortions, and increased incidence of delivery of a preterm, but not small for gestational age infant.
Sano, Masayuki; Nemoto, Kaoru; Miura, Takafumi; Suzuki, Yasutomo
Background: An intrauterine device is commonly used for contraception globally. Although intrauterine device placement is an effective and safe method of contraception, migration into the bladder with stone formation is a rare and serious complication. The management approaches for an intrauterine device embedded in the bladder include endoscopic procedures and open surgical removal. In this study, we report the case of a patient with recurrent urinary tract infection associated with intrauterine device migration and urolithiasis, who successfully underwent endoscopic treatment combined with laser fragmentation. Case Presentation: A 22-year-old woman presented to our hospital with a 1-month history of lower abdominal pain, hematuria, and pain on urination. Transvaginal ultrasound showed a hyperechoic lesion in the bladder. A plain abdominal radiograph showed the presence of a T-shaped intrauterine device with calculus formation in the pelvis. CT revealed a vesical stone fixed to the top of the bladder wall, and there was no vesicovaginal fistula formation. She had undergone intrauterine device insertion several years previously. Cystoscopy confirmed the diagnosis. She underwent endoscopic lithotripsy, and the intrauterine device was extracted from the bladder wall. Repair of the bladder wall and disappearance of symptoms were confirmed. Conclusion: Endoscopic treatment combined with laser fragmentation of stones surrounding a migrated intrauterine device should be considered as a minimally invasive approach, which can be performed safely.
Boyon, C; Giraudet, G; Guérin Du Masgenêt, B; Lucot, J-P; Goeusse, P; Vinatier, D
Intrauterine device insertion is common. It is however not harmless and uterine perforation can be serious. Eleven cases of uterine perforation after intrauterine device insertion were listed at Tourcoing hospital between 2005 and 2009. They were analyzed to identify risk factors of uterine perforation and specify management. The main symptom was pelvic pain (4 cases), pregnancy occurrence (3 cases) or inability to remove the IUD (2 cases). The intrauterine device was set during the first 9 months of post-partum in 7 cases, 2 patients were still breastfeeding. Seven patients underwent laparoscopy, 2 needed switch for laparotomy, one was treated by laparotomy only and one was lost of follow-up. Incidence of uterine perforation after IUD insertion ranges from 0,1 to 3/1000. Pelvic pain is the most revealing symptom. Fifteen percent of perforations complicate with adjacent organ lesion. Perforation incidence seems greater if the intrauterine device is set during the 6 first weeks of post-partum and breastfeeding, but non influenced by operator practical experience. Ultrasound follow-up of patients carrying intrauterine device is controversial. Facing a suspicion of ectopic intrauterine device, pelvic ultrasound examination is the first step imaging modality and using 3D could be useful. If it fails to localize the intrauterine device, an abdominal X-ray must be performed. Ectopic intrauterine device removal is recommended. Copyright © 2012 Elsevier Masson SAS. All rights reserved.
OBJECTIVE: To estimate the acceptance rate and trend of Intrauterine Contraceptive Device (IUCD) use in Enugu,Nigeria PATIENTS AND METHODS: A review of all new acceptors of intrauterine contraceptive device (IUCD) over a nine year period(1999-2007) . RESULTS: A total of 133,375 clients were seen at the UNTH ...
Farr, G; Rivera, R
This paper is a reassessment of earlier findings from a preliminary analysis of data from a multicenter international trial regimen on breast-feeding and non-breast-feeding women in which events related to insertion, expulsion, and removal of the TCu-380A intrauterine contraceptive device (ParaGard 380) were investigated. Performance of the TCu-380A through 12 months after insertion was compared with life-table rate analysis, chi 2, Fisher exact test, or Student's t test. Variables were events reported during intrauterine contraceptive device insertion and events throughout the 12 months of study participation by breast-feeding status. Breast-feeding among intrauterine contraceptive device users was associated with fewer insertion-related complaints and lower removal rates for bleeding and pain. No uterine perforations were reported throughout the study. Differences in the performance of the TCu-380A intrauterine contraceptive device suggest physiologic effects associated with lactational amenorrhea. The TCu-380A intrauterine contraceptive device is a viable option for women breast-feeding at the time of intrauterine contraceptive device insertion.
Lara Ricalde, Roger; Menocal Tobías, Gerardo; Ramos Pérez, Carlos; Velázquez Ramírez, Norma
To evaluate safety and effectiveness of the intrauterine device Multiload Cu375 compared with the TCu 380A inserted in the postpartum period. In a randomized comparative study carried out in the National Perinatology Institute, intrauterine devices MLCu 375 and Tcu 380A were inserted to 157 patients who voluntary accepted, and previously signed informed consent. There were four instances for the intrauterine devices insertion: within 10 minutes after vaginal delivery, during cesarean section (immediate postplacental insertion) and postpartum-postcesarean insertion (in the time range of 10 min to 48 h). All insertions were made with ring forceps. From 1 h to 24 h later, abdominal ultrasound examinations were performed to assess the distances between the upper part of the device to the fundus of uterine cavity. Follow up visits were scheduled at 3, 6, 9 and 12 months. Net cumulative life table event rates of discontinuations were estimated at one year. The expulsion rates were 10.4 for the MLCu 375 and 7.7 for the TCu 380A and they were not influenced by the moment of the intrauterine device insertion, not by the cervical dilatation, neither by the distance of the intrauterine device to the fundus of uterine cavity. The removal rates for bleeding and pain were 4.9 and 4.8, the removal rates for non medical reasons were 3.7 and 4.9 respectively. There was one case of genital infection in the MLCu 375 group. There were no pregnancies, nor uterine perforation. The one year continuation rates were 77.1 and 82.6 respectively. There were no statistical significant differences in the comparative rates. The intrauterine device MLCu 375 is as safe and effective as the TCu380A when they are inserted in the postpartum period.
Penney, Gillian; Brechin, Susan; de Souza, Alison; Bankowska, Urszula; Belfield, Toni; Gormley, Maggie; Olliver, Mary; Hampton, Naomi; Howlett-Shipley, Ruth; Hughes, Sarah; Mack, Noel; O'Brien, Paul; Rowlands, Sam; Trewinnard, Karen
This Guidance provides information for clinicians providing women with copper-bearing intrauterine devices as long-term contraception. A key to the grades of recommendations, based on levels of evidence, is given at the end of this document. Details of the methods used by the Clinical Effectiveness Unit (CEU) in developing this Guidance and evidence tables summarising the research basis of the recommendations are available on the Faculty website (www.ffprhc.org.uk). Abbreviations (in alphabetical order) used include: acquired immune deficiency syndrome (AIDS); actinomyces-like organisms (ALOs); automated external defibrillator (AED); blood pressure (BP); British National Formulary (BNF); confidence interval (CI); copper-bearing intrauterine contraceptive device (IUD); emergency contraception (EC); Faculty Aid to Continuing Professional Development Topic (FACT); levonorgestrel-releasing intrauterine system (IUS); human immunodeficiency virus (HIV); Medicines and Healthcare products Regulatory Agency (MHRA); non-steroidal antiinflammatory drugs (NSAIDs); odds ratio (OR); pelvic inflammatory disease (PID); relative risk (RR); Royal College of Obstetricians and Gynaecologists (RCOG); Scottish Intercollegiate Guidelines Network (SIGN); sexually transmitted infection (STI); termination of pregnancy (TOP); World Health Organization (WHO); WHO Medical Eligibility Criteria (WHOMEC); WHO Selected Practice Recommendations (WHOSPR).
Tian, Kuan; Xie, Changsheng; Xia, Xianping
To reduce such side effects as pain and bleeding caused by copper-containing intrauterine device (Cu-IUD), a novel medicated intrauterine device, which is coated with an indomethacin (IDM) delivery system on the surface of copper/low-density polyethylene (Cu/LDPE) composite intrauterine device, has been proposed and developed in the present work. The IDM delivery system is a polyelectrolyte multilayer film, which is composed of IDM containing chitosan and alginate layer by layer, is prepared by using self-assembled polyelectrolyte multilayer method, and the number of the layers of this IDM containing chitosan/alginate multilayer film can be tailored by controlling the cyclic repetition of the deposition process. After the IDM containing chitosan/alginate multilayer film is obtained on the surface of Cu/LDPE composite intrauterine device, its release behavior of both IDM and cupric ion has been studied in vitro. The results show that the release duration of IDM increase with the increasing of thickness of the IDM containing chitosan/alginate multilayer film, and the initial burst release of cupric ion cannot be found in this novel medicated Cu/LDPE composite IUD. These results can be applied to guide the design of novel medicated Cu-IUD with minimal side effects for the future clinical use. Copyright © 2013 Elsevier B.V. All rights reserved.
Full Text Available Background. Actinomycosis is a rare slowly progressive infection caused by Gram-positive anaerobic bacteria from the genus Actinomyces. The disease is characterized by the formation of the abscesses surrounded by dense fibrosis that extend slowly across natural anatomic boundaries.Patients and methods. The case of a 49-year-old patient with pelvic actinomycosis associated with an intrauterine device is presented. The patient was successfully treated with the combination of antibiotic and surgical therapy.Conclusions. Pelvic actinomycosis is a rare disorder. The infection may occur as a consequence of an abdominal disease or an ascending infection from the genito-urinary tract. Diagnosis of the actinomycosis can be difficult, malignant disease if often suspected. The diagnosis is frequently not established until after surgery.
A medical device is any product used to diagnose, cure, or treat a condition, or to prevent disease. They ... may need one in a hospital. To use medical devices safely Know how your device works. Keep ...
Implantable Electronic Medical Devices provides a thorough review of the application of implantable devices, illustrating the techniques currently being used together with overviews of the latest commercially available medical devices. This book provides an overview of the design of medical devices and is a reference on existing medical devices. The book groups devices with similar functionality into distinct chapters, looking at the latest design ideas and techniques in each area, including retinal implants, glucose biosensors, cochlear implants, pacemakers, electrical stimulation t
Valenzuela, Reuben M; Rai, Ruju; Kirk, Brian H
Because of a previous association of pseudotumor cerebri (PTC) with levonorgestrel, we wished to evaluate the use of levonorgestrel-eluting intrauterine devices ("levonorgestrel intrauterine systems", LNG-IUS) in our University of Utah and Rigshospitalet PTC patients. In our retrospective series...
Krasniqi, Salih; Ahmeti, Elvis; Hoxha, Sejdullah A; Ymeri, Halit; Shaqiri, Ismet; Kastrati-Spahija, Nexhmije B; Krasniqi, Avdyl S
Intrauterine devices are often accompanied by various complications, of which the uterine perforation constitutes the most dangerous one. We present a case of a 41-year-old woman complaining of right upper quadrant pain. She had an intrauterine device inserted 12 years earlier without regular follow-up. Abdominal plain X-ray revealed the intrauterine device trans-located into the right subdiaphragmal area. Abdominal ultrasound showed gallbladder stones without any other sonographic pathologic finding. Patient underwent simultaneous laparoscopic cholecystectomy and removal of the intrauterine device from the right subdiaphragmal area. Laparoscopy is an appropriate method for removal of intrauterine device translocated to the right subdiaphragmatic region.
Straub, T; Reynaud, M; Yaron, M
Intrauterine device (IUD) is a reliable contraceptive method that is long term reversible, and well tolerated. Numerous studies prove its efficiency and report rare complications that are attributed to it. However, its use is limited due to fear that it can cause a pelvic inflammatory disease (PID). This is based on historical data on infections related to the "Dalkon Shield", which was removed from the market in 1974. The analyzed articles were extracted from PUBMED database between 2000 and 2016. In total, 22 studies were retained. A meta-analysis was not possible due to the methodological diversity among the selected articles contributing to this narrative review of the literature. After analysis, the following factors influence the risk of PID linked to IUDs: an advanced age and sexually transmitted infections. The risk of PID linked to IUDs is lower than 1%. This is explained by new models of IUD, better screening tests, more frequent follow-up of the patients and the improvement of care PID patients. In the light of our results, the threat of pelvic inflammatory disease should not hinder the use of IUDs. Copyright © 2018 Elsevier Masson SAS. All rights reserved.
Jatlaoui, Tara C; Marcus, Michele; Jamieson, Denise J; Goedken, Peggy; Cwiak, Carrie
To determine whether postplacental intrauterine device (IUD) insertion can be safely and effectively performed within a teaching program. This was a prospective cohort of 177 subjects planning vaginal delivery enrolled antenatally who desired postplacental IUD insertion of either the copper T380A IUD or levonorgestrel IUS. Insertions were performed primarily by resident physicians following a training session. Follow-up included a 4- to 8-week visit and telephone calls at 3 and 6 months. Ninety-nine subjects underwent successful postplacental IUD insertion of 100 attempts. Seventeen expulsions (17%) were noted: 10 complete and 7 partial. The study identified no differences in outcome by training level; however, the study lacked statistical power to evaluate anything other than large differences. Postplacental IUD insertions can be safely and effectively performed within a training program. A training protocol may safely and feasibly be initiated among physicians, advanced practice clinicians or trainees with no prior experience with postplacental IUD insertion. By initiating this practice, access to highly effective contraception may increase for patients who have difficulty returning for a visit or otherwise receiving effective methods. © 2014.
Aleknaviciute, Jurate; Tulen, Joke H M; De Rijke, Yolanda B; Bouwkamp, Christian G; van der Kroeg, Mark; Timmermans, Mirjam; Wester, Vincent L; Bergink, Veerle; Hoogendijk, Witte J G; Tiemeier, Henning; van Rossum, Elisabeth F C; Kooiman, Cornelis G; Kushner, Steven A
The levonorgestrel-releasing intrauterine device (LNG-IUD) is currently recommended as a first-line contraceptive with an exclusively local intrauterine influence. However, recent clinical trials have identified side effects of LNG-IUD that appear to be systemically mediated, including depressed mood and emotional lability. We performed two experimental studies and a cross-sectional study. For each study, women were included from three groups: LNG-IUD (0.02mg/24h), oral ethinylestradiol/levonorgestrel (0.03mg/0.15mg; EE30/LNG) and natural cycling (NC). Study 1-Salivary cortisol was measured at baseline and at defined intervals following the Trier Social Stress Test (TSST). Heart rate was monitored continuously throughout the TSST. Study 2-Salivary cortisol and serum total cortisol were evaluated relative to low-dose (1μg) adrenocorticotropic hormone (ACTH) administration. Study 3-Hair cortisol was measured as a naturalistic index of long-term cortisol exposure. Women using LNG-IUD had an exaggerated salivary cortisol response to the TSST (24.95±13.45 nmol/L, 95% CI 17.49-32.40), compared to EE30/LNG (3.27±2.83 nmol/L, 95% CI 1.71-4.84) and NC (10.85±11.03nmol/L, 95% CI 6.30-15.40) (P<0.0001). Heart rate was significantly potentiated during the TSST in women using LNG-IUD (P=0.047). In response to ACTH challenge, women using LNG-IUD and EE30/LNG had a blunted salivary cortisol response, compared to NC (P<0.0001). Women using LNG-IUD had significantly elevated levels of hair cortisol compared to EE30/LNG or NC (P<0.0001). Our findings suggest that LNG-IUD contraception induces a centrally-mediated sensitization of both autonomic and hypothalamic-pituitary-adrenal (HPA) axis responsivity. LNG-IUD sensitization of HPA axis responsivity was observed acutely under standardized laboratory conditions, as well as chronically under naturalistic conditions. Copyright © 2017 Elsevier Ltd. All rights reserved.
Sohn, Myung Hee; Jeong, Hwan Jeong; Lim, Seok Tae [Chonbuk National University Medical School, Jeonju (Korea, Republic of)
A 44-year-old female underwent three-phase bone scintigraphy for an evaluation of right hip joint pain. The blood-flow and blood-pool images show a pelvic blush with a photopenic center (doughnut) prior to bladder filling. On the three hour delayed image, the pelvic uptake disappeared. The scintigraphic findings indicated the possibility of an early pregnancy. However, plain radiography demonstrated an intrauterine device. A uterine doughnut developed as a result of photon attenuation of intrauterine device.
Full Text Available A number of complications are reported with the use of intrauterine contraceptive devices. These may pursue asymptomatic course or present as an acute abdomen after migration into peritoneal cavity. The authors here are reporting an abdominal wall swelling caused by transuterine migration of a copper intrauterine contraceptive device in a 28-year-old female. An open approach was used, and impacted foreign body was retrieved.
Sanders, Jessica N; Turok, David K; Gawron, Lori M; Law, Amy; Wen, Lonnie; Lynen, Richard
As the popularity of long-acting reversible contraception increases, so does the need for accurate data on method continuation in diverse clinical settings. We determined 2-year continuation rates for the levonorgestrel 52-mg intrauterine device, the copper T380A intrauterine device, and the 68-mg etonogestrel contraceptive implant in an academic healthcare system with mixed-payer reimbursement. The purpose of this study was to examine the proportion and characteristics of women who continue intrauterine device and implant use to 2 years and to relate continuation to device type when controlling for patient characteristics. This retrospective chart review assessed University of Utah Healthcare System patients who had an intrauterine device or contraceptive implant inserted between January 1, 2004, and December 31, 2012. We identified users and dates of insertions and removals by querying billing, medication, and procedural data in the Electronic Data Warehouse. Multivariable Poisson regression was conducted to estimate incidence risk ratios and to relate the probability of 2-year continuous use to device type. Data on 8603 device insertions were obtained with the following distribution: levonorgestrel 52-mg intrauterine devices (6459; 75.1%), copper T380A intrauterine devices (1136; 13.2%), and 68-mg etonogestrel implant (1008; 11.7%). Two-year continuation rates were 77.8%, 73.1%, and 75.9%, respectively. There was no statistical difference in 2-year continuation between levonorgestrel 52-mg intrauterine device users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0-1.1) and 68-mg etonogestrel implant users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0-1.1) compared with copper device users, after we controlled for age, Hispanic ethnicity, payer type, and year of insertion. Older-age, self-pay, or public payer insurance (reference commercial payer) and Hispanic ethnicity were associated with 2-year continuation. Three-quarters of women with an
Weerasekera, Amila; Wijesinghe, Pravin; Nugaduwa, Nilhan
The intrauterine device is a form of contraception with a long duration of action and few systemic side effects. Migration into the abdominal cavity may occur early or years after insertion giving rise to bowel obstruction, perforation, ischemia, mesenteric injury, strictures or fistulae. Colocolic fistula formation is a rare but serious complication of intrauterine device migration, which may lead to difficulties in diagnosis and device retrieval. We report the case of a 29-year-old Sri Lankan woman who became pregnant 5 years after intrauterine device insertion. The device could not be located during pregnancy. She was asymptomatic and defaulted follow up during the antenatal period. She had an uncomplicated vaginal delivery. A subsequent laparotomy for device retrieval failed due to technical difficulties. A repeat laparotomy identified a sigmoid colocolic fistula with adhesions to the fallopian tube. The device was removed and colonic defects primarily closed following which the patient made an uneventful recovery. All translocated intrauterine devices should be removed regardless of type and location. This case illustrates that they may cause complex bowel lesions leading to serious technical difficulties during retrieval. With the increasing use of minimally invasive approaches for intrauterine device retrieval, a low threshold for open surgery in complicated cases is advocated.
Kumar, Somesh; Sethi, Reena; Balasubramaniam, Sudharsanam; Charurat, Elaine; Lalchandani, Kamlesh; Semba, Richard; Sood, Bulbul
Postpartum intrauterine contraceptive devices (PPIUCD) are increasingly included in many national postpartum family planning (PPFP) programs, but satisfaction of women who have adopted PPIUCD and complication rates need further characterization. Our specific aims were to describe women who accepted PPIUCD, their experience and satisfaction with their choice, and complication of expulsion or infection. We studied 2,733 married women, aged 15-49 years, who received PPIUCD in sixteen health facilities, located in eight states and the national capital territory of India, at the time of IUCD insertion and six weeks later. The satisfaction of women who received IUCD during the postpartum period and problems and complications following insertion were assessed using standardized questionnaires. Mean (SD) age of women accepting PPIUCD was 24 (4) years. Over half of women had parity of one, and nearly one-quarter had no formal schooling. Nearly all women (99.6%) reported that they were satisfied with IUCD at the time of insertion and 92% reported satisfaction at the six-week follow-up visit. The rate of expulsion of IUCD was 3.6% by six weeks of follow-up. There were large variations in rates of problems and complications that were largely attributable to the individual hospitals implementing the study. Women who receive PPIUCD show a high level of satisfaction with this choice of contraception, and the rates of expulsion were low enough such that the benefits of contraceptive protection outweigh the potential inconvenience of needing to return for care for that subset of women.
Colwill, Alyssa Covelli; Schreiber, Courtney A; Sammel, Mary D; Sonalkar, Sarita
We sought to evaluate the 6-week clinical outcomes (intrauterine device [IUD] retention, recognized expulsions, ability to visualize or palpate strings, and need for ultrasound evaluation) in women who received a TCu380A postplacental IUD (PPIUD) after vaginal (VD) or cesarean delivery (CD). We conducted a retrospective cohort study to examine the 6-week retention of TCu380A IUDs placed within 10 min of placental delivery in VD (n=137) and CD (n=73). We used Student's t test and Wilcoxon rank sum tests for continuous data and Pearson χ 2 test and Fisher's Exact Test for categorical data. Of the 169 women who had follow-up, 151 (89.3%) retained their IUD at 6 weeks (95% CI 84.7%-93.9%). All women who underwent CD retained their IUD at 6 weeks postpartum (56/56), whereas 95/113 (84% [95% CI 76.0%-90.3%]) who underwent VD retained their original IUD (p<.01). Strings were detected more frequently in women who had a VD (93.1% [95% CI 85.6-97.4]) compared to those who delivered by CD (44.2% [95% CI 30.5-58.7]; p<.01). Women who underwent CD had an ultrasound to evaluate IUD location more frequently (42.9% [95% CI 29.7-56.8]) compared to women who underwent VD (13.7% [95% CI 7.5-22.3]; p<.01). Women are more likely to retain a PPIUD after CD compared to a VD (p<.01); however, women who have a PPIUD placed after CD are more likely to have nonvisible strings with a pelvic exam (p<.01) and undergo pelvic ultrasound evaluation (p<.01) compared to a PPIUD placed at the time of a VD. Copyright © 2017 Elsevier Inc. All rights reserved.
Bailey, Amelia P; Darracott, Mixon M
Patients using an intrauterine device (IUD) who require a loop electrosurgical excision procedure (LEEP) for cervical dysplasia have traditionally had the IUD removed prior to the procedure. The only other options have been methods that lead to suboptimal sampling or risk cutting the strings. Our study suggests a procedure for performing the LEEP without removing the IUD, and review of the literature suggests that this method has not been reported before. The LEEP is performed using a conization electrode or a cone biopsy excisor. After noting that the IUD strings are of adequate length, a 0-polyglactin free tie is secured around the visible portion of the IUD strings without applying tension on the strings. A large, sterile absorbent-tipped applicator with a hollow handle becomes an 8 cm hollow plastic tube by removing the cotton tip with sterile scissors. The long end of the suture is threaded through the sterile tube. Without pulling on the IUD, the tube is then passed over the strings into the cervical canal approximately 2.5 cm to protect the strings from the excisor well into the cervical canal. Then, the LEEP is performed. After the specimen is removed, hemostasis can be obtained using a ball cautery electrode, keeping the protecting tube with the enclosed IUD strings out of the way. The tube is then carefully removed. The suture is now cut close to the polyglactin knot around the IUD strings, making certain not to shorten the IUD strings and making certain the visible length of the strings is the same as before the procedure. Ferric subsulfate is applied to the operative area to provide continued hemostasis. Follow-up for the LEEP is unchanged. This procedure may be performed on either levonorgestrel-releasing or copper IUDs. Copyright 2010 Mosby, Inc. All rights reserved.
Madden, Tessa; Cortez, Sarah; Kuzemchak, Marie; Kaphingst, Kimberly A; Politi, Mary C
Intrauterine devices (IUDs) are highly effective methods of contraception, but use continues to lag behind less effective methods such as oral contraceptive pills and condoms. Women who are aware of the actual effectiveness of various contraceptive methods are more likely to choose the IUD. Conversely, women who are misinformed about the safety of IUDs may be less likely to use this method. Individuals increasingly use the Internet for health information. Information about IUDs obtained through the Internet may influence attitudes about IUD use among patients. Our objective was to evaluate the quality of information about IUDs among World Wide Web sites providing contraceptive information to the public. We developed a 56-item structured questionnaire to evaluate the quality of information about IUDs available through the Internet. We then conducted an online search to identify web sites containing information about contraception and IUDs using common search engines. The search was performed in August 2013 and web sites were reviewed again in October 2015 to ensure there were no substantial changes. Our search identified >2000 web sites, of which 108 were eligible for review; 105 (97.2%) of these sites contained information about IUDs. Of sites, 86% provided at least 1 mechanism of the IUD. Most web sites accurately reported advantages of the IUD including that it is long acting (91%), highly effective (82%), and reversible (68%). However, only 30% of sites explicitly indicated that IUDs are safe. Fifty percent (n = 53) of sites contained inaccurate information about the IUD such as an increased risk of pelvic inflammatory disease beyond the insertion month (27%) or that women in nonmonogamous relationships (30%) and nulliparous women (20%) are not appropriate candidates. Among sites, 44% stated that a mechanism of IUDs is prevention of implantation of a fertilized egg. Only 3% of web sites incorrectly stated that IUDs are an abortifacient. More than a quarter of
Aoun, Joelle; Dines, Virginia A; Stovall, Dale W; Mete, Mihriye; Nelson, Casey B; Gomez-Lobo, Veronica
To conduct an analysis of intrauterine device (IUD)-related outcomes including expulsion, contraceptive failure, and early discontinuation and to compare these outcomes in regard to age, parity, and IUD type. This was a multicenter retrospective chart review of adolescents and women aged 13-35 years who had an IUD inserted for contraception between June 2008 and June 2011. A total of 2,523 patients' charts were reviewed. Of these, 2,138 patients were included in our analysis. After a mean follow-up of 37±11 months, the overall rates of IUD expulsion and pregnancy were 6% and 1%, respectively, and were not significantly different by age or parity. Intrauterine device discontinuation rates were 19% at 12 months and 41% after a mean follow-up of 37 months. Despite similar rates of IUD discontinuation between age groups at 12 months of use, teenagers and young women aged 13-19 years were more likely to request early discontinuation at the end of the total follow-up period. No significant difference was noted in pelvic inflammatory disease rates (2%) based on age. After adjusting for age and parity, we found that copper IUD users were more likely to experience expulsion and contraception failure compared with levonorgestrel intrauterine system users (hazard ratios 1.62, 95% confidence interval [CI] 1.06-2.50 and hazard ratios 4.89, 95% CI 2.02-11.80, respectively). Similar to adults, IUD use in adolescents and nulliparous women is effective and associated with low rates of serious complications. Health practitioners should therefore consider IUDs for contraception in all females. Teenagers and young women are more likely to request premature discontinuation of their IUDs and may benefit from additional counseling.
João Henrique Araújo Fernandes
Full Text Available Objective: To evaluate the relation of postplacental intrauterinedevice insertion immediately after vaginal delivery and cesareansection and its effects on the following: continuation, expulsionrate and eventual removals. To verify if ultrasound is an adequatemethod to follow-up postplacental IUD insertions. To assess if theimmediate insertion of postplacental IUD leads to an increasedrisk of uterine infections and perforations, or greater likelihood ofpregnancy during the observation period. Methods: A group of 50patients who had an intrauterine device introduced within tenminutes after delivery of the placenta were studied. Twenty-fivewomen had vaginal delivery and 25 had cesarean sections. Theintrauterine device used in this study was the Multiload CU 375,standard model, manufactured by Organon Ltd., in Ireland. Theintrauterine device was inserted in those who had vaginal deliveryeither manually and under anesthesia, or with an inserter, whichdid not require anesthesia. In patients who had cesarean sections,the insertion was manual. Clinical and ultrasound follow up wasperformed four times: 48 hours postpartum, and at 6, 12 and 24weeks. The distance from the top of the intrauterine device to theuterine fundus was measured by ultrasound. Results: This studyshowed a significant difference in postplacental intrauterinedevices inserted after vaginal deliveries and cesarean sections.The expulsion/removal rate was 32% among the subjects who hadan intrauterine device inserted after vaginal delivery. There wereno expulsions or removals in those submitted to cesarean sections.In the control ultrasound of intrauterine devices inserted aftervaginal delivery, at 6 weeks, the distance of 10 mm from the top ofthe device to the fundus was an average standard measurementto determine continuation (distance 10 mm,the IUD would be expelled or be removed. There were no cases ofuterine infections or perforations, and no pregnancies during thecourse of this study
Galgon, Richard E
The purpose of this article is to provide a structural and functional understanding of the systems used for the regulation of medical devices in the USA and European Union (EU). Safe and effective anesthesia care depends heavily on medical devices, including simple, low risk devices to complex life-supporting and life-sustaining devices. In the USA and EU, the Food and Drug Administration and European Commission, respectively, provide regulatory oversight to ensure medical devices are reasonably safe and effective when used for their intended purposes. Unfortunately, practicing anesthesiologists generally have little or no understanding of how medical devices are regulated, nor do they have sufficient knowledge of available adverse event reporting systems. The US and EU medical device regulatory systems are similar in many ways, but differ in important ways too, which impacts the afforded level of safety and effectiveness assurance. In both systems, medical devices are classified and regulated on a risk basis, which fundamentally differs from drug regulation, where uniform requirements are imposed. Anesthesia providers must gain knowledge of these systems and be active players in both premarket and postmarket activities, particularly with regard to vigilance and adverse event/device failure reporting.
Parker, S E; Jick, S S; Werler, M M
To determine the association between intrauterine device (IUD) use, timing of removal prior to pregnancy, and the risk of pre-eclampsia. A case-control study within the Clinical Practice Research Datalink, UK. Medical record database in the UK. Cases of pre-eclampsia (n = 2744) were identified among pregnancies resulting in singleton deliveries from 1993 to 2010. Four controls, or pregnancies unaffected by pre-eclampsia, were matched to each case on maternal age, general practice, and year of delivery. Data on IUD use were obtained from patient records. The odds ratios (ORs) for the association between IUD and pre-eclampsia were adjusted for covariates identified a priori, and analyses were stratified by BMI and number of prior deliveries. Odds ratios (95% confidence intervals, 95% CIs) of pre-eclampsia in pregnancies among women with a history of IUD use, compared with women without a history of IUD use. Prior IUD use was associated with a reduced risk of pre-eclampsia (OR 0.76; 95% CI 0.58-0.98). The timing of removal in relation to the start of pregnancy showed an inverse association, with shorter intervals associated with a larger decrease in risk of pre-eclampsia. IUD removal within a year prior to pregnancy had an OR of 0.68 (95% CI 0.46-1.00). Among women with a prior delivery, the association between IUD use and pre-eclampsia was null. Intrauterine device use is associated with a small decreased risk of pre-eclampsia, specifically if removed within the year prior to conception. A case-control study of pregnancies in the UK suggests a reduced risk of pre-eclampsia for former IUD users. © 2015 Royal College of Obstetricians and Gynaecologists.
Patchen, Loral; Berggren, Erica K
This report contributes to limited empirical data regarding use of the Copper T380A intrauterine device among adolescent mothers. We conducted a retrospective case series of adolescent mothers aged 15 to 21 years whose index delivery occurred before age 18 and met study inclusion criteria. All adolescent mothers received obstetrics and gynecology care at one urban clinical site in Washington, DC. All participated in a teen secondary pregnancy prevention program from April 2002 to November 2008 and used the Copper T380A intrauterine device. We abstracted data to evaluate intrauterine device utilization, expulsion, removal, and pregnancy diagnosis. Thirty-nine adolescent mothers met inclusion criteria. Six patients had partial or complete expulsion (15%; 95% CI, 6-29), and 10 requested removal (26%; 95% CI, 14-41) within 24 months of placement. Four users (10%; 95% CI, 3-23) became pregnant. Three had an intrauterine device in place at time of conception, while one became pregnant due to unrecognized device expulsion. In this case series, many adolescent mothers discontinued Copper T380A use within two years of placement. The numbers of patients were too limited to provide stable estimates of contraceptive effectiveness. Larger comparative studies will further evaluate both effectiveness and acceptability of this device among teen mothers. Copyright © 2011 North American Society for Pediatric and Adolescent Gynecology. Published by Elsevier Inc. All rights reserved.
Insausti Jaca, N; Urresola Olabarrieta, A; Ibáñez, S; Atilano Santos, L; Aguinaga Alexanco, A; Larrea Bilbao, L
Uterovesical perforation is an uncommon complication in patients with intrauterine devices (IUD). When this complication occurs, intravesical lithiasis is often associated. We present two cases of uterovesical perforation with a description of the radiological findings and a review of the literature.
Nobiling, Brandye; Drolet, Judy C.
Intrauterine devices (IUDs) have not been popular contraceptives in the US for the past 40 years. Recent evidence, however, has shown a slight rebirth in use, from a rate of approximately 2% in 2002 to over 5% in 2008 (Guttmacher Institute, 2010). Empirical evidence is favorable of IUD use in most women, but the still-low usage rate suggests…
Lethaby, A E; Cooke, I; Rees, M
Heavy menstrual bleeding (HMB) is an important cause of ill health in women and it accounts for 12% of all gynaecology referrals in the UK. Heavy menstrual bleeding is clinically defined as greater than, or equal to, 80mls blood loss per menstrual cycle but women may complain of excessive bleeding when their blood loss is less than 80ml. Hysterectomy is often used to treat women with this complaint but medical therapy may be a successful alternative. The intrauterine coil device was originally developed as a contraceptive but the addition of uterine relaxing hormones, or progestogens, to these devices resulted in a large reduction in menstrual blood loss. Case studies of 2 types of progesterone/progestogen releasing systems, Progestasert and Mirena, report reductions of up to 90% and dysmenorrhoea may be improved. Insertion, however, may be regarded as invasive by some women affecting its acceptability as a treatment and frequent intermenstrual bleeding and spotting is likely during the first few months. To determine the effectiveness and acceptability of progesterone/progestogen-releasing intrauterine devices in achieving a reduction in heavy menstrual bleeding. All studies which might describe randomised controlled trials of progesterone/progestagen-releasing intrauterine devices for the treatment of heavy menstrual bleeding were obtained by electronic searches of the MEDLINE 1966-1999, EMBASE 1980-1999 databases and the Cochrane Library. Companies producing progestogen releasing intrauterine devices and experts in the field were contacted for information on published and unpublished trials. Randomised controlled trials in women of reproductive age treated with progesterone/progestogen-releasing intrauterine devices versus no treatment, placebo, or other medical or surgical therapy for heavy menstrual bleeding within either the primary care, family planning or specialist clinic setting were eligible for inclusion. Women with postmenopausal bleeding
Wu, S; Hu, J; Wu, M
To observe the clinical performances of the new intrauterine device (IUD)-GyneFix IN. The present study is a randomized comparative clinical trial. 607 healthy parous women were randomly allocated into GyneFix IN group (n = 302) or TCu 380A group (n = 305). IUD was inserted during the menstrual interval by the trained investigators. Follow-up were arranged at 1, 3, 6 and 12 months after insertion. The discontinuation rates were calculated by life table method. At the end of the first year, there was no pregnancy occurred in GyneFix IN group. Its expulsion rate and removal rate for medical reasons were 2.67 and 1.02 per 100 women respectively. The use-related discontinuation rates was 3.66, which was significantly lower than that in the TCu 380A group (7.88, P < 0.05). The number of women with complaint of pain was also less in GyneFix IN group. The excellent performance of the new IUD which is a frameless device with high copper surface and anchoring system was confirmed by this multicentre trial. Due to lower expulsion rate and less side effect of pain, it could be recommended.
Full Text Available Intrauterine contraceptive device (IUCD is the commonest form of contraception used in view of less systemic side effects. However, there are a multitude of local complications caused by it. Of all the local complications described, migration of the device into adjacent organs is the most morbid of all complications. A patient presenting with history of loss or disappearance of the intrauterine contraceptive device accompanied by urinary symptoms should raise the doubt of a migrated device with the formation of a secondary calculus. This prompts further radiological investigations and merits surgical intervention either endourologically or by open surgery depending upon the merits of the case. A case report elucidating this fact is presented.
Bryant, Amy G; Kamanga, Gift; Stuart, Gretchen S; Haddad, Lisa B; Meguid, Tarek; Mhango, Chisale
This study aimed to evaluate the feasibility of conducting a randomized controlled trial of postpartum intrauterine device insertion and to demonstrate that the postpartum intrauterine device is acceptable to women. Women attending prenatal care at a maternity hospital in Lilongwe, Malawi were recruited into a trial comparing immediate (10 minutes to 48 hours) to 6 week postpartum insertion. Feasibility of recruiting and consenting 140 women and randomizing 70% of them was evaluated. Satisfaction with the intrauterine device was also assessed. One hundred fifteen women consented and 49 (61%) were randomized. Twenty-six women were assigned to immediate insertion, and 23 to insertion at 6 weeks postpartum. Thirty (24%) women received the device as part of the study protocol, and 28 (93%) had the device in place at 12 weeks postpartum. The intrauterine device is acceptable to some postpartum women in Malawi, but conducting a randomized clinical trial may not be feasible.
Cai, Huihua; Qiao, Lin; Song, KaiJing; He, Yuanli
To compare the efficacy of an oxidized, regenerated cellulose adhesion barrier (Interceed; Ethicon, Somerville, NJ) combined with an intrauterine device (IUD) versus an IUD alone for preventing adhesion recurrence following hysteroscopic adhesiolysis for moderate to severe intrauterine adhesions (IUAs). Retrospective case series (Canadian Task Force classification III). Tertiary care teaching hospital. Patients undergoing treatment for moderate to severe IUAs. The severity of IUA was determined based on the American Fertility Society scoring system (mild, moderate, or severe). All cases of hysteroscopic adhesiolysis were reviewed. Seventy-six women with moderate to severe IUAs treated between March 2009 and August 2015 were included. After hysteroscopic adhesiolysis, 35 patients were treated with an IUD alone (group 1), and 41 patients were treated with Interceed plus an IUD (group 2). A second hysteroscopy was performed in all cases three months after the initial hysteroscopy and both groups achieved significant reduction in adhesion scores and grade, especially in group 2 (scores, p < .001; grade, p = .039). Compared with group 1, menstruation dysfunction, pregnancy rate, and live birth rate in group 2 improved with no statistical difference (menstruation improvement, p = .764; pregnancy rate, p = .310; live birth rate, p = .068). However, an adhesion-free uterine cavity was regained significantly owing to the fewer operations in group 2 compared with group 1 (median, 3 vs 4; p = .001). The interval from initial hysteroscopy to conception was significantly shorter in group 2 (median, 12 months vs 51 months; p < .001). For moderate to severe IUAs, Interceed combined with an IUD may be an alternative approach for reducing adhesion recurrence after hysteroscopic adhesiolysis. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.
Simonatto, Paula; Bahamondes, Maria Valeria; Fernandes, Arlete; Silveira, Carolina; Bahamondes, Luis
To assess if there is a difference in the characteristics of the women who expelled a copper-intrauterine device (TCu-IUD) or the levonorgestrel-releasing intrauterine system (LNG-IUS) and the frequency of expulsions over different periods of observation. We retrospectively analyzed 19 697 medical charts of women consulting between January 1980 and December 2013 who requested a TCu-IUD or a LNG-IUS. The medical records of 17 644 Cu-IUD and 2053 LNG-IUS users returning to the clinic for a follow-up visit after insertion of an IUC were reviewed. Of these, 1532 Cu-IUD and 254 LNG-IUS parous users were found to have expelled the IUC for a first time. The mean age at insertion (± standard deviation) was 26.3 ± 6.6 years (range 16-49) for Cu-IUD users and 31.7 ± 7.6 years (range 18-48) for LNG-IUS users (P < 0.001). A total of 263 (13.4%) and 12 (4.3%) of the Cu-IUD and the LNG-IUS users were ≤19 years old, and 49.1% and 54.1% of the expulsions among the Cu-IUD and LNG-IUS users, respectively, were reported in the first six months after placement. A regression model showed that the variables significantly associated with an expulsion of either a Cu-IUD or LNG-IUS were age < 25 years, less than two deliveries and using a Cu-IUD. Our findings showed that the characteristics associated with IUC expulsion were age under 25 years, having had less than two deliveries and being users of Cu-IUD. © 2016 Japan Society of Obstetrics and Gynecology.
The present invention relates to a medical delivery device comprising at least two membrane electrode assembly units each of which comprises three layers: an upper and a lower electrode and a selective ionic conductive membrane provided there-between. At least one of the three layers are shared...
IUCD) that was discovered incidentally in the course of evaluation for secondary infertility in a woman who denied knowledge of insertion of the device. The IUCD was easily retrieved at cystoscopy as a day case procedure. Key Words ...
Intrauterine contraceptive devices (IUDs) are a popular method of contraception worldwide. However, some serious problems have been associated with them. Finland has developed and now manufactures and exports IUDs. Therefore, drug control and the quality of drug information existing in Finland are significant for other countries, as well. This study analyzes the information in the Finnish commercial drug catalog on copper-releasing IUDs and compares it with the scientific literature, the instructions from the licensing authority, and material in its U.S. counterpart, during the last two decades. The results indicate that the distribution of scientific knowledge to the drug catalogs has often been slow. In the early 1980s Finnish manufacturers did not give any practical information on their products, and then and later the Finnish catalog was less comprehensive than the U.S. catalog. The variations in the control system in different nations were reflected in the contents of the Finnish catalog. For practitioners, drug catalogs are important sources of medical information. The results of this study demonstrate (1) that more attention should be paid to the contents of these catalogs, and (2) the continuous need for up-to-date, unbiased drug information.
Nilsson, O; Hagenfeldt, K
Biopsies were taken from 3 healthy controls and 4 women who had used the Copper TCu device to determine the influence of the IUD on the secretory mechanism of the uterine epithelium. The normal endometrium possessed apical protrusions containing glycogen and its degradation products. Endometrial biopsies from women with an intrauterine Tatum-T device with copper had these protrusions infrequently. The reduction in apical protrusions was the one structural difference observed between control and TCu-influenced luminal epithelium. This finding might support the view that one effect of the TCu device is to interfere with the secretion of carbohydrates by the epithelium.
Introduction to Medical Device RequirementsIntroductionThe ChallengesSources of ErrorsUnderstanding the Science of Safety Overview of FDA Quality System Regulation Overview of Risk Management Standard ISO 14971 Overview of FDA Device Approval Process Overview of Regulatory Requirements for Clinical TrialsSummaryReferencesPreventing Recalls during Specification WritingIntroductionConduct Requirements Analysis to Identify Missing RequirementsSpecifications for Safety, Durability, and
van Grootheest, Kees; Sachs, Bernhardt; Harrison-Woolrych, Mira; Caduff-Janosa, Pia; van Puijenbroek, Eugene
Background: Levonorgestrel-releasing intrauterine devices (LNG-IUD) are commonly used for contraception and other indications in many countries. National pharmacovigilance centres have been receiving reports from healthcare professionals and patients of uterine perforation associated with the use of
Bourdrez, Petra; Bongers, Marlies Y.; Mol, Ben W. J.
OBJECTIVE: To investigate patient preferences for endometrial ablation and a levonorgestrel-releasing intrauterine device (IUD) as alternatives to hysterectomy in the treatment of dysfunctional uterine bleeding. DESIGN: Comparative study based on structured interviews. SETTING: A large teaching
Jiménez, Mirela F; Passos, Eduardo P; Fagundes, Paulo A P; de Freitas, Fernando M; Arbo, Elisangela; Cunha-Filho, João S L
During this cohort study, the copper-intrauterine device (IUD) did not modify subendometrial microvascularization. However, subendometrial blood flow increased in patients who experienced IUD-induced side effects.
Yaprak Engin Üstün
Full Text Available The intrauterine devices (IUDs have been used widely by women of childbearing years. In this report, we presented a case of a 25-year-old gravida 4, parity 3 woman with an abdominal wall penetration by an IUD. She had an IUD (TCu-380A inserted immediately after dilatation & curettage. The IUD was removed laparoscopically.
Full Text Available Though intrauterine contraceptive device (IUCD is a safe and most frequently used long-term contraceptive method, it has some complications. Uterine perforation and intra-abdominal migration have been reported often, but a retroperitoneal migration is exceptional. Here, we are reporting an IUCD which perforated the uterus and migrated to the retroperitoneum; impinging into and obstructing left ureter causing severe hydroureteronephrosis due to the development of the left lower ureteric stricture.
Full Text Available The presence of an intrauterine device (IUD within the colon is rare. Complications have been reported with IUDs among which uterine perforation. Translocation of IUDs to the uterine cavity, to the bladder and also through the wall of the bowel, and sigmoid colon has been reported. We believe there may be a case that surgeons should know the result of despite being a priori gynaecological complication. This paper reports on a case of colon perforation by an IUD.
Tosun, Migraci; Celik, Handan; Yavuz, Erhan; Çetinkaya, Mehmet B.
The intrauterine device (IUD) is common method of contraception among women because of its low cost and high efficacy. Perforations are possible; most perforations occur at the time of insertion, yet the complication can occur with a previously inserted IUD. Perforation of the bladder by an IUD is extremely rare. In this report, we present a case in which the IUD perforated the uterus and migrated to the bladder. At the time of the diagnosis, the patient was 8 weeks pregnant. PMID:20944794
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Zhou, Xin-Xin; Yu, Mo-Sang; Gu, Meng-Li; Zhong, Wei-Xiang; Wu, Hong-Ru; Ji, Feng; Pan, Hang-Hai
Intrauterine contraceptive devices (IUDs) are recommended as a means of contraception. Translocation of IUD is a rare and serious complication. Colonic inflammatory mass caused by translocated IUD initially misdiagnosed as a colonic polyp is extremely rare and has not been reported yet. This report presents a case of sigmoid colon translocation of intrauterine device on a 37-year-old female patient. Colonoscopy was performed due to her complain of repeated blood in stools and subsequently the patient was misdiagnosed as a sigmoid colon polyp. Nonetheless, the "polyp" was not able to be removed endoscopically. Sigmoid colon translocation of an intrauterine device. To further clarify the diagnosis, computed tomography (CT) scan was performed and the "polyp" was confirmed to be caused by a translocated IUD. The translocated IUD was removed easily by surgery, and the patient recovered soon after the operation. The present case indicates that an annual gynaecologic examination is necessary to determine the position of the IUD, and a CT examination may help confirm an ectopic IUD.
Full Text Available Infection with genital herpes simplex virus (HSV remains a common viral sexually transmitted disease, often subclinical and a major worldwide problem of women of reproductive age group. Herpes cervicitis is an unusual presentation of Herpes simplex virus infection in females. The finding of herpes cervicitis on routine pap smear of an asymptomatic woman on Intrauterine contraceptive device still further supports the need for increased awareness on the possibility of Herpes simplex virus infection among women, particularly those on Intrauterine contraceptive device. The index case is a 28 years old Nigerian female who was referred to our Special Treatment Clinic on account of an abnormal pap smear cytology which was in keeping with Herpes cervicitis. There was no history of genital ulcer in this patient; however ELISA for HSV 2 IgM was positive in her. We therefore describe a case of herpes cervicitis in an asymptomatic woman on intrauterine contraceptive device. This case highlights to clinicians the need to be aware of the possibility of this association and to carry out relevant investigations so as to identify and treat these patients appropriately. Therefore, there is a need to put in place adequate public health intervention strategy to prevent genital herpes in women of reproductive age group with a view to preventing the possibility of congenital herpes in subsequent pregnancy.
De Silva, W S L; Kodithuwakku, K A S U A; Aponsu, G U E; Rathnayake, R M M; Rajasegaram, E
A wide variety of complications due to the extrauterine migration of intrauterine contraceptive devices have been reported in the literature. Here we describe the case of a large bladder stone formed around a migrated Copper T380A device that was neglected and detected 15 years after insertion. A 48-year-old Sri Lankan woman underwent a workup for lower urinary tract symptoms and recurrent urinary tract infections over the previous 6 months. The radiographs showed a large bladder stone with an imprint of an intrauterine contraceptive device in the center of it. The device had been inserted 15 years previously. Two years after the insertion, it was considered to be missing, but our patient did not comply with the recommended follow-up. She had been completely asymptomatic until she developed lower urinary tract symptoms. After confirming the location of the stone via ultrasonography, a vesicolithotomy was performed, revealing a stone with three limbs corresponding to the shape of the Copper T380A device. The device and the threads were fully covered with the stone material. Our patient was asymptomatic following the surgery. A migrated intrauterine contraceptive device can act as the nidus for the formation of a secondary bladder stone. The detailed imprint of the device inside the stone and the laminated appearance of the stone material were characteristic of a secondary bladder stone formed around an intrauterine contraceptive device. Radiography and ultrasonography are adequate for the diagnosis of intravesical migration of intrauterine contraceptive devices.
Column D details the expulsions after reinsertion, and column E shows the details of cases in which it was necessary to remove the shield for medical reasons. Out of these 47 cases, the severity of the complication contra-indicated further. Dalkon Shield use in 43. Column F records removals for personal reasons-practically ...
Abdinasab, Mahnaz; Dehghani Firouzabadi, Razieh; Farajkhoda, Tahmineh; Abdoli, Ali Mohammad
Background The appropriate choice of a contraceptive method has been a major issue in reproductive health research. Cu T intrauterine device (Cu T IUD) has been introduced as one of the most effective contraceptive methods in the world, however, the relationship between prior use of Cu T IUD and secondary infertility has not been evaluated in Iran. To examine the association of Cu T-380A IUD and secondary infertility in Iran. Materials and Methods A retrospective cohort study was conducted from December 2010 to September 2011 in the Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. A total of 750 married women (15-49 years old) with at least one parity, whom were referred to four educational healthcare centers of Shahid Sadoughi University of Medical Sciences, were selected as participants. They were divided into two groups (case and control) based on previous history of using Cu T-380A IUD. Data were gathered using a standard reliable questionnaire along with a face-to-face interview and were analyzed with descriptive and analytical (χ²) tests. Results Mean period of Cu T-380A IUD usage in the case group was 57.46 ± 47.74 months and mean time length from Cu T-380A IUD removal to pregnancy was 14.87 ± 5.18 months in this group. We observed no relationship between the use of Cu T-380A IUD and frequency of secondary infertility (3.5% in the case group versus 2.7% in the control group, P=0.52). Conclusion Given the relatively large sample size studied here, it is unlikely that Cu T-380A IUD results in secondary infertility and may be used by Iranian women as a safe contraceptive method. PMID:28042414
Champion, C B; Behlilovic, B; Arosemena, J M; Randic, L; Cole, L P; Wilkens, L R
A randomized, comparative, multicenter clinical trial of TCu 380Ag and Multiload Cu 375 intrauterine devices (IUDs) was conducted. Safety and acceptability were evaluated through three years following insertion in 884 patients. The two IUDs were similar with respect to all event rates. Thirty-six month life table pregnancy rates were 0.6 per 100 TCu 380Ag users and 1.8 per 100 Multiload Cu 375 users. Continuation rates were 67.4 and 61.4 per 100 users of the respective devices at three years after insertion.
Goldstuck, N D
The notion that the intrauterine contraceptive device (IUCD) has a central, as well as a local action, is examined. Although the IUCD undoubtedly has a local action, certain IUCD related side effects, e.g. galactorrhoea, bloating and premenstrual syndrome and inadequate luteal function can be explained if the IUCD has some central action. The powerful postcoital anti-fertility effect of both copper-bearing and plain plastic IUCDs probably also depends to some extent on a central action. The central action of the IUCD is probably due to initiation of reflex hypothalamic activity following intrauterine reflex stimulation. The hypothalamic response to IUCD insertion consists of release of beta-endorphin accompanied by raised levels of prolactin, vasopressin and oxytocin.
Lin, Xiao-Na; Zhou, Feng; Wei, Min-Ling; Yang, Yang; Li, Ying; Li, T C; Zhang, Song-Ying
To compare the efficacy of heart-shaped intrauterine balloon and intrauterine contraceptive device (IUD) in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Prospective, randomized, controlled trial. University hospital. A total of 201 women with Asherman syndrome. Women were randomized to having either a heart-shaped intrauterine balloon or an IUD fitted after hysteroscopic adhesiolysis. The devices were removed after 7 days. A second-look hysteroscopy was carried out 1 to 2 months after the surgery. Incidence of adhesion reformation and reduction of adhesion score before and after surgery. Initially 201 cases were recruited; 39 cases dropped out, resulting in 82 cases in the balloon group and 80 cases in IUD group. The age, menstrual characteristics, pregnancy history, and American Fertility Society score before surgery were comparable between the two groups. The median adhesion score reduction (balloon group, 7; IUD group, 7) and the adhesion reformation rate (balloon group, 30%; IUD group, 35%) were not significantly different between the two groups. The heart-shaped intrauterine balloon and IUD are of similar efficacy in the prevention of adhesion reformation after hysteroscopic adhesiolysis for Asherman syndrome. ISRCTN 69690272. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Pohjoranta, Elina; Suhonen, Satu; Mentula, Maarit; Heikinheimo, Oskari
To assess the success and factors affecting early intrauterine device (IUD) provision after first trimester medical termination of pregnancy (MTOP). Subgroup analysis of a randomized contraceptive trial assessing the long-term effects of early provision of intrauterine contraception following abortion. Altogether, 606 women undergoing MTOP were included and followed for 3 months. The intervention group (n=307) was offered an IUD (either the levonorgestrel-releasing intrauterine system or copper-IUD) at a follow-up visit 1-4 weeks after MTOP. The control group (n=299) contacted primary health care for follow-up and contraceptive provision. Adverse events (infections, bleeding, residual tissue and incomplete abortion) were analyzed on intention-to-treat basis and IUD expulsions on per-protocol (PP) basis. In the intervention group, 234 women (76.2%) received the IUD as scheduled, 46 later (altogether 91.2%). In the control group, the corresponding figures were 8 (2.7%) and 64 [altogether 24.1%, Odds ratio (OR) (95% Confidence interval (CI))=32.7 (20.3-52.6)]. Eighty-five (27.7%) women in the intervention group and 38 (12.7%) in the control group received treatment (administration of antibiotics, misoprostol or surgical evacuation) because of presumed adverse event [2.63 (1.72-4.01)], mainly residual tissue. In the control group, 23 (60.5%) of these occurred during the first 2 weeks. IUD expulsion occurred in 12 (5.4%) of the 222 women in the intervention group (PP basis). When provided as part of abortion service, most early insertions following MTOP were performed as planned. The main reason for postponement was overdiagnosis of adverse events suspected at follow-up. The rate of IUD expulsion was similar to that reported previously. Early insertion following MTOP is safe, and the rate of IUD expulsion is low. Most adverse events possibly delaying IUD insertion occur early. Based on timing of adverse events in the control group, IUD insertion at approximately 2 weeks
Full Text Available Introduction: Increased bleeding is the most common cause of intrauterine device (IUD removal. The use of alternative therapies to treat bleeding has increased due to the complications of medications. But most alternative therapies are not accepted by women. Therefore, conducting studies to find the right treatment with fewer complications and being acceptable is necessary. This study aimed to compare the effect of mefenamic acid and vitex agnus castus on IUD induced bleeding.Methods: This was a double blinded randomized controlled clinical trial. It was conducted on 84 women with random allocation in to two groups of 42 treated with mefenamic acid and vitex agnus capsules taking three times a day during menstruation for four months. Data were collected by demographic questionnaire and Higham 5 stage chart (1 month before the treatment and 4 months during the treatment., Paired t-test, independent t-test, chi-square test, analysis of variance (ANOVA with repeated measurements, and SPSS software were used to determine the results.Results: Mefenamic acid and vitex agnus significantly decreased bleeding. This decrease in month 4 was 52% in the mefenamic acid group and 47.6% in the vitex agnus group. The mean bleeding score changes was statistically significant between the two groups in the first three months and before the intervention. In the mefenamic acid group, the decreased bleeding was significantly more than the vitex agnus group. However, during the 4th month, the mean change was not statistically significant. Conclusion: Mefenamic acid and vitex agnus were both effective on IUD induced bleeding; however, mefenamic acid was more effective.
Yavarikia, Parisa; Shahnazi, Mahnaz; Hadavand Mirzaie, Samira; Javadzadeh, Yousef; Lutfi, Razieh
Increased bleeding is the most common cause of intrauterine device (IUD) removal. The use of alternative therapies to treat bleeding has increased due to the complications of medications. But most alternative therapies are not accepted by women. Therefore, conducting studies to find the right treatment with fewer complications and being acceptable is necessary. This study aimed to compare the effect of mefenamic acid and vitex agnus castus on IUD induced bleeding. This was a double blinded randomized controlled clinical trial. It was conducted on 84 women with random allocation in to two groups of 42 treated with mefenamic acid and vitex agnus capsules taking three times a day during menstruation for four months. Data were collected by demographic questionnaire and Higham 5 stage chart (1 month before the treatment and 4 months during the treatment)., Paired t-test, independent t-test, chi-square test, analysis of variance (ANOVA) with repeated measurements, and SPSS software were used to determine the results. Mefenamic acid and vitex agnus significantly decreased bleeding. This decrease in month 4 was 52% in the mefenamic acid group and 47.6% in the vitex agnus group. The mean bleeding score changes was statistically significant between the two groups in the first three months and before the intervention. In the mefenamic acid group, the decreased bleeding was significantly more than the vitex agnus group. However, during the 4(th) month, the mean change was not statistically significant. Mefenamic acid and vitex agnus were both effective on IUD induced bleeding; however, mefenamic acid was more effective.
Berenson, Abbey B; Tan, Alai; Hirth, Jacqueline M; Wilkinson, Gregg S
Many U.S. health care providers remain reluctant to prescribe intrauterine devices (IUDs) to teenagers as a result of concerns about serious complications. This study examined whether 15-19-year-old IUD users were more likely to experience complications, failure, or early discontinuation than adult users aged 20-24 years and 25-44 years and whether there were differences in these outcomes between users of levonorgestrel-releasing intrauterine systems and copper IUDs. A retrospective cohort study was conducted using health insurance claims obtained from a private insurance company of 90,489 women who had an IUD inserted between 2002 and 2009. Logistic regression models were used to estimate the odds of experiencing complications, method failure, or early discontinuation within 12 months of insertion by age group and type of IUD inserted. Serious complications, including ectopic pregnancy and pelvic inflammatory disease, occurred in less than 1% of patients regardless of age or IUD type. Women aged 15-19 years were more likely than those aged 25-44 years to have a claim for dysmenorrhea (odds ratio [OR] 1.4, confidence interval [CI] 1.1-1.6), amenorrhea (OR 1.3, CI 1.1-1.5), or normal pregnancy (OR 1.4, CI 1.1-1.8). Overall, early discontinuation did not differ between teenagers and women aged 25-44 years (13% compared with 11%, P>.05). However, use of the levonorgestrel-releasing intrauterine system was associated with fewer complications and less early discontinuation than the copper IUD in all age groups. The IUD is as appropriate for teenagers to use as it is for older women, with serious complications occurring infrequently in all groups. The levonorgestrel-releasing intrauterine system may be a better choice than the copper IUD as a result of lower odds of complications, discontinuation, and failure. II.
Bayer, Lisa L; Hillard, Paula J Adams
The levonorgestrel intrauterine system (LNG-IUS) is an underused contraceptive method in adolescent populations. In addition to being a highly effective, reversible, long-acting contraception, the LNG-IUS has many noncontraceptive health benefits including reduced menstrual bleeding, decreased dysmenorrhea and pelvic pain related to endometriosis, and menstruation suppression in teens with physical or developmental disabilities. The LNG-IUS can also provide endometrial protection in teens with chronic anovulation, and may be used to treat endometrial hyperplasia and cancer. This review examines the evidence supporting the use of the LNG-IUS in adolescents for these noncontraceptive benefits. Copyright © 2013 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.
Allen, Caitlin; Kolehmainen, Christine
A variety of contraception options are available in addition to traditional combined oral contraceptive pills. Newer long-acting reversible contraceptive (LARC) methods such as intrauterine devices and subcutaneous implants are preferred because they do not depend on patient compliance. They are highly effective and appropriate for most women. Female and male sterilization are other effective but they are irreversible and require counseling to minimize regret. The contraceptive injection, patch, and ring do not require daily administration, but their typical efficacy rates are lower than LARC methods and similar to those for combined oral contraceptive pills. Copyright © 2015 Elsevier Inc. All rights reserved.
Helena von Eye Corleta
Full Text Available We report the case of a nulliparous 33-year-old woman who had a uneventful insertion of levonorgestrel-releasing intrauterine device (LNG-IUD; Mirena, Schering, Brazil inserted on august/2005. She was amenorrheic from august 2005 to may 2006, when she referred the beginning of an intermittent spotting. On september/2006, she had a normal transvaginal ultrasound, showing a well-placed device. One year later, she informed the occurrence of regular menstrual cycles, but with menorrhagia. At that time, during the physical examination, the retrieval thread was not visible at the cervix. Another ultrasound was then performed, showing a device outside the uterine cavity, probably in the uterine serosa
Palmara, Vittorio; Sturlese, Emanuele; Villari, Daniela; Giacobbe, Valentina; Retto, Annalisa; Santoro, Giuseppe
Abnormal uterine bleeding is defined as any alteration in the pattern or volume of menstrual blood flow, and it is preferably treated using hysterectomy, endometrial destruction or the levonorgestrel-releasing intrauterine system (Mirena(®) ). Recently, it has been demonstrated that studies of Mirena(®) were generally small and consequently imprecise. Our study was aimed at assessing the effects of a slow-release levonorgestrel (20 μg/day) intrauterine device in fertile and postmenopausal women experiencing abnormal uterine bleeding that did not respond to traditional medical management. A total of 40 women, of whom 24 were of reproductive capacity and 16 were postmenopausal, were enrolled in the trial. Removal of the intrauterine device was required for only 2 of the 24 fertile women and for only 3 of the 16 postmenopausal women. After 6 and 12 months of treatment, the remaining women were clinically evaluated and underwent ultrasound and hysteroscopy using biopsy specimens as a control. The EuroQol Group EQ-5D questionnaire was used for evaluation of quality of life. The device showed good tolerability and efficacy. It resulted in a reduction in the endometrial mucosal thickness with a regression of bleeding and collateral effects, which were more evident after 12 months of treatment. A positive effect of the device on the woman's quality of life was demonstrated. The slow-release levonorgestrel intrauterine device may be a valid therapeutic tool for treating basic symptomatology and increasing quality of life in women with abnormal uterine bleeding. © 2013 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
Wu, Justine P; Pickle, Sarah
There are multiple advantages to "extended use" of the intrauterine device (IUD) use beyond the manufacturer-approved time period, including prolongation of contraceptive and non-contraceptive benefits. We performed a literature review of studies that have reported pregnancy outcomes associated with extended use of IUDs, including copper IUDs and the levonorgestrel intrauterine system (LNG-IUS). Among parous women who are at least 25 years old at the time of IUD insertion, there is good evidence to support extended use of the following devices: the TCu380A and the TCu220 for 12 years, the Multiload Cu-375 for 10 years, the frameless GyneFix® (330 mm²) for 9 years, the levonorgestrel intrauterine system 52 mg (Mirena®) for 7 years and the Multiload Cu-250 for 4 years. Women who are at least 35 years old at the time of insertion of a TCu380A IUD can continue use until menopause with a negligible risk of pregnancy. We found no data to support use of the LNG-IUS 13.5 mg (Skyla®) beyond 3 years. When counseling about extended IUD use, clinicians should consider patient characteristics and preferences, as well as country- and community-specific factors. Future research is necessary to determine the risk of pregnancy associated with extended use of the copper IUD and the LNG-IUS among nulliparous women and women less than 25 years old at the time of IUD insertion. More data are needed on the potential effect of overweight and obesity on the long-term efficacy of the LNG-IUS. Copyright © 2014 Elsevier Inc. All rights reserved.
Azzam, Mohamed-Ezz-Eldin A.; Hemaly, Abdu-El-Karim; Kandil, Ahmad K.; Ahmed, Saeed A. I.; Ahmoudo, H.
The role of Metraplant as a levonogrestrel releasing intrauterine device in the treatment of dysfunctional menorrhagia was evaluated. Fifty women with a failed trial of medical therapy and awaiting hysterectomy were treated with Metraplant. Menstrual blood loss was estimated using bleeding index (BI) and total bleeding score/month (TBS/mo) together with estimation of haemoglobin concentration and serum feritin preinsertion and at 6 and 12 months. The bleeding patterns in the form of mean BI and mean TBS/mo decreased significantly (p<0.001) one year after the device was used in the responded group (38) of the regularly followed up women. The mean haemoblobin concentration and mean serum ferritin were increased significantly one after the device was used (p<0.001 and p, 0.05 respectively). The mean endometrial thickness increased significantly (p<0.001) one year after using the device. Metraplant was found to be a good alternative to the oral therapy and hysterectomy in the treatment of perimenopausal dysfunctional menorrhagia. (author)
Espey, Eve; Ogburn, Tony
The provision of effective contraception is fundamental to the practice of women's health care. The most effective methods of reversible contraception are the so-called long-acting reversible contraceptives, intrauterine devices and implants. These methods have multiple advantages over other reversible methods. Most importantly, once in place, they do not require maintenance and their duration of action is long, ranging from 3 to 10 years. Despite the advantages of long-acting reversible contraceptive methods, they are infrequently used in the United States. Short-acting methods, specifically oral contraceptives and condoms, are by far the most commonly used reversible methods. A shift from the use of short-acting methods to long-acting reversible contraceptive methods could help reduce the high rate of unintended pregnancy in the United States. In this review of long-acting reversible contraceptive methods, we discuss the intrauterine devices and the contraceptive implant available in the United States, and we describe candidates for each method, noncontraceptive benefits, and management of complications.
Pereda, M D; Farina, S B; Fernández Lorenzo, M
Copper wire is the main component of a type of intrauterine device used as a contraceptive. Its contraceptive effect is attributed to the copper ions released as a result of the dissolution of copper in the uterus. Even though 10-year intrauterine device life is estimated on the basis of the dissolution rate of copper measured in vivo and in vitro, some cases of breakdown or fragmentation of the copper wire after short periods of insertion (2-3 months) have been reported. Due to the possible existence of residual stresses as a consequence of the manufacturing process, stress corrosion cracking has been previously proposed as an explanation for the early ruptures. In the present work, the susceptibility of copper wires to stress corrosion cracking in simulated uterine fluids was investigated. Results indicate that early ruptures should not be attributed to stress corrosion cracking. They could be explained by considering the increase in corrosion rate under certain conditions (pH decrease during infections; changes in the concentration of organic components along the menstrual cycle; etc.) that reduces the wire section leading to the rupture of the specimen by overloading.
Medical device hardware- and software-driven user interfaces should be designed to minimize the likelihood of use-related errors and their consequences. The role of design-induced errors in medical device incidents is attracting widespread attention. The U.S. Food and Drug Administration (FDA) is fully cognizant that human factors engineering is critical to the design of safe medical devices, and user interface design is receiving substantial attention by the agency. Companies are paying more attention to the impact of device design, including user instructions, upon the performance of those health professionals and lay users who operate medical devices. Concurrently, the FDA is monitoring human factors issues in its site inspections, premarket device approvals, and postmarket incident evaluations. Overall, the outlook for improved designs and safer device operation is bright
Taiwo O Alabi
Full Text Available The most commonly used long-term reversible female contraception is intrauterine contraceptive device (IUCD. Its use is however associated with documented complications. Uterine perforation, though rare, is arguably the most surgically important of all these complications. We report a case of a 48-year-old para 4+0 (4 alive woman who had IUCD insertion 17 years earlier and had forgotten she had the device having had two children thereafter. The IUCD was subsequently translocated through the dome of the bladder into the peritoneal cavity with calculus formation around the tail and thread of the IUCD in the urinary bladder causing recurrent urinary tract infection. This “Collar Stud” effect made either cystoscopic or laparoscopic retrieval alone unsuccessful necessitating a combined approach. This case report highlights the need for a combined laparoscopic and cystoscopic approach in the retrieval of the unusual presentation of translocated IUCD.
Singh, R; al-Amari, M
The study examined the reproductive and health profile of Benghazi women using intrauterine contraceptive devices (IUDs) and evaluated one such device, the TCu-380 A. An historical longitudinal study was carried out using data from the Fertility Regulation Clinic, Keish Polyclinic, Benghazi. The subjects were 457 women registered for TCu-380 A insertion between 1995 and 1998, who had been under follow-up for at least 6 months. The majority were Libyan (87.8%), aged 20-29 years (63.4%), of parity 1-6 (67.1%), non-lactating (64.3%) and with normal delivery at last conception (95.1%). Half had a chronic disease. The cumulative 36-month follow-up of those using TCu-380 A revealed an effectiveness rate of 99.8%, a continuation rate of 96.1% and complications in 3.5%. TCu-380 A appears to be an effective, durable and safe IUD.
Andreasen, Lisbeth Anita; Antonsen, Sofie Leisby; Settnes, Annette
but with a minimum of symptoms and side effects. At the final examination there were no signs of extra uterine disease. The levonorgestrel-releasing intrauterine device may be an acceptable alternative to surgery in severely comorbid patients, or if the patient refuses surgical treatment. © 2016, Springer......In this case report we describe the treatment of a 95-year-old woman with endometrioid adenocarcinoma. She suffered from cardiovascular comorbidity and did not want surgical treatment. Instead a levonorgestrel-releasing intrauterine device (Mirena) was inserted. She had progression of the tumor...
Simón, Elisa; Tejerizo, Álvaro; Muñoz, José Luis; Álvarez, Carmen; Marqueta, Laura; Jiménez, Jesús S
Endometriosis can affect up to 10% of women of reproductive age, in a wide range of clinical presentations that vary from mild to severe or deep endometriosis. Deep endometriosis can affect the urinary tract in 1-5% to 15-25% cases. Even though deep endometriosis' surgeries are usually complex with higher rate of complications, conservative management is not always considered as an option because of its high failure rates. This paper describes two cases of deep endometriosis with ureteric involvement (hydronephrosis) treated conservatively with a double-pigtail stent plus a Levonorgestrel intrauterine device, after conservative surgery, who remained symptom free with no evidence of recurrence at 3 years follow-up, avoiding radical high-risk surgery. Impact statement Several treatments have been described for endometriosis. From a symptomatic perspective, conservative medical management has been proposed with a variable response. Concerning deep endometriosis (affecting the urinary or digestive tract), the definitive treatment has always been thought to be radical surgery. However, this can lead to several complications. To illustrate a possible more conservative approach this paper describes two cases of deep infiltrating endometriosis affecting the ureter, treated conservatively with a temporary pigtail ureter stent plus a Levonorgestrel intrauterine device. The management demonstrates that, in a selected population, conservative treatment solves the urinary disease avoiding the surgical complications and, what is more, improving patients' symptoms in a permanent way. Further prospective studies are needed to confirm whether the introduction of this management in clinical practice would reduce the need for surgery thereby, avoiding high-risk surgery and improving the success rate of conservative management.
Goldstuck, Norman D; Wildemeersch, Dirk
The purpose of this study was to examine factors that could help reduce primary perforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion. We compared known IUD insertion forces for "framed" devices with known perforation forces in vitro (hysterectomy specimens) and known IUD removal forces and calculated a range of possible intrauterine forces using pressure and surface area. These were compared with known perforation forces. IUD insertion forces range from 1.5 N to 6.5 N. Removal forces range from 1 N to 5.8 N and fracture forces from 8.7 N to 30 N depending upon device. Measured perforation forces are from 20 N to 54 N, and calculations show the uterus is capable of generating up to 50 N of myometrial force depending on internal pressure and surface area. Primary perforation with conventional framed IUDs may occur if the insertion pressure exceeds the perforation resistance of the uterine fundus. This is more likely to occur if the front end of the inserter/IUD is narrow, the passage through the cervix is difficult, and the procedure is complex. IUD embedment and secondary perforation and IUD expulsion may be due to imbalance between the size of the IUD and that of the uterine cavity, causing production of asymmetrical uterine forces. The uterine muscle seems capable of generating enough force to cause an IUD to perforate the myometrium provided it is applied asymmetrically. A physical theory for IUD expulsion and secondary IUD perforation is given.
Goldstuck, Norman D; Wildemeersch, Dirk
Background The purpose of this study was to examine factors that could help reduce primary perforation during insertion of a framed intrauterine device (IUD) and to determine factors that contribute in generating enough uterine muscle force to cause embedment and secondary perforation of an IUD. The objective was also to evaluate the main underlying mechanism of IUD expulsion. Methods We compared known IUD insertion forces for “framed” devices with known perforation forces in vitro (hysterectomy specimens) and known IUD removal forces and calculated a range of possible intrauterine forces using pressure and surface area. These were compared with known perforation forces. Results IUD insertion forces range from 1.5 N to 6.5 N. Removal forces range from 1 N to 5.8 N and fracture forces from 8.7 N to 30 N depending upon device. Measured perforation forces are from 20 N to 54 N, and calculations show the uterus is capable of generating up to 50 N of myometrial force depending on internal pressure and surface area. Conclusion Primary perforation with conventional framed IUDs may occur if the insertion pressure exceeds the perforation resistance of the uterine fundus. This is more likely to occur if the front end of the inserter/IUD is narrow, the passage through the cervix is difficult, and the procedure is complex. IUD embedment and secondary perforation and IUD expulsion may be due to imbalance between the size of the IUD and that of the uterine cavity, causing production of asymmetrical uterine forces. The uterine muscle seems capable of generating enough force to cause an IUD to perforate the myometrium provided it is applied asymmetrically. A physical theory for IUD expulsion and secondary IUD perforation is given. PMID:25143756
Malchesky, P S; Chamberlain, V C; Scott-Conner, C; Salis, B; Wallace, C
Advances in medical science and, in particular, minimally invasive surgical and diagnostic procedures have stimulated the development of new and improved medical devices. This has been made possible because of developments in engineering and material sciences. The design of devices for reusability is particularly important in an effort to provide cost effective healthcare. Concerns and issues include the ability to safely and effectively reprocess the devices, infection prevention and control, safety of the patient and healthcare worker, environmental concerns, and effective use of resources. From an infection prevention point of view, present requirements are based upon the intended use of the devices. Critical devices require sterilization. Semi-critical devices require, as a minimum, high level disinfection. Sterilization is, however, preferred whenever possible. Before sterilization or disinfection, devices should be cleaned adequately. Device designs should be readily amenable to cleaning and sterilization. In the past, design requirements focused primarily on the clinical user and device functionality, with reuse considerations left to the user. In the current market, the customer is redefined and, for reusable medical devices, includes all those associated with the device through the reprocessing procedure. In addition, regulations require that manufacturers give detailed instructions for reprocessing medical devices. The device users have the obligation to follow reprocessing instructions. Many choices exist today in device designs, including disposable or reusable devices. The user needs to balance cost versus convenience and reprocessing requirements for reusables. Current trends are to reuse more devices, including many of which were meant to be disposable. Cost effective designs can best be achieved when the user and manufacturer work together on the design.(ABSTRACT TRUNCATED AT 250 WORDS)
This new edition presents information and knowledge on the field of biomedical devices and surgical tools. The authors look at the interactions between nanotechnology, nanomaterials, design, modeling, and tools for surgical and dental applications, as well as how nanostructured surfaces can be created for the purposes of improving cell adhesion between medical devices and the human body. Each original chapter is revised in this second edition and describes developments in coatings for heart valves, stents, hip and knee joints, cardiovascular devices, orthodontic applications, and regenerative materials such as bone substitutes. There are also 8 new chapters that address: Microvascular anastomoses Inhaler devices used for pulmonary delivery of medical aerosols Surface modification of interference screws Biomechanics of the mandible (a detailed case study) Safety and medical devices The synthesis of nanostructured material Delivery of anticancer molecules using carbon nanotubes Nano and micro coatings for medic...
Ebtesam Moustafa Kamal
Conclusion: Either copper intrauterine device or injectable contraceptive usage for more than 9 months results in significant decrease in endometrial proliferative or cell mitotic activity. While copper IUD has no effect on serum estradiol or progesterone levels, DMPA usage increased serum progesterone level with no effect on serum estradiol.
E. Hitzerd (Emilie); H. Bogers (Hein); N.A. Kianmanesh Rad (Noush); J.J. Duvekot (Hans)
markdownabstract__Background:__ Although the levonorgestrel-releasing intrauterine device (LNG-IUD) is one of the most reliable methods of contraception, it is associated with an increased risk of ectopic pregnancy in case of unintended pregnancy. A rare form of ectopic pregnancy is the caesarean
Shanmugasundaram, Uma; Hilton, Joan F; Critchfield, J William; Greenblatt, Ruth M; Giudice, Linda C; Averbach, Sarah; Seidman, Dominika; Shacklett, Barbara L; Smith-McCune, Karen
There is little information regarding the impact of the intrauterine device on immune parameters of the upper female reproductive tract related to risk of HIV acquisition. We collected cervical and endometrial samples from women using the hormonal intrauterine device to study its effects on endocervical cytokines/chemokine concentrations, phenotypic markers of T cells, responses of endometrial T cells to activation, and alterations of endometrial cellular infiltrates. Hormonal intrauterine device use was associated with: increased concentrations of inflammatory cytokines/chemokines (endocervix); increased coexpression of CXCR4 and CCR5 (endocervix and endometrium); increased coexpression of CD38 and HLADR (endocervix and endometrium); increased intracellular IL-10 production after T-cell stimulation (endometrium); and increased density of T cells, most notably regulatory T cells (endometrium). Hormonal intrauterine device use resulted in both inflammatory and immunosuppressive alterations. Further research is needed to determine the significance of these changes for HIV risk. © 2016 The Authors. American Journal of Reproductive Immunology Published by John Wiley & Sons Ltd.
van Dijk, Myrthe M.; van Hanegem, Nehalennia; de Lange, Maria E.; Timmermans, Anne
We performed a literature review of reports comparing a levonorgestrel-releasing intrauterine device (LNG-IUD) with transcervical polyp resection (TCRP) as a treatment for heavy menstrual bleeding (HMB). Our second objective was to investigate the effectiveness of LNG-IUD and TCRP in reducing
Eskew, Ashley M; Crane, Erin K
Young women with breast cancer face contraceptive challenges. Data are limited and conflicting on the use of the levonorgestrel intrauterine device (LNG-IUD) in this patient population. A 32-year-old nulligravid woman with a history of breast cancer on tamoxifen presented with new-onset vaginal bleeding. Further workup revealed a previously undiagnosed bicornuate uterus. She underwent hysteroscopy, dilation and curettage, and LNG-IUD placement in each uterine horn. Postoperative follow-up confirmed retention and proper placement of both IUDs. Pathology from the dilation and curettage was benign, and the abnormal uterine bleeding abated. LNG-IUD placement in a young patient with a personal history of breast cancer on tamoxifen and a bicornuate uterus is a safe and feasible alternative for contraception. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.
Achilles, Sharon L; Chen, Beatrice A; Lee, Jessica K; Gariepy, Aileen M; Creinin, Mitchell D
Assess feasibility of randomizing women to intrauterine device (IUD) type. Women enrolling in a 2-month study who desired an IUD for contraception were randomized 1:1 to receive a levonorgestrel-releasing 52-mg IUD (LNG-IUD) or copper T380A IUD (Cu-IUD), understanding they could switch IUD type at the end of the study. Randomization to IUD type was acceptable to 54/55 (98%) women who screened. All 32 enrolled participants completed follow-up. Two women exchanged their IUD (Cu-IUD to LNG-IUD), and two requested removal (one LNG-IUD, one Cu-IUD). Overall, 88% continued their assigned IUD. Randomization to IUD type is feasible, and few women change their IUD. Copyright © 2015 Elsevier Inc. All rights reserved.
Torky, Haitham; Moussa, Asem; El-Desouky, El-Sayed; Dief, Osama; Ahmed, Ali
The aim of this study was to compare the pain-relieving effect of intracervical lidocaine gel with that of lidocaine spray or no local anaesthesia in decreasing pain during insertion of the intrauterine contraceptive device (IUCD). In a prospective multicentre non-randomised comparative study design, 420 women were divided into three groups of 140 and fitted with the same type of IUCD. Group 1 received cervical lidocaine gel, group 2 received cervical lidocaine spray and group 3 received no topical anaesthesia. A visual analogue scale was used to measure the degree of pain experienced. There were no significant differences between the three groups with regard to baseline characteristics such as age and number of deliveries. Significantly less pain was felt during cervical traction in women using a local anaesthetic. However, there were no significant differences in pain due to IUCD insertion. Application of a local anaesthetic decreased the pain resulting from cervical traction but not that resulting from IUCD insertion.
Chai, Wei; Zhang, Wenlei; Jia, Guifeng; Cui, Miao; Cui, Lifeng
Displacement of an intrauterine contraceptive device (IUD) is a rare and serious complication of IUD insertion. Theoretically, it can migrate to anywhere in the pelvic and abdominal cavity. However, it is not usual for an IUD to migrate to the bladder. In this case report, we reported a patient with chronic urinary symptoms caused by the migration of an IUD into the bladder. The displacement of the IUD led to contraception failure and IUD retention in the bladder for 5 years. Pelvic ultrasonography (US), radiography, and cystoscopy examinations confirmed the migration of IUD in bladder. The patient underwent cystoscopy. The MCu IUD was successfully removed without any complications. Our study demonstrated that a missing IUD should be followed up and removed early to avoid possible serious complications.
Sivin, I; Tatum, H J
A study of the United States acceptors of the Copper T, model TCu 380A, initiated in 1972, was carried to the completion of 4 years of observation. The 1051 receptors, whose median age was 22.3 years, accumulated a total of 1927 years of use. At the end of 4 years, the cumulative net pregnancy rate was 1.9 per 100 women, and the gross rate was 2.8 per 100. The annual continuation rate over the 4-year interval averaged 77 per 100. The TCu 380A intrauterine device (IUD) has provided extremely effective and undiminishing protection against pregnancy through 4 years of use in a group of young women. This degree of protection has not as yet been equaled when randomized comparative trials have been carried out with other copper-bearing IUDs.
Mishell, D R; Israel, R; Freid, N
A study of the effectiveness and complications associated with the Model 200 copper T intrauterine device in 471 nulliparous women ranging in age from 14-33 years is reported, including 6044 woman-months of device use. 128 of the patients had had 1 or more previous abortions. This T-shaped device is made of polyethylene impregnated with barium sulfate, wound with .2 mm diameter copper wire providing a copper surface area of 200 square mm, and is inserted easily without anesthesia and with minimal pain. Continuation and failure rates were calculated for the first 12 months of use by life-table analysis. The overall continuation rate of device use was 74.2 per 100 women, the expulsion rate was 5.4, removal rate for bleeding or pain was 10.7, and pregnancy failure occurred at a rate of 1.7 per 100 women per year. These discontinuation event rates are lower than those reported for other IUDs in nulliparous women and comparable to IUD rates in multiparas. In the past, other IUD designs have been very unsatisfactory in nulliparas because of high expulsion and removal rates, but this study indicates that the TCu 200 IUD model is well accepted by nulliparas with good safety and effectiveness, and provides a promising and highly desired contraceptive alternative to oral contraception for young women.
Nguyen, Brian T; Allen, Allison J
YouTube's online archive of video testimonials related to health information are more commonly viewed than those developed by clinicians and professional groups, suggesting the importance of the patient experience to viewers. We specifically sought to examine the accuracy of information on, and projected acceptability of, the intrauterine device (IUD) from these YouTube testimonials. We searched YouTube for videos about individual uploaders' IUD experiences, using the search terms 'intrauterine device', 'IUD', 'Mirena' and 'Paragard'. Given interest in user testimonials, we excluded professional and instructional videos belonging to commercial or non-profit entities. Two reviewers independently analysed the videos using a structured guide, with attention to inaccurate information. Of 86 identified videos, four videos featured clinicians and were excluded; 62 met inclusion criteria. Interrater agreement on IUD portrayal was good (K=0.73). Young (mean age 25, range 19-38, years), white (75%), nulliparous (61%) women primarily uploaded content. Most described placement of the LNG-IUS (65%), were posted within 1 month of insertion (45%), and mentioned side effects (66%) - bleeding, pain, and partner sensation of the strings. About one-third of videos contained inaccurate information (34%) and were thought to project an overall negative experience (30%). Videos portraying IUDs negatively were associated with inaccurate information and/or mention of side effects. While one-third of IUD user testimonials on YouTube contained inaccurate information, the majority of IUD experiences were perceived by our study viewers to be positive. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.
Levi, Erika E; Stuart, Gretchen S; Zerden, Matthew L; Garrett, Joanne M; Bryant, Amy G
To compare intrauterine device (IUD) use at 6 months postpartum among women who underwent intracesarean delivery (during cesarean delivery) IUD placement compared with women who planned for interval IUD placement 6 or more weeks postpartum. In this nonblinded randomized trial, women who were undergoing a cesarean delivery and desired an IUD were randomized to intracesarean delivery or interval IUD placement. The primary outcome was IUD use at 6 months postpartum. A sample size of 112 (56 in each group) was planned to detect a 15% difference in IUD use at 6 months postpartum between groups. From March 2012 to June 2014, 172 women were screened and 112 women were randomized into the trial. Baseline characteristics were similar between groups. Data regarding IUD use at 6 months postpartum were available for 98 women, 48 and 50 women in the intracesarean delivery and interval groups, respectively. A larger proportion of the women in the intracesarean delivery group were using an IUD at 6 months postpartum (40/48 [83%]) compared with those in the interval group (32/50 [64%], relative risk 1.3, 95% confidence interval 1.02-1.66). Among the 56 women randomized to interval IUD insertion, 22 (39%) of them never received an IUD; 14 (25%) never returned for IUD placement, five (9%) women declined an IUD, and three (5%) had a failed IUD placement. Intrauterine device placement at the time of cesarean delivery leads to a higher proportion of IUD use at 6 months postpartum when compared with interval IUD placement. I.
Verma, Usha; Astudillo-Dávalos, Fausto E; Gerkowicz, Sabrina A
To evaluate the efficacy and difference in cost of ultrasound guided removal of retained intrauterine device (IUD). A total of 23 women underwent ultrasound-guided retrieval of retained IUDs between January 2013 and March 2014. Transvaginal ultrasound was performed in all cases to assess the localization of the IUD. Under transabdominal ultrasound guidance, either the crochet type IUD hook (Gyneas, Goussainville, France) or Alligator forceps were used to grasp the IUD and remove it from the uterine cavity. The costs of the ultrasound guided procedure and the hysteroscopic removal of the IUD were compared. Twenty-three patients who failed IUD removal in the clinic were referred to our department for ultrasound-guided removal. All patients had an IUD present in the uterine cavity. Eleven patients had Paragard IUDs (48%), eight had Mirena IUDs (35%), three had Lippes loop (13%), and one had a ring IUD (4%). The patients' ages ranged from 20-56 years. The IUDs were in place for 8 months to 23 years. Of the 23 patients with retained IUDs, 19 were successfully removed (83%), and 4 underwent hysteroscopic removal of IUD. The IUD removal cost in the operating room on average was $3562 US dollars and the cost of ultrasound-guided removal was $465 US dollars. Retained intrauterine devices with or without strings can often be safely removed in an office-based setting under ultrasound guidance at less cost than in the operating room, even in cases with embedded IUDs. Our experience leads us to propose in-office IUD removal under ultrasound guidance as the first line in management of retained IUDs after failed removal by conventional practices. Ultrasound provides numerous advantages including direct visualization in a less invasive manner than hysteroscopy. Three-dimensional imaging can also be used for enhanced perspective. Copyright © 2015 Elsevier Inc. All rights reserved.
Mao, Xiaoyan; Zhang, Jie; Chen, Qiuju; Kuang, Yanping; Zhang, Shaozhen
To study if hysteroscopy and short-term copper intrauterine device placement (Cu-IUD) improves the pregnancy rates of women with repeated implantation failure (RIF) undergoing frozen-thawed embryo transfer (FET). Retrospective study. Medical university hospital. Infertile women with at least two implantation failures with the use of at least one good-quality embryo. All patients received operative hysteroscopy in the follicular cycle, and if endometrial polyps, polypoid endometrium, or intrauterine adhesions were found they were removed. In some patients, a Cu-IUD was inserted immediately after hysteroscopy and removed after two menstrual periods before embryo implantation. All patients underwent in vitro fertilization or intracytoplasmic sperm injection and FET. Clinical pregnancy and implantation rates. A total of 440 women with a mean age of 33.42 ± 4.45 years (range 23-47 y) were included. There were 382 patients (554 cycles) in the IUD group and 58 patients (87 cycles) in the non-IUD group. The two groups were similar regarding age, body mass index, and infertility factors. The IUD group had a significantly higher implantation rate (29.29% vs. 16.56%), chemical pregnancy rate (53.25 vs. 41.38%), and clinical pregnancy rate (45.13% vs. 26.44%) than the non-IUD group. Multivariable regression analysis indicated that the odds of a chemical pregnancy was significantly increased with IUD usage. Cu-IUD placement for two menstrual cycles at the time of hysteroscopy can improve the implantation and pregnancy rates in women with RIF. Copyright © 2017 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.
Aziz, Mirette; Ahmed, Sabra; Ahmed, Boshra
To assess the attitudes of physicians providing family planning services at the public sector in Egypt about recommending intrauterine device (IUD) for family planning clients, and to identify the factors that could affect their attitudes. A descriptive cross sectional study, in which all the physicians providing family planning services in Assiut Governorate were invited to complete self-administered questionnaires. The study participants were recruited at the family planning sector monthly meetings of the 13 health directorates of Assiut Governorate, Upper Egypt. 250 physicians accepted to participate in the study. Bivariate and Multivariate regression analyses were performed to identify the most important predictors of recommending IUD to family planning clients when appropriate. Less than 50% of physicians would recommend IUD for clients with proper eligibility criteria; women younger than 20 years old (49.2%), women with history of ectopic pregnancy (34%), history of pelvic inflammatory diseases (40%) or sexually transmitted diseases (18.4%) and nulliparous women (22.8%). Receiving family planning formal training within the year preceding data collection and working in urban areas were the significant predictors of recommending IUD insertion for appropriate clients. Physicians providing family planning services in Upper Egypt have negative attitudes about recommending IUD for family planning clients. Continuous education and in-service training about the updated medical eligibility criteria, especially for physicians working in rural areas may reduce the unfounded medical restrictions for IUD use. Copyright © 2017 Elsevier B.V. All rights reserved.
Three intrauterine devices (IUDs), one copper and two containing the progestin levonorgestrel, are available for use in the United States. IUDs offer higher rates of contraceptive efficacy than nonlong-acting methods, and several studies have demonstrated higher satisfaction rates and continuation rates of any birth control method. This efficacy is not affected by age or parity. The safety of IUDs is well studied, and the risks of pelvic inflammatory disease, perforation, expulsion, and ectopic pregnancy are all of very low incidence. Noncontraceptive benefits include decreased menstrual blood loss, improved dysmenorrhea, improved pelvic pain associated with endometriosis, and protection of the endometrium from hyperplasia. The use of IUDs is accepted in patients with multiple medical problems who may have contraindications to other birth control methods. Yet despite well-published data, concerns and misperceptions still persist, especially among younger populations and nulliparous women. Medical governing bodies advocate for use of IUDs in these populations, as safety and efficacy is unchanged, and IUDs have been shown to decrease unintended pregnancies. Dispersion of accurate information among patients and practitioners is needed to further increase the acceptability and use of IUDs. PMID:25050062
Harper, Cynthia C.; Speidel, J. Joseph; Drey, Eleanor A.; Trussell, James; Blum, Maya; Darney, Philip D.
Objective The copper intrauterine device (IUD) is the most effective emergency contraceptive available but is largely ignored in clinical practice. We examined clinicians’ recommendation of the copper IUD for emergency contraception in a setting with few cost obstacles. Methods We conducted a survey among clinicians (n=1,246; response rate 65%) in a California State family planning program, where U.S. Food and Drug Administration-approved contraceptives are available at no cost to low-income women. We used multivariable logistic regression to measure the association of intrauterine contraceptive training and evidence-based knowledge with having recommended the copper IUD for emergency contraception. Results The large majority of clinicians (85%) never recommended the copper IUD for emergency contraception, and most (93%) required two or more visits for an IUD insertion. Multivariable analyses showed insertion skills were associated with having recommended the copper IUD for emergency contraception, but the most significant factor was evidence-based knowledge of patient selection for IUD use. Clinicians who viewed a wide range of patients as IUD candidates were twice as likely to have recommended the copper IUD for emergency contraception. While over 93% of obstetrician–gynecologists were skilled in inserting the copper IUD, they were no more likely to have recommended it for emergency contraception than other physicians or advance practice clinicians. Conclusion Recommendation of the copper IUD for emergency contraception is rare, despite its high efficacy and long-lasting contraceptive benefits. Recommendation would require clinic flow and scheduling adjustments to allow same-day IUD insertions. Patient-centered and high-quality care for emergency contraception should include a discussion of the most effective method. PMID:22270272
Dos Santos, Odelta; Rigo, Graziela Vargas; Macedo, Alexandre José; Tasca, Tiana
The parasitism by Trichomonas vaginalis is complex and in part is mediated by cytoadherence accomplished via five surface proteins named adhesins and a glycoconjugate called lipophosphoglycan (TvLPG). In this study, we evaluated the ability of T. vaginalis isolates to adhere to cells, plastic (polystyrene microplates), intrauterine device (IUD), and vaginal ring. Of 32 T. vaginalis isolates, 4 (12.5%) were strong adherent. The T. vaginalis isolates TV-LACM6 and TV-LACM14 (strong polystyrene-adherent) were also able to adhere to IUD and vaginal ring. Following chemical treatments, results demonstrated that the T. vaginalis components, lipophosphoglycan, cytoskeletal proteins, and surface molecules, were involved in both adherence to polystyrene and cytoadherence. The gene expression level from four adhesion proteins was highest in trophozoites adhered to cells than trophozoites adhered to the abiotic surface (polystyrene microplate). Our data indicate the major involvement of TvLPG in adherence to polystyrene, and that adhesins are important for cytoadherence. Furthermore, to our knowledge, this is the first report showing the T. vaginalis adherence to contraceptive devices, reaffirming its importance as pathogen among women in reproductive age.
Ramakrishnan, Reshmi; B, Bharaniraja; Aprem, Abi Santhosh
The adverse effects of copper intrauterine devices (IUDs) such as abnormal bleeding, pain and cramps may be due in part to the burst release of copper ions during the first few months of usage. This study focuses on controlling the initial burst release of copper ions. This study evaluated in vitro release rates of copper for a period of 1 year from standard CuT380 IUDs (n=6) and from CuT380 IUDs coated with poly(dl-lactide-co-glycolide) (PLGA) films (n=6). This study characterized the coated device for its morphological changes during degradation of film by scanning electron microscopy (SEM). CuT380 IUDs coated with PLGA film with a thickness of 0.10±0.02 mm showed a reduced initial copper release (40-80 mcg/day) compared with uncoated CuT380 IUDs (150-200 mcg/day). Statistically significant (p<.05) results were obtained at different time intervals during the overall study period of 1 year. SEM images showed degradation of coating. Coating a CuT380 IUD with biodegradable polymer reduced the initial copper release without affecting release at 1 year. Clinical trials are required to determine whether this could reduce side effects such as bleeding and pain associated with copper containing IUDs. Copyright © 2015 Elsevier Inc. All rights reserved.
Sinning, K M; Jude, D C; Yoost, J L
To quantify the "normal" adolescent experience after IUD insertion, in order to provide appropriate counseling for future adolescents. Prospective cohort study. Marshall University Department of Obstetrics and Gynecology generalist and adolescent gynecology clinics. Nulliparous adolescents age 13-18 and parous adults ≥18 years receiving a levonorgestrel intrauterine system (LNG-IUS). Visual analog scale pain score (VAS) and medication log was used for data collection for two weeks after LNG-IUS. A separate chart review was completed for demographic factors and indications for procedure. VAS pain scores and medication use was compared between groups. 93 subjects returned the VAS record and medication log (46 adolescents and 47 adults). There was no difference in the incidence of endometriosis or dysmenorrhea, but there was a higher prevalence of menorrhagia among adolescents (65.2% vs 21.3%, p= 5 during the first three days, p=0.022. A statistical difference in amount of ibuprofen recorded was only noted on day 1 (p=.023) and day 4 (p=.046). Nulliparous adolescents undergoing LNG-IUS placement experience more post-insertional discomfort compared to parous adults; however, this method should still be considered first-line in this age group. Copyright © 2018. Published by Elsevier Inc.
Uysal, A.; Taner, C.E.; Mun, S.; Celimli, F.H.; Uysal, F.
To evaluate the effects of a levonorgestrel-releasing intrauterine device in the treatment of adenomyosis associated with heavy menstrual bleeding. Methods: The retrospective study was conducted at a tertiary referral hospital in Izmir, Turkey, and comprised data on adenomyosis patients who were implanted with a levonorgestrel-releasing intrauterine device for heavy menstrual bleeding between December 2004 and January 2008. After the insertion of the device, all patients were followed up by transvaginal ultrasonography and serum haemoglobin levels and menstrual patterns were determined at the 6th and 12th month. Data was analysed using SPSS 10. Results: The mean age of the 42 women in the study was 43.2+-0.8 years. At the sixth month, amenorrhoea, oligomenorrhoea, spotting and regular menstrual flow were 9.5% (n=4), 7% (n=3), 19% (n=8), and 64% (n=27), respectively. At the 12th month, the same parametres were 9.5% (n=4), 7% (n=3), 12% (n=5), and 71% (n=30), respectively. Haemoglobin levels had increased and endometrial thickness had decreased, and these differences were statistically significant (p<0.001). Conclusion: The easy-to-use levonorgestrel-releasing intrauterine device can be added to the treatment options as a well-tolerated alternative in cases where a woman who has completed her fertility and does not request a hysterectomy has anaemia associated with adenomyosis. (author)
Uysal, Ahmet; Taner, Cüneyt Eftal; Mun, Semih; Uysal, Fatma; Celimli, Fatma Horasan
To evaluate the effects of a levonorgestrel-releasing intrauterine device in the treatment of adenomyosis associated with heavy menstrual bleeding. The retrospective study was conducted at a tertiary referral hospital in Izmir, Turkey, and comprised data on adenomyosis patients who were implanted with a levonorgestrel-releasing intrauterine device for heavy menstrual bleeding between December 2004 and January 2008. After the insertion of the device, all patients were followed up by transvaginal ultrasonography and serum haemoglobin levels and menstrual patterns were determined at the 6th and 12th month. Data was analysed using SPSS 10. The mean age of the 42 women in the study was 43.2 +/- 0.8 years. At the sixth month, amenorrhoea, oligomenorrhoea, spotting and regular menstrual flow were 9.5% (n = 4), 7% (n = 3), 19% (n = 8), and 64% (n = 27), respectively. At the 12th month, the same parametres were 9.5% (n = 4), 7% (n = 3), 12% (n = 5), and 71% (n = 30), respectively. Haemoglobin levels had increased and endometrial thickness had decreased, and these differences were statistically significant (p intrauterine device can be added to the treatment options as a well-tolerated alternative in cases where a woman who has completed her fertility and does not request a hysterectomy has anaemia associated with adenomyosis.
Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy
With China's growing old-age population and economic presence on the international stage, it has become important to evaluate its domestic and foreign market contribution to medical devices. Medical devices are instruments or apparatuses used in the prevention, rehabilitation, treatment, or knowledge generation with respect to disease or other abnormal conditions. This article provides information drawn from recent publications to describe the current state of the Chinese domestic market for medical devices and to define opportunities for foreign investment potential therein. Recent healthcare reforms implemented to meet rising demand due to an aging and migrating population are having a positive effect on market growth-a global market with a projected growth of 15% per year over the next decade. Copyright © 2015 International Center for Artificial Organs and Transplantation and Wiley Periodicals, Inc.
Bronzino, Joseph D
Known as the bible of biomedical engineering, The Biomedical Engineering Handbook, Fourth Edition, sets the standard against which all other references of this nature are measured. As such, it has served as a major resource for both skilled professionals and novices to biomedical engineering.Medical Devices and Human Engineering, the second volume of the handbook, presents material from respected scientists with diverse backgrounds in biomedical sensors, medical instrumentation and devices, human performance engineering, rehabilitation engineering, and clinical engineering.More than three doze
Full Text Available Actinomycosis is a rare, chronic suppurative infection caused by the Gram-positive anaerobic filamentous bacterium, Actinomyces Israeli. In most cases, the diagnosis is made postoperatively because of its unusual clinical presentation. Abdominal actinomycosis is the second most common site of the disease and may mimic abdominal cancer, inflammatory bowel disease or diverticulitis. The abdominal-pelvic form of this disease mostly results from the prolonged use of an intrauterine device. We report a rare case of combined intra- and extra-abdominal actinomycosis mimicking urachal tumor that was diagnosed by computed tomography, which presented as two tender abdominal palpable masses following long-term intrauterine device use. The disease was confirmed by postoperative histopathologic examination, which revealed sulfur granules microscopically, and was successfully treated by complete surgical resection following a period of appropriate antibiotic treatment.
Maguire, Karla; Davis, Anne; Rosario Tejeda, Linette; Westhoff, Carolyn
Pain during intrauterine device (IUD) insertion can be a barrier to initiation. Clinical trials have found misoprostol and nonsteroidal drugs to be ineffective (Am J Obstet Gynecol 2006;195:1272-1277, Hum Reprod 2011;26:323-329, Hum Reprod 2007;22:2647-2652). One study suggested that 2% lidocaine gel decreased pain; however, study design problems limit its validity (Brit J Fam Plann 1996;22:177-180). We tested whether intracervical 2% lidocaine gel decreased insertion pain compared to placebo. We planned a randomized, double-blinded clinical trial of 200 women. We placed 2% lidocaine gel or placebo in the cervix prior to uterine sounding. Participants rated pain by marking a 100-mm visual analogue scale at four time points. We randomized 200 participants and placed 197 IUDs. Pain was greatest at uterine sounding and similar between groups: placebo group mean 51.6 mm (SD 25), lidocaine group mean 55.5 mm (SD 30, p=.33). Stratified analyses accounting for parity showed no treatment effect. Multivariable analyses identified longer time since last pregnancy, lower parity and higher anticipated pain as predictors of pain during sounding, and dysmenorrhea and the levonorgestrel IUD as additional predictors during IUD insertion. Intracervical 2% lidocaine gel does not decrease IUD insertion pain. Understanding predictors of increased pain may help providers with preprocedure counseling. Copyright © 2012 Elsevier Inc. All rights reserved.
Lin, X; Gao, E S; Li, D; Zhang, M; Dou, L X; Yuan, W
To investigate whether tranexamic acid (Transamin) therapy reduces the amount of menstrual blood loss (MBL) and occurrence of menorrhagia after intrauterine device (IUD) insertion. Some 175 Chinese women attending for IUD insertion were equally assigned into 2 Transamin groups (1,000 and 500 mg, twice daily) and a placebo group. Their MBL was recorded with a pictorial chart in 3 subsequent menstrual cycles after insertion, while the MBL of 64 patients, collecting used sanitary towels, was also measured by an alkaline hematin method. A significant decline in post-insertion MBL and occurrence of menorrhagia was found in the 2 Transamin groups compared with the placebo group (p<0.05), whereas the difference in the results from the pictorial chart score was not statistically significant between the 1 g group and placebo group. Transamin treatment with a generally recommended dosage can effectively reduce the amount of IUD-induced MBL and prevent menorrhagia in Chinese women. A lower dosage than recommended (50% of recommended dosage) may have a similar preventive effect.
Wu, S; Godfrey, E M; Wojdyla, D; Dong, J; Cong, J; Wang, C; von Hertzen, H
To determine the effectiveness of the Copper T380A (CuT380A) intrauterine device (IUD) as an emergency contraceptive in women. Prospective, multicentre, cohort clinical trial. Eighteen family planning clinics in China. A cohort of 1963 women, aged 18-44 years, requesting emergency contraception within 120 hours of unprotected sexual intercourse. Women requesting emergency contraception were followed at 1, 3 and 12 months after the insertion of CuT380A. Efficacy of CuT380A as emergency contraception and for up to 12 months of postinsertion use. Insertion complication rates, reported side-effects and continuation rates at 12 months were also recorded. No pregnancies occurred prior to or at the first follow-up visit, making CuT380A 100% effective as emergency contraception in this study. The pregnancy rate over the 12-month period was 0.23 per 100 women. In all, 29 (1.5%) women experienced a difficult IUD insertion process, requiring local anaesthesia or prophylactic antibiotics. No uterine perforations occurred. The main side-effects were increased menstrual bleeding and menstrual disturbances. The 12-month postinsertion continuation rate was 94.0 per 100 woman-years. CuT380A is a safe and effective method for emergency contraception. The advantages of CuT380A include its ability to provide effective, long-term contraception.
Jagroep, Sherani R; Pichardo, Margaret S; Arribas, Lia; Heredia, Graciela; Coccio, Elina; Palermo, Tia M
The intrauterine device (IUD) is a long-acting reversible contraceptive method that is safe for a wide range of women, including adolescents and nulliparous women. Globally, it is often underutilised due to misperceptions among patients. Examination of characteristics associated with IUD discontinuation including adverse effects and IUD expulsion can inform provider practices to improve contraception success and patient satisfaction with this method. We studied IUD performance at a public family planning clinic in Buenos Aires, Argentina, serving a predominantly immigrant, low-income population. We conducted a retrospective evaluation of 1047 IUD insertions between 2002 and 2007 with 5 years of follow-up data. We performed bivariate and survival analysis to examine characteristics associated with IUD discontinuation: adverse outcomes including pain, bleeding, and IUD expulsion, and time to removal. Of 1047 patients, only 188 (18%) had their IUD removed within 5 years. The main causes of IUD discontinuation were involuntary (38%) reasons such as an IUD expulsion and personal choice (34%) such as desiring pregnancy. Findings suggest overall good long-term performance with IUD insertion, with minimal complaints or adverse outcomes. These findings may help to support providers serving similar populations in promoting this method. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Chen, Xiu-ying; Guo, Qing-yun; Wang, Wen; Huang, Li-li
To compare the diagnostic accuracy of two-dimensional (2D) versus three-dimensional (3D) ultrasonography for the diagnosis of intrauterine device (IUD) malposition. In a prospective study, women with a history of failed IUD removal and/or ultrasonography results indicating malposition were recruited at a center in Hangzhou, China, between March 1, 2009, and September 30, 2011. All patients underwent 2D and 3D ultrasonography. Hysteroscopy, laparoscopy, or laparotomy was carried out to remove the IUDs and was considered the gold standard for diagnosing malposition. Among 130 participants, 128 (98.5%) were diagnosed with IUD malposition by hysteroscopy, laparoscopy, or laparotomy. Malposition had been correctly identified with 2D ultrasonography in 83 (64.8%) cases, and with 3D ultrasonography in 107 (83.6%) cases. The diagnostic accuracy of 3D ultrasonography was significantly better than was that of 2D ultrasonography (P<0.001). The use of 2D ultrasonography is recommended for the follow-up of women who use IUDs as a contraceptive method. However, 3D ultrasonography should be used when malposition is suspected. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.
Singh, Rameet H; Thaxton, Lauren; Carr, Shannon; Leeman, Lawrence; Schneider, Emily; Espey, Eve
To evaluate the effectiveness of inhaled nitrous oxide for pain management among nulliparous women undergoing intrauterine device (IUD) insertion. A double-blind, randomized controlled trial was conducted among nulliparous women aged 13-45years who underwent IUD insertion at a US center between October 1, 2013, and August 31, 2014. Using a computer-generated randomization sequence, participants were randomly assigned to inhale either oxygen (O 2 ) or a mixture of 50% nitrous oxide and 50% oxygen (N 2 O/O 2 ) through a nasal mask for 2minutes before insertion. Only the person administering the inhalation agent was aware of group assignment. The primary outcome was maximum pain assessed 2minutes after insertion via a 100-mm visual analog scale. Analyses were by intention to treat. Forty women were assigned to each group. Mean maximum pain score at the time of insertion was 54.3±24.8mm for the N 2 O/O 2 group and 55.3±20.9mm for the O 2 group (P=0.86). Adverse effects were reported for 6 (15%) women in the N 2 O/O 2 group and 7 (18%) in the O 2 group (P=0.32). N 2 O/O 2 did not reduce the pain of IUD insertion among nulliparous women. ClinicalTrials.gov: NCT02391714. Published by Elsevier Ireland Ltd.
Patil, Eva; Darney, Blair; Orme-Evans, Kaebah; Beckley, Ethan H; Bergander, Linn; Nichols, Mark; Bednarek, Paula H
Immediate postabortion intrauterine device (IUD) insertion is a safe, effective strategy to prevent subsequent unplanned pregnancy. Oregon is one of 5 US states where advanced practice clinicians perform aspiration abortions. This study compares outcomes of first-trimester aspiration abortion with immediate IUD insertion between advanced practice clinicians and physicians. We conducted a historical cohort study of first-trimester aspiration abortions with immediate IUD insertion performed at our center from 2009 to 2011. We extracted demographic and clinical data from patient charts. Immediate complications including excessive blood loss, perforation, and reaspirations were recorded at the time of procedure. We used descriptive statistics and multivariable logistic regression to test for differences in outcomes by clinician type. Data were available on 669 of the 1134 combined procedures. Advanced practice clinicians performed 224 of these. There were no significant differences in immediate outcomes. The only immediate complications were reaspirations; 1.8% (4/224) in the advanced practice clinician group, and 2.0% (9/445) in the physician group (P = .83). We found no differences in outcomes between provider type for immediate IUD insertion after first-trimester aspiration abortion. This study helps reinforce that advanced practice clinicians can provide immediate postaspiration abortion IUD insertions with similar outcomes to those of physicians. Many countries do not allow advanced practice clinicians to perform this service, but a change in policy could help address family planning provider shortages. © 2016 by the American College of Nurse-Midwives.
Melo, Juliana; Tschann, Mary; Soon, Reni; Kuwahara, Melissa; Kaneshiro, Bliss
To determine how many intrauterine device (IUD) users are willing and able to palpate their IUD strings. A cross-sectional survey was conducted among IUD users presenting for their 6-week follow-up visit after insertion at the University of Hawaii, USA, between January 2011 and January 2012. Participants were asked whether they had previously felt the strings and whether they were willing to do so during the visit. Bivariate analyses and multiple logistic regression were performed. Previous attempts to palpate IUD strings were reported by 74 (58.7%) of 126 participants, of whom 49 (66.2%) could feel the strings. At the study visit, 60 (47.6%) participants were willing to try to feel their strings; 33 (55.0%) were successful. Overall, 58 (46.0%) participants were willing and able to palpate their IUD strings at home and/or at the study visit. Fewer women who self-identified as native Hawaiian than women of other races reported previous attempts (P=0.005). Previous instruction to check IUD strings was associated with willingness to palpate them before and after controlling for native Hawaiian race (odds ratio 8.78, 95% CI 3.43-22.43; adjusted odds ratio 9.64, 95% CI 3.57-26.04). Approximately half the participants were willing and able to palpate their IUD strings. Routinely counseling women to check their IUD strings could have limited clinical utility. © 2017 International Federation of Gynecology and Obstetrics.
Brady, Paula C; Soiffer, Robert J; Ginsburg, Elizabeth S
During treatment of hematologic malignancies in premenopausal women, both menstrual suppression and contraception are crucial. Continuation of hormonal intrauterine devices (IUDs) - widely used and highly effective contraceptives that also decrease menstrual flow - is controversial during hematopoietic stem cell transplants (SCTs) due to infectious and vaginal bleeding concerns. A 23-year-old nulligravid female was diagnosed with acute myeloid leukemia (AML, positive for FLT3-ITD, DNMT3A and RUNX1, with normal cytogenetics). She elected to retain her existing levonorgestrel-containing IUD during chemotherapy and SCT. During and following treatment, she remained amenorrheic without infection, despite severe neutropenia and thrombocytopenia. Eight months later, she remains in remission without IUD-related complications. This is the first report of levonorgestrel IUD retention during hematopoietic SCT. Despite severe neutropenia and thrombocytopenia, the patient developed neither pelvic infection by retaining her IUD nor significant vaginal bleeding. Future studies are needed to confirm the safety of levonorgestrel IUDs in women undergoing SCT. Copyright© 2017, International Institute of Anticancer Research (Dr. George J. Delinasios), All rights reserved.
Sakinci, Mehmet; Ercan, Cihangir Mutlu; Olgan, Safak; Coksuer, Hakan; Karasahin, Kazim Emre; Kuru, Oguzhan
To examine the effect of copper intrauterine device (Cu-IUD) on female sexual dysfunction (FSD) subtypes. There were 159 sexually active women (ninety Cu-IUD users and sixty-nine women with no contraception) who attended the gynecology clinic for routine gynecologic control informed about the study and asked to fill Female Sexual Function Index (FSFI) and Beck Depression Inventory questionnaires. The prevalence of FSD was 41.1% (n=37) and 37.7% (n=26) in Cu-IUD users and control groups, respectively (p > 0.05). In analyses of mean overall and subgroup scores of FSFI, significantly lower scores for arousal (p=0.021), lubrication (p=0.021), orgasm (p=0.040), pain (p < 0.001), and overall FSFI (p=0.031) were noted in Cu-IUD users. When the results for FSFI domains were considered for Cu-IUD users separately, the only difference to reach statistical significance, using a Bonferroni adjustment, was found to be the pain domain. Finally, we determined that Cu-IUD status made the strongest unique contribution to explaining the dependent variable pain in multiple logistic regression model (β = -0.26, p=0.001). Cu-IUD users have increased sexual pain compared to women with no contraception, which in turn possibly causes decreased sexual arousal, lubrication, and orgasm in these women. Copyright © 2016. Published by Elsevier B.V.
Ducharne, G; Girard, J; Pasquier, G; Migaud, H; Senneville, E
Intrauterine devices (IUD) used for contraception can be the source of local infections or can migrate, which justifies regular checking recommendations and limitations around the implantation period. To our knowledge, bone and joint infections related to an infected IUD have not been described in the scientific literature. This paper reports on a case of the repeated infection of a total hip prosthesis related to an infected IUD that had been forgotten after being implanted 34years previously. The arthroplasty infection revealed itself through dislocation of a dual mobility cup. Commensal bacteria that colonize the female genital tract (Streptococcus agalactiae) were identified at the site of hip arthroplasty. This led to the discovery of the IUD that was infected by the same bacterium. Despite lavage of the non-loosened arthroplasty, removal of the IUD and 2months of antibiotic treatment, the dislocation recurred and the prosthesis was again infected with the same microorganism 4months later. This recurrence of the infection, with persistence of a uterine abscess containing the same bacterium, was treated with repeated lavage of the joint, total hysterectomy and antibiotics treatment. The infection had resolved when followed-up 3years later. The occurrence of a bone and joint infection with this type of bacterium should trigger the evaluation of a possible IUD infection. Copyright © 2012 Elsevier Masson SAS. All rights reserved.
Huss, A; Schaap, K; Kromhout, H
Based on a previous case report of menometrorrhagia (prolonged/excessive uterine bleeding, occurring at irregular and/or frequent intervals) in MRI workers with intrauterine devices (IUDs), it was evaluated whether this association could be confirmed. A survey was performed among 381 female radiographers registered with their national association. Logistic regression was used to analyze associations of abnormal uterine bleeding with the frequency of working with MRI scanners, presence near the scanner/in the scanner room during image acquisition, and with scanner strength or type. A total of 68 women reported using IUDs, and 72 reported abnormal uterine bleeding. Compared with unexposed women not using IUDs, the odds ratio in women with IUDs working with MRI scanners was 2.09 (95% confidence interval 0.83-3.66). Associations were stronger if women working with MRI reported being present during image acquisition (odds ratio 3.43, 95% CI 1.26-9.34). Associations with scanner strength or type were not consistent. Radiographers using IUDs who are occupationally exposed to stray fields from MRI scanners report abnormal uterine bleeding more often than their co-workers without an IUD, or nonexposed co-workers with an IUD. In particular, radiographers present inside the scanner room during image acquisition showed an increased risk. Magn Reson Med 79:1083-1089, 2018. © 2017 International Society for Magnetic Resonance in Medicine. © 2017 International Society for Magnetic Resonance in Medicine.
Full Text Available Introduction. Women who do not switch to alternate methods after contraceptive discontinuation, for reasons other than the desire to get pregnant or not needing it, are at obvious risk for unplanned pregnancies or unwanted births. This paper examines the factors that influence women to switch from Intrauterine Contraceptive Device (IUCD to other methods instead of terminating contraceptive usage altogether. Methods. The data used for this study comes from a larger cross-sectional survey conducted in nine (9 randomly selected districts of Sindh and Punjab provinces of Pakistan, during January 2011. Using Stata 11.2, we analyzed data on 333 women, who reported the removal of IUCDs due to reasons other than the desire to get pregnant. Results. We found that 39.9% of the women do not switch to another method of contraception within one month after IUCD discontinuation. Use of contraception before IUCD insertion increases the odds for method switching by 2.26 times after removal. Similarly, postremoval follow-up by community health worker doubles (OR = 2.0 the chances of method switching. Compared with women who received free IUCD service (via voucher scheme, the method switching is 2.01 times higher among women who had paid for IUCD insertion. Conclusion. To increase the likelihood of method switching among IUCD discontinuers this study emphasizes the need for postremoval client counseling, follow-up by healthcare provider, improved choices to a wider range of contraceptives for poor clients, and user satisfaction.
Hameed, Waqas; Azmat, Syed Khurram; Ali, Moazzam; Hussain, Wajahat; Mustafa, Ghulam; Ishaque, Muhammad; Ali, Safdar; Ahmed, Aftab; Temmerman, Marleen
Introduction. Women who do not switch to alternate methods after contraceptive discontinuation, for reasons other than the desire to get pregnant or not needing it, are at obvious risk for unplanned pregnancies or unwanted births. This paper examines the factors that influence women to switch from Intrauterine Contraceptive Device (IUCD) to other methods instead of terminating contraceptive usage altogether. Methods. The data used for this study comes from a larger cross-sectional survey conducted in nine (9) randomly selected districts of Sindh and Punjab provinces of Pakistan, during January 2011. Using Stata 11.2, we analyzed data on 333 women, who reported the removal of IUCDs due to reasons other than the desire to get pregnant. Results. We found that 39.9% of the women do not switch to another method of contraception within one month after IUCD discontinuation. Use of contraception before IUCD insertion increases the odds for method switching by 2.26 times after removal. Similarly, postremoval follow-up by community health worker doubles (OR = 2.0) the chances of method switching. Compared with women who received free IUCD service (via voucher scheme), the method switching is 2.01 times higher among women who had paid for IUCD insertion. Conclusion. To increase the likelihood of method switching among IUCD discontinuers this study emphasizes the need for postremoval client counseling, follow-up by healthcare provider, improved choices to a wider range of contraceptives for poor clients, and user satisfaction.
Baldwin, Maureen K; Edelman, Alison B; Lim, Jeong Y; Nichols, Mark D; Bednarek, Paula H; Jensen, Jeffrey T
To investigate whether early placement of an intrauterine device (IUD) at 3 weeks after delivery, compared to placement at 6 weeks, is associated with greater use at 3 months postpartum. This prospective randomized, controlled trial enrolled inpatient postpartum women intending to use intrauterine contraception. Participants were assigned to an early (3 week) or standard (6 week) postpartum visit with IUD placement and were followed for 6 months. We used transvaginal ultrasonography to confirm placement and measure uterine dimensions. We measured pain with IUD insertion and satisfaction with IUD timing using 100-mm visual analog scales. Data were analyzed based on randomization and actual timing of insertion (18-24 vs. 39-45 days). Between February 2012 and December 2013, 201 subjects were enrolled (early=101; standard=100). Most participants returned for IUD placement as scheduled; 70.1% (53/75) in the early group, 74.3% (58/78) in the standard group (p=.06). IUD use did not differ between groups at 3 months (73/100, 73.0% and 73/97, 75.3%, respectively, p=.72) or 6 months (80.3% and 82.8%, p=.71) amongst those women for whom follow-up was available. Women randomized to 6-week insertion were more likely to have resumed intercourse prior to the IUD appointment (15/64, 23.4% vs. 5/68, 7.3%, p=.01). Pain with insertion (19.9 vs. 25.1, respectively, p=.21) and satisfaction (89.6 vs. 93.4, respectively, p=.23) did not vary based on actual timing of insertion. Offering IUD placement at 3 weeks postpartum compared to standard scheduling at 6 weeks does not result in increased use at 3 months. However, early IUD placement is acceptable to women and without increased pain. This study demonstrates that IUD placement as early as 3 weeks postpartum is feasible. Larger studies are needed to evaluate risks and benefits of IUD placement at this early interval. While earlier timing does not result in increased IUD uptake, early placement should be explored as an option since many
Kaluska, I.; Stuglik, Z.
Overview of sterilization methods of medical devices has been given, with the special stress put on radiation sterilization. A typical validation program for radiation sterilization has been shown and also a comparison of European and ISO standards concerning radiation sterilization has been discussed. (author). 13 refs, 1 fig., 2 tabs
Pakarinen, Päivi; Luukkainen, Tapani
A randomized study was performed to compare the efficacy, safety and acceptability of a new model of an intracervical/intrauterine contraceptive device (ICD) releasing 20 microg of levonorgestrel (LNG) per day. The LNG-ICD was inserted in Group I into the cervical canal and in Group II into the uterine cavity. Group I included 151 women (age, 18-43 years) whereas Group II included 147 (age, 19-43 years). The number of nulliparous women was 145. The 5-year results are presented here. The results showed a total continuation rate of 50%; the continuation rate in the cervical group and that in the uterine group were 53.6% and 46.3%, respectively--the difference being statistically insignificant (p=.3593). The main reason for termination was a wish for pregnancy, which is explained by the relatively young age and degree of nulliparity of the study population. During the first year, two pregnancies occurred in both groups. Two of these were ectopic, one in each group. The other two occurred after unnoticed expulsions. Thereafter, no pregnancies occurred. The cumulative gross rate for pregnancy was 1.3 and the Pearl index at 5 years was 0.425. The total expulsion rate was relatively high (11.1%). Expulsions occurring during the first few months of the first year were related to insertion. Removals because of bleeding and because of amenorrhea were low, the combined gross rate being 5.7 and the Pearl rate 1.8 at 5 years. Also, the gross rate of infection was low (0.7). The continuation was high in spite of a high rate of removals for planning pregnancy (15.4). The method is safe and effective. There were only minor differences between the groups. There were no perforations and the incidence of infection was low. The device can also be used by young nulliparous women.
Felix, Ashley S.; Gaudet, Mia M.; La Vecchia, Carlo; Nagle, Christina M.; Ou Shu, Xiao; Weiderpass, Elisabete; Olov Adami, Hans; Beresford, Shirley; Bernstein, Leslie; Chen, Chu; Cook, Linda S.; De Vivo, Immaculata; Doherty, Jennifer A.; Friedenreich, Christine M.; Gapstur, Susan M.; Hill, Dierdre; Horn-Ross, Pamela L.; Lacey, James V.; Levi, Fabio; Liang, Xiaolin; Lu, Lingeng; Magliocco, Anthony; McCann, Susan E.; Negri, Eva; Olson, Sara H.; Palmer, Julie R.; Patel, Alpa V.; Petruzella, Stacey; Prescott, Jennifer; Risch, Harvey A.; Rosenberg, Lynn; Sherman, Mark E.; Spurdle, Amanda B.; Webb, Penelope M.; Wise, Lauren A.; Xiang, Yong-Bing; Xu, Wanghong; Yang, Hannah P.; Yu, Herbert; Zeleniuch-Jacquotte, Anne; Brinton, Louise A.
Intrauterine devices (IUDs), long-acting and reversible contraceptives, induce a number of immunological and biochemical changes in the uterine environment that could affect endometrial cancer (EC) risk. We addressed this relationship through a pooled analysis of data collected in the Epidemiology of Endometrial Cancer Consortium. We combined individual-level data from 4 cohort and 14 case-control studies, in total 8,801 EC cases and 15,357 controls. Using multivariable logistic regression, we estimated pooled odds ratios (pooled-ORs) and 95% confidence intervals (CIs) for EC risk associated with ever use, type of device, ages at first and last use, duration of use, and time since last use, stratified by study and adjusted for confounders. Ever use of IUDs was inversely related to EC risk (pooled-OR=0.81, 95% CI=0.74–0.90). Compared with never use, reduced risk of EC was observed for inert IUDs (pooled-OR=0.69, 95% CI=0.58–0.82), older age at first use (≥35 years pooled-OR=0.53, 95% CI=0.43–0.67), older age at last use (≥45 years pooled-OR=0.60, 95% CI=0.50–0.72), longer duration of use (≥10 years pooled-OR=0.61, 95% CI=0.52–0.71), and recent use (within 1 year of study entry pooled-OR=0.39, 95% CI=0.30–0.49). Future studies are needed to assess the respective roles of detection biases and biologic effects related to foreign body responses in the endometrium, heavier bleeding (and increased clearance of carcinogenic cells), and localized hormonal changes. PMID:25242594
Modesto, Waleska; de Nazaré Silva dos Santos, Priscila; Correia, Vinicius Machado; Borges, Luiza; Bahamondes, Luis
Data on record regarding weight variation in depot-medroxyprogesterone acetate (DMPA) and levonorgestrel-releasing intrauterine system (LNG-IUS) users are controversial. To date, no studies have yet evaluated weight variation in DMPA and LNG-IUS users in up to ten years of use compared to non-hormonal contraceptive users. A retrospective study analysed weight variations in 2138 women using uninterruptedly DMPA (150 mg intramuscularly, three-monthly; n = 714), the LNG-IUS (n = 701) or a copper-intrauterine device (Cu-IUD; n = 723). At the end of the first year of use, there was a mean weight increase of 1.3 kg, 0.7 kg and 0.2 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively, compared to weight at baseline (p < 0.0001). After ten years of use, the mean weight had risen by 6.6 kg, 4.0 and 4.9 kg among the DMPA-, LNG-IUS- and Cu-IUD users, respectively. DMPA-users had gained more weight than LNG-IUS- (p = 0.0197) and than Cu-IUD users (p = 0.0294), with the latter two groups not differing significantly from each other in this respect (p = 0.5532). Users of hormonal and non-hormonal contraceptive methods gained a significant amount of weight over the years. DMPA users gained more weight over the treatment period of up to ten years than women fitted with either a LNG-IUS or a Cu-IUD.
Full Text Available OBJECTIVE: To undertake an economic evaluation alongside the largest randomised controlled trial comparing Levonorgestrel-releasing intrauterine device ('LNG-IUS' and usual medical treatment for women with menorrhagia in primary care; and compare the cost-effectiveness findings using two alternative measures of quality of life. METHODS: 571 women with menorrhagia from 63 UK centres were randomised between February 2005 and July 2009. Women were randomised to having a LNG-IUS fitted, or usual medical treatment, after discussing with their general practitioner their contraceptive needs or desire to avoid hormonal treatment. The treatment was specified prior to randomisation. For the economic evaluation we developed a state transition (Markov model with a 24 month follow-up. The model structure was informed by the trial women's pathway and clinical experts. The economic evaluation adopted a UK National Health Service perspective and was based on an outcome of incremental cost per Quality Adjusted Life Year (QALY estimated using both EQ-5D and SF-6D. RESULTS: Using EQ-5D, LNG-IUS was the most cost-effective treatment for menorrhagia. LNG-IUS costs £100 more than usual medical treatment but generated 0.07 more QALYs. The incremental cost-effectiveness ratio for LNG-IUS compared to usual medical treatment was £1600 per additional QALY. Using SF-6D, usual medical treatment was the most cost-effective treatment. Usual medical treatment was both less costly (£100 and generated 0.002 more QALYs. CONCLUSION: Impact on quality of life is the primary indicator of treatment success in menorrhagia. However, the most cost-effective treatment differs depending on the quality of life measure used to estimate the QALY. Under UK guidelines LNG-IUS would be the recommended treatment for menorrhagia. This study demonstrates that the appropriate valuation of outcomes in menorrhagia is crucial.
R Please use this checklist to use and maintain your medical device safely and effectively in your home. As a homecare medical device user, you ... home monitoring devices. Home Healthcare Medical Devices: A Checklist For additional government sources and information visit: CDRH ...
Gottert, Ann; Jacquin, Karin; Rahaivondrafahitra, Bakoly; Moracco, Kathryn; Maman, Suzanne
We explored influences on decision making about intrauterine device (IUD) use among women in the Women's Health Project (WHP), managed by Population Services International in Madagascar. We conducted six small group photonarrative discussions (n=18 individuals) and 12 individual in-depth interviews with women who were IUD users and nonusers. All participants had had contact with WHP counselors in three sites in Madagascar. Data analysis involved creating summaries of each transcript, coding in Atlas.ti and then synthesizing findings in a conceptual model. We identified three stages of women's decision making about IUD use, and specific forms of social support that seemed helpful at each stage. During the first stage, receiving correct information from a trusted source such as a counselor conveys IUD benefits and corrects misinformation, but lingering fears about the method often appeared to delay method adoption among interested women. During the second stage, hearing testimony from satisfied users and receiving ongoing emotional support appeared to help alleviate these fears. During the third stage, accompaniment by a counselor or peer seemed to help some women gain confidence to go to the clinic to receive the IUD. Identifying and supplying the types of social support women find helpful at different stages of the decision-making process could help program managers better respond to women's staged decision-making process about IUD use. This qualitative study suggests that women in Madagascar perceive multiple IUD benefits but also fear the method even after misinformation is corrected, leading to a staged decision-making process about IUD use. Programs should identify and supply the types of social support that women find helpful at each stage of decision making. Copyright © 2015 Elsevier Inc. All rights reserved.
Ngo, Lynn L.; Ward, Kristy K.; Mody, Sheila K.
Objective To evaluate intramuscular ketorolac compared to placebo saline injection for pain control with intrauterine device (IUD) placement. Methods We conducted a randomized, double-blind, placebo controlled trial between July 2012 and March 2014. Patients received ketorolac 30mg or placebo saline intramuscular injection 30 minutes prior to IUD placement. The primary outcome was pain with IUD placement on a 10cm visual analog scale (VAS). Sample size was calculated to provide 80% power to show a 2.0cm difference (α=0.05) in the primary outcome. Secondary outcomes included pain with study drug injection, speculum insertion, tenaculum placement, uterine sounding, and at 5 and 15 minutes after IUD placement. Results A total of 67 women participated in the study, 33 in the ketorolac arm and 34 in the placebo arm. There were no differences in baseline demographics including age, BMI, and race. There were no differences in median pain scores for IUD placement in the placebo versus ketorolac groups (5.2cm vs 3.6cm, p=0.99). There was a decrease in median pain scores at 5 minutes (2.2cm vs 0.3cm, p=<0.001) and 15 minutes (1.6cm vs 0.1cm, p=<0.001) after IUD placement but no difference for all other time points. Nulliparous participants (n=16, 8 per arm) had a decrease in pain scores with IUD placement (8.1cm vs 5.4cm, p=0.02). In this study, 22% of participants in the placebo group and 18% in the ketorolac group reported injection pain was as painful as IUD placement. Conclusions Ketorolac does not reduce pain with IUD placement but does reduce pain at 5 and 15 minutes after placement. PMID:26241253
Grentzer, Jaclyn M; Peipert, Jeffrey F; Zhao, Qiuhong; McNicholas, Colleen; Secura, Gina M; Madden, Tessa
The objective was to compare three strategies for Chlamydia trachomatis and Neisseria gonorrhoeae screening prior to intrauterine device (IUD) insertion. This was a secondary analysis of the Contraceptive CHOICE Project. We measured the prevalence of C. trachomatis and/or N. gonorrhoeae at the time of IUD insertion. We then compared sensitivity, specificity, negative and positive predictive values, and likelihood ratios for three screening strategies for C. trachomatis and N. gonorrhoeae prior to IUD insertion: (a) "age-based" — age ≤25 years alone; (b) "age/partner-based" — age ≤25 and/or multiple sexual partners; and (c) "risk-based" — age ≤25, multiple sexual partners, inconsistent condom use and/or history of prior sexually transmitted infection (STI). Among 5087 IUD users, 140 (2.8%) tested positive for C. trachomatis, 16 (0.3%) tested positive for N. gonorrhoeae, and 6 (0.1%) were positive for both at the time of IUD insertion. The "risk-based" screening strategy had the highest sensitivity (99.3%) compared to "age-based" and "age/partner-based" screening (80.7% and 84.7%, respectively.) Only one (0.7%) woman with a chlamydia or gonorrhea infection would not have been screened using "risk-based" screening. A risk-based strategy to screen for C. trachomatis and N. gonorrhoeae prior to IUD insertion has higher sensitivity than screening based on age alone or age and multiple sexual partners. Using a risk-based screening strategy (age≤25, multiple sexual partners, inconsistent condom use and/or history of an STI) to determine who should be screened for C. trachomatis and N. gonorrhoeae prior to IUD insertion will miss very few cases of infection and obviates the need for universal screening. Copyright © 2015 Elsevier Inc. All rights reserved.
Cortessis, Victoria K; Barrett, Malcolm; Brown Wade, Niquelle; Enebish, Temuulen; Perrigo, Judith L; Tobin, Jessica; Zhong, Charlie; Zink, Jennifer; Isiaka, Vanessa; Muderspach, Laila I; Natavio, Melissa; McKean-Cowdin, Roberta
To estimate the association between use of an intrauterine device (IUD) and risk of cervical cancer by subjecting existing data to critical review, quantitative synthesis, and interpretation. We searched PubMed, Web of Science, ClinicalTrials.gov, and catalogs of scientific meetings and abstracts, theses, and dissertations queried from inception through July 2016. Examination of abstracts from 225 reports identified 34 studies with individual-level measures of use of an IUD and incident cervical cancer. By critically assessing the full text of these reports, independent reviewers identified 17 studies conducted without recognized sources of systematic error, of which 16 could be harmonized for meta-analysis. Point and interval estimates of the association between use of an IUD and incident cervical cancer were extracted from original reports into a structured database along with key features of study design and implementation. A random-effects meta-analysis was implemented to quantitatively synthesize extracted estimates and assess likely influence of publication bias, residual confounding, heterogeneity of true effect size, and human papillomavirus prevalence and cervical cancer incidence in source populations. Women who used an IUD experienced less cervical cancer (summary odds ratio 0.64, 95% CI 0.53-0.77). Neither confounding by recognized risk factors nor publication bias seems a plausible explanation for the apparent protective effect, which may be stronger in populations with higher cervical cancer incidence. Invasive cervical cancer may be approximately one third less frequent in women who have used an IUD. This possible noncontraceptive benefit could be most beneficial in populations with severely limited access to screening and concomitantly high cervical cancer incidence.
Nadia van der Westhuizen
Full Text Available Background: The intrauterine device (IUCD is a highly effective and safe method of contraception. Prevention of unwanted pregnancies has made its use a matter of national priority in certain countries.Despite numerous advantages and suitability the uptake of the IUCD is poor. Patients in South Africa seem to lack knowledge regarding this contraceptive. Objectives: The aim of this study was to determine the quantity and quality of knowledge of the IUCD, and to evaluate its acceptability for future use. Methods: A prospective cross-sectional study was conducted at Pelonomi Tertiary Hospital. 201 consecutive patients were interviewed using structured questionnaires. Results: Awareness of the IUCD was found in almost half (49%, n=95 of our patients. Its use was very low, with only one patient having used it before. Overall qualitative knowledge was poor, even among those that were aware of the IUCD. There was a significant association between level of education and knowledge, with patients having passed Grade 12 or higher significantly more likely to have knowledge of the IUCD than those at lower levels (RR 1.57, 95% CI 1.18-2.08. Forty-five percent (n=86 of patients indicated a desire for future IUCD use. Conclusion: Despite the availability of the IUCD in South African clinics and hospitals, its uptake is still poor. Awareness of this method seemed to have improved over the past few years, but the qualitative knowledge still lacks considerably. Education plays a major role in the knowledge of contraception and better educational aids in all facilities will increase its use and reduce unwanted pregnancies.
Zhang, Weiwei; Xia, Xianping; Qi, Cheng; Xie, Changsheng; Cai, Shuizhou
To improve the rates of both cupric ion release and the utilization of copper in non-porous copper/low-density polyethylene (Cu/LDPE) composite, a porous Cu/LDPE composite is proposed and developed in the present work. Here 2,5-di-tert-butylhydroquinone was chosen as the porogen, ethyl acetate was chosen as the solvent for extraction, and the porous Cu/LDPE composite was obtained by using injection molding and the particulate leaching method. After any residual ethyl acetate remaining inside the porous Cu/LDPE composite had been removed by vacuum drying, the composite was characterized by X-ray diffraction, scanning electron microscopy, Fourier transform infrared spectroscopy, gas chromatography-mass spectrometry and absorption measurement. For comparison, a non-porous Cu/LDPE composite was also characterized in the same way. The results show that the porous structure was successfully introduced into the polymeric base of the non-porous Cu/LDPE composite, and the porous Cu/LDPE composite is a simple hybrid of copper particles and porous LDPE. The results also show that the introduction of a porous structure can improve the cupric ion release rate of the non-porous Cu/LDPE composite with a certain content of copper particles, indicating that the utilization rate of copper can be improved either the introduction of a porous structure, and that the porous Cu/LDPE composite is another promising material for copper-containing intrauterine devices. Copyright © 2011 Acta Materialia Inc. Published by Elsevier Ltd. All rights reserved.
Oderich, Carolina L; Wender, Maria Celeste O; Lubianca, Jaqueline N; Santos, Letícia M; de Mello, Grasiele C
We investigated the influence of an etonogestrel-releasing (ETG) implant and copper intrauterine device (IUD) on carbohydrate metabolism. In this nonrandomized, open-label, prospective controlled trial, 40 healthy women received an implant or IUD (20 per group). Outcome measures were fasting glucose, fasting insulin, oral glucose tolerance test (OGTT) and glycosylated hemoglobin A(1)C (HbA(1)C) levels at baseline and after 6 and 12 months. The groups were similar in age, body mass index and laboratory parameters at baseline. Carbohydrate metabolism was not modified by the ETG implant at baseline and at 6 and 12 months (mean ± SD) (fasting glucose: 85.9 ± 5.13, 87.05 ± 5.36, 88.19 ± 5.05; insulin: 7.77 ± 2.42, 10.64 ± 9.4, 8.82 ± 3.73; OGTT: 94.8 ± 25.28, 96.5 ± 19.67, 99.47 ± 24.6; HbA(1)C: 5.27 ± .34, 5.55 ± .39, 5.7 ± 0.37). The same was true for the IUD (fasting glucose: 88.87 ± 7.2, 89.65 ± 5.86, 88.75 ± 4.79; insulin: 7.94 ± 3.6, 8.3 ± 4.1, 7.34 ± 3.02; OGTT: 96.85 ± 15.16, 97.48 ± 13.42, 91.3 ± 22.16; HbA(1)C: 5.41 ± .49, 5.75 ± .41, 5.9 ± 0.73). The ETG-releasing implant did not affect carbohydrate metabolism in normal women after 12 months. Copyright © 2012 Elsevier Inc. All rights reserved.
Whitaker, Amy K; Endres, Loraine K; Mistretta, Stephanie Q; Gilliam, Melissa L
This trial was designed to compare levonorgestrel intrauterine device (LNG-IUD) use at 1 year after delivery between women randomized to postplacental insertion at the time of cesarean delivery and delayed insertion 4-8 weeks after delivery. This randomized controlled trial was conducted at two urban medical centers. Eligible pregnant women with planned cesarean deliveries were randomized to immediate postplacental insertion during cesarean or delayed insertion after 4-8 weeks. We used intention-to-treat analysis for the primary outcome of LNG-IUD use 12 months after delivery. Forty-two women were randomized, 20 into the postplacental group and 22 in the delayed group. Although confirmed use of the LNG-IUD 12 months after delivery was higher in the postplacental group (60.0% vs. 40.9%, p=.35), this difference was not statistically significance. Expulsion was significantly more common in the postplacental group (20.0% vs. 0%, p=.04). There were significant differences between the two sites in baseline population characteristics, follow-up and expulsion. The trial did not answer the intended question as it was halted early due to slow enrollment. Our results show higher expulsion after postplacental insertion compared to delayed insertion but suggest similar IUD use at 12 months. Moreover, it provides valuable lessons regarding a randomized controlled trial of postplacental LNG-IUD placement due to the challenges of estimating effect size and the nature of the population who might benefit from immediate insertion. Postplacental insertion of an IUD may improve use of highly effective contraception during the postpartum period. While our results suggest higher expulsion after postplacental insertion compared to delayed insertion and similar IUD use at 12 months, our trial was insufficient to definitively test our hypothesis. Copyright © 2014 Elsevier Inc. All rights reserved.
Foda, Ashraf A; El-Malky, Mohamed M
This study was performed to study the prevalence and potential pathogenicity of E. gingivalis in the genital tracts of intrauterine contraceptive device (IUD) users. A prospective study conducted at the Obstetrics and Gynecology Department and Fertility Care Unit, Mansoura University Hospital, Egypt. The study was carried out on 87 IUD users and 87 nonusers. The copper T 380A IUD was removed from each woman and washed with phosphate-buffered saline (PBS) pH 7.4; the IUD wash was centrifuged. The sediment was resuspended in 2 ml PBS and divided into two portions. One portion was used for preparation of direct and iron hematoxylin-stained smears. Direct smears and stained smears were examined for detailed morphology. The second portion of the sediment was used for DNA extraction and subsequent PCR amplification targeting the small subunit ribosomal RNA of E. gingivalis. The parasite was found in 12.64% of IUD users and in 6.9% of non users (p>.3). It was found that 90.9% of those harboring E. gingivalis in their genital tract had the parasite in their oral cavity. The percentage of genital infection in IUD users increased with low level of education, rural areas, insertion in primary health-care center and among those not washing hands before checking the strings. In the infected cases, vaginal discharge was more common (81.8%) than in noninfected cases (32.9%), such difference was statistically significant (p<.05). Also, excessive vaginal discharge is more common than backache and menorrhagia in the infected cases. Higher incidence of E. gingivalis infection in IUD users is related to oral cavity infection, residence, the facility where they inserted their IUD and washing hands attitude before checking the strings. We recommend treatment of gingival infection, proper counseling and medical education on oral and genital tract hygiene for IUD users. Copyright © 2012 Elsevier Inc. All rights reserved.
Pagano, H Pamela; Zapata, Lauren B; Berry-Bibee, Erin N; Nanda, Kavita; Curtis, Kathryn M
Women with depressive or bipolar disorders are at an increased risk for unintended pregnancy. To examine the safety of hormonal contraception among women with depressive and bipolar disorders. We searched for articles published through January 2016 on the safety of using any hormonal contraceptive method among women with depressive or bipolar disorders, including those who had been diagnosed clinically or scored above threshold levels on a validated screening instrument. Outcomes included changes in symptoms, hospitalization, suicide and modifications in medication regimens such as increase or decrease in dosage or changes in type of drug. Of 2376 articles, 6 met the inclusion criteria. Of three studies that examined women clinically diagnosed with depressive or bipolar disorder, one found that oral contraceptives (OCs) did not significantly change mood across the menstrual cycle among women with bipolar disorder, whereas mood did significantly change across the menstrual cycle among women not using OCs; one found no significant differences in the frequency of psychiatric hospitalizations among women with bipolar disorder who used depot medroxyprogesterone acetate (DMPA), intrauterine devices (IUDs) or sterilization; and one found no increase in depression scale scores among women with depression using and not using OCs, for both those treated with fluoxetine and those receiving placebo. Of three studies that examined women who met a threshold for depression on a screening instrument, one found that adolescent girls using combined OCs (COCs) had significantly improved depression scores after 3 months compared with placebo, one found that OC users had similar odds of no longer being depressed at follow-up compared with nonusers, and one found that COC users were less frequently classified as depressed over 11 months than IUD users. Limited evidence from six studies found that OC, levonorgestrel-releasing IUD and DMPA use among women with depressive or bipolar
Davis, J. R
... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...
Ramakrishna, Seeram; Wang, Charlene
Medical Devices and Regulations: Standards and Practices will shed light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices. Based on the authors' practical experience, this book provides a concise, practical guide on key issues and processes in developing new medical devices to meet international regulatory requirements and standards. Provides readers with a global perspective on medical device regulationsConcise and comprehensive information on how to desig
Todorović Nada 1
Full Text Available Pyometra is the accumulation of pus in the uterine cavity, thus streaching its walls and thinning and enlarging the uterus. This change is characteristic of the senium period of life, when the uterus is atrophie with a stenotic cervical canal. It most frequently occurs as a result of secondary infection of the cancerogenic tissue of the uterus and additional stenosation and clogging up of cervical canal by a malignant process. Apart from carcinomas of the body and uterus cervix, pyometra less often can occur in other illnesses such as senile endometritis and senile colpitis. As pyometra most frequently occurs in uterine carcinomas, in detection of this state, we must think of malignancy and direct our examination to this direction. In this paper we present a patient in whom pyometra developed because she carried an intrauterine device for forty years that resulted in chronic endometritis. The main symptoms for which the patient was admited to hospital were abdominal pain and intensive suppurative vaginal excretion a month after removal of intrauterine device. The diagnosis of pyometra was made by gynaecological and ultrasound examinations, and also on the basis of gynecological and ultrasound examinations one month after chronic endometritis was confirmed. On the basis of this finding we suspected that chronic endometritis was caused by this state. By cytological, PAP and histopathological examinations of samples obtained by explorative curettage and biopsy of the uterine cervix, malignant changes were eliminated a possible cause. By laboratory analysis and bacteriological examination of the uterine cavity and vaginal excretion, inflammatory changes of the uterine mocous membrane were confirmed as a cause of the pyometra. This conditions was due to carrying the intrauterine device for more decades. The therapy consisted of dilatation of the cervical canal and evacuation of accumulated suppurative contents and irrigation of uterine cavity with 3
Atasoy, C.; Fitoz, S.; Akyar, S.
Perforation of the uterus is a recognized complication associated with the use of an intrauterine contraceptive (IUCD). However, migration of an IUCD into the bladder, with or without stone formation, is exceptionally rare. We report the case of a patient with a displaced IUCD that acted as a nidus for bladder lithiasis. (author)
Atasoy, C.; Fitoz, S.; Akyar, S. [Ankara Univ. School of Medicine, Dept. of Radiology, Ibn-i Sina Hospital, Ankara (Turkey)
Perforation of the uterus is a recognized complication associated with the use of an intrauterine contraceptive (IUCD). However, migration of an IUCD into the bladder, with or without stone formation, is exceptionally rare. We report the case of a patient with a displaced IUCD that acted as a nidus for bladder lithiasis. (author)
Hoffman, Steven J; Guindon, G Emmanuel; Lavis, John N; Randhawa, Harkanwal; Becerra-Posada, Francisco; Boupha, Boungnong; Shi, Guang; Turdaliyeva, Botagoz S
It is widely agreed that the practices of clinicians should be based on the best available research evidence, but too often this evidence is not reliably disseminated to people who can make use of it. This "know-do" gap leads to ineffective resource use and suboptimal provision of services, which is especially problematic in low- and middle-income countries (LMICs) which face greater resource limitations. Family planning, including intrauterine device (IUD) use, represents an important area to evaluate clinicians' knowledge and practices in order to make improvements. A questionnaire was developed, tested and administered to 438 individuals in China (n = 115), Kazakhstan (n = 110), Laos (n = 105), and Mexico (n = 108). The participants responded to ten questions assessing knowledge and practices relating to contraception and IUDs, and a series of questions used to determine their individual characteristics and working context. Ordinal logistic regressions were conducted with knowledge and practices as dependent variables. Overall, a 96 % response rate was achieved (n = 438/458). Only 2.8 % of respondents were able to correctly answer all five knowledge-testing questions, and only 0.9 % self-reported "often" undertaking all four recommended clinical practices and "never" performing the one practice that was contrary to recommendation. Statistically significant factors associated with knowledge scores included: 1) having a masters or doctorate degree; and 2) often reading scientific journals from high-income countries. Significant factors associated with recommended practices included: 1) training in critically appraising systematic reviews; 2) training in the care of patients with IUDs; 3) believing that research performed in their own country is above average or excellent in quality; 4) being based in a facility operated by an NGO; and 5) having the view that higher quality available research is important to improving their work. This
Singh, Sharad; Das, Vinita; Agarwal, Anjoo; Dewan, Rupali; Mittal, Pratima; Bhamrah, Renita; Lerma, Klaira; Blumenthal, Paul D
To assess the feasibility, acceptability, and safety of a dedicated postpartum intrauterine device (PPIUD) inserter specifically designed for the post-delivery setting. Primary objectives of fundal placement and expulsion rates were assessed. Secondary objectives were participant satisfaction and IUD retention. In this pilot proof of concept, we enrolled 80 women who presented for PPIUD insertion at 2 government hospitals in Delhi and Lucknow, India, between March and July 2015. PPIUD insertion was completed with the dedicated inserter in all cases, by trained providers with no prior experience in PPIUD insertion, followed immediately by ultrasound to assess location and fundal placement of the IUD. Follow-up took place at 6 to 8 weeks post-insertion, and ultrasound was used to assess IUD location. Providers and participants also completed satisfaction surveys. High fundal placement (≤10 mm from uterine fundus) was achieved with the dedicated PPIUD inserter in 82% of cases (n = 65). There were no perforations or infections among the participants and no other complications associated with use of the dedicated inserter. The mean distance between the IUD and the endometrial verge immediately post-insertion was 5.8 mm (range, 0-31; N = 80); this distance at follow-up was also 5.8 mm (range, 0-25; n = 50). Complete expulsion was observed in 6 cases (7.5%), and asymptomatic partial expulsion in 8 cases (10%). Providers reported the majority (93%, n = 74) of insertions to be easy. The majority (74%, n = 59) of participants reported the same level of pain before and after insertion. This dedicated PPIUD inserter performed as intended and was found to be safe, with high acceptability among the participants and providers. Further study and use of the dedicated inserter may reveal reduced risk of infection among PPIUD users as well as increased convenience compared with standard PPIUD insertion techniques, and could improve acceptability of postpartum
Toumi, Omar; Ammar, Houssem; Ghdira, Abdessalem; Chhaidar, Amine; Trimech, Wided; Gupta, Rahul; Salem, Randa; Saad, Jamel; Korbi, Ibtissem; Nasr, Mohamed; Noomen, Faouzi; Golli, Mondher; Zouari, Khadija
Intrauterine devices (IUDs) are commonly used as a contraceptive method. However, they may cause rare but potentially serious complications such as migration through the uterine wall and gastrointestinal perforation. We report a case of a 26-year woman, carrying an IUD for 2 years, who presented to the emergency with pelvic pain with breakthrough bleeding. Abdominal imaging revealed the presence of two devices the first of which was located in the uterine cavity and the other in the wall of the sigmoid colon associated with a 5-centimeter pelvic collection. Intraoperatively, the IUD was found to be embedded in the wall of the sigmoid colon which was removed by wedge resection of the involved segment followed by a closure of the puncture with drainage. The Intrauterine Device (IUD) is an effective method of contraception, relatively well tolerated, reversible, inexpensive and widely used. However, it is not without risk. Indeed, serious complications can occur such as uterine perforation and migration to adjacent abdomino-pelvic structures. Our observation illustrates its rarity given the fact that this complication has been observed the first time in our department over the last ten years. The migration of IUD must be treated even in asymptomatic patients due to the risk of severe complications. Published by Elsevier Ltd.
Costa Monteiro, E.; Leon, L. F.
The prominent development of health technologies of the 20th century triggered demands for metrological reliability of physiological measurements comprising physical, chemical and biological quantities, essential to ensure accurate and comparable results of clinical measurements. In the present work, aspects concerning metrological reliability in premarket and postmarket assessments of medical devices are discussed, pointing out challenges to be overcome. In addition, considering the social relevance of the biomeasurements results, Biometrological Principles to be pursued by research and innovation aimed at biomedical applications are proposed, along with the analysis of their contributions to guarantee the innovative health technologies compliance with the main ethical pillars of Bioethics.
Full Text Available Today, a large proportion of early abortions are medical terminations, in accordance to the woman's choice. Intrauterine contraceptives (IUC provide highly effective, reversible, long-acting contraception. However, the effects of timing of IUC insertion after medical abortion are not known.Women undergoing medical abortion with mifepristone and misoprostol up to 63 days gestation and opting for IUC were randomised to early insertion (day 5-9 after mifepristone or delayed (routine insertion (at 3-4 weeks after mifepristone. The primary outcome was the rate of IUC expulsion at six months after IUC insertion.A total of 129 women were randomized, and 116 women had a successful IUC insertion. There was no difference in expulsion rate between early (9.7% vs. delayed (7.4% IUC insertion (risk difference -9.2-13.4. Furthermore, 1.5% of women randomized to early and 11.5% to delayed insertion did not attend the follow up (proportion difference 10.0%, 95% CI: 1.8-20.6%, p = 0.015, and a higher proportion of women (41% had had unprotected intercourse prior to returning for insertion in the delayed group compared with the early group (16% (p = 0.015. Adverse events were rare and did not differ between the groups.Early insertion of IUC after medical abortion was safe and well tolerated with no increased incidence for expulsions or complications. Women were more likely to return for the IUC insertion if scheduled early after the abortion, and less likely to have had an unprotected intercourse prior to the IUC insertion. Early insertion should be offered as a routine for women undergoing first trimester medical abortion.ClinicalTrials.gov NCT01537562.
Ezegwui, H U; Nwogu-Ikojo, E E; Ikeako, L C; Nweze, S
To estimate the acceptance rate and trend of Intrauterine Contraceptive Device (IUCD) use in Enugu, Nigeria A review of all new acceptors of intrauterine contraceptive device (IUCD) over a nine year period (1999-2007). A total of 133,375 clients were seen at the UNTH family planning clinic between 1999 and 2007. Out of 6,947 users of IUCD, during the period, 1,659 were new acceptors. The IUCD acceptance rate was 5.21%. Majority of the clients (29.7%) were aged 40 years and above. Eight hundred and forty seven (51.4%) had attained post secondary education. Majority of the clients (99.4%) were married . Twenty-six percent (26.0%) had completed their desired family size. Majority 1,359 (82.4%) did not use any method contraception prior to IUCD insertion. The commonest complication was menorrhagia (5.8%) and this was responsible for removal in 3.0% of cases. Eight (0.5%) and nine (0.6%) requested for removal for fear of causing cancer and migration to the brain or heart respectively. Two (0.1%) became pregnant while having the IUCD in-situ. Majority of the clients (50.5%) had the knowledge of lUCD through friends. This study has shown that IUCD (TCU 380A) is both safe and effective in Enugu, Nigeria. Its use is for both child spacing and limiting family size.
... generally that the term ``device'' means an instrument, apparatus, implement, machine, contrivance, implant...) whether the device generally must be implanted, inserted, operated, or otherwise administered by a medical... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...
Hernández Valencia, M; Becerril Flores, L C
Postpartum insertion of the intrauterine device (IUD) can provide an effective and convenient means of contraception. As a result, the use of IUD's has steadily increased, and the Family Planning Program recommends it because it offers many advantages. However, a major risk associated with the use of IUD's is the possibility of its expulsion, which ranges from 4 to 60%. Furthermore, 20% of women who expelled IUD's were unaware that it occurred, thus increasing their susceptibility to unwanted pregnancies. IUD's modified by the addition of biodegradable strands of chromic suture at time of implantation are thought to be less likely to be expelled, as the sutures anchor the IUD more firmly to the endometrium, and it is possible that the use of these sutures may decrease the risk of expulsion. Therefore we determined if the chromic extension to IUD enhance retention and decreased the rate of expulsion. In one year of study, 150 women received a modified IUD (TCu 380) with chromic catgut number 0 (ccO) in the transversal arm within 10 minutes of delivery of the placenta. However, only 84 women completed the follow-up study. To evaluate IUD expulsion, exploratory examinations were conducted during the immediate postpartum, at 7 days postpartum and at 6 weeks after delivery. We determined the presence or expulsion of the IUD in these three periods postpartum. Other parameters such as parity, age and marital status were also considered. A total of 14 modified IUD's (16.6%) were expelled. This represents a similar frequency of expulsion both during the immediate postpartum and the 7 days postpartum period. There was no significant difference in the rate of expulsion between the two periods. Moreover, there was no expulsion at 6 weeks postpartum. The primiparity women had the highest percentage of expulsion (22.8%). Single mothers either living with or without their sexual partner had expulsion rates of 20.6 and 20.5%, respectively. The highest rate of expulsion when we
Jatlaoui, Tara C; Riley, Halley E M; Curtis, Kathryn M
The objective was to determine the association between use of intrauterine devices (IUDs) by young women and risk of adverse outcomes. We searched Pubmed, CINAHL, Embase, Popline and the Cochrane Library for articles from inception of database through December 2015. For outcomes specific to IUD use (IUD expulsion and perforation), we examined effect measures for IUD users generally aged 25 years or younger compared with older IUD users. For outcomes of pregnancy, infection, pelvic inflammatory disease (PID), and heavy bleeding or anemia, we examined young IUD users compared with young users of other contraceptive methods or no method. We identified 3169 articles of which 16 articles from 14 studies met our inclusion criteria. Six studies (Level II-2, good to poor) reported increased risk of expulsion among younger age groups compared with older age groups using copper-bearing (Cu-) IUDs. Two studies (Level II-2, fair) examined risks of expulsion among younger compared with older women using levonorgestrel-releasing (LNG-) IUDs; one reported no difference in expulsion, while the other reported increased odds for younger women. Four studies (Level II-2, good to poor) examined risk of expulsion among Cu- and LNG-IUD users combined and reported no significant differences between younger and older women. For perforation, four studies (Level II-2, fair to poor) found very low perforation rates (range, 0%-0.1%), with no significant differences between younger and older women. Pregnancies were generally rare among young IUD users in nine studies (Level I to II-2, fair to poor), and no differences were reported for young IUD users compared with young combined oral contraceptive (COC) or etonogestrel (ENG) implant users. PID was rare among young IUD users; one study reported no cases among COC or IUD users, and one reported no difference in PID among LNG-IUD users compared with ENG implant users from nationwide insurance claims data (Level I to II-2, fair). One study
Full Text Available Dirk Wildemeersch,1 Sohela Jandi,2 Ansgar Pett,2 Kilian Nolte,3 Thomas Hasskamp,4 Marc Vrijens5 1Gynecological Outpatient Clinic and IUD Training Center, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, 3Gynecological Outpatient Clinic, Uetze, 4GynMünster, Münster, Germany; 5Gynecological Outpatient Clinic, Ghent, Belgium Background: The purpose of this study was to provide additional data on the experience with frameless copper and levonorgestrel (LNG intrauterine devices (IUDs in nulliparous and adolescent women. Methods: Nulliparous and adolescent women, 25 years of age or younger, using the frameless copper IUD or the frameless LNG-releasing intrauterine system (IUS, were selected from previous studies and a current multicenter post-marketing study with the frameless copper IUD. The small copper-releasing GyneFix® 200 IUD consists of four copper cylinders, each 5 mm long and only 2.2 mm wide. The frameless FibroPlant® LNG-IUS consists of a fibrous delivery system releasing the hormone levonorgestrel (LNG-IUS. The main features of these intrauterine contraceptives are that they are frameless, flexible, and anchored to the fundus of the uterus. Results: One hundred and fifty-four nulliparous and adolescent women participated in the combined study. One pregnancy occurred with the GyneFix 200 IUD after unnoticed early expulsion of the device (cumulative pregnancy rate 1.1 at one year. Two further expulsions were reported, one with the GyneFix 200 IUD and the other with the FibroPlant LNG-IUS. The cumulative expulsion rate at one year was 1.1 with the copper IUD and 2.2 with the LNG-IUS. The total discontinuation rate at one year was low (3.3 and 4.3 with the copper IUD and LNG-IUS, respectively and resulted in a high rate of continuation of use at one year (96.7 with the copper IUD and 95.7 with the LNG-IUS, respectively. Continuation rates for both frameless copper IUD and frameless LNG-IUS remained high at 3 years (>90%. There
Macchia, Gabriella; Deodato, Francesco; Cilla, Savino; Legge, Francesco; Carone, Vito; Chiantera, Vito; Valentini, Vincenzo; Morganti, Alessio Giuseppe; Ferrandina, Gabriella
The present study investigated the combination of levonorgestrel-releasing intrauterine device (LNG-IUD) insertion and palliative radiotherapy (RT) as a potential approach for treating frail, elderly endometrial cancer (EC) patients considered unfit for curative oncological treatments. The inclusion criteria were an age of ≥65 years, pathological confirmation of a uterine neoplasm, a Charlson comorbidity index (CCI) value of ≥4 and the presence of vaginal bleeding. Patients underwent intrauterine insertion of an LNG-IUD, and thereafter, received a total dose of 30 Gy at 3 Gy per fraction, over 10 days. The clinical target volume (CTV) was defined as the uterus and disease-involved tissues in the pelvis plus a 1-cm margin. The planning target volume was obtained by adding a 1-cm isotropic margin to the CTV. A total of 9 patients with EC (median age, 85 years; Eastern Cooperative Oncology Group performance status ≥2, ≥88.8%; obesity, 55.5%; median CCI, 5) received an LNG-IUD plus RT. An early complete resolution of bleeding was documented in 8 patients (88.8%), while the remaining patient experienced a marked improvement. The median duration of bleeding control was 18 months, while the 2-year actuarial rate of bleeding-free survival was 53.3% (median follow-up time, 20 months; range, 9-60 months). No LNG-IUD- or severe RT-related complications were documented. Overall, a high rate of bleeding remission, durable bleeding-free survival in face of the easy intrauterine insertion of an LNG-IUD and a negligible toxicity profile of the complete treatment were documented in this study, indicating a requirement for further investigation in a larger series.
Nguyen, Yvonne; Fischer, Gayle
Chronic vulvovaginal candidiasis is usually responsive to therapy with oral antifungals. We present a case series of 13 patients with this condition who were also using a levonorgestrel intrauterine system (LNG-IUS). All cases responded to ongoing oral fluconazole therapy while the LNG-IUS was in situ. The LNG-IUS was removed in six patients and of these, two experienced clinical improvement with lower fluconazole dosage requirements and three experienced complete resolution of symptoms. One remains on fluconazole 100 mg daily. © 2016 The Australasian College of Dermatologists.
National Aeronautics and Space Administration — A compact microgravity and hypogravity compatible vacuum device is proposed to provide medical suction and containment of extracted fluids. The proposed aspirator...
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image hardcopy device. 892.2040 Section... (CONTINUED) MEDICAL DEVICES RADIOLOGY DEVICES Diagnostic Devices § 892.2040 Medical image hardcopy device. (a) Identification. A medical image hardcopy device is a device that produces a visible printed record of a medical...
... used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of devices... practitioners; and health care and consumer advocacy organizations, including individual physicians and hospital...
Yang, Zhihong; Xie, Changsheng; Xiang, Hua; Feng, Jinqing; Xia, Xianping; Cai, Shuizhou
Copper/indomethacin/low-density polyethylene (Cu/IDM/LDPE) nanocomposite was prepared as a novel material for intra-uterine device (IUD). IDM release profile of the nanocomposite was investigated by using spectrophotometer. The results show that IDM release rate of Cu/IDM/LDPE nanocomposite is higher in simulated uterine solution than that in methanol, confirming that the release process of IDM is dominated mainly by pore diffusion. The decrease in copper particle size and the increase in copper mass content all accelerate IDM release, indicating that IDM release rate can be adjusted by changing copper loading or copper particle size. The surface of the incubated nanocomposite was characterized by X-ray diffraction, scanning electron microscopy and energy dispersive X-ray microanalysis. A few deposits composed of P, Cl, Ca, Cu and O were observed on the nanocomposite surface, which may be related to the presence of IDM particles with large particle size.
Reinprayoon, D; Gilmore, C; Farr, G; Amatya, R
The long-term effectiveness of the copper-bearing intrauterine device (IUD) has been documented. This paper reports 12-month results from a multiyear comparative study of the Copper T (TCu) 380A and Multiload (ML) 250 IUD in Bangkok, Thailand, among 1396 women. Continuation of the assigned IUD was relatively high after 12 months of use, with continuation rates of 90.17 and 87.54 per 100 women, respectively. Whereas the accidental pregnancy rate was higher for the ML 250 IUD than for the TCu 380A IUD (1.0 and 0.2 per 100 women, respectively), this difference was not considered statistically significant (p TCu 380A IUD (4.61 and 2.40 per 100 women, respectively, p = 0.05).
Andrade, Carla Maria Araujo; Araujo Júnior, Edward; Torloni, Maria Regina; Moron, Antonio Fernandes; Guazzelli, Cristina Aparecida Falbo
To compare the rates of success of two-dimensional (2D) and three-dimensional (3D) sonographic (US) examinations in locating and adequately visualizing levonorgestrel intrauterine devices (IUDs) and to explore factors associated with the unsuccessful viewing on 2D US. Transvaginal 2D and 3D US examinations were performed on all patients 1 month after insertion of levonorgestrel IUDs. The devices were considered adequately visualized on 2D US if both the vertical (shadow, upper and lower extremities) and the horizontal (two echogenic lines) shafts were identified. 3D volumes were also captured to assess the location of levonorgestrel IUDs on 3D US. Thirty women were included. The rates of adequate device visualization were 40% on 2D US (95% confidence interval [CI], 24.6; 57.7) and 100% on 3D US (95% CI, 88.6; 100.0). The device was not adequately visualized in all six women who had a retroflexed uterus, but it was adequately visualized in 12 of the 24 women (50%) who had a nonretroflexed uterus (95% CI, -68.6; -6.8). We found that 3D US is better than 2D US for locating and adequately visualizing levonorgestrel IUDs. Other well-designed studies with adequate power should be conducted to confirm this finding. © 2015 Wiley Periodicals, Inc.
Kim, Caron R; Martinez-Maza, Otoniel; Magpantay, Larry; Magyar, Clara; Gornbein, Jeffrey; Rible, Radhika; Sullivan, Peggy
The objective was to describe the endometrial milieu of stable transplant patients and healthy women before and after levonorgestrel intrauterine system (LNG-IUS) insertion. Women between 18 and 45 years of age desiring LNG-IUS insertion were enrolled with a 2:1 ratio of healthy to stable solid organ transplant patients. The first visit entailed a blood draw, uterine lavage and endometrial biopsy followed by LNG-IUS insertion. Follow-up visit involved a repeat serum draw, uterine lavage and endometrial biopsy. Cytokine levels were measured in the uterine lavage and serum by quantifying inflammatory biomarkers. Immunohistochemistry staining was performed on the endometrial tissue to measure macrophage levels. Statistical analysis included a nonparametric analysis that compared medians of the marker levels before and after intrauterine device (IUD) insertion within the group and between the two groups. Sixteen participants completed the study: 5 solid organ transplant patients and 11 healthy patients. For the serum, there were no marked changes in the cytokines or soluble receptor levels in either group after IUD insertion. However, in the uterine lavage, there was an increase in cytokine levels post-IUD insertion for both healthy and transplant women. For the endometrial tissue, there was evidence of macrophage activity in both groups after device insertion. This pilot study investigated the uterine environment of the transplant patient population. Findings have pointed to the strong local inflammatory response following LNG-IUS insertion for the transplant recipients. In addition, these preliminary findings will help power a larger study that can investigate the safety and effectiveness of the IUD in this patient population. Findings from this pilot study suggest that the IUD is inducing a local inflammatory reaction in the uterus of the transplant patient as in the healthy control. A larger study can build on these preliminary results to pursue the efficacy and
Ogrodnik, Peter J
The Case Studies in Medical Devices Design series consists of practical, applied case studies relating to medical device design in industry. These titles complement Ogrodnik's Medical Device Design and will assist engineers with applying the theory in practice. The case studies presented directly relate to Class I, Class IIa, Class IIb and Class III medical devices. Designers and companies who wish to extend their knowledge in a specific discipline related to their respective class of operation will find any or all of these titles a great addition to their library. Class 1 Devices is a companion text to Medical Devices Design: Innovation from Concept to Market. The intention of this book, and its sister books in the series, is to support the concepts presented in Medical Devices Design through case studies. In the context of this book the case studies consider Class I (EU) and 510(k) exempt (FDA) . This book covers classifications, the conceptual and embodiment phase, plus design from idea to PDS. These title...
Dhillon, Balbir S
.... Although the history of reliability engineering can be traced back to World War II, the application of reliability engineering concepts to medical devices is a fairly recent idea that goes back to the latter part of the 1960s when many publications on medical device reliability emerged. Today, a large number of books on general reliability have been...
... in 2011 as a forum to discuss future directions in medical device regulatory harmonization. It is a... auditing and monitoring the manufacturing of medical devices to ensure safe medical devices. The IMDRF, at... addition to regulatory authority inspectorates, allows greater coverage in auditing manufacturers as...
Privitera, Mary Beth
Contextual Inquiry for Medical Device Design helps users understand the everyday use of medical devices and the way their usage supports the development of better products and increased market acceptance. The text explains the concept of contextual inquiry using real-life examples to illustrate its application. Case studies provide a frame of reference on how contextual inquiry is successfully used during product design, ultimately producing safer, improved medical devices. Presents the ways contextual inquiry can be used to inform the evaluation and business case of technologyHelps users
Dennis, J; Webb, A; Kishen, M
To assess the first year's use with the GyneFix intra-uterine device. This has been used in Liverpool since early 1997. It is offered mainly to nulliparous women wishing to use an effective non-hormonal method and parous women who have had pain with, or expulsion of, a framed device previously. It is also used as emergency contraception. Retrospective study, by means of casenote review and client questionnaire. All GyneFix users from February 1997 to January 1998; 215 women in total. Data were extracted from casenotes to determine reasons for choice of GyneFix, parity, whether the insertion was planned or as an emergency measure, problems reported at follow-up and reasons for removal. Users were asked by questionnaire to comment on insertion procedure, menstrual or other changes since insertion and to state their overall satisfaction. Over half of the users (57%) were nulliparous and a quarter of insertions were for emergency contraceptive use. A third reported that insertion was 'very painful'. Half reported that their periods had become heavier since insertion, but only 8% said that they were now unmanageable. Unacceptable bleeding was the most common reason for removal. Some reported intermenstrual bleeding and dysmenorrhoea. Satisfaction with the GyneFix was high; 86% of questionnaire responders said that they would recommend it to a friend. The GyneFix is well accepted in Liverpool inappropriately selected clients, and is an effective non-hormonal method for nulliparous as well as parous women.
Imani, Somaieh; Moghaddam-Banaem, Lida; Roudbar-Mohammadi, Shahla; Asghari-Jafarabadi, Mohammad
OBJECTIVE To assess the effects of the copper intrauterine device (IUD) TCu-380A, on copper and zinc serum levels. MATERIAL AND METHODS This longitudinal study enrolled 121 women attending Health Centres in Tehran between November 2011 and August 2012. A blood sample was obtained before use and three months after insertion of a TCu-380A IUD. Serum levels of copper and zinc were measured for the 101 women who had completed three months with the device in situ. Analyses of change included paired t-tests, McNemar tests and linear regression. RESULTS Significant elevations in mean serum levels were found for both copper (170.22 μg/dl at three months vs.160.40 μg/dl at baseline, p = 0.034) and zinc (107.67 μg/dl at three months vs. 94.61 μg/dl at baseline, p TCu-380A IUD insertion. Zinc levels too had risen significantly, which was quite unexpected, and warrants further investigation.
Mobile medical devices, such as infusion pumps, provide an important therapeutic function. They are also valuable sources of information about treatment patterns at the point of care. However, these mobile devices have been independent islands of valuable information, unable to share the data they gather with other hospital information resources on a real time basis. Although data from these devices can provide significant improvements for medical safety and vital information needed for clinical best practice development, gathering that data poses significant challenges when interfacing with hospital information systems. Mobile medical devices move from place to place as independent actors, raising a series of security and identification issues when they need to be disconnected and reconnected using traditional tethered cable connections. The continuing lack of accepted communications protocol standards, in spite of the concentrated efforts of organizations like the IEEE and the Medical Information Bus (IEEE 1073) to establish them, has made integration into the hospital information system a complex and non-standard task. The rapid spread in availability and adoption of high-speed 802.11 wireless systems in hospitals offers a realistic connectivity solution for mobile medical devices. Inspite of this, the 802.11 standard is still evolving, and current security methods designed for user-based products like PDAs and laptop computers are not ideal for unmanned mobile medical devices because they assume the availability of a human operator to authenticate a wireless session. In the absence of accepted standards, manufacturers have created practical and innovative solutions to support the collection of clinical data from mobile medical devices and the integration of that data with hospital information systems. This paper will explore the potential benefits of integrating mobile medical devices into the hospital information system, and describe the challenges in
National Aeronautics and Space Administration — An innovative Microgravity Compatible Medical Suction Device (MCMSD) is proposed for the efficient aspiration and containment of bodily fluids and vomitus in a...
Full Text Available Christopher U Iklaki, Anthony U Agbakwuru, Atim E Udo, Sylvester E Abeshi Department of Obstetrics and Gynaecology, University of Calabar, Calabar, Nigeria Background: The intrauterine devices (IUDs are widely used contraceptive methods all over the world today. They are effective and recommended for use up to 10 years. They are not without side effects, which often prompt the users to request for removal. Objective: To determine the utilization rate of copper T intrauterine contraceptive device (IUCD, side effects, and request for removal at the University of Calabar Teaching Hospital, Calabar. Methods: The data on usage of the various forms of temporary contraception provided by the Family Planning Clinic of this center from January 1, 2006 to December 31, 2010 were collated. The records of usage of IUCD during same period were carefully studied. Results: During this period, a total of 10,880 users were provided with various forms of contraceptives. Copper T IUD was the commonest form of contraception used at the University of Calabar Teaching Hospital Family Planning Unit over the period under review (2006–2010 with a rate of 4,069 (37.40%. There was a yearly higher request for IUCD over other forms of contraceptives over the period. Of a total of 4,069 users of the copper T IUD method over the period, 1,410 (34.65% belonged to the age group of 25–29 years. Eleven (4.61% of the users requested for its removal due to abnormal vaginal bleeding, while five (2.08% removed theirs due to abnormal vaginal discharge. The major reason for removal was the desire for pregnancy that accounted for 165 (70.26%, while one (0.51% was removed due to dysmenorrhea. Conclusion: The copper T380A was very effective, safe with fewer side effects, and easily available in this study. The request for removal is also low in our environment. Keywords: copper T380A, contraception, request for removal
uterine device (IUD) is discussed against a background of well over 25000 insertions, A Lippes loop series and a Dalkon Shield evaluation are presented. Insertions into nulliparous young women, and post-Caesarean cases are discussed, and the ...
Full Text Available Joyce M Black,1 Peggy Kalowes2 1Adult Health and Illness Department, College of Nursing, University of Nebraska Medical Center, Omaha, NE, 2Nursing Research and Innovation, Long Beach Memorial Miller Children’s & Women’s Hospital, Long Beach, CA, USA Abstract: Pressure ulcers from medical devices are common and can cause significant morbidity in patients of all ages. These pressure ulcers appear in the shape of the device and are most often found from the use of oxygen delivery devices. A hospital program designed to reduce the number of pressure ulcers from medical devices was successful. The program involved the development of a team that focused on skin, the results were then published for the staff to track their performance, and it was found that using foam dressings helped reduce the pressure from the device. The incidence of ulcers from medical devices has remained at zero at this hospital since this program was implemented. Keywords: pressure ulcer, medical device related
Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin
Mobile devices have fundamentally changed personal computing, with many people forgoing the desktop and even laptop computer altogether in favor of a smaller, lighter, and cheaper device with a touch screen. Doctors and patients are beginning to expect medical images to be available on these devices for consultative viewing, if not actual diagnosis. However, this raises serious concerns with regard to the ability of existing mobile devices and networks to quickly and securely move these images. Medical images often come in large sets, which can bog down a network if not conveyed in an intelligent manner, and downloaded data on a mobile device are highly vulnerable to a breach of patient confidentiality should that device become lost or stolen. Some degree of regulation is needed to ensure that the software used to view these images allows all relevant medical information to be visible and manipulated in a clinically acceptable manner. There also needs to be a quality control mechanism to ensure that a device's display accurately conveys the image content without loss of contrast detail. Furthermore, not all mobile displays are appropriate for all types of images. The smaller displays of smart phones, for example, are not well suited for viewing entire chest radiographs, no matter how small and numerous the pixels of the display may be. All of these factors should be taken into account when deciding where, when, and how to use mobile devices for the display of medical images. Copyright © 2014 American College of Radiology. Published by Elsevier Inc. All rights reserved.
Liu, Z; Chen, Q; Ni, X
To investigate the morphologic changes of endometrial spiral arterioles and its relationship with bleeding pattern after insertion of gamma-shape copper indomethacin-medicated (gamma CuI) and T-shape copper (TCu 220C) intrauterine devices (IUD). Endometrium specimens of late secretory phase were obtained from fertile age women: 10 from preinsertion, 10 obtained after insertion of TCu 220C IUD, and 9 obtained after insertion of gamma CuI IUD. Samples were sectioned serially and morphometric analysis of endometrial spiral arterioles was performed under light microscope. The average cross section area (Area), maximum diameter (Dmax) and minimum diameter (Dmin) of spiral arterioles in both spongeous and dense layers of endometrium increased significantly after insertion of TCu 220C IUD. After insertion of gamma CuI IUD, the Area and Dmax increased in dense layer only, though less obviously than that occurred in TCu 220C group. However, the Dmin increased more obviously in both spongeous and dense layers than after insertion of TCu 220C IUD, implying that the shape of spiral arterioles was more regular in gamma CuI group. gamma CuI IUD has less effects on the morphological changes of endometrial spiral arterioles, and this may relate to its indomethacin-contained which causes less bleeding.
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Full Text Available Background: Promoting family planning practices aid considerably in attaining Millennium Development Goals by various mechanisms. Despite concerted health system efforts, adoption of especially reversible contraceptive methods such as intrauterine devices (IUDs has remained negatively skewed in India, which is the pioneer country to implement Family Planning programme way back in 1952. Although few studies in India have looked into the reasons for its nonacceptance, literature from Odisha was scant and hence the study was undertaken. Methodology: A cross-sectional study using qualitative methods was done in the Mahanga Tehsil of Cuttack district. In-depth interviews were conducted with women of reproductive age (WRA and focused group discussions (FGDs among health workers and health professionals were held separately. Data analysis was done using thematic framework approach supported by Atlas Ti software. Results: There were 31 in-depth interviews with WRA, two FGDs with health workers, and one FGD with health professionals. Availability of IUD services was low and wherever available, being located far away affected its physical accessibility. Most women were reluctant to ask health workers about services owing to their shyness while many women felt using IUDs breached their autonomy and privacy. The existence of fear and misconceptions regarding its use rooting from lack of knowledge and poor service quality also impeded its adoption by women. Conclusion: There is a pressing need to enhance the demand of IUDs by dispelling the myths among women through effective information, education, and communication and also to improve the availability of IUDs.
Aksoy, Hüseyin; Aksoy, Ülkü; Ozyurt, Sezin; Açmaz, Gökhan; Babayigit, Mustafa
Fear of pain during intrauterine device (IUD) insertion can be a barrier to widespread use of this safe and highly effective contraceptive method. Our objective was to determine the effectiveness of topical 10% lidocaine spray for pain control during IUD insertion. A total of 200 subjects with the request for IUD insertion were included in the study. The patients were randomly divided into two groups: lidocaine spray (n=100) and placebo (n=100). The pain experienced during the procedure was measured immediately after insertion by a standard Visual Analogue Scale (VAS) administered by a separate researcher with maintenance of allocation concealment. The mean pain score during the procedure was 1.01±1.20 in the lidocaine spray group and 3.23±1.60 in the placebo spray group (pLidocaine spray treatment significantly lowered the overall procedural pain score compared with placebo. Significant pain reduction during IUD insertion can be achieved by using 10% lidocaine spray alone. Lidocaine spray can be accepted as a non-invasive, easy to apply and more comfortable local anaesthetic method for IUD insertion. NCT02020551. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Berger-Kulemann, Vanessa; Einspieler, Henrik; Hachemian, Nilouparak; Prayer, Daniela; Trattnig, Siegfried; Weber, Michael; Ba-Ssalamah, Ahmed
An ex vivo study found a copper-containing intrauterine device (IUD) to be safe for women undergoing an MRI examination at a 3.0-T field. No significant artifacts caused by the metallic implant were detected. However, there are still no in vivo data about these concerns. The aim of this study was to evaluate 3.0-T magnetic field interactions of copper-containing IUDs in vivo. Magnetic field interactions and potential adverse events were evaluated in 33 women using a questionnaire-based telephone survey. Two experienced radiologists performed artifact evaluation on MR images of the pelvis. Eighteen patients were eligible for the survey. One patient reported a dislocation of the IUD after the MR examination. All other patients had no signs of field interactions. No IUD-related artifacts were found. MRI at 3.0-T is possible for women with copper-containing IUDs. However, consulting a gynecologist to check the correct position of the IUD and exclude complications after an MR examination is highly recommended. High-quality clinical imaging of the female pelvis can be performed without a loss in image quality.
van Dijk, Myrthe M; van Hanegem, Nehalennia; de Lange, Maria E; Timmermans, Anne
We performed a literature review of reports comparing a levonorgestrel-releasing intrauterine device (LNG-IUD) with transcervical polyp resection (TCRP) as a treatment for heavy menstrual bleeding (HMB). Our second objective was to investigate the effectiveness of LNG-IUD and TCRP in reducing menstrual bleeding and the patient satisfaction with each technique. No previously reported studies have compared TCRP and LNG-IUD as treatment for HMB in premenopausal women with an endometrial polyp. Likewise, no studies are available on LNG-IUD as a treatment for HMB in the presence of an endometrial polyp. Several studies have found the LNG-IUD to be an effective treatment option for HMB, with high patient satisfaction rates. Evidence of the effectiveness of TCRP as treatment of HMB is scarce. Patient satisfaction is reported relatively good, although persistent or recurrent symptoms appear to be frequent. We conclude that no evidence is available on LNG-IUD as treatment for HMB in women with an endometrial polyp. We hypothesize that LNG-IUD could be a good alternative to TCRP for treating HMB in premenopausal women with a polyp; however, further evidence is needed, and a randomized controlled trial should be performed. Copyright © 2015 AAGL. Published by Elsevier Inc. All rights reserved.
Hitzerd, Emilie; Bogers, Hein; Kianmanesh Rad, Noush A; Duvekot, Johannes J
Although the levonorgestrel-releasing intrauterine device (LNG-IUD) is one of the most reliable methods of contraception, it is associated with an increased risk of ectopic pregnancy in case of unintended pregnancy. A rare form of ectopic pregnancy is the caesarean scar pregnancy (CSP), with a high risk of serious maternal morbidity, such as uterine rupture, massive haemorrhage and resulting infertility. This report describes the first case of a viable CSP at 13 weeks of gestation in association with the use of a LNG-IUD. Case-presentation: A 36-year-old Caucasian woman was referred to our outpatient clinic because of suspicion of a CSP. The pregnancy was unintended and was diagnosed during replacement of the LNG-IUD after five years. The patient had undergone two caesarean sections in the past. Ultrasound investigation showed an intact pregnancy of approximately 13 weeks of gestation located in the uterine scar. Because of the size of the gestational sac, a laparotomy was performed under general anaesthesia using a Joel-Cohen incision. The procedure was complicated by a total blood loss of 1500 mL, mostly caused by diffuse bleeding from the placental bed. Unintended pregnancies in women using a LNG-IUD are frequently ectopic pregnancies with a preponderance to nidate outside the fallopian tube. Therefore, early diagnosis and location of the pregnancy in women using a LNG-IUD is essential.
Bryant, Amy G; Hamela, Gloria; Gotter, Ann; Stuart, Gretchen S; Kamanga, Gift
The copper intrauterine device (IUD) is a safe, long-acting, and effective method of contraception that is under-utilized in many countries, including Malawi. A unique cohort of women who had enrolled in a trial of postpartum IUD use one year earlier gave insights into reasons for using, discontinuing, or not using the IUD. We conducted in-depth interviews with 18 women one year after they participated in a pilot study of a randomized controlled trial of postpartum IUD insertion, and 10 of their male partners. Women and their partners expressed a strong desire for family planning, and perceived numerous benefits of the IUD. However, fear of the IUD was common among successful users and non-users alike. This fear arose from rumours from friends and neighbors who were non-users. How women and their partners responded to this fear affected IUD adoption and continuation. Key themes included (1) Trust in information received from health care providers versus rumours from community members; (2) Partner involvement in IUD decision-making; and (3) Experience with side effects from short-term hormonal contraceptive methods. Broad community education about the IUD's benefits and safety, and proactive counseling to address couples' specific fears, may be needed to increase uptake of the method.
Shimizu, Takuya; Hatanaka, Kazuo; Kaneko, Hitomi; Shimada, Toshihide; Imada, Kazunori
A 49-year-old female from China was referred to our hospital after endocervical polypectomy. Twenty years before admission, after the birth of her first child, an intrauterine device (IUD) had been inserted due to the one-child policy in China. She had noticed abnormal vaginal bleeding with a foul smell 3 years before admission. Then the IUD was removed and a polyp was found at the IUD contact site. Two months before admission, endocervical polypectomy was performed. Lymphoma was suspected by histological examination and she was referred to our hospital. Further examination confirmed the diagnosis of primary uterine diffuse large B-cell lymphoma (DLBCL). Subsequently, a combination of three cycles of R-CHOP regimen and involved-field radiation therapy was performed, followed by maintenance therapy with five cycles of rituximab. She has remained in complete remission for over 1 year. This case suggests that chronic inflammation induced by prolonged IUD insertion may contribute to the development of primary uterine lymphoma. To the best of our knowledge, this is the first reported case of DLBCL associated with prolonged IUD insertion.
Pfitzer, Anne; Mackenzie, Devon; Blanchard, Holly; Hyjazi, Yolande; Kumar, Somesh; Lisanework Kassa, Serawit; Marinduque, Bernabe; Mateo, Marie Grace; Mukarugwiro, Beata; Ngabo, Fidele; Zaeem, Shabana; Zafar, Zonobia; Smith, Jeffrey Michael
Initiation of family planning at the time of birth is opportune, since few women in low-resource settings who give birth in a facility return for further care. Postpartum family planning (PPFP) and postpartum intrauterine device (PPIUD) services were integrated into maternal care in six low- and middle-income countries, applying an insertion technique developed in Paraguay. Facilities with high delivery volume were selected to integrate PPFP/PPIUD services into routine care. Effective PPFP/PPIUD integration requires training and mentoring those providers assisting women at the time of birth. Ongoing monitoring generated data for advocacy. The percentages of PPIUD acceptors ranged from 2.3% of women counseled in Pakistan to 5.8% in the Philippines. Rates of complications among women returning for follow-up were low. Expulsion rates were 3.7% in Pakistan, 3.6% in Ethiopia, and 1.7% in Guinea and the Philippines. Infection rates did not exceed 1.3%, and three countries recorded no cases. Offering PPFP/PPIUD at birth improves access to contraception. Copyright © 2015. Published by Elsevier Ireland Ltd.
Catherine S. Todd
Full Text Available Objective. To assess awareness of and interest in intrauterine contraceptive device (IUCD use among HIV-positive women in Cape Town, South Africa. Design. Cross-sectional survey. Methods. HIV-positive women aged 18 through 45 years presenting for care at a primary health care clinic in Cape Town, South Africa participated in this study. Consented participants completed a staff-administered questionnaire in a private setting. Descriptive statistics were generated. Comparisons between demographic and reproductive health-related variables and IUCD awareness and interest were performed with multiple logistic regression. Analyses for IUCD interest excluded women with prior surgical sterilization. Results. Of 277 HIV-positive women, 37% were aware of the IUCD; awareness was independently associated with greater age (adjusted odds ratio (AOR = 1.15, 95%; confidence interval (CI: 1.10–1.20 and not switching contraceptive methods in the last year (AOR = 2.45, 95% CI: 1.03–5.83. Following an IUCD information session, 86% of women (=206/240 were interested in IUCD use. IUCD interest was inversely associated with age (AOR = 0.91, 95% CI: 0.86–0.97 and marginally positively associated with current menstrual bleeding pattern complaints (AOR = 2.14, 95% CI: 0.98–4.68. Conclusions. Despite low levels of method awareness, HIV-positive women in this setting are frequently interested in IUCD use, indicating need for programming to expand method access.
Chandrasekar, T S; Gokul, B J; Yogesh, K Raja; Sathiamoorthy, S; Prasad, M S; Viveksandeep, T C; Ali, M Ahmed
A 45-year-old lady presented with left lower quadrant abdominal pain and hematochezia of 1 month duration. She had Copper-T, an intrauterine contraceptive device (IUCD) inserted in the immediate post-partum period 25 years ago elsewhere and was lost to follow up. CT abdomen done 2 weeks earlier before reporting to us revealed a migrated and translocated IUCD embedded in the right lateral wall of the rectum. On colonoscopy, an area of friable mucosal nodule was noticed in the right lateral wall 10 cm from the anal verge but the IUCD was not visible intraluminally. Fluoroscopy showed the horizontal limb lying in close approximation with the rectal wall and the vertical limb of the IUCD embedded at the site of mucosal nodule in the rectum. After a careful endoscopic mucosotomy, the vertical limb was exposed and the Copper-T in its entirety was retrieved using a polypectomy snare. The mucosal defect was closed with hemoclips. She became asymptomatic after the procedure.
Berger-Kulemann, Vanessa; Einspieler, Henrik [Department of Radiology, Medical University of Vienna, Vienna 1090 (Austria); Hachemian, Nilouparak [Department of Obstetrics and Gynecology, Medical University of Vienna, Vienna 1090 (Austria); Prayer, Daniela; Trattnig, Siegfried; Weber, Michael; Ba-Ssalamah, Ahmed [Department of Radiology, Medical University of Vienna, Vienna 1090 (Austria)
An ex vivo study found a copper-containing intrauterine device (IUD) to be safe for women undergoing an MRI examination at a 3.0-T field. No significant artifacts caused by the metallic implant were detected. However, there are still no in vivo data about these concerns. The aim of this study was to evaluate 3.0-T magnetic field interactions of copper-containing IUDs in vivo. Magnetic field interactions and potential adverse events were evaluated in 33 women using a questionnaire-based telephone survey. Two experienced radiologists performed artifact evaluation on MR images of the pelvis. Eighteen patients were eligible for the survey. One patient reported a dislocation of the IUD after the MR examination. All other patients had no signs of field interactions. No IUD-related artifacts were found. MRI at 3.0-T is possible for women with copper-containing IUDs. However, consulting a gynecologist to check the correct position of the IUD and exclude complications after an MR examination is highly recommended. High-quality clinical imaging of the female pelvis can be performed without a loss in image quality.
Alvarez, Florencia; Grillo, Claudiaa; Schilardi, Patricial; Rubert, Aldo; Benítez, Guillermo; Lorente, Carolina; de Mele, Mónica Fernández Lorenzo
The copper intrauterine device (IUD) based its contraceptive action on the release of cupric ions from a copper wire. Immediately after the insertion, a burst release of copper ions occurs, which may be associated to a variety of side effects. 6-Mercaptopurine (6-MP) and pterin (PT) have been proposed as corrosion inhibitors to reduce this harmful release. Pretreatments with 1 × 10(-4) M 6-MP and 1 × 10(-4) M PT solutions with 1h and 3h immersion times were tested. Conventional electrochemical techniques, EDX and XPS analysis, and cytotoxicity assays with HeLa cell line were employed to investigate the corrosion behavior and biocompatibility of copper with and without treatments. Results showed that copper samples treated with PT and 6-MP solutions for 3 and 1 h, respectively, are more biocompatible than those without treatment. Besides, the treatment reduces the burst release effect of copper in simulated uterine solutions during the first week after the insertion. It was concluded that PT and 6-MP treatments are promising strategies able to reduce the side effects related to the "burst release" of copper-based IUD without altering the contraceptive action.
Kasza, Kenneth E [Palos Park, IL; Oras, John [Des Plaines, IL; Son, HyunJin [Naperville, IL
The present invention relates to an apparatus for producing sterile ice slurries for medical cooling applications. The apparatus is capable of producing highly loaded slurries suitable for delivery to targeted internal organs of a patient, such as the brain, heart, lungs, stomach, kidneys, pancreas, and others, through medical size diameter tubing. The ice slurry production apparatus includes a slurry production reservoir adapted to contain a volume of a saline solution. A flexible membrane crystallization surface is provided within the slurry production reservoir. The crystallization surface is chilled to a temperature below a freezing point of the saline solution within the reservoir such that ice particles form on the crystallization surface. A deflector in the form of a reciprocating member is provided for periodically distorting the crystallization surface and dislodging the ice particles which form on the crystallization surface. Using reservoir mixing the slurry is conditioned for easy pumping directly out of the production reservoir via medical tubing or delivery through other means such as squeeze bottles, squeeze bags, hypodermic syringes, manual hand delivery, and the like.
Sivin, I; Stern, J; Diaz, S; Pavéz, M; Alvarez, F; Brache, V; Mishell, D R; Lacarra, M; McCarthy, T; Holma, P
The objectives were to measure rates of planned pregnancy and factors affecting these rates after use of very-long-acting contraceptive methods (Norplant or Norplant II implants, a levonorgestrel-releasing intrauterine contraceptive device, or the copper T (model TCu 380Ag) intrauterine contraceptive device. The design was a concurrent, multicenter prospective study of 372 women who stopped contraception for planned pregnancy. Analysis was by life-table, log-rank, and standard chi 2 methods. Pregnancy rates 12 and 24 months after cessation of contraceptive use were 82 and 89 per 100, respectively. Age at removal and family planning intentions at initiation of contraception were both significantly correlated with pregnancy rates (p less than 0.05), but former contraceptive regimen and duration of contraceptive use were not. Pregnancy outcomes did not deviate from normal limits and did not differ by contraceptive formerly used. Contraceptive implants releasing 30 micrograms/day of levonorgestrel or intrauterine contraceptive devices releasing 20 micrograms/day of levonorgestrel or having copper surface areas of 380 mm2 are associated with normal fertility after use for women seeking pregnancy at termination. Durations of use do not affect pregnancy rates.
Ansari Maulana Mohammed
Full Text Available Abstract Introduction Intrauterine contraceptive devices may at times perforate and migrate to adjacent organs. Such uterine perforation usually passes unnoticed with development of potentially serious complications. Case presentation A 25-year-old woman of North Indian origin presented with an acute tender lump in the right iliac fossa. The lump was initially thought to be an appendicular lump and treated conservatively. Resolution of the lump was incomplete. On exploratory laparotomy, a hard suspicious mass was found in the anterior abdominal wall of the right iliac fossa. Wide excision and bisection of the mass revealed a copper-T embedded inside. Examination of the uterus did not show any evidence of perforation. The next day, the patient gave a history of past copper-T Intrauterine contraceptive device insertion. Conclusions Copper-T insertion is one of the simplest contraceptive methods but its neglect with inadequate follow-up may lead to uterine perforation and extra-uterine migration. Regular self-examination for the "threads" supplemented with abdominal X-ray and/or ultrasound in the follow-up may detect copper-T migration early. To the best of our knowledge, this is the first report of intrauterine contraceptive device migration to the anterior abdominal wall of the right iliac fossa.
Full Text Available Nataliya Brima,1 Hannat Akintomide,2 Vivian Iguyovwe,3 Susan Mann4 1Medical Statistics, Centre for Sexual Health and HIV Research, Research Department of Infection and Population Health, University College London, London, UK; 2Sexual and Reproductive Health, CNWL Camden Provider Services, Margaret Pyke Centre, London, UK; 3Department of Sexual and Reproductive Health, Camberwell Sexual Health Centre, Denmark Hill, London, UK; 4Sexual and Reproductive Health, Kings College Hospital, London, UK Objective: To compare the expected and actual pain experienced with the insertion of intrauterine contraception in women, and to determine whether either of these are related to their personal circumstances, or affected their satisfaction with the procedure. Design: A convenience sample of 89 women aged 15–50 years attending a sexual health clinic for same day intrauterine contraception insertion were given a questionnaire that they completed following the procedure. The women were asked to rate their expectation of pain prior to insertion and to rate the actual pain they experienced immediately after insertion, on a scale of 1–10, with 10 being severe pain. Information on the women's circumstances and their level of satisfaction with the procedure was also obtained. Results: Overall, the median actual pain experienced by women during insertion (4 was significantly lower than the expected pain median (6 (P<0.001. For those women who had not had a previous vaginal delivery, actual pain was significantly higher compared with women who had had a previous vaginal delivery (median [interquartile range]: 6 [3.5–7.5] and 3 [1–5], P<0.001, respectively, but there was no significant difference between expected and actual pain experiences. In women who had a previous vaginal delivery, actual pain was much lower than expected (P<0.001. Neither actual nor expected pain experiences were linked to any other sociodemographic reproductive health or service use
Health during prolonged use of levonorgestrel 20 micrograms/d and the copper TCu 380Ag intrauterine contraceptive devices: a multicenter study. International Committee for Contraception Research (ICCR).
Sivin, I; Stern, J
To measure and compare the incidence of adverse events during use of two medicated intrauterine devices (IUDs). A multicenter prospective 7-year randomized study. Family planning clinics, primarily in developing countries. Women age 18 to 38 years at admission, desiring contraception and without contraindications to IUDs. Incidence of complaints, conditions, and rates of specific termination for each IUD. Subjects recorded menstrual events, and clinical staff registered all complaints and conditions found on examination at four first-year clinic visits and at semiannual visits thereafter. Difference in rates were analyzed by chi 2 statistics. Annual pregnancy rates for each IUD averaged 0.2/100 women whereas upper genital tract infection occurred at rates of 0.6 to 0.7 per 100 years of use. The levonorgestrel-releasing IUD significantly decreased bleeding and spotting days in comparison with historical data for noncontraceptors and with the copper-medicated IUD. Dysmenorrhea, vaginitis, and myoma in women with the levonorgestrel IUD were markedly decreased in comparison with the experience of copper IUD users. Significantly higher rates of amenorrhea, delayed ovarian follicular atresia, skin and hair conditions, and headache were observed with the steroid IUD than with the copper-releasing IUD. Rates of reported adverse effects for either IUD were highest in the first 2 years of use and among women under age 25. Long-term use of copper or levonorgestrel IUDs is characterized by very low rates of pregnancy and by a low and declining annual incidence of side effects, including pelvic infection and borderline anemia. The levonorgestrel-releasing IUD reduced the incidence of bleeding and, in the long term, of myoma and myoma-related surgery in comparison with the copper T IUD. Both IUDs proved highly acceptable and had few unanticipated side effects.
McNicholas, Colleen; Swor, Erin; Wan, Leping; Peipert, Jeffrey F
The subdermal contraceptive implant and the 52-mg levonorgestrel intrauterine device are currently Food and Drug Administration approved for 3 and 5 years of use, respectively. Limited available data suggested both of these methods are effective beyond that time. Demonstration of prolonged effectiveness will improve the cost-effectiveness of the device, and potentially patient continuation and satisfaction. We sought to evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device in women using the method for 2 years beyond the current Food and Drug Administration-approved duration. We initiated this ongoing prospective cohort study in January 2012. We are enrolling women using the contraceptive implant or 52-mg levonorgestrel intrauterine device for a minimum of 3 and 5 years, respectively (started intrauterine device in ≥2007 or implant in ≥2009). Demographic and reproductive health histories, as well as objective body mass index, were collected. Implant users were offered periodic venipuncture for analysis of serum etonogestrel levels. The primary outcome, unintended pregnancy rate, was calculated per 100 woman-years. We analyzed baseline demographic characteristics using χ 2 test and Fisher exact test, and compared serum etonogestrel levels stratified by body mass index using the Kruskal-Wallis test. Implant users (n = 291) have contributed 444.0 woman-years of follow-up. There have been no documented pregnancies in implant users during the 2 years of postexpiration follow-up. Calculated failure rates in the fourth and fifth years for the implant are calculated as 0 (1-sided 97.5% confidence interval, 0-1.48) per 100 woman-years at 4 years and 0 (1-sided 97.5% confidence interval, 0-2.65) per 100 woman-years at 5 years. Among 496 levonorgestrel intrauterine device users, 696.9 woman-years of follow-up have been completed. Two pregnancies have been reported. The failure rate in the sixth year of use of the
Lee, Phong Ching; Dixon, John
Obesity is a major public health concern that leads to numerous metabolic, mechanical and psychological complications. Although lifestyle interventions are the cornerstone of obesity management, subsequent physiological neurohormonal adaptations limit weight loss, strongly favour weight regain and counteract sustained weight loss. A range of effective therapies are therefore needed to manage this chronic relapsing disease. Bariatric surgery delivers substantial, durable weight loss but limited access to care, perceived high risks and costs restrict uptake. Medical devices are uniquely positioned to bridge the gap between more conservative lifestyle intervention and weight-loss pharmacotherapy and more disruptive bariatric surgery. In this Review, we examine the range of gastrointestinal medical devices that are available in clinical practice to treat obesity, as well as those that are in advanced stages of development. We focus on the mechanisms of action as well as the efficacy and safety profiles of these devices. Many of these devices are placed endoscopically, which provides gastroenterologists with exciting opportunities for treatment.
Tadir, Yona; Berns, Michael W.; Svaasand, Lars O.; Tromberg, Bruce J.
An improved device for delivery of photoenergy from a light source, such as a laser, into a uterine cavity for photodynamic therapy is comprised of a plurality of optic fibers, which are bundled together and inserted into the uterine cavity by means of a uterine cannula. The cannula is positioned within the uterine cavity at a preferred location and then withdrawn thereby allowing the plurality of optic fibers to splay or diverge one from the other within the cavity. Different portions of the distal tip of the optic fiber is provided with a light diffusing tip, the remainder being provided with a nondiffusing tip portion. The fiber optic shape, as well as the segment which is permitted to actively diffuse light through the tip, is selected in order to provide a more uniform exposure intensity of the photo energy or at least sufficient radiation directed to each segment of the uterine walls.
Tadir, Y.; Berns, M.W.; Svaasand, L.O.; Tromberg, B.J.
An improved device for delivery of photoenergy from a light source, such as a laser, into a uterine cavity for photodynamic therapy is comprised of a plurality of optic fibers, which are bundled together and inserted into the uterine cavity by means of a uterine cannula. The cannula is positioned within the uterine cavity at a preferred location and then withdrawn thereby allowing the plurality of optic fibers to splay or diverge one from the other within the cavity. Different portions of the distal tip of the optic fiber is provided with a light diffusing tip, the remainder being provided with a nondiffusing tip portion. The fiber optic shape, as well as the segment which is permitted to actively diffuse light through the tip, is selected in order to provide a more uniform exposure intensity of the photo energy or at least sufficient radiation directed to each segment of the uterine walls. 5 figs.
Amato, Stephen F; Amato, B
All biomaterials and medical devices are subject to a long list of regulatory practises and policies which must be adhered to in order to receive clearance. This book provides readers with information on the systems in place in the USA and the rest of the world. Chapters focus on a series of procedures and policies including topics such as commercialization, clinical development, general good practise manufacturing and post market surveillance.Addresses global regulations and regulatory issues surrounding biomaterials and medical devicesEspecially useful for smaller co
After much work and research, the Food and Drug Administration is preparing to publish a proposed rule for unique device identifier (UDI) standards for medical devices. The UDI would be used to identify a vast array of medical products and would streamline the hospital supply chain while improving patient safety. For instance, having a UDI in place would assist product recall efforts. But getting hospital supply chain leaders, manufacturers, group purchasing organizations and others to embrace UDI standards won't be easy. Here's a look at what's ahead.
The use of bioresorbable polymers in stents, fixation devices and tissue engineering is revolutionising medicine. Both industry and academic researchers are interested in using computer modelling to replace some experiments which are costly and time consuming. This book provides readers with a comprehensive review of modelling polymers and polymeric medical devices as an alternative to practical experiments. Chapters in part one provide readers with an overview of the fundamentals of biodegradation. Part two looks at a wide range of degradation theories for bioresorbable polymers and devices.
Thiery, M; Van Der Pas, H; Van Kets, H; Boogers, W; Haspels, A; Amy J-j
4 years of experience with the TCu 220C (901 women; 28,071 woman months of use) - a long-acting multisleeved copper IUD - are analyzed. Event rates were calculated by life-table analysis with a computer program on an IBM 370/148-OS/VS1. Net cumulative rates at 4 years were as follows: pregnancy 3.3, expulsion 5.2, removal for bleeding, pain and other medical reasons 7.7, and 4.3 respectively. The incidence of pregnancy, expulsions, and removal for bleeding/pain decreases with time. Parity influences the performance of the TCu 220C. It seems to affect the pregnancy rate only marginally, but the expulsion and removal rates (for bleeding, pain, or other medical reasons) are higher in the nulliparae, and the same trends appear to be present for women of lower age groups. The IUD insertion technique seems to be important when determining the effectiveness of the method. The expulsion rate is significantly higher when the push-in technique (without sounding) is used, and the same tendency is present for pregnancies and removals for bleeding/pain, albeit to a lesser degree. Refraining from sounding the uterus and pushing-in the TCu 220C introduces the risk of not inserting the IUD high enough into the uterine cavity and therefore increases the risk of expulsion.
Abdelrahman M. Abdelkader
Full Text Available Objective. There is an asymmetric allocation of technology and other resources for infertility services. Intrauterine insemination (IUI is a process of placing washed spermatozoa transcervically into the uterine cavity for treatment of infertility. This is a review of literature for the potential use of IUI as a basic infertility treatment in technology-limited settings. Study design. Review of articles on treatment of infertility using IUI. Results. Aspects regarding the use of IUI are reviewed, including ovarian stimulation, semen parameters associated with good outcomes, methods of sperm preparation, timing of IUI, and number of inseminations. Implications of the finding in light of the needs of low-technology medical settings are summarized. Conclusion. The reviewed evidence suggests that IUI is less expensive, less invasive, and comparably effective for selected patients as a first-line treatment for couples with unexplained or male factor infertility. Those couples may be offered three to six IUI cycles in technology-limited settings.
Nippita, Siripanth; Oviedo, Johana D; Velasco, Margarita G; Westhoff, Carolyn L; Davis, Anne R; Castaño, Paula M
Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection. This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians. Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01). Participants reporting bleeding via text messages provided more complete data than women using paper diaries. Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes. Copyright © 2015 Elsevier Inc. All rights reserved.
Bateson, Deborah; Harvey, Caroline; Trinh, Lieu; Stewart, Mary; Black, Kirsten I
Copper intrauterine device (Cu-IUD) use in Australia is low despite being a highly effective, cost effective non-hormonal contraceptive with reported 12-month continuation rates of 85% compared to 59% for oral contraception. To describe the characteristics of Cu-IUD users in the Australian context, their experiences of side effects, continuation rates and reasons for discontinuation. Between August 2009 and January 2012 we undertook a prospective cohort study of consecutive women presenting for Cu-IUD insertion to three family planning clinics in Queensland and New South Wales. We used survival analysis for continuation rates and univariate and multivariable analyses to characterise users, their experiences up to three years and reasons for discontinuation. Of the 211 enrolled women, a third (36.0%) were aged under 30 and a third were nulliparous (36.5%). Efficacy and lack of hormones were the most frequently cited reasons to choose the method. Four women were lost to follow-up. Overall continuation rates were 79.1% at one year and 61.3% at three years. Early discontinuation was reduced in those with two or more children (adjusted hazards ratio 0.22, 95% CI 0.09-0.50). Heavy menstrual bleeding was the commonest reason for removal in 28 of 59 (47.5%) discontinuations due to complications or side effects. One uterine perforation and one method failure resulting in an ectopic pregnancy occurred. Cu-IUDs were chosen for their efficacy and lack of hormones by a range of Australian women, including young and nulliparous women. While bleeding-related side effects were relatively common, overall continuation rates were high. Serious complications and failures were rare. © 2016 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
Anand, K; Saini, Sk; Singh, Bk; Veermaram, C
In the medical device field, there are a number of players, having quite different responsibilities and levels of understanding of the processes, but all with one common interest, that of ensuring the availability of sound medical devices to the general public. To assist in this very important process, there is a need for a common method for describing and identifying these medical devices in an unambiguous manner. The Global Medical Device Nomenclature (GMDN) now provides, for the first time, an international tool for identifying all medical devices, at the generic level, in a meaningful manner that can be understood by all users. Prior to the GMDN, many nomenclature systems existed, all built upon different structures, and used locally or nationally for special purposes, with unusual approaches. These diverse systems, although often workable in their own right, have had no impact on improving the overall situation of providing a common platform, whereby, medical devices could be correctly identified and the related data safely exchanged between the involved parties. Work by standard organizations such as, CEN (European Committee for Standardization) and ISO (International Organization for Standardization), from 1993 to 1996, resulted in a standard that specified a structure for a new nomenclature, for medical devices. In this article we are trying to explain GMDN as the prime method to reduce medical device errors, and to understand the concept of GMDN, to regulate the medical device throughout the globe. Here we also make an attempt to explain various aspects of the GMDN system, such as, the process of development of the GMDN-CEN report, purpose, benefits, and their structural considerations. In addition, there will be an explanation of the coding system, role of the GMDN agency, and their utilization in the unique device identification (UDI) System. Finally, the current area of focus and vision for the future are also mentioned.
Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. The article will focus on 1 of 14 elements of the Quality System Regulation (QSR)-Design Controls. A high-level overview of these design control requirements is provided to increase awareness of the device development process and provide a basis for mutual understanding for continued dialogue with end users. Design control requirements were established by the US Food and Drug Administration (FDA) as an element of the QSR in 1996. Device manufacturers are required to have a quality management system (QMS) to ensure their devices are safe and effective. The QMS is established by writing operating procedures to achieve consistent application of the methods used to control quality and comply with regulatory requirements. The FDA has the responsibility to audit device manufacturers for compliance with the regulation. The requirements of the QSR and the resulting device design control procedures lend themselves to what is commonly known as the waterfall development process. This iterative process results in documented evidence that is defined in the QSR as the Design History File. This record of development is essential for managing the product life cycle. The elements and purpose of the design control process will be presented to illuminate today's development environment. Collaboration between device developers and the practitioner is essential for improving clinical outcomes and reducing time to market of innovative devices.
Goldstuck, Norman D; Steyn, Petrus S
Background. Women with diabetes mellitus type I and type II need effective contraception for personal and medical reasons. Long acting reversible contraceptive (LARC) methods are among the most efficient and cost-effective methods. Study Design. We searched the Popline, PubMed, and clinicaltrials.gov databases from 1961 to March 2013 for studies on the efficacy of the IUD in diabetic women and the possible changes it may produce in laboratory parameters. Studies of at least 30 subjects with DM1 or DM2 who were studied for 6 to 12 months depending on the method of analysis were eligible. Results. The search produced seven articles which gave event rate efficacy evaluable results and three which evaluated the effect of the IUD on laboratory parameters. One of the earlier efficacy studies showed an abnormally high pregnancy rate which sparked a controversy which is discussed in the Introduction section. The remaining 6 studies produced acceptable pregnancy rates. The three laboratory studies showed that the copper and levonorgestrel releasing IUD/IUS do not affect the diabetic state in any way. Conclusions. The copper bearing and levonorgestrel releasing IUDs are safe and effective in women with diabetes type I and diabetes type II although the evidence in the latter is limited.
Full Text Available Introduction. Modern IUDs are as effective as surgical contraception long acting, reversible and medically safe. This study was performed to evaluate efficacy and complications of IUD TCU 380 among users of this IUO in referred women to Isfahan health centers. Methods. In this study, we inserted IUD TCU 380 A in 767 porous women who get their health cares in Isfahan health centers. They were followed for one year in four visits (1 week, 1, 6 and 12 months after insertion. Findings. Success rate was 99.3 percent. The most frequent complication was hyper menorrhea (44.4 percent, and the majority of complications occurred 7 to 8 months after IUD insertion. Pap smears were normal in 55.3 percent of women. Removal rate was 13.8 percent and the most frequent cause of it, was hyper menorrhea. Expulsion rate was 3.4 percent and PID was seen in 0.4 percent of them. The major recommended sources for putting IUD were health centers (76.7 percent, and 90 percent of couples were satisfied with this method. Conclusion. IUD TCU 380 A is safe and effective and represents a suitable contraceptive method for the appropriate patient.
The United States' medical device color additive regulations are unknown to some, and confusing to many. This article reviews statutory language on color additives in the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended, including the Delaney Clause on carcinogenicity; color additive regulatory language as it relates to medical devices in Title 21 of the Code of Federal Regulations (C.F.R.), Parts 70-82; reports on the Food and Drug Administration's (FDA's) likely current and historical practices in dealing with color additives in medical devices; and speculates on what may have given rise to decades of seemingly ad hoc color additives practices, which may now be difficult to reconstruct and satisfactorily modify. Also addressed is the Center for Devices and Radiological Health's (CDRH's) recent publicly-vetted approach to color additives in Section 7 of its April 2013 draft guidance, Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," which the author concludes is a change in the right direction, but which, at least in its current draft form, is not a fix to the CDRH's color additives dilemma. Lastly, the article suggests what the CDRH might consider in further developing a new approach to color additives. Such an approach would treat color additives as if they were any other potentially toxic group of chemicals, and could be fashioned in such a way that the CDRH could still satisfy the broad aspects of Congressional color additives mandates, and.yet be consistent with ISO 10993. In doing this, the CDRH would need to recommend a more directed use of its Quality System Regulation, 21 C.F.R. Part 820, for material and vendor qualification and validation in general; approach Congress for needed statutory changes; or make administrative changes. In order for any approach to be successful, whether it is a new twist on past practices, or an entirely new path forward, the FDA must, to the best of its
Babušiak, Branko; Borik, Štefan
wireless communication eliminates obtrusive cables associated with wearable sensors and considerably increases patient comfort during measurement and collection of medical data. Wireless communication is very popular in recent years and plays a significant role in telemedicine and homecare applications. Bluetooth technology is one of the most commonly used wireless communication types in medicine. This paper describes the design of a universal wireless communication device with excellent price/performance ratio. The said device is based on the low-cost RN4020 Bluetooth module with Microchip Low-energy Data Profile (MLDP) and due to low-power consumption is especially suitable for the transmission of biological signals (ECG, EMG, PPG, etc.) from wearable medical/personal health devices. A unique USB dongle adaptor was developed for wireless communication via UART interface and power consumption was evaluated under various conditions.
Obremskey, William T; Dail, Teresa; Jahangir, A Alex
Health care in the United States is known for its continued innovation and production of new devices and techniques. While the intention of these devices is to improve the delivery and outcome of patient care, they do not always achieve this goal. As new technologies enter the market, hospitals and physicians must determine which of these new devices to incorporate into practice, and it is important these devices bring value to patient care. We provide a model of a physician-engaged process to decrease cost and increase review of physician preference items. We describe the challenges, implementation, and outcomes of cost reduction and product stabilization of a value-based process for purchasing medical devices at a major academic medical center. We implemented a physician-driven committee that standardized and utilized evidence-based, clinically sound, and financially responsible methods for introducing or consolidating new supplies, devices, and technology for patient care. This committee worked with institutional finance and administrative leaders to accomplish its goals. Utilizing this physician-driven committee, we provided access to new products, standardized some products, decreased costs of physician preference items 11% to 26% across service lines, and achieved savings of greater than $8 million per year. The implementation of a facility-based technology assessment committee that critically evaluates new technology can decrease hospital costs on implants and standardize some product lines.
Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying
Through the establishment of implantable medical device information management system, with the aid of the regional joint sharing of resources, we further enhance the implantable medical device traceability management level, strengthen quality management, control of medical risk.
Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore
The aim of this study was to analyze all available evidence regarding the use of intrauterine morcellator (IUM), for treatment of the most prevalent intrauterine benign lesions, compared to both traditional resectoscopy and conventional outpatient operative hysteroscopy in terms of safety, efficacy, contraindications, perioperative complications, operating time, and estimated learning curve. We reported data regarding a total of 1185 patients. Concerning polypectomy and myomectomy procedures, IUM systems demonstrated a better outcome in terms of operative time and fluid deficit compared to standard surgical procedures. Complication rates in the inpatient setting were as follows: 0.02% for IUM using Truclear 8.0 (Smith & Nephew Endoscopy, Andover, Massachusetts) and 0.4% for resectoscopic hysteroscopy. No complications were described using Versapoint devices. Office polipectomy reported a total complication rate of 10.1% using Versapoint device (Ethicon Women's Health and Urology, Somerville, New Jersey) and 1.6% using Truclear 5.0 (Smith & Nephew Endoscopy). The reported recurrence rate after polypectomy was 9.8% using Versapoint device and 2.6% using Truclear 8.0. Finally, the reported intraoperative and postoperative complication rate of IUM related to removal of placental remnants using Truclear 8.0 and MyoSure (Hologic, Marlborough, Massachusetts) was 12.3%. The available evidence allows us to consider IUM devices as a safe, effective, and cost-effective tool for the removal of intrauterine lesions such as polyps, myomas (type 0 and type 1), and placental remnants. Evidence regarding Truclear 5.0 suggests that it may represent the best choice for office hysteroscopy. Further studies are needed to confirm the available evidence and to validate the long-term safety of IUM in procedures for which current data are not exhaustive (placental remnants removal). © The Author(s) 2015.
...] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY... an amendment to the notice of meeting of the Obstetrics and Gynecology Devices Panel of the Medical... Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee would be held on September...
A. Yu. Galkin
Full Text Available In article we analyzed national and international regulations concerning the quality and safety of medical devices for in vitro diagnostics. We discussed the possibility of a partial application of the recommendations of the State Pharmacopoeia of Ukraine to this type of product. The main guiding regulatory documents establishing requirements for quality and safety tools for the serological diagnosis products are The technical regulation on medical devices for the diagnosis in vitro, DSTU ISO 13485 “Medical devices. Quality management system. Regulatory requirements”, and DSTU ISO/IEC 17025 “General requirements for the competence of testing and calibration laboratories”. Similar requirements of the State Pharmacopoeia of Ukraine which are used for drug standardization can not be directly applied to the medical devises for in vitro diagnostics due to a number of features, namely, the serological diagnosis products pre-designed to determine the unknown concentration of a particular analyte in a biological material, the diagnostic kits has to include the control samples (internal standard systems that need to be calibrated. It was determined following parameters of bioanalytical standardization and validation characterization for of qualitative (semi quantitative test-kits for serological diagnosis: precision (convergence, intralaboratory precision and reproducibility, diagnostic and analytical specificity, diagnostic sensitivity. It’s necessary to inspect additional parameters for quantitative test-kits such as accuracy (precision, linearity, analytical sensitivity and range.
Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold
Open-source hardware is hardware whose design is made publicly available so anyone can study, modify, distribute, make and sell the design or the hardware based on that design. Some open-source hardware projects can potentially be used as active medical devices. The open-source approach offers a unique combination of advantages, including reducing costs and faster innovation. This article compares 10 of open-source healthcare projects in terms of how easy it is to obtain the required components and build the device.
Martin-Loeches, M; Ortí, R M; Monfort, M; Ortega, E; Rius, J
To compare the influence of oral hormonal contraceptives (OCs) and the use of intrauterine contraceptive devices (IUDs) on the modification of sexual desire. A prospective observational study of 1073 women using OCs or an IUD at the Family Planning Center 'Marina Alta' in Alicante, Spain. In order to evaluate the relative risk regarding the decrease in libido attributed to each contraceptive method, a logistic regression analysis was undertaken which considered the factors of age adjustment, level of studies, family planning information, relationship with partner, age when sexual relationships were initiated, parity, contraceptive method previously used and the duration of use of the contraceptive method. No differences in the decrease of sexual desire were observed between the use of the OC and IUD (odds ratio (OR) 1.32; 95% confidence interval (CI) 0.70-2.49), yet differences were noted, however, in relation to age (OR 1.05; 95% CI 1.01-1.10). Although these differences were not statistically significant, a high level of awareness regarding family planning was shown to increase sexual desire when compared to a lower level of information on this subject (OR 0.64; 95% CI 0.41-1.01). Sexual desire was seen to decrease if the quality of the relationship with the partner was average (OR 2.24; 95% CI 1.36-3.69) or poor (OR 4.69; 95% CI 1.93-11.4). Nulliparous women showed a greater decrease in sexual desire in relation to women who had already given birth (OR 1.57; 95% CI 1.00-2.47). Sexual desire was greater if the contraceptive method had already been in use for 6-12 months (OR 0.41; 95% CI 0.17-0.98). Sexual desire does not vary in relation to the use of OCs or IUDs, yet it does decrease with age, in nulliparous women and in those with an average or poor relationship with their partner. Furthermore, sexual desire shows an increase between the first 6 and 12 months of contraceptive treatment.
Tilahun, Yewondwossen; Mehta, Sarah; Zerihun, Habtamu; Lew, Candace; Brooks, Mohamad I; Nigatu, Tariku; Hagos, Kidest Lulu; Asnake, Mengistu; Tasissa, Adeba; Ali, Seid; Desalegn, Ketsela; Adane, Girmay
ABSTRACT In Ethiopia, modern contraceptive prevalence among currently married women nearly tripled over the last decade, but the method mix remains skewed toward short-acting methods. Since 2011, the Integrated Family Health Program (IFHP+), jointly implemented by Pathfinder International and John Snow Inc., has supported the Federal Ministry of Health to introduce intrauterine devices (IUDs) in more than 800 health centers across 4 regions to improve access to a wider range of methods. Between March and August 2014, Pathfinder conducted a mixed-methods study in 40 purposively selected health centers to assess shifts in the contraceptive method mix following introduction of IUDs using data from family planning registers; determine the characteristics of IUD users through a cross-sectional survey of 2,943 family planning clients who accepted the IUD; explore reasons for method discontinuation among 165 clients seeking IUD removal services; and identify facilitators and barriers to IUD use through focus group discussions (N = 115 clients) and key informant interviews (N = 36 providers, facility heads, and health office heads). Introduction of IUDs into the 40 health centers participating in the study was correlated with a statistically significant increase in the contribution of all long-acting reversible contraceptives (LARCs)—both IUDs and implants—to the method mix, from 6.9% in 2011 to 20.5% in 2014 (P<.001). Our study found that latent demand for the IUD was more prevalent than anticipated and that the method was acceptable to a broad cross-section of women. Of the 2,943 women who sought IUDs during the 6-month study period, 18.0% were new contraceptive users (i.e., those using a contraceptive method for the first time ever), 44.7% reported no educational attainment, 62.5% were from rural areas, and 59.3% were younger than 30 years old, with almost 3 in 10 (27.7%) under the age of 25. The most commonly cited reason for seeking IUD removal services
Steinauer, Jody E; Upadhyay, Ushma D; Sokoloff, Abby; Harper, Cynthia C; Diedrich, Justin T; Drey, Eleanor A
Women who have abortions are at high risk of contraception discontinuation and subsequent unintended pregnancy. The objective of this analysis was to identify factors associated with choice of highly effective, long-acting, progestin-only contraceptive methods after abortion. Women presenting for surgical abortion who selected the levonorgestrel intrauterine device (IUD), the progestin implant or the progestin injection (depot medroxyprogesterone acetate or DMPA) as their postabortion contraceptives were recruited to participate in a 1-year prospective cohort study. We used multivariable multinomial logistic regression to identify factors associated with choosing long-acting reversible contraceptives (IUD or implant) compared to DMPA. A total of 260 women, aged 18-45 years, enrolled in the study, 100 of whom chose the IUD, 63 the implant and 97 the DMPA. The women were 24.9 years old on average; 36% were black, and 29% were Latina. Fifty-nine percent had had a previous abortion, 66% a prior birth, and 55% were undergoing a second-trimester abortion. In multivariable analyses, compared with DMPA users, women who chose the IUD or the implant were less likely to be currently experiencing intimate partner violence (IPV); reported higher stress levels; weighed more; and were more likely to have finished high school, to have used the pill before and to report that counselors or doctors were helpful in making the decision (all significant at p<.05, see text for relative risk ratios and confidence intervals.) In addition, women who chose the IUD were less likely to be black (p<.01), and women who chose the implant were more likely to report that they would be unhappy to become pregnant within 6 months (p<.05) than DMPA users. A variety of factors including race/ethnicity, past contraceptive use, feelings towards pregnancy, stress and weight were different between LARC and DMPA users. Notably, current IPV was associated with choice of DMPA over the IUD or implant, implying
... she has an infection, it could lead to pelvic inflammatory disease (PID) . Abstinence (not having sex) is the only ... the uterus while it is being put in. Pelvic inflammatory disease (PID) . There's a very low risk of infection ...
Ghaffari, Roozbeh; Kim, Dae-Hyeong
This book highlights recent advances in soft and stretchable biointegrated electronics. A renowned group of authors address key ideas in the materials, processes, mechanics, and devices of soft and stretchable electronics; the wearable electronics systems; and bioinspired and implantable biomedical electronics. Among the topics discussed are liquid metals, stretchable and flexible energy sources, skin-like devices, in vitro neural recording, and more. Special focus is given to recent advances in extremely soft and stretchable bio-inspired electronics with real-world clinical studies that validate the technology. Foundational theoretical and experimental aspects are also covered in relation to the design and application of these biointegrated electronics systems. This is an ideal book for researchers, engineers, and industry professionals involved in developing healthcare devices, medical tools and related instruments relevant to various clinical practices.
Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha
The industry of implantable medical devices (IMDs) is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable dev...
Ethylene oxide gas is an agent in the sterilization of medical devices due to its effectiveness and compatibility with most materials. The advantages and disadvantages, as well as its recommended uses, are explored in this review article. The variables and their relevance on process optimization are described, the types of processing cycles are detailed and emphasis is given to the design and validation of the sterilization process.
Full Text Available The industry of implantable medical devices (IMDs is constantly evolving, which is dictated by the pressing need to comprehensively address new challenges in the healthcare field. Accordingly, IMDs are becoming more and more sophisticated. Not long ago, the range of IMDs’ technical capacities was expanded, making it possible to establish Internet connection in case of necessity and/or emergency situation for the patient. At the same time, while the web connectivity of today’s implantable devices is rather advanced, the issue of equipping the IMDs with sufficiently strong security system remains unresolved. In fact, IMDs have relatively weak security mechanisms which render them vulnerable to cyber-attacks that compromise the quality of IMDs’ functionalities. This study revolves around the security deficiencies inherent to three types of sensor-based medical devices; biosensors, insulin pump systems and implantable cardioverter defibrillators. Manufacturers of these devices should take into consideration that security and effectiveness of the functionality of implants is highly dependent on the design. In this paper, we present a comprehensive study of IMDs’ architecture and specifically investigate their vulnerabilities at networking interface.
Bertoloni, G; Bertucco, A; Rassu, M; Vezzù, K
The employment of disinfection-sterilisation processes for the re-use of medical devices without negative effects such as the presence of toxic residues, material degradation or other modifications is an important consideration for reducing the costs of surgical and medical procedures. Ethylene oxide is the most commonly used low temperature sterilisation technique in healthcare facilities, but its associated toxicity has reduced interest in this technology for the reprocessing of medical equipment. The aim of this study was to examine the disinfection efficiency of a novel low temperature approach, based on dense carbon dioxide on artificially contaminated catheters. The results obtained demonstrated that this method provided a complete inactivation of all bacteria and yeast strains tested, and that no obvious modifications to the surfaces tested were observed with multiple treatments. Copyright © 2010 The Hospital Infection Society. Published by Elsevier Ltd. All rights reserved.
.... FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian....), as amended by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 94-295), the Safe Medical Devices Act of 1990 (the SMDA) (Pub. L. 101-629), and the Food and Drug Administration...
.... FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus... commercial distribution before May 28, 1976, the date of enactment of the Medical Device Amendments of 1976... ``requirements'' to address each identified risk to health presented by these specific medical devices under 21 U...
The objective of our study was to document the efficacy and possible complications in women who were treated for menorrhagia with the simultaneous use of endometrial ablation and the levonorgestrel-releasing intrauterine device. Women were offered this combined treatment if they complained of menorrhagia and needed contraception. A structured questionnaire was mailed to 150 women who had undergone this combined treatment; 105 (70%) returned a completed questionnaire. The mean duration of follow-up was 25 months (range 6-54 months). Following treatment, 53 women (50.5%) described their periods as being lighter than normal and 49 (46%) had become amenorrhoeic. Overall, 101 (96%) stated that they were satisfied with the treatment. Of the women, 95 (90.5%) said that the treatment had been a \\'complete success\\'; eight (7.6%) \\'partly successful\\' and two women (1.9%) said the treatment had been a \\'failure\\'. One woman subsequently required a hysterectomy. This observational study supports the hypothesis that combined endometrial ablation and insertion of a levonorgestrel-releasing intrauterine device is an effective treatment for menorrhagia and has some advantages when compared with the individual use of these treatments.
Kant, Shashi; Archana, S; Singh, Arvind Kumar; Ahamed, Farhad; Haldar, Partha
Acceptance rate of postpartum intrauterine contraceptive device (PPIUCD) offered through a public health approach is unknown. Our aim was to describe the acceptance rate, expulsion, and follow-up and factors associated with it when PPIUCD was offered to women delivering at two primary health centers (PHCs). We analyzed routine health data of deliveries at two PHCs in district Faridabad, India between May and December 2014, having sociodemographic variables, obstetric history, and during the follow-up check-up at 6-weeks postpartum for in situ status of intrauterine contraceptive device, side effects, and complications. The overall acceptance rate among those eligible for PPIUCD was 39% (95% confidence interval [CI]: 35.1-42.9). Independent predictor of acceptance was a monthly family income of 25 years (O.R.: 2.21, 95% CI: 1.03-4.73), gravida ≥4 (O.R.: 4.01, 95% CI: 1.28-12.56), and a living previous-child (O.R.: 1.51, 95% CI: 1.04-2.19). Acceptance rate of PPIUCD was higher than that reported in literature. Women from lower income family, having at least one living child, and having attended antenatal care clinic were more likely to accept PPIUCD.
May-Newman, Karen; Cornwall, G Bryan
The design of medical devices requires an understanding of a large number of factors, many of which are difficult to teach in the traditional educational format. This subject benefits from using a challenge-based learning approach, which provides focused design challenges requiring students to understand important factors in the context of a specific device. A course was designed at San Diego State University (CA, USA) that applied challenge-based learning through in-depth design challenges in cardiovascular and orthopedic medicine, and provided an immersive field, needs-finding experience to increase student engagement in the process of knowledge acquisition. The principles of US FDA 'design control' were used to structure the students' problem-solving approach, and provide a format for the design documentation, which was the basis of grading. Students utilized a combination of lecture materials, industry guest expertise, texts and readings, and internet-based searches to develop their understanding of the problem and design their solutions. The course was successful in providing a greatly increased knowledge base and competence of medical device design than students possessed upon entering the course.
Hu, Wei; Gu, Hanqing
To study the USA government's administrative system about medical device standards as well as the standard making. The relevant documents, regulations, website that USA Food and Drug Administration announced were extensively reviewed, knowing the USA medical device standards synthetically. The USA standards system of medical device included regulatory requirements and voluntary consensus standards. This article simply introduced the laws, regulations, performance standards and consensus standards. The USA's administrative system about medical device standards as well as many standards can be referenced.
Programmable, implantable and external biomedical devices (such as pacemakers, defibrillators, insulin pumps, pain management pumps, vagus nerve stimulators and others) may be vulnerable to unauthorized access, commonly referred to as hacking. This intrusion may lead to compromise of confidential patient data or loss of control of the device itself, which may be deadly. Risks to health from unauthorized access is in addition to hazards from faulty (buggy) software or circuitry. Historically, this aspect of medical device design has been underemphasized by both manufacturers and regulatory bodies until recently. However, an insulin pump was employed as a murder weapon in 2001 and successful hacking of an implantable defibrillator was demonstrated in 2008. To remedy these problems, professional groups have announced a variety of design standards and the governmental agencies of several countries have enacted device regulations. In turn, manufacturers have developed new software products and hardware circuits to assist biomedical engineering firms to improve their commercial offerings. In this paper the author discusses these issues, reviewing known problems and zero-day threats, with potential solutions. He outlines his approach to secure software and hardware challenges using the Forth language. A plausible scenario is described in which hacking of an implantable defibrillator by terrorists results in a severe national security threat to the United States.
..., to enact needed regulatory reforms so that medical device manufacturers can bring their safe and...] Medical Device User Fee Act; Public Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice of... public meeting to discuss proposed recommendations for the reauthorization of the Medical Device User Fee...
Genina, Natalja; Hollander, Jenny; Jukarainen, Harri
The main purpose of this work was to investigate the printability of different grades of ethylene vinyl acetate (EVA) copolymers as new feedstock material for fused-deposition modeling (FDM™)-based 3D printing technology in fabrication of custom-made T-shaped intrauterine systems (IUS) and subcut......The main purpose of this work was to investigate the printability of different grades of ethylene vinyl acetate (EVA) copolymers as new feedstock material for fused-deposition modeling (FDM™)-based 3D printing technology in fabrication of custom-made T-shaped intrauterine systems (IUS......) and subcutaneous rods (SR). The goal was to select an EVA grade with optimal properties, namely vinyl acetate content, melting index, flexural modulus, for 3D printing of implantable prototypes with the drug incorporated within the entire matrix of the medical devices. Indomethacin was used as a model drug...
Bringing together the concepts of design control and reliability engineering, this book is a must for medical device manufacturers. It helps them meet the challenge of designing and developing products that meet or exceed customer expectations and also meet regulatory requirements. Part One covers motivation for design control and validation, design control requirements, process validation and design transfer, quality system for design control, and measuring design control program effectiveness. Part Two discusses risk analysis and FMEA, designing-in reliability, reliability and design verific
Teixeira, Marie B
The second edition of a bestseller, Design Controls for the Medical Device Industry provides a comprehensive review of the latest design control requirements, as well as proven tools and techniques to ensure your company's design control program evolves in accordance with current industry practice. The text assists in the development of an effective design control program that not only satisfies the US FDA Quality System Regulation (QSR) and ISO 9001 and 13485 standards, but also meets today's third-party auditor/investigator expectations and saves you valuable time and money.The author's cont
To Investigate necessity of safety evaluation, research ideas, evaluation methods of DEHP in PVC medical devices. The ideas of The United States, Japan and the European Union on safety evaluation of DEHP in PVC medical devices was reviewed and sorted, regarding to currently requirements for PVC medical devices in our country, the research ideas and methods of DEHP in PVC medical devices was explored. DEHP released from High-risk PVC medical devices may exceed human tolerance intake values and thus potentially be harmful to human health. So it is necessary for production enterprise to assess safety of DEHP in PVC medical device. The assessment can be done by material control and detecting release of DEHP from PVC medical devices. In order to assess safety of DEHP in PVC medical device, production enterprise can firstly assess materials according to national standard. Secondly, production enterprise can detect release of DEHP from PVC medical devices simulating clinical application. By comparing release of DEHP from PVC medical devices and TI, safety of DEHP in PVC medical device can be evaluated.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Microbiology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...
Sridhar, Radhakrishnan; Pliszka, Damian; Luo, He-Kuan; Chin Lim, Keith Hsiu; Ramakrishna, Seeram
Medical devices form a broad range of appliances from a basic nanoparticle coating or surgical gloves to a complicated laser therapy device. These devices are designed to support patients, surgeons and healthcare personnel in meeting patients' healthcare needs. Regulatory authorities of each country regulate the process of approval, manufacturing and sales of these medical devices so as to ensure safety and quality to patients or users. Recent recalls of medical devices has increased importance of safety, awareness and regulation of the devices. Singapore and India have strong presence and national priorities in medical devices development and use. Herein we capture the rationale of each of these national regulatory bodies and compare them with the medical devices regulatory practices of USA and European nations. Apart from the comparison of various regulatory aspects, this review will specifically throw light on the polymer material based medical devices and their safety.
This book presents a systematic approach to analyzing the challenging engineering problems posed by the need for security and privacy in implantable medical devices (IMD). It describes in detail new issues termed as lightweight security, due to the associated constraints on metrics such as available power, energy, computing ability, area, execution time, and memory requirements. Coverage includes vulnerabilities and defense across multiple levels, with basic abstractions of cryptographic services and primitives such as public key cryptography, block ciphers and digital signatures. Experts from engineering introduce to some IMD systems that have recently been proposed and developed. Experts from Computer Security and Cryptography present new research, which shows vulnerabilities in existing IMDs and proposes solutions. Experts from Privacy Technology and Policy will discuss the societal, legal and ethical challenges surrounding IMD security as well as technological solutions that build on the latest in C...
Pinedo Herbert, Michael; Kraaijenhagen Roderik, Adriaan; Van Den Berg, Albert
The invention relates to a capsule or chip or sensor comprising a marker/detector and signalling device/method associated with the development of a medical condition/disease and to its use. This In Situ Lab On a Chip Signalling device (ISLOGS device) is used for detecting a medical condition/disease
Drake, Robin W; Martins, Summer L; Whitaker, Amy K
The objective was to describe infection rates after intrauterine device (IUD) placement at an urban teaching hospital that did not restrict IUD eligibility based on risk factors for sexually transmitted infections (STIs). We reviewed charts of patients undergoing IUD placement at the University of Chicago obstetrics and gynecology resident clinic from July 2007 to June 2008 (n=283). The primary outcome was diagnosis of pelvic inflammatory disease (PID) within 12 months. Almost half (49.5%) of patients reported a history of any STI. Two patients (0.7%) were diagnosed with PID. Postplacement infection in this unrestricted population was infrequent and comparable to reported rates in previous studies. Copyright © 2015 Elsevier Inc. All rights reserved.
Hollander, Jenny; Genina, Natalja; Jukarainen, Harri
the products. Diffusion of the drug from the polymer was the predominant mechanism of drug release, whereas poly(ε-caprolactone) biodegradation had a minor effect. This study shows that 3D printing is an applicable method in the production of drug-containing IUS and can open new ways in the fabrication......The goal of the present study was to fabricate drug-containing T-shaped prototypes of intrauterine system (IUS) with the drug incorporated within the entire backbone of the medical device using 3-dimensional (3D) printing technique, based on fused deposition modeling (FDM™). Indomethacin was used...... as a model drug to prepare drug-loaded poly(ε-caprolactone)–based filaments with 3 different drug contents, namely 5%, 15%, and 30%, by hot-melt extrusion. The filaments were further used to 3D print IUS. The results showed that the morphology and drug solid-state properties of the filaments and 3D...
To get funding approved for medical device integration, ClOs suggest focusing on specific patient safety or staff efficiency pain points. Organizations that make clinical engineering part of their IT team report fewer chain-of-command issues. It also helps IT people understand the clinical goals because the engineering people have been working closely with clinicians for years. A new organization has formed to work on collaboration between clinical engineers and IT professionals. For more information, go to www.ceitcollaboration.org. ECRI Institute has written a guide to handling the convergence of medical technology and hospital networks. Its "Medical Technology for the IT Professional: An Essential Guide for Working in Today's Healthcare Setting" also details how IT professionals can assist hospital technology planning and acquisition, and provide ongoing support for IT-based medical technologies. For more information, visit www.ecri.org/ITresource.
Dogan, Ülkü Balcı; Dogan, Mehmet Ugur; Ülgen, Yekta; Özkan, Mehmed
In the proposed study, a medical device maintenance management system (MEDEMAS) is designed and implemented which provides a data pool of medical devices, the maintenance protocols and other required information for these devices. The system also contains complete repair and maintenance history of a specific device. MEDEMAS creates optimal maintenance schedule for devices and enables the service technician to carry out and report maintenance/repair processes via remote access. Thus predicted future failures are possible to prevent or minimize. Maintenance and repair is essential for patient safety and proper functioning of the medical devices, as it prevents performance decrease of the devices, deterioration of the equipment, and detrimental effects on the health of a patient, the user or other interacting people. The study aims to make the maintenance process more accurate, more efficient, faster and easier to manage and organize; and much less confusing. The accumulated history of medical devices and maintenance personnel helps efficient facility planning.
Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil
European industry of medical device technologies represents 30% of all worlds sales. New health technologies bring effective treatment approaches, help shorten stays in hospital1),bring better treatment results and accelerate rehabilitation which leads to the earlier patients recovery.Legislative aspects are one of the key areas influencing the speed of development of medical devices and their launching. The aim of this article is to specify current state of legislation in the development of medical devices in the European Union in comparison with the market leaders such as China, Japan and USA.The best established market of medical devices is in the USA. Both Japan and China follow the USA model. However, a non-professional code of ethics in China in some respect contributes to the decrease of quality of medical devices, while Japan as well as the EU countries try really hard to conform to all the regulations imposed on the manufacturing of medical devices.
.... The factors are (i) whether the device generally must be implanted, inserted, operated, or otherwise... with respect to an orthotic or prosthetic device that is not implanted. The final regulations provide a... circumstances test. 6. Dental Devices Several commenters suggested that dental devices that are customized for...
Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid
Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems.
Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.
Mobile phones' electromagnetic interference with medical devices is an important issue for the medical safety of patients who are using life-supporting medical devices. This review mainly focuses on mobile phones' interference with implanted medical devices and with medical equipment located in critical areas of hospitals. A close look at the findings reveals that mobile phones may adversely affect the functioning of medical devices, and the specific effect and the degree of interference depend on the applied technology and the separation distance. According to the studies' findings and the authors' recommendations, besides mitigating interference, using mobile phones at a reasonable distance from medical devices and developing technology standards can lead to their effective use in hospital communication systems. (authors)
Full Text Available for detection of cardiovascular disease (CVD) risk factors implicated in most non- communicable diseases (NCDs) FROM POINT OF APPLICATION POINT OF CARE South Africa-UK Newton Collaborative Research Development Programme in Precision Medicine... contributes to product control 2. Post-market surveillance ensures that medical devices in use continue to be safe and effective. A third element is the representation of the product to the user - Label, Advertising and Education/ Training From Simone...
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory...). The meeting will be open to the public. Name of Committee: Immunology Devices Panel of the Medical...
... (CONTINUED) MEDICAL DEVICES LABELING Labeling Requirements for Over-the-Counter Devices § 801.63 Medical... class I ozone-depleting substances. (a) All over-the-counter devices containing or manufactured with... harms public health and environment by destroying ozone in the upper atmosphere. (2) The alternative...
Soonawalla, R P
This article is presented to give an idea as to how far the IUD can fulfill the purpose of population control. For the couple, this intrauterine method is most ideal. The main drawback is the side effect of bleeding, which is the cause of the high drop out rate. The other handicaps are spontaneous expulsion and pregnancy with the IUD in situ. It is also unsuited to nulliparous women. The general practitioner needs to become concerned with the gravity of the problem of overpopulation, and he must encourage his patients into the use of contraceptives. At the moment, the IUD is the method of choice.
... Handle Power Outages for Medical Devices that Require Electricity Center for De CDRH vices and Rad lth ... Handle Power Outages for Medical Devices that Require Electricity As a home medical device user, it is ...
... strategy and policy for the custom device exemption criteria in the FD&C Act amended by FDASIA. FDA is... States in finished form through labeling or advertising by the manufacturer, importer, or distributor for...
.... The hotel telephone number is 301-977-8900. Contact Person: Jamie Waterhouse, Center for Devices and..., pneumatically, or electrically and (2) devices that aid the emergency medical professional in delivering manual...
Yu, Sicong; Pan, Ying; Yu, Xiping; Zhu, Yinfeng
The article intends to analyze the software safety problems in high-risk medical devices based on the investigation of software R & D Quality control procedures in Shanghai medical device manufacturing enterprises. The idea of improving the software pre-market safety evaluation method in China is also explored through the way of comparing those in U.S. and Europe.
Kuyvenhoven, JD; Lahorte, P; Persyn, K; De Geest, E; van Loon, PW; Jacobs, F; van Rijk, PP; Lemahieu, [No Value; Dierckx, R A
The European Council Directive 93/42/EEC concerning medical devices (14 June 1993) assigns new responsibilities and imposes technical requirements both to the manufacturer and user of medical devices. In this paper the general outlines of the directive are discussed with a particular emphasis on the
Hanson, Jacob J; Hitchcock, Robert W
Despite their sophistication and value, single-use medical devices have become commodity items in the developed world. Cheap raw materials along with large scale manufacturing and distribution processes have combined to make many medical devices more expensive to resterilize, package and restock than to simply discard. This practice is not sustainable or scalable on a global basis. As the petrochemicals that provide raw materials become more expensive and the global reach of these devices continues into rapidly developing economies, there is a need for device designs that take into account the total life-cycle of these products, minimize the amount of non-renewable materials consumed and consider alternative hybrid reusable / disposable approaches. In this paper, we describe a methodology to perform life cycle and functional analyses to create additional design requirements for medical devices. These types of sustainable approaches can move the medical device industry even closer to the "triple bottom line"--people, planet, profit.
Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi
This paper demonstrates the benefits of adopting model-based design techniques for engineering medical device software. By using a patient-controlled analgesic (PCA) infusion pump as a candidate medical device, the authors show how using models to capture design information allows for i) fast and efficient construction of executable device prototypes ii) creation of a standard, reusable baseline software architecture for a particular device family, iii) formal verification of the design against safety requirements, and iv) creation of a safety framework that reduces verification costs for future versions of the device software. 1.
Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin
Abstract Medical devices increasingly depend on software. While this expands the ability of devices to perform key therapeutic and diagnostic functions, reliance on software inevitably causes exposure to hazards of security vulnerabilities. This article uses a recent high‐profile case example to outline a proactive approach to security awareness that incorporates a scientific, risk‐based analysis of security concerns that supports ongoing discussions with patients about their medical devices. PMID:28512774
Hao, Aiyu; Wang, Ling
At present, hospitals in our country have basically established the HIS system, which manages registration, treatment, and charge, among many others, of patients. During treatment, patients need to use medical devices repeatedly to acquire all sorts of inspection data. Currently, the output data of the medical devices are often manually input into information system, which is easy to get wrong or easy to cause mismatches between inspection reports and patients. For some small hospitals of which information construction is still relatively weak, the information generated by the devices is still presented in the form of paper reports. When doctors or patients want to have access to the data at a given time again, they can only look at the paper files. Data integration between medical devices has long been a difficult problem for the medical information system, because the data from medical devices are lack of mandatory unified global standards and have outstanding heterogeneity of devices. In order to protect their own interests, manufacturers use special protocols, etc., thus causing medical decices to still be the "lonely island" of hospital information system. Besides, unfocused application of the data will lead to failure to achieve a reasonable distribution of medical resources. With the deepening of IT construction in hospitals, medical information systems will be bound to develop towards mobile applications, intelligent analysis, and interconnection and interworking, on the premise that there is an effective medical device integration (MDI) technology. To this end, this paper presents a MDI model based on the Internet of Things (IoT). Through abstract classification, this model is able to extract the common characteristics of the devices, resolve the heterogeneous differences between them, and employ a unified protocol to integrate data between devices. And by the IoT technology, it realizes interconnection network of devices and conducts associate matching
Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott
In the United States, regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of all Food and Drug Administration-regulated products. Good regulatory science facilitates consumer access to innovative medical devices that are safe and effective throughout the Total Product Life Cycle (TPLC). Because the need to measure things is fundamental to the regulatory science of medical devices, analytical chemistry plays an important role, contributing to medical device technology in two ways: It can be an integral part of an innovative medical device (e.g., diagnostic devices), and it can be used to support medical device development throughout the TPLC. In this review, we focus on analytical chemistry as a tool for the regulatory science of medical devices. We highlight recent progress in companion diagnostics, medical devices on chips for preclinical testing, mass spectrometry for postmarket monitoring, and detection/characterization of bacterial biofilm to prevent infections. Expected final online publication date for the Annual Review of Analytical Chemistry Volume 11 is June 12, 2018. Please see http://www.annualreviews.org/page/journal/pubdates for revised estimates.
.... 66, rm. 2460, Silver Spring, MD 20993-0002, 301- 796-6493. SUPPLEMENTARY INFORMATION: I. What is the... functioning of other medical devices; Adverse tissue reaction; Hazards associated with electrical equipment...-clinical analysis and testing. other medical devices. Labeling. Adverse tissue reaction Biocompatibility...
Prototypes of medical devices are made in accordance with the needs of clinical practice, and for systems required during the initial process of medical device development for new surgical practices. Verification of whether these prototypes produce the intended performance specifications is conducted using basic tests such as mechanical and animal tests. The prototypes are then improved and modified until satisfactory results are obtained. After a prototype passes through a clinical trial process similar to that for new drugs, application for approval is made. In the approval application process, medical devices are divided into new, improved, and generic types. Reviewers judge the validity of intended use, indications, operation procedures, and precautions, and in addition evaluate the balance between risk and benefit in terms of efficacy and safety. Other characteristics of medical devices are the need for the user to attain proficiency in usage techniques to ensure efficacy and safety, and the existence of a variety of medical devices for which assessment strategies differ, including differences in impact on the body in cases in which a physical burden to the body or failure of a medical device develops. Regulatory science of medical devices involves prediction, judgment, and evaluation of efficacy, safety, and quality, from which data result which can become indices in the development stages from design to application for approval. A reduction in the number of animals used for testing, improvement in efficiency, reduction of the necessity for clinical trials, etc. are expected through rational setting of evaluation items.
... From the Federal Register Online via the Government Publishing Office DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Immunology Devices Panel of the Medical Devices Advisory.... SUMMARY: The Food and Drug Administration (FDA) is postponing the meeting of the Immunology Devices Panel...
.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... composed of surgical grade stainless steel (with or without coating in gold, silver, or titanium) from... steps: (1) Receives a recommendation from a device classification panel (an FDA advisory committee); (2...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee; Notice... be open to the public. Name of Committee: Clinical Chemistry and Clinical Toxicology Devices Panel of...
Jones, Judith K; Tave, Arlene; Pezzullo, John C; Kardia, Sharon; Lippes, Jack
To determine the long-term risk of reproductive tract cancer in women using the quinacrine hydrochloride pellet system of permanent contraception (QS) relative to the comparable risk in women using Copper T intrauterine device (IUD) or tubal ligation surgery (TL) for long-term or permanent contraception. This was a retrospective cohort study, conducted in the Northern Vietnamese provinces of Ha Nam, Nam Dinh, Ninh Binh and Thai Binh. Women who had their first QS procedure, last IUD insertion or TL between 1989 and 1996 were interviewed regarding post-procedure health outcomes, particularly reproductive tract cancers. A 95% response rate resulted in 21,040 completed interviews. Reproductive cancer incidence rates were very low (5.77/100,000 women years of follow-up time; 95%CI = 3.72-8.94). No significant excess hazard of reproductive tract cancer was associated with QS. No significant excess long-term risk of reproductive tract cancer was found after an average 16 years of follow-up among a large group of women using QS vs. IUD/TL for contraception.
Rubin, Susan E; Cohen, Hillel W; Santelli, John S; McKee, M Diane
The intrauterine device (IUD) is a highly effective contraceptive, yet not all primary care providers (PCPs) counsel adolescents about IUDs. We sought to describe PCPs' frequency of counseling adolescents about IUDs and identify whether different factors are associated with frequent counseling by pediatricians compared with family physicians and gynecologists. Surveyed PCPs affiliated with a Bronx, New York academic institution. Frequent counseling of female adolescents about IUDs. Frequent counseling was lower in pediatricians compared with family physicians and gynecologists (35.8% and 81.6%, respectively, P < .001). Among all PCP types, frequent counseling was associated with feeling more competent counseling and managing expected IUD side effects (P < .001). Other significant variables included inserting IUDs themselves (P < .001, family physicians and gynecologists) or having access to an inserter in their office (P = .04, pediatricians). Correlates of frequent IUD counseling differed according to PCP specialty. Our results suggest that interventions to increase IUD counseling should focus on improving PCPs' competency around counseling and side effect management as well as increasing access to IUD inserters. © The Author(s) 2015.
González-Angulo, A; Aznar-Ramos, R
Endometrial biopsies obtained from 12 young women wearing TCu-200 intrauterine contraceptive devices from six to 12 months were studied by means of transmission and scanning electron microscopes as well as with the use of rubeanic acid stains and x-ray dispersive analysis. Six biopsies were taken at Day 10 and six were taken at Day 20 of the menstrual cycle. The aim was to investigate epithelial and stromal changes possibly related to copper deposition. The main changes were located in the cell organelles at Day 10 of the cycle. The mitochondria disclosed vacuolization of the matrix and myelin figure formation in 70 to 80% of the epithelial cells. There were also increased numbers of lysosomes. There were similar alterations of secretory endometrium in only a few cases. Instead, there was an increased number of mitochondria, and most of them were dividing. Rubeanic acid stains as well as energy-dispersive x-ray analysis failed to reveal significant amounts of copper in the various cell organelles studied. The above observations seem to indicate that there is a definite alteration of the mitochondria of epithelial cells which may result in impairment of respiratory mechanisms and energy production, rendering the endometrial environment inhospitable to the fertilized egg. These changes are thought to be reversible. The absence of copper is explained on the basis of a rapid turnover of the endometrium or to a problem in sampling common to this methodology.
Xu, J; Zhuang, L; Yu, G
To compare the efficacy of hand-insertion and ring forceps-insertion of TCu 380A intrauterine device (IUD) in immediate postplacental insertion (IPPI). 910 vaginal delivery women in Shanghai received a TCu 380A IUD inserted within 10 minutes after delivery of the placenta. Among them, 97.7% were primipara. The women were randomly divided into two groups: 470 cases in hand-insertion group and 440 in ring forceps-insertion group. Using life-tale method and X2 test, we compared the expulsion rates and other causes of removal after follow-up for 12 months in the two groups. The follow-up rate at 6 and 12 months were 95.16% and 92.64%, respectively. No uterine perforation and infection occurred in the 910 cases, and only one pregnancy in the hand-insertion group. Expulsions were the main reason for discontinuation. The 12-month gross cumulative expulsion rates were 15.86 and 15.88 per 100 women in the hand-insertion group and ring forceps-insertion group, respectively, and the removal rates due to bleeding and (or) pain were 2.11 and 1.57, respectively. No difference was statistically significant (P > 0.05). The two different insertion techniques do not significantly affect discontinuation rates in vaginal IPPI using the TCu 38)A IUD; the TCu 380A IUD appears to be suitable for postpartum insertion in Chinese women.
The impact of physicians' communication styles on evaluation of physicians and information processing: A randomized study with simulated video consultations on contraception with an intrauterine device.
Bientzle, Martina; Fissler, Tim; Cress, Ulrike; Kimmerle, Joachim
This study aimed at examining the impact of different types of physicians' communication styles on people's subsequent evaluation of physician attributes as well as on their information processing, attitude and decision making. In a between-group experiment, 80 participants watched one of three videos in which a gynaecologist displayed a particular communication style in a consultation situation on contraception with an intrauterine device. We compared doctor-centred communication (DCC) vs patient-centred communication (PCC) vs patient-centred communication with need-orientation (PCC-N). In the PCC condition, participants perceived the physician to be more empathetic and more competent than in the DCC condition. In the DCC condition, participants showed less attitude change compared to the other conditions. In the PCC-N condition, the physician was perceived as more empathetic and more socially competent than in the other conditions. However, participants acquired less knowledge in the PCC-N condition. We conclude that appropriate application of particular communication styles depends on specific consultation goals. Our results suggest that patients' needs should be addressed if the main goal is to build a good relationship, whereas a traditional PCC style appears to be more effective in communicating factual information. © 2016 The Authors Health Expectations Published by John Wiley & Sons Ltd.
Stringer, Elizabeth M; Kaseba, Christine; Levy, Jens; Sinkala, Moses; Goldenberg, Robert L; Chi, Benjamin H; Matongo, Inutu; Vermund, Sten H; Mwanahamuntu, Mulindi; Stringer, Jeffrey S A
The purpose of this study was to determine whether the intrauterine contraceptive device (IUD) is effective and safe among women who are infected with the human immunodeficiency virus (HIV). We randomly assigned 599 postpartum, HIV-infected women in Zambia to receive either a copper IUD or hormonal contraception and followed them for at least 2 years. Women who were assigned randomly to hormonal contraception were more likely to become pregnant than those who were assigned randomly to receive an IUD (rate, 4.6/100 vs 2.0/100 woman-years; hazards ratio, 2.4; 95% CI, 1.3-4.7). One woman who was assigned to the IUD experienced pelvic inflammatory disease (crude rate, 0.16/100 woman-years; 95% CI, 0.004-868); there was no pelvic inflammatory disease among those women who were assigned to hormonal contraception. Clinical disease progression (death or CD4+ lymphocyte count dropping below 200 cells/microL) was more common in women who were allocated to hormonal contraception (13.2/100 woman-years) than in women who were allocated to the IUD (8.6/100 woman-years; hazard ratio, 1.5; 95% CI, 1.04-2.1). The IUD is effective and safe in HIV-infected women. The unexpected observation that hormonal contraception was associated with more rapid HIV disease progression requires urgent further study.
Shipp, Thomas D; Bromley, Bryann; Benacerraf, Beryl R
The purpose of this study was to determine whether women with intrauterine devices (IUDs) embedded in the myometrium or cervix have a narrower fundal transverse endometrial diameter as seen on 3-dimensional (3D) sonography compared to women whose IUDs are in a normal location. A sonographer blinded to the study hypothesis retrospectively evaluated the 3D images and reconstructed coronal views of the uterine cavity in 172 consecutive women who had an IUD in the uterus. The width of the endometrial cavity at the fundus of the uterus was measured transversely on the rendered coronal sonogram using the calipers on a picture archiving and communications system. The measurements obtained from women who had nonembedded IUDs were compared to those with embedded IUDs. Measurement of the width of the endometrial cavity at the fundus was successfully performed in 132 patients with nonembedded IUDs and 29 with embedded IUDs. The mean ± SD values of the fundal uterine cavity for the nonembedded and embedded IUDs were 32 ± 1.0 and 25 ± 0.8 mm, [corrected] respectively (P = .0003). Patients with embedded IUDs have a smaller fundal endometrial cavity diameter compared to those with normally placed IUDs as documented using 3D rendering of the uterus. Whether preprocedural 3D sonography for women who are IUD candidates would be useful deserves further study.
Taneepanichskul, Surasak; Reinprayoon, Damrong; Thaithumyanon, Pimolratn; Praisuwanna, Pramote; Tosukhowong, Piyaratana; Dieben, Thom
The study objectives were to compare the effects of an etonogestrel-releasing implant (Implanon) and a nonmedicated intrauterine device (IUD) on parameters of lactation in breast-feeding women and on the growth of their breast-fed infants over a 3-year period. Healthy lactating women (28-56 days postpartum) chose either the implant (n=42) or the IUD (n=38). Infant growth during a 3-year follow-up period is reported here. Total duration of breast-feeding coinciding with the mothers' treatment was 421.0 and 423.4 days in the Implanon and IUD groups, respectively. There were no differences between the infant groups in terms of body length, biparietal head circumference and body weight. No abnormalities were reported in psychomotor development or during physical examination. No treatment-related side effects were observed in either group. In conclusion, there were no differences in the growth of breast-fed infants of women treated with Implanon or a nonmedicated IUD. Implanon, therefore, appears to be a safe contraceptive option for breast-feeding women and their infants.
Großkopf, Volker; Jäkel, Christian
The processing of single-use products is permissible pursuant to medical device law. This is apparent both from the wording of the German Law on Medical Devices and from the purpose and the objectives underpinning the legislative materials. The prerequisite for processing is, however, compliance with the the Joint Recommendation of the Commission for Hospital Hygiene and the Prevention of Infection at the Robert Koch Institute (RKI) and the Federal Institute for Drugs and Medical Products (BfArM). For medical devices in the category “critical C”, the RKI/BfArM-recommendation provides that the processor’s quality management system must be certified by a body accredited by the Central Authority of the Federal States for Health Protection with regard to Medicinal Products and Medical Devices (Zentralstelle der Länder für Gesundheitsschutz bei Arzneimitteln und Medizinprodukten, ZLG). The certification must be carried out in accordance with EN ISO 13485:2003+AC:2007. On April 4, 2008 the Federal Health Ministry (Bundesministerium für Gesundheit, BMG) presented a progress report on the processing of medical devices. The BMG concludes that the legal framework for the processing of medical devices is sufficient, and that a prohibition on the processing of single-use products is inappropriate. PMID:20204096
Turin, E M; Nagle, C A; Lahoz, M; Torres, M; Turin, M; Mendizabal, A F; Escofet, M B
A copper-bearing intrauterine device (IUD), designed to cause a slight distention of the uterus, was inserted through the cervix into each uterine horn of 230 heifers; an additional 230 heifers served as the control group. Blood was drawn at 0, 1, 2, 20 and 120 d for progesterone and testosterone assays. The heifers were checked twice daily for estrus and examined at 0, 60 and 120 d for weight gain. Thereafter they were bred over a 120-d period. The IUD caused anestrus in 98% of the heifers, with a daily weight gain 25.5 % higher than in the control heifers. Moreover, the device was 100% effective in preventing pregnancy. At 20 and 120 d after IUD insertion progesterone levels averaged 0.7 ng/ml, which was 4 to 5 times lower than in the control animals, suggesting a failure in ovulation or in corpus luteum (CL) formation due to the IUD. Simultaneously, testosterone values were increased up to 8 times in IUD-treated heifers, reaching a mean concentration of 163 pg/ml. Associated histological evaluations of the ovaries from UD-treated heifers revealed the presence of 2 or more cysts per ovary, with marked hyperthecosis in many antral follicles in which the granulosa cell layers were either thinned or lacking. The results suggest that the action of the copper-releasing IUD used in this study resulted in high contraceptive efficiency but also in disturbance of ovarian function. Our findings further raise the possibility of a cause and effect relationship between hyperandrogenism and the higher body weight gain observed in heifers treated with the IUD.
Phillips, J Matthew; Mossop, Paula; Bartol, Carolyn; Hodgson, Barbara
Technology and medical equipment devices have become integrated in the delivery of health care. These technologies and devices can introduce new risks, either through user error or malfunction. When these incidents occur, it is important they are reported so that learning and improvements are possible. A just culture encourages reporting of incidents by not blaming individuals, but rather by seeking to understand incidents in relation to how they occurred because of the systems in place. These concepts are explored through a case study in a dialysis unit where a malfunction of a medical equipment device (central venous catheter) was identified. The process for addressing the issue is defined and includes reviewing applicable data, reporting incidents, and evaluating devices that malfunctioned. Finally, the role of the frontline health care professional is identified as an important stakeholder in identifying issues with technology and medical devices, reporting these incidents, and participating in the process that resolves the issues.
U.S. Department of Health & Human Services — SUMMARY DDOD use case request for consolidated, consistent reporting of medical device recalls. WHAT IS A USE CASE? A “Use Case” is a request that was made by the...
... poor usability is among the top 10 health technology hazards of 2012. Examples include users having difficulty ... handle the device in an emergency. Designing Visual Learning Guides, using mostly pictures. The first two guides ... and Players . Language Assistance Available: EspaÃ±ol | ç¹é«ä¸æ | ...
Black, Amanda; Guilbert, Edith; Costescu, Dustin; Dunn, Sheila; Fisher, William; Kives, Sari; Mirosh, Melissa; Norman, Wendy; Pymar, Helen; Reid, Robert; Roy, Geneviève; Varto, Hannah; Waddington, Ashley; Wagner, Marie-Soleil; Whelan, Anne Marie; Mansouri, Shireen
To provide guidelines for health care providers on the use of contraceptive methods to prevent pregnancy and on the promotion of healthy sexuality. Overall efficacy of cited contraceptive methods, assessing reduction in pregnancy rate, safety, ease of use, and side effects; the effect of cited contraceptive methods on sexual health and general well-being; and the relative cost and availability of cited contraceptive methods in Canada. Published literature was retrieved through searches of Medline and The Cochrane Database from January 1994 to January 2015 using appropriate controlled vocabulary (e.g., contraception, sexuality, sexual health) and key words (e.g., contraception, family planning, hormonal contraception, emergency contraception). Results were restricted to systematic reviews, randomized control trials/controlled clinical trials, and observational studies published in English from January 1994 to January 2015. Searches were updated on a regular basis in incorporated in the guideline to June 2015. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. The quality of the evidence in this document was rated using the criteria described in the Report of the Canadian Task Force on Preventive Health Care (Table 1). CHAPTER 7: INTRAUTERINE CONTRACEPTION: 1. Intrauterine contraceptives are as effective as permanent contraception methods. (II-2) 2. The use of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg by patients taking tamoxifen is not associated with recurrence of breast cancer. (I) 3. Intrauterine contraceptives have a number of noncontraceptive benefits. The levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg significantly decreases menstrual blood loss (I) and dysmenorrhea. (II-2) Both the copper intrauterine
This paper presents an overview of the medical device manufacturing industry in Taiwan. Taiwan’s medical device manufacturers have achieved mature production technology in homecare products. With assistance provided to international giants through Original Equipment Manufacturer and through sales of self-owned brands, they are securing a predominant position on the global market. Contact lenses and glucose meters made in Taiwan have also shown significant growth in production and exports for...
Lavin, P; Bravo, C; Waskaz, C; Andrade, M I; Bravo, M; Caceres, R; Castro, J; Miranda, L; Namur, L; Olmos, G
The author presents a comparative analysis of results obtained in a follow-up study of the 1st 12 months following insertion immediately postpartum (following delivery) of the TCu200 and IPCS 52 IUDs in a group of 400 women. The devices were inserted either manually or by using a plastic insertion aid at the maternity unit of the Barros Luco-Trudeau Hospital, Santiago, Chile, between November 1978-February 1980. The devices were retained during the 1st 12 months in 86.1% of the cases in which the TCu200 was inserted manually, 86.3% of cases in which they were inserted using the plastic aid, 59.3% of those cases in which the IPCS devices were inserted manually, and 57.2% of cases in which the IPCS was inserted using the aid. The different levels of retention among the 2 groups was due mainly to the high levels of expulsion in the IPCS 52 patients. The expulsion levels in the TCu200 groups were 9.2 and 8.1% respectively and 35.8 and 35.2% in the IPCS 52 groups. Although an IUD contraceptive system involving progesterone was selected in order to reduce bleeding and pain associated with the IUD, the incidence of such reactions was no lower in the IPCS 52 groups than in the others. However, specific levels of dysmenorrhea were significantly lower (p0.05) among IPCS 52 groups than among TCu200 groups. In general, results obtained with the TCu200 were better than those obtained with the IPCS 52, and the insertion method had no influence on the recorded reactions. (author's modified)
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical image storage device. 892.2010 Section 892.2010 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED..., and digital memory. (b) Classification. Class I (general controls). The device is exempt from the...
Problems associated with reprocessing of disposable medical devices such as hemodialysers with resterilization for reuse and changes in material properties with resterilization of polymeric (PVC, polypropylene, polyester, polycarbonate) materials intended for development of disposable devices are reviewed. Reprocessing of hospital supplies, polystyrene microtiter plate and angiographic catheter for reuse is also discussed.
Over 10 years ago, the Public Health Agency of Canada released the results of a nation-wide survey of hospitals that demonstrated that the reuse of single-use medical devices was widespread in Canadian healthcare institutions. In this article, the author discusses the reuse and reprocessing of these devices, as well as the risks this practice presents. She then goes on to outline the legal implications of reusing single-use devices. Copyright © 2013 Longwoods Publishing.
From the first pacemaker implant in 1958, numerous engineering and medical activities for implantable medical device development have faced challenges in materials, battery power, functionality, electrical power consumption, size shrinkage, system delivery, and wireless communication. With explosive advances in scientific and engineering technology, many implantable medical devices such as the pacemaker, cochlear implant, and real-time blood pressure sensors have been developed and improved. This trend of progress in medical devices will continue because of the coming super-aged society, which will result in more consumers for the devices. The inner body is a special space filled with electrical, chemical, mechanical, and marine-salted reactions. Therefore, electrical connectivity and communication, corrosion, robustness, and hermeticity are key factors to be considered during the development stage. The main participants in the development stage are the user, the medical staff, and the engineer or technician. Thus, there are three different viewpoints in the development of implantable devices. In this review paper, considerations in the development of implantable medical devices will be presented from the viewpoint of an engineering mind. PMID:24143287
Moorman, Bridget A; Cockle, Richard A
Financial pressures, an aging population, and a rising number of patients with chronic diseases, have encouraged the use of remote monitoring technologies. This usually entails at least one physiological parameter measurement for a clinician. Mobile telecommunication technologies lend themselves to this functionality, and in some cases, avoid some of the issues encountered with device integration. Moreover, the inherent characteristics of the mobile telecommunications infrastructure allow a coupling of business and clinical functions that were not possible before. Table I compares and contrasts some key aspect of device integration in and out of a healthcare facility. An HTM professional may be part of the team that acquires and/or manages a system using a mobile telecommunications technology. It is important for HTM professionals to ensure the data is in a standard format so that the interfaces across this system don't become brittle and break easily if one part changes. Moreover, the security and safety considerations of the system and the data should be a primary consideration in and y purchase, with attention given to the proper environmental and encryption mechanisms. Clinical engineers and other HTM professionals are unique in that they understand the patient/clinician/device interface and the need to ensure its safety and effectiveness regardless of geographical environment.
... TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical... removes the partial list of examples of unproven drugs, devices, and medical treatments or procedures... partial list of examples of unproven drugs, devices, and medical treatments or procedures proscribed under...
...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Multiplexed Microbiology/ Medical Countermeasure Devices'' that published in the Federal Register of August 8... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices,'' for FDA's proposed...
Vesical Calculus 10 Years Post Missing Intrauterine. Contraceptive Device. Abdullahi Abdulwahab-Ahmed, Oluwagbemiga Olabisi Ogunleye. INTRODUCTION. Intrauterine contraceptive devices (IUCD) are acceptable means of contraception world over.[1-4] There have been reports of its migration to other adjourning sites ...
Daw, Zamira; Cleaveland, Rance; Vetter, Marcus
Software-based devices have increasingly become an important part of several clinical scenarios. Due to their critical impact on human life, medical devices have very strict safety requirements. It is therefore necessary to apply verification methods to ensure that the safety requirements are met. Verification of software-based devices is commonly limited to the verification of their internal elements without considering the interaction that these elements have with other devices as well as the application environment in which they are used. Medical guidelines define clinical procedures, which contain the necessary information to completely verify medical devices. The objective of this work was to incorporate medical guidelines into the verification process in order to increase the reliability of the software-based medical devices. Medical devices are developed using the model-driven method deterministic models for signal processing of embedded systems (DMOSES). This method uses unified modeling language (UML) models as a basis for the development of medical devices. The UML activity diagram is used to describe medical guidelines as workflows. The functionality of the medical devices is abstracted as a set of actions that is modeled within these workflows. In this paper, the UML models are verified using the UPPAAL model-checker. For this purpose, a formalization approach for the UML models using timed automaton (TA) is presented. A set of requirements is verified by the proposed approach for the navigation-guided biopsy. This shows the capability for identifying errors or optimization points both in the workflow and in the system design of the navigation device. In addition to the above, an open source eclipse plug-in was developed for the automated transformation of UML models into TA models that are automatically verified using UPPAAL. The proposed method enables developers to model medical devices and their clinical environment using clinical workflows as one
Wood, Houston G; Throckmorton, Amy L; Untaroiu, Alexandrina; Song Xinwei
Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year
Sheinman, Victor; Rudnitsky, Arkady; Toichuev, Rakhmanbek; Eshiev, Abdyrakhman; Abdullaeva, Svetlana; Egemkulov, Talantbek; Zalevsky, Zeev
An evolving area of biomedical research is related to the creation of implantable units that provide various possibilities for imaging, measurement, and the monitoring of a wide range of diseases and intrabody phototherapy. The units can be autonomic or built-in in some kind of clinically applicable implants. Because of specific working conditions in the live body, such implants must have a number of features requiring further development. This topic can cause wide interest among developers of optical, mechanical, and electronic solutions in biomedicine. We introduce preliminary clinical trials obtained with an implantable pill and devices that we have developed. The pill and devices are capable of applying in-body phototherapy, low-level laser therapy, blue light (450 nm) for sterilization, and controlled injection of chemicals. The pill is also capable of communicating with an external control box, including the transmission of images from inside the patient's body. In this work, our pill was utilized for illumination of the sinus-carotid zone in dog and red light influence on arterial pressure and heart rate was demonstrated. Intrabody liver tissue laser ablation and nanoparticle-assisted laser ablation was investigated. Sterilization effect of intrabody blue light illumination was applied during a maxillofacial phlegmon treatment.
Wood, Houston G [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States); Throckmorton, Amy L [Biomedical Engineering Department, Virginia Artificial Heart Institute, University of Virginia, Charlottesville, VA (United States); Untaroiu, Alexandrina [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States); Song Xinwei [Mechanical and Aerospace Engineering Department, Virginia Artificial Heart Institute, 122 Engineers Way, University of Virginia, Charlottesville, VA (United States)
Millions of patients, from infants to adults, are diagnosed with congestive heart failure each year all over the world. A limited number of donor hearts available for these patients results in a tremendous demand for alternative, supplemental circulatory support in the form of artificial heart pumps or ventricular assist devices (VADs). The development procedure for such a device requires careful consideration of biophysical factors, such as biocompatibility, haemolysis, thrombosis, implantability, physiologic control feasibility and pump performance. Conventional pump design equations based on Newton's law and computational fluid dynamics (CFD) are readily used for the initial design of VADs. In particular, CFD can be employed to predict the pressure-flow performance, hydraulic efficiencies, flow profile through the pump, stress levels and biophysical factors, such as possible blood cell damage. These computational flow simulations may involve comprehensive steady and transient flow analyses. The transient simulations involve time-varying boundary conditions and virtual modelling of the impeller rotation in the blood pumps. After prototype manufacture, laser flow measurements with sophisticated optics and mock circulatory flow loop testing assist with validation of pump design and identification of irregular flow patterns for optimization. Additionally, acute and chronic animal implants illustrate the blood pump's ability to support life physiologically. These extensive design techniques, coupled with fundamental principles of physics, ensure a reliable and effective VAD for thousands of heart failure patients each year.
Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V
New technologies introduced over the past three decades have transformed medical diagnosis and treatment, and significantly improved patient outcomes. These changes have been mediated by the introduction of new medical devices, particularly for the treatment of cardiovascular, orthopedic, and ophthalmic disorders. These devices, in turn, have created large markets and spawned a burgeoning medical device industry, including six Fortune 500 companies whose combined market capitalization now exceeds 400 billion dollars. This success story, which has unquestionably benefited patients and society alike, has been dependent upon an intense collaboration among industry, clinicians, and regulatory authorities. However, when physicians actively involved in patient care participate in such collaborations, they are increasingly vulnerable to creating potential conflicts between these two (clinical and device development) roles. Such conflicts, which may ultimately erode public trust, have important consequences not only for the individual physicians, but also for their parent institutions, their patients, sponsoring companies, and the entire clinical research enterprise that makes the development and introduction of new devices possible. The third Dartmouth Device Development Symposium held in October 2005 brought together thought leaders within the medical device community, including academicians, clinical investigators, regulators from the Food and Drug Administration and Centers for Medicare and Medicaid Services (CMS), large and small device manufacturers and the financial (venture capital and investment banks) community. The Symposium examined the conflicts of interest encountered during the early development and commercialization of a medical device. The goal of these discussions was to (1) identify and characterize the conflicts that arise and (2) provide strategies to address these conflicts. This manuscript was prepared by a writing committee to provide a summary
Envall, Niklas; Groes Kofoed, Nina; Kopp-Kallner, Helena
Emergency contraception must be followed by the use of an effective method of contraception in order to reduce future risk of unintended pregnancies. Provision of long-acting reversible contraception (LARC) is highly effective in this regard. The aim of our study was to compare use of an effective method of contraception 6 months following insertion of a copper intrauterine device (Cu-IUD) or intake of ulipristal acetate (UPA) for emergency contraception (EC). Women (n = 79) presenting with need for EC at an outpatient midwifery clinic chose either Cu-IUD or UPA according to preference. Follow up was 3 and 6 months later through telephone interviews. Primary outcome was use of an effective contraceptive method at the 6-month follow up. Secondary outcomes included use of an effective contraceptive method at 3 months follow up and acceptability of Cu-IUD. A total of 30/36 (83.3%) women who opted for Cu-IUD for EC used an effective contraceptive method 6 months after their first visit compared with 18/31 (58.1%) women who opted for UPA (p = 0.03). In the Cu-IUD group 28/36 (77.8%) were still using Cu-IUD at 6 months and 31/36 (86%) stated that they would recommend the Cu-IUD to others as an EC method. Significantly more women who chose Cu-IUD for EC used an effective method for contraception at the 6-month follow up. The results of this study support increased use of Cu-IUDs for EC. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.
Dorjgochoo, Tsogzolmaa; Shu, Xiao-Ou; Li, Hong-Lan; Qian, Han-Zhu; Yang, Gong; Cai, Hui; Gao, Yu-Tang; Zheng, Wei
The association of contraceptive methods, including oral contraceptives (OC), intrauterine devices (IUD) and tubal sterilization (TS), with overall and site-specific cancer were prospectively investigated in a cohort of 66,661 Chinese women in Shanghai, 76.7% of whom used contraception. During a median follow-up time of 7.5 years, 2,250 women were diagnosed with cancer. Ever-use of any contraceptive method was not associated with overall cancer risk [adjusted hazard ratio (HR(adj)) = 1.02, 95% CI, 0.92-1.12]. Use of any contraceptive method was associated with increased risk of rectal cancer (HR(adj) = 1.68, 95% CI, 1.08-2.62) and reduced risk of thyroid cancer (HR(adj) = 0.63, 95% CI, 0.38-1.04). Risk of gallbladder cancer increased with ever use of OC (HR(adj) = 2.38, 95% CI, 1.26-4.49). IUD use was associated with a possible reduced risk of thyroid cancer (HR(adj) = 0.64, 95% CI, 0.38-1.07). Longer duration of IUD use decreased risk for breast, thyroid and lung cancers. Ever having a TS was associated with increased uterine body cancer (HR(adj) = 2.50, 95% CI, 1.47-4.25) and decreased risk of stomach cancer (HR(adj) = 0.59, 95% CI, 0.39-0.91). We did not find any contraceptive method to be related to the risk of ovarian cancer but the analyses were based on few events. Although chance findings are a likely explanation for some of the associations found in our study, these findings suggest that various contraceptive methods or reproductive patterns may play a role in the etiology of cancer. (c) 2008 Wiley-Liss, Inc.
Abdellah, Mohamed S; Abbas, Ahmed M; Hegazy, Aml M; El-Nashar, Ihab M
The current study aims to evaluate if vaginal misoprostol (400 mcg) administered prior to intrauterine device (IUD) insertion increases the ease and success of insertion among women who had delivered only by elective cesarean delivery (CD). The current study was a randomized, double-blind, placebo-controlled trial conducted in Assiut Women's Health Hospital, Egypt, between the 1st of April 2015 and the 31st of March 2016 and included women who delivered only by elective CD. One hundred forty women were randomized into two groups; misoprostol group received two misoprostol 400-mcg tablets vaginally, and placebo group received two placebo tablets 3 h before a copper T380A IUD insertion. The primary outcome measure was the difference in the ease of insertion score using a 10-cm visual analog scale between both groups with 0=very easy insertion, and 10=terribly difficult insertion. The ease of insertion score was lower in the misoprostol group (2.2±0.5 vs. 4.2±0.5, p=.0001) with higher number of successful IUD insertions than the placebo group (69 [98.6%] vs. 61 [87.1%], p=.009). The mean pain score reported by the women was lower in misoprostol group (2.7±0.6 vs. 4.3±0.8) with higher level of satisfaction from the whole procedure (8.9±0.4 vs. 7.9±0.2) with p=.001 for both. Misoprostol 400 mcg vaginally prior to IUD insertion eases and increase the success of insertion with reduction of pain among women who had delivered only by elective CD. The use of vaginal misoprostol before IUD insertion in women who had never delivered vaginally before may increase the ease and success of insertion. Moreover, it may reduce the pain felt by women during the procedure. Copyright © 2017 Elsevier Inc. All rights reserved.
Pashkov, Vitalii; Hutorova, Nataliia; Harkusha, Andrii
In Ukraine differentiated VAT rates is a matter of debate. Today the Cabinet approved a list of medical products that has been changed three times resulting in changed VAT rates for specific products. European Union provides another method of regulation of VAT rates on medical devices. The abovementioned demonstrates the relevance of this study. Comparative analysis of Ukrainian and European Union legislation based on dialectical, comparative, analytic, synthetic and comprehensive research methods were used in this article. In Ukraine general rate of VAT for all business activities is 20 %. But for medical devices, Tax Code of Ukraine provides special rules. VAT rate of 7% for transactions supplies into Ukraine and imported into the customs territory of Ukraine of medical products on the list approved by the Cabinet. The list generated by the medical product name and nomenclature code that does not correspond to European experience and Council Directive 2006/112/EC. In our opinion, reduced VAT rates should to be established for all medical devices that are in a stream of commerce, have all necessary documents, that proved their quality and safety and fall under definition of medical devices.
... validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design... HUMAN SERVICES Food and Drug Administration 21 CFR Part 886 Medical Devices; Ophthalmic Devices; Classification of the Eyelid Thermal Pulsation System AGENCY: Food and Drug Administration, HHS. ACTION: Final...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES [Docket No. FDA-2011-N-0002] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS... and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Microbiology...
... lipids from these cells for noninvasive aesthetic use. (b) Classification. Class II (special controls.... FDA-2011-N-0188] Medical Devices; General and Plastic Surgery Devices; Classification of the Low Level.... DATES: This rule is effective May 16, 2011. The classification was effective on August 24, 2010. FOR...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2010-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass Assessment Score Test System; Correction AGENCY: Food and Drug Administration, HHS. ACTION...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2012-N-0165] Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological Reagents; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Final rule; correction...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] Clinical Chemistry and Clinical Toxicology Devices Panel of the Medical Devices Advisory Committee: Notice of Change of Meeting Schedule AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction...
In this study, a new protective design compatible with existing non-secure systems was proposed, since it is focused on the secure communication of wireless IMD systems in all transmissions. This new protector is an external wearable device and appears to be a belt fitted around for the patients IMD implanted. However, in order to provide effective full duplex transmissions and physical layer security, some sophisticated transceiver antennas have been placed on the belt. In this approach, beam-focused multi-antennas in optimal positions on the belt are randomly switched when transmissions to the IMD are performed and multi-jammer switching with MRC combining or majority-rule based receiving techniques are applied when transmissions from the IMD are carried out. This approach can also reduce the power consumption of the IMDs and contribute to the prolongation of the IMD's battery life.
Bachmor, T; Schöchlin, J; Bolz, A
Equipping medical devices with long range telemetry opens completely new possibilities for emergency response, home care and remote diagnosis. Mobile communications nowadays seem to be a generally accepted part of our modern world, but bridging the gap between new (consumer-) technologies and medical devices still is a challenge today. Providing a telemetry link (GSM) is just the trivial part--ensuring security, reliability and service management are the more critical tasks that need to be addressed. Therefore, a complete system concept consists of an automatic fleet management (e.g. periodic device-initiated service calls) as well as customer relationship management (CRM), including technical service and a trouble-ticket system.
Peng, Xiangchi; Hu, Shanshan; Meng, Tianqing; Suo, Jinping; Xiong, Chengliang
This study was conducted to investigate the antifertility effectiveness of a novel copper-containing composite used in intrauterine contraceptive devices (IUDs) that contain cupric chloride/silicon dioxide/poly(vinyl alcohol) (CuCl₂/SiO₂/PVA) and the releasing behavior of cupric ions in the composite into the serum and uterine fluid in rats. Two hundred and forty sexually mature female Sprague-Dawley rats were randomly divided into six groups: sham-operated control group (n=20), bulk copper group (Cu group, n=40), SiO₂/PVA group (n=40), CuCl₂/SiO₂/PVA groups I (n=40, copper ion was released from IUD at a rate of 5-10 mcg/220 mm² per day) and II (n=40, copper ion was released from IUD at a rate of 10-20 mcg/220 mm² per day), and normal control group (n=20). IUD was inserted into the uterus of rats after acclimatization of 1 week. At different time points after implantation of the IUDs, cupric ion concentrations were measured in the serum and local uterine fluid in each group by flame atomic absorption, respectively. After 30 days of insertion, half of the rats in each group were mated with fertile male rats, and the antifertility rates were observed at 14 days of pregnancy. After the IUDs were removed, the remaining rats in each group were mated again to determine their fertility. Antifertility rates in the Cu group and CuCl₂/SiO₂/PVA groups I and II were 100%, and each of these rates was significantly higher than that in the other groups (p.05). No significant change in time dependence was found for the serum cupric ion concentrations in each group (p>.05), while the local uterine fluid cupric ion concentrations in the other groups were significantly lower than those in the Cu group (pcontraceptive devices (CuCl₂/SiO₂/PVA composite IUD) had a low pregnancy rate and high contraceptive efficacy without a burst release of cupric ions in the initial days of application. Copyright © 2012 Elsevier Inc. All rights reserved.
The Food and Drug Administration (FDA or we) is classifying the irrigating wound retractor device into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the irrigating wound retractor device's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.
Hinrichs, Saba; Dickerson, Terry; Clarkson, John
This study identifies the stakeholders who have a role in medical device purchasing within the wider system of health-care delivery and reports on their particular challenges to promote patient safety during purchasing decisions. Data was collected through observational work, participatory workshops, and semi-structured qualitative interviews, which were analyzed and coded. The study takes a systems-based and engineering design approach to the study. Five hospitals took part in this study, and the participants included maintenance, training, clinical end-users, finance, and risk departments. The main stakeholders for purchasing were identified to be staff from clinical engineering (Maintenance), device users (Clinical), device trainers (Training), and clinical governance for analyzing incidents involving devices (Risk). These stakeholders display varied characteristics in terms of interpretation of their own roles, competencies for selecting devices, awareness and use of resources for purchasing devices, and attitudes toward the purchasing process. The role of "clinical engineering" is seen by these stakeholders to be critical in mediating between training, technical, and financial stakeholders but not always recognized in practice. The findings show that many device purchasing decisions are tackled in isolation, which is not optimal for decisions requiring knowledge that is currently distributed among different people within different departments. The challenges expressed relate to the wider system of care and equipment management, calling for a more systemic view of purchasing for medical devices.
records and will introduce error resistance into networked medical device systems. We are producing a standardization framework consisting of a...We have also begun collecting data on the issue related to device clock time errors and erroneous data time-stamps in preparation for a White House...advances in mind. We also recognize that, as in all technological advances, interoperability poses safety and medico -legal challenges as well. The
Jang, Hye Jung; Choi, Young Deuk; Kim, Nam Hyun
This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to medical devices, following the enactment of the Medical Device Act in Korea. Medical device safety information reports were analyzed for 190 cases that took place prior to the application of a medical device safety information reporting system and during a period when the reporting system was used. Also, questionnaires were used to measure the effectiveness of the medical device safety information reporting system. The analysis was based on the questionnaire responses of 15 reporters who submitted reports in both the pre- and post-reporting system periods. Sixty-two reports were submitted in paper form, but after the system was set up, this number more than doubled to 128 reports in electronic form. In terms of itemized reporting, a total of 45 items were reported. Before the system was used, 23 items had been reported, but this increased to 32 items after the system was put to use. All survey variables of satisfaction received a mean of over 3 points, while positive attitude , potential benefits , and positive benefits all exceeded 4 points, each receiving 4.20, 4.20, and 4.13, respectively. Among the variables, time-consuming and decision-making had the lowest mean values, each receiving 3.53. Satisfaction was found to be high for system quality and user satisfaction , but relatively low for time-consuming and decision-making . We were able to verify that effective reporting and monitoring of adverse incidents and the safety of medical devices can be implemented through the establishment of an in-hospital medical device safety information reporting system that can enhance patient safety and medical device risk management.
Full Text Available In applied research for medical devices exists a conflict between effective research and regulations. While researchers need sufficient freedom the regulations require a complex technical documentation for a medical device. One relevant aspect of the regulations is risk management which takes time and therefore is ignored in many research projects. With adoptions to the standard the effort can be reduced: Identifying of risks can be focused on critical risks, measures can be categorised and only some categories need to be implemented. Research teams using this method can provide results which can be transferred into commercial products easier, cheaper and faster.
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory...
series of dynamic protocols to isolate and assess balance function deficiencies. The technology was based on Nashner s novel, engineering-inspired concept of balance as an adaptable collaboration between multiple sensory and motor systems. CDP proved useful not only for examining astronauts, but for anyone suffering from balance problems. Today, CDP is the standard medical tool for objectively evaluating balance control.
Full Text Available Standards are produced for many different products and services, and may be created for company, national, regional or global application. In Europe there are three different categories of standard: International standard – a standard adopted by an international standardization organization; European standard – a standard adopted by a European standardization body; National standard – a standard adopted by a national standardization body and made available to the public. Harmonized standards play a special role in the EU. A harmonised standard is a European standard elaborated on the basis of a request from the European Commission to a recognised European Standards Organisation to develop a European standard that provides solutions for compliance with a legal provision. Most standards for dental materials have been harmonized through a so-called cumulative standard (EN 1641:2009 - Dentistry - Medical devices for dentistry - Materials. This European Standard specifies general requirements for materials used in the practice of dentistry for the restoration of the form and function of the dentition and which are medical devices. A multiplicity of laws, standards, and recommendations regulate the marketing of medical devices. The medical doctor and the dentist should be informed about the European and international standards concerning medical devices and use only those for which appropriate information is available. The manufacturer/importer is responsible for its products and is potentially liable for damages.
Vargas, Eric J; Rizk, Monika; Bazerbachi, Fateh; Abu Dayyeh, Barham K
Endoscopic bariatric therapies (EBTs) are effective tools for the management of obesity. By mimicking restrictive and bypass surgery physiology, they provide a safe and effective treatment option with the added capabilities of reaching a broader population. Multiple efficacious medical devices, such as intragastric balloons, endoscopic suturing/plication devices, and bypass liners, at various stages of development are available in the United States. EBTs represent the newest addition to a multidisciplinary approach in obesity management. This article reviews several devices' safety and efficacy for primary care providers in the era of evolving obesity treatment. Copyright © 2017 Elsevier Inc. All rights reserved.
In the market of medical devices, non-Japanese products hold a large part even in Japan. To overcome this situation, the Japanese government has been announcing policies to encourage the medical devices industry, such as the 5-year strategy for medical innovation (June 6, 2012). The Division of Medical Devices has been contributing to rapid marketing of medical devices by working out the standards for approval review and accreditation of medical devices, guidances on evaluation of medical devices with emerging technology, and test methods for biological safety evaluation of medical devices, as a part of practice in the field of regulatory science. The recent outcomes are 822 standards of accreditation for Class II medical devices, 14 guidances on safety evaluation of medical devices with emerging technology, and the revised test methods for biological safety evaluation (MHLW Notification by Director, OMDE, Yakushokuki-hatsu 0301 No. 20 "Basic Principles of Biological Safety Evaluation Required for Application for Approval to Market Medical Devices").
Yadav, Vivek; Balasubramaniam, Sudharsanam; Das, Saswati; Srivastava, Ashish; Srivastava, Ashish; Kumar, Somesh; Sood, Bulbul
Objective As part of a strategy to revitalize postpartum family planning services, Government of India revised its policy in 2013 to permit trained nurses and midwives to insert postpartum intrauterine contraceptive devices (PPIUCDs). This study compares two key outcomes of PPIUCD insertions — expulsion and infection — for physicians and nurses/midwives to generate evidence for task sharing. Study design We analyzed secondary data from the PPIUCD program in seven states using a case–control study design. We included facilities where both doctors and nurses/midwives performed PPIUCD insertions and where five or more cases of expulsion and/or infection were reported during the study period (January–December 2013). For each case of expulsion and infection, we identified a time-matched control who received a PPIUCD at the same facility and had no complaints. We performed a multiple logistic regression analysis focusing on provider cadre while controlling for potential confounding factors. Results In 137 facilities, 792 expulsion and 382 infection cases were matched with 1041 controls. Provider type was not significantly associated with either expulsion [odds ratio (OR) 1.84; 95% confidence interval (CI): 0.82–4.12] or infection (OR 0.73; 95% CI: 0.39–1.37). Compared with centralized training, odds of expulsion were higher for onsite (OR 2.32, 95% CI: 1.86–2.89) and on-the-job training (OR 1.23, 95% CI: 1.11–1.36), but odds of infection were lower for onsite (OR 0.45, 95% CI: 0.27–0.75) and on-the-job training (OR 0.31, 95% CI: 0.25–0.37). Conclusion Trained nurses and midwives who conduct deliveries at public health facilities can perform PPIUCD insertions as safely as physicians. Implications Institutional deliveries are increasing in India, but most normal vaginal deliveries at public health facilities are attended by nurses and midwives due to a shortage of physicians. Task sharing with nurses and midwives can increase women's access to and the
Yadav, Vivek; Balasubramaniam, Sudharsanam; Das, Saswati; Srivastava, Ashish; Srivastava, Ashish; Kumar, Somesh; Sood, Bulbul
As part of a strategy to revitalize postpartum family planning services, Government of India revised its policy in 2013 to permit trained nurses and midwives to insert postpartum intrauterine contraceptive devices (PPIUCDs). This study compares two key outcomes of PPIUCD insertions--expulsion and infection--for physicians and nurses/midwives to generate evidence for task sharing. We analyzed secondary data from the PPIUCD program in seven states using a case-control study design. We included facilities where both doctors and nurses/midwives performed PPIUCD insertions and where five or more cases of expulsion and/or infection were reported during the study period (January-December 2013). For each case of expulsion and infection, we identified a time-matched control who received a PPIUCD at the same facility and had no complaints. We performed a multiple logistic regression analysis focusing on provider cadre while controlling for potential confounding factors. In 137 facilities, 792 expulsion and 382 infection cases were matched with 1041 controls. Provider type was not significantly associated with either expulsion [odds ratio (OR) 1.84; 95% confidence interval (CI): 0.82-4.12] or infection (OR 0.73; 95% CI: 0.39-1.37). Compared with centralized training, odds of expulsion were higher for onsite (OR 2.32, 95% CI: 1.86-2.89) and on-the-job training (OR 1.23, 95% CI: 1.11-1.36), but odds of infection were lower for onsite (OR 0.45, 95% CI: 0.27-0.75) and on-the-job training (OR 0.31, 95% CI: 0.25-0.37). Trained nurses and midwives who conduct deliveries at public health facilities can perform PPIUCD insertions as safely as physicians. Institutional deliveries are increasing in India, but most normal vaginal deliveries at public health facilities are attended by nurses and midwives due to a shortage of physicians. Task sharing with nurses and midwives can increase women's access to and the acceptability of quality PPIUCD services. Copyright © 2016 The Authors
Abbas, Ahmed M; Abdellah, Mohamed S; Khalaf, Mohamed; Bahloul, Mustafa; Abdellah, Noura H; Ali, Mohamed K; Abdelmagied, Ahmed M
The objective was to investigate the analgesic effect of cervical lidocaine-prilocaine (LP) cream in alleviating pain during copper T380A intrauterine device (IUD) insertion among parous women. We conducted a randomized, double-blind, placebo-controlled trial at Assiut Women's Health Hospital, Egypt, from October 2015 to April 2016 of parous women desiring copper IUD insertion. We randomized the subjects in a 1:1 ratio to LP cream or placebo. Seven minutes prior to IUD insertion, women received 2 ml of LP cream or placebo to the anterior cervical lip, followed by 2 ml placed in the cervical canal using a Q-tip applicator. The study end point was the subjects' self-reported pain using a 10-cm visual analog scale (VAS) during cervical tenaculum placement, sound insertion, IUD insertion and 5 min postprocedure. We considered a 2-cm difference in VAS scores between study groups as clinically significant. Also, the difference in the ease of insertion score using a 10-cm VAS with 0=very easy insertion and 10=terribly difficult insertion was assessed. The study included 120 women (n=60 in each group). LP cream reduces the median VAS pain scores during tenaculum placement (2 vs. 4), sound insertion (3 vs. 6) and IUD insertion (3 vs. 6.5) with p=.0001 at all steps. A lower ease of insertion score was also determined among LP women (2.5±0.98 vs. 4.5±2.7, p=.001). Participants reported no side effects. Use of cervical LP cream prior to copper T380A IUD insertion may alleviate the IUD insertion pain among parous women. Cervical LP cream could be effective as an analgesic prior to copper T380A IUD insertion with no side effects. Further studies are needed to assess the women's satisfaction from lying with a speculum in place for 7 min while waiting for the cream to be effective. Copyright © 2016 Elsevier Inc. All rights reserved.
McNicholas, Colleen; Maddipati, Ragini; Zhao, Qiuhong; Swor, Erin; Peipert, Jeffrey F.
Objective To evaluate the effectiveness of the contraceptive implant and the 52mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration–approved duration of 3 and 5 years respectively. Methods Women willing to continue using their implant or 52mg levonorgestrel IUD (LNG-IUD) beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum etonogestrel levels. The Kruskal-Wallis test was used to compare the etonogestrel levels across BMI groups. Results Implant users (n=237) have contributed 229.4 women-years of follow-up, with 123 using the etonogestrel implant for 4 years, and 34 using it for 5 years. Zero pregnancies have been documented, for a failure rate of 0 (one-sided 97.5% CI: 0, 1.61) per 100 women-years. Among 263 LNG-IUD users, 197.7 women-years of follow-up have been completed. One pregnancy was confirmed, for a failure rate of 0.51 (95% CI: 0.01, 2.82) per 100 women-years. Among implant users with serum etonogestrel results, the median and range of etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8, 802.6) and 177.0 pg/mL (67.9, 470.5) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: p=0.79; 4 years: p=0.47). Conclusion Preliminary findings indicate the contraceptive implant and 52mg hormonal IUD continue to be highly-effective for an additional year, beyond the FDA approved 3 and 5 years.. Serum etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use. PMID:25730221
McNicholas, Colleen; Maddipati, Ragini; Zhao, Qiuhong; Swor, Erin; Peipert, Jeffrey F
To evaluate the effectiveness of the contraceptive implant and the 52-mg hormonal intrauterine device (IUD) in women using the method beyond the current U.S. Food and Drug Administration (FDA)-approved duration of 3 and 5 years, respectively. Women willing to continue using their implant or 52-mg levonorgestrel IUD beyond the FDA-approved duration were followed prospectively for contraceptive effectiveness. Unintended pregnancy rate per 100 women-years was calculated. Implant users are offered periodic venipuncture for analysis of serum etonogestrel levels. The Kruskal-Wallis test was used to compare the etonogestrel levels across body mass index (BMI) groups. Implant users (n=237) have contributed 229.4 women-years of follow-up, with 123 using the etonogestrel implant for 4 years and 34 using it for 5 years. Zero pregnancies have been documented, for a failure rate of 0 (one-sided 97.5% confidence interval [CI] 0-1.61) per 100 women-years. Among 263 levonorgestrel IUD users, 197.7 women-years of follow-up have been completed. One pregnancy was confirmed, for a failure rate of 0.51 (95% CI 0.01-2.82) per 100 women-years. Among implant users with serum etonogestrel results, the median and range of etonogestrel level at 3 years of use was 188.8 pg/mL (range 63.8-802.6 pg/mL) and 177.0 pg/mL (67.9-470.5 pg/mL) at 4 years of use. Etonogestrel levels did not differ by BMI at either time point (3 years: P=.79; 4 years: P=.47). Preliminary findings indicate the contraceptive implant and 52-mg hormonal IUD continue to be highly effective for an additional year beyond the FDA-approved 3 and 5 years. Serum etonogestrel levels indicate the implant contains adequate hormone for ovulation suppression at the end of both 3 and 4 years of use. II.
Zhou, Jie; Tan, Xiaodong; Song, Xiangjing; Zhang, Kaining; Fang, Jing; Peng, Lin; Qi, Wencai; Nie, Zonghui; Li, Ming; Deng, Rui; Yan, Chaofang
Copper-bearing intrauterine device (IUD) insertion for long-term contraceptive use is high in China, but there has been evidence that first-year discontinuation rate of copper-bearing IUD has also increased rapidly in recent years especially among rural married women. To investigate long-term use of copper-bearing IUD, the authors examined the 7-year temporal trends of copper-bearing IUD discontinuation in a population-based birth-cohort study among 720 rural married women in China, from 2004 to 2012. Women requesting contraception were followed-up twice per year after the insertion of IUD. The gross cumulative life table discontinuation rates were calculated for each of the main reasons for discontinuation as well as for all reasons combined. By the end of 7 years, 384 discontinuations were observed. With a stepped-up trend, the gross cumulative life table rate for discontinuation increased from 10.06 (95% confidence interval = 7.86-12.27) per 100 women by the first year to 52.69 (95% confidence interval = 48.94-56.44) per 100 women by the end of 7 years, which increased rapidly in the first 2 years after copper-bearing IUD insertion, flattened out gradually in the following 2 years, then increased again in the last 3 years. Among reported method failure, expulsion and side effects were the main reasons for discontinuation of the copper-bearing IUD but not pregnancy. Personal reasons, such as renewal by personal will had influenced copper-bearing IUD use since the second year and should not be neglected. Based on this study, the temporal trends of copper-bearing IUD discontinuation was in a stepped-up trend in 7 years after insertion. Both reported method failure (expulsion and side effect) and personal reason had effect on the discontinuation of copper-bearing IUD, but pregnancy was no more the most important reason affecting the use of copper-bearing IUD. © 2014 APJPH.
comprising -a medical device for transporting fluids having a lumen and a first connector part, and -at least one light source configured to emit light having bactericidal effect which light source has a corresponding second connector part, and comprises an optical window being transparent for light from...
Kaluska, I.; Stuglik, Z. [Institute of Nuclear Chemistry and Technology, Warsaw (Poland)
Overview of sterilization methods of medical devices has been given, with the special stress put on radiation sterilization. A typical validation program for radiation sterilization has been shown and also a comparison of European and ISO standards concerning radiation sterilization has been discussed. (author). 13 refs, 1 fig., 2 tabs.
... facility best practices. This is part of an ongoing effort to address patient exposure to inadequately... of reusable medical devices. DATES: Submit either electronic or written comments by September 26... the heading of this document, by any of the following methods: Electronic Submissions Submit...
Kibriya, Nabil, E-mail: email@example.com; Hall, Rebecca; Powell, Steven [The Royal Liverpool University Hospital, Radiology Department (United Kingdom); How, Thien [University of Liverpool, Faculty of Health and Life Sciences (United Kingdom); McWilliams, Richard G. [The Royal Liverpool University Hospital, Radiology Department (United Kingdom)
PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed.
Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.
PurposeThe purpose of the study is to quantify the variation in the metric equivalent of French size in a range of medical devices, from various manufacturers, used in interventional radiology.MethodsThe labelling of a range of catheters, introducers, drains, balloons, stents, and endografts was examined. Products were chosen to achieve a broad range of French sizes from several manufacturers. To assess manufacturing accuracy, eight devices were selected for measurement using a laser micrometer. The external diameters of three specimens of each device were measured at centimeter intervals along the length of the device to ensure uniformity.ResultsA total of 200 labels of interventional radiology equipment were scrutinized. The results demonstrate a wide variation in the metric equivalent of French sizing. Labelled products can vary in diameter across the product range by up to 0.79 mm.The devices selected for measurement with the non-contact laser micrometer demonstrate acceptable manufacturing consistency. The external diameter differed by 0.05 mm on average.ConclusionsOur results demonstrate wide variation in the interpretation of the French scale by different manufacturers of medical devices. This has the potential to lead to problems using coaxial systems especially when the products are from different manufacturers. It is recommended that standard labelling should be employed by all manufacturers conveying specific details of the equipment. Given the wide variation in the interpretation of the French scale, our opinion is that this scale either needs to be abandoned or be strictly defined and followed
Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina
Wearable devices are currently at the heart of just about every discussion related to the Internet of Things. The requirement for self-health monitoring and preventive medicine is increasing due to the projected dramatic increase in the number of elderly people until 2020. Developed technologies are truly able to reduce the overall costs for prevention and monitoring. This is possible by constantly monitoring health indicators in various areas, and in particular, wearable devices are considered to carry this task out. These wearable devices and mobile apps now have been integrated with telemedicine and telehealth efficiently, to structure the medical Internet of Things. This paper reviews wearable health care devices both in scientific papers and commercial efforts. MIoT is demonstrated through a defined architecture design, including hardware and software dealing with wearable devices, sensors, smart phones, medical application, and medical station analyzers for further diagnosis and data storage. Wearables, with the help of improved technology have been developed greatly and are considered reliable tools for long-term health monitoring systems. These are applied in the observation of a large variety of health monitoring indicators in the environment, vital signs, and fitness. Wearable devices are now used for a wide range of healthcare observation. One of the most important elements essential in data collection is the sensor. During recent years with improvement in semiconductor technology, sensors have made investigation of a full range of parameters closer to realization.
Gerson Roberto Luqueta
Full Text Available Abstract Introduction Ozonization is an alternative sterilization process for heat-sensitive medical devices. However, the side effects of this process on packaging materials should be verified. Methods Four types of commercial disposable packaging for medical devices were evaluated after undergoing ozone sterilization: crepe paper sheet, non-woven fabric sheet (SMS, medical grade paper-plastic pouch and Tyvec©-plastic pouch. For each material, the gas penetration through the microbiological barrier was measured. Other packaging properties, such as chemical composition, color, tactile and mechanical resistance, were also evaluated after sterilization, by using characterization techniques, namely microbiological indicators, infrared spectroscopy, tensile test and optical microscopy. Results All commercial disposable packaging showed good ozone penetration. Crepe paper and SMS were chemically and mechanically modified by ozone, while Tyvec© only suffered mechanical modification. Paper-plastic pouch was the packaging material which just experienced an acceptable reduction in tensile resistance, showing no variations on chemical or visual properties. Conclusion The results suggest that medical grade paper-plastic pouch is the most appropriate disposable medical device packaging to be sterilized by ozone when compared to other materials.
...] Advancing Regulatory Science for Highly Multiplexed Microbiology/ Medical Countermeasure Devices; Public... Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices.'' The purpose of the public meeting is to discuss performance evaluation of highly multiplexed microbiology/medical...
This book presents an introduction to biomaterials with the focus on the current development and future direction of biomaterials and medical devices research and development in Indonesia. It is the first biomaterials book written by selected academic and clinical experts experts on biomaterials and medical devices from various institutions and industries in Indonesia. It serves as a reference source for researchers starting new projects, for companies developing and marketing products and for governments setting new policies. Chapter one covers the fundamentals of biomaterials, types of biomaterials, their structures and properties and the relationship between them. Chapter two discusses unconventional processing of biomaterials including nano-hybrid organic-inorganic biomaterials. Chapter three addresses biocompatibility issues including in vitro cytotoxicity, genotoxicity, in vitro cell models, biocompatibility data and its related failure. Chapter four describes degradable biomaterial for medical implants...
Kusche, Kristopher P
The academic medical center is faced with the unique challenge of meeting the multi-faceted needs of both a modern healthcare organization and an academic institution, The need for security to protect patient information must be balanced by the academic freedoms expected in the college setting. The Albany Medical Center, consisting of the Albany Medical College and the Albany Medical Center Hospital, was challenged with implementing a solution that would preserve the availability, integrity and confidentiality of business, patient and research data stored on mobile devices. To solve this problem, Albany Medical Center implemented a mobile encryption suite across the enterprise. Such an implementation comes with complexities, from performance across multiple generations of computers and operating systems, to diversity of application use mode and end user adoption, all of which requires thoughtful policy and standards creation, understanding of regulations, and a willingness and ability to work through such diverse needs.
Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R
Wearable devices are arguably one of the most rapidly growing technologies in the computing and health care industry. These systems provide improved means of monitoring health status of humans in real-time. In order to cope with continuous sensing and transmission of biological and health status data, it is desirable to move towards energy autonomous systems that can charge batteries using passive, ambient energy. This not only ensures uninterrupted data capturing, but could also eliminate the need to frequently remove, replace, and recharge batteries. To this end, energy harvesting is a promising area that can lead to extremely power-efficient portable medical devices. This paper presents an experimental prototype to study the feasibility of harvesting two energy sources, solar and thermoelectric energy, in the context of wearable devices. Preliminary results show that such devices can be powered by transducing ambient energy that constantly surrounds us.
Ali Syed R
Full Text Available Abstract Intrauterine growth retardation refers to a rate of growth of a fetus that is less than normal for the growth potential of a fetus (for that particular gestational age. As one of the leading causes of perinatal mortality and morbidity, intrauterine growth retardation has immense implications for the short term and long term growth of children. It is an important public health concern in the developing countries. Health statistics encompassing parameters for maternal and child health in the Indian subcontinent have shown improvement in the past few years but they are still far from perfect. Maternal health, education and empowerment bears a strong influence on perinatal outcomes including intrauterine growth retardation and should be the primary focus of any stratagem targeted at reducing the incidence of intrauterine growth retardation. A concerted liaison of various medical and social disciplines is imperative in this regard.
Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal
The purpose of this paper is to address three topical themes: user involvement in health services research; determining the value of new medical technologies in patient care pathways, furthering knowledge related to quality in health and social care; and knowledge exchange between manufacturers, health service supply chain networks and device users. The model is being validated in a case study in progress. The latter is a "proving ground" study for a translational research company. Medical devices play a pivotal role in the management of chronic diseases, across all care settings. Failure to engage users in device development inevitably affects the quality of clinical outcomes. A model of user engagement is presented, turning unmet needs for medical devices into viable commercial propositions. A case study investigating the perceptions of individuals with Epidermolysis Bullosa (EB), their lay and professional carers into unmet needs. EB is an inherited condition affecting the skin and mucosal linings that leads to blistering and wounds. Qualitative data are being collected to generate understanding of unmet needs and wound care products. These needs are being translated into new design concepts and prototypes. Prototypes will be evaluated in an n = 1 experimental design, generating quantitative outcomes data. There are generalisations from the case study, and the model outlined. New products for managing EB wounds can logically benefit other groups. The model is transferable to other clinical problems, which can benefit from research and technological advances that are integral to clinical needs and care.
Avaliação do desempenho de novilhas nelore implantadas com dispositivo intra-uterino (DIU recebendo ou não mistura mineral Evaluation of Nelore heifers performance with intrauterine devices with or without mineral mixture
Lúcia Maria Zeoula
Full Text Available Trinta e duas novilhas nelore (208,3kg foram distribuídas em 16 baias (duas/baia, em um delineamento experimental inteiramente casualizado, sendo analisado em parcela sub-subdividida. Os tratamentos com sal comum ou mistura mineral constituíram as parcelas, o implante ou não do DIU as subparcelas e os períodos as sub-subparcelas. A ração concentrada participou em média 40% do total da matéria seca fornecida. Os tratamentos estudados não afetaram (P > 0,05 o ganho de peso e o rendimento de carcaça. Independentemente de tratamento, houve um ganho compensatório (P 0,05 comparado ao dos animais sem DIU.Thirty-two Nelore heifers (208.3kg were allocated into 16 pens (two/pen in randomized design, analyzed as split-splitplot. The treatments with salt or mineral mixture were considered plot, with or without intrauterine devices as split plots and periods as split-split plots. The concentrated ration participated with 40% of the total dry matter offered. There was no effect of the treatments (P > 0.05 on live weight gain or carcass yield. Apart from treatments, a compensatory growth (P 0.05 between animals using intrauterine devices and control groups.
Hindelang, Florine; Zurbach, Raphael; Roggo, Yves
Biomedical device and medicine product manufacturing are long processes facing global competition. As technology evolves with time, the level of quality, safety and reliability increases simultaneously. Micro Computer Tomography (Micro CT) is a tool allowing a deep investigation of products: it can contribute to quality improvement. This article presents the numerous applications of Micro CT for medical device and pharmaceutical packaging analysis. The samples investigated confirmed CT suitability for verification of integrity, measurements and defect detections in a non-destructive manner. Copyright © 2015 Elsevier B.V. All rights reserved.
Sivin, I; Stern, J; Diaz, J; Diaz, M M; Faundes, A; el Mahgoub, S; Diaz, S; Pavez, M; Coutinho, E; Mattos, C E
IUDs releasing 20 mcg/day of levonorgestrel (LNg20) were in randomized trial together with the Copper T, model TCu 380Ag, in seven centers involving 2244 women. Two-year (25 months) gross cumulative pregnancy rates were 0.2 +/- 0.2 and 0.9 +/- 0.3 for the levonorgestrel and copper releasing devices, respectively (P greater than 0.05). There were no ectopic pregnancies in more than 1600 woman-years of use of each device. Removal rates for bleeding and/or pain or for medical reasons other than menstrual problems did not differ significantly between devices. Oligomenorrhea or amenorrhea prompted 10.7 per hundred (gross rate, 8.4 net rate) women using the LNg 20 IUD to request removal in the two-year period, significantly above the 0.2 per hundred rate among women with the Copper IUD (P less than 0.001). At the end of two years an estimated 59.4 per 100 women were continuing use of the LNg 20 IUD, and 67.5 per 100 (P less than 0.001) with the TCu 380Ag. This difference is almost wholly ascribable to a marked reduction in bleeding episodes and days among women using the LNg 20 device with concomitant removal of device. Hemoglobin rose an average of 0.5 g/dl (P less than 0.001) for this group whereas women using the TCu 380Ag experienced a decline of 0.2 g/dl compared with baseline values (P less than 0.001).
Craven Michael P
Full Text Available Abstract Background Academic literature and international standards bodies suggest that user involvement, via the incorporation of human factors engineering methods within the medical device design and development (MDDD process, offer many benefits that enable the development of safer and more usable medical devices that are better suited to users' needs. However, little research has been carried out to explore medical device manufacturers' beliefs and attitudes towards user involvement within this process, or indeed what value they believe can be added by doing so. Methods In-depth interviews with representatives from 11 medical device manufacturers are carried out. We ask them to specify who they believe the intended users of the device to be, who they consult to inform the MDDD process, what role they believe the user plays within this process, and what value (if any they believe users add. Thematic analysis is used to analyse the fully transcribed interview data, to gain insight into medical device manufacturers' beliefs and attitudes towards user involvement within the MDDD process. Results A number of high-level themes emerged, relating who the user is perceived to be, the methods used, the perceived value and barriers to user involvement, and the nature of user contributions. The findings reveal that despite standards agencies and academic literature offering strong support for the employment formal methods, manufacturers are still hesitant due to a range of factors including: perceived barriers to obtaining ethical approval; the speed at which such activity may be carried out; the belief that there is no need given the 'all-knowing' nature of senior health care staff and clinical champions; a belief that effective results are achievable by consulting a minimal number of champions. Furthermore, less senior health care practitioners and patients were rarely seen as being able to provide valuable input into the process. Conclusions Medical
Wolozny Gomez Robelo, Daniel Andre
Additive manufacturing in the form of 3D printing is a revolutionary technology that has developed within the last two decades. Its ability to print an object with accurate features down to the micro scale have made its use in medical devices and research feasible. A range of life-saving technologies can now go from the laboratory and into field with the application of 3D-printing. This technology can be applied to medical diagnosis of patients in at-risk populations. Living biosensors a...
Mc Hugh, Martin; McCaffery, Fergal; Fitzgerald, Brian; Klass-Jan, Stol; Casey, Valentine; Coady, Garret
peer-reviewed Agile development techniques are becoming increasingly popular in the generic software development industry as they appear to offer solutions to the problems associated with following a plan-driven Software Development Life Cycle (SDLC). However, agile methods may not be suited to all industries or organisations. For agile methods to succeed, an organisation must be structured in a way to accommodate agile methods. Medical device software development organisations are bound b...
Regan, Gilbert; Biro, Miklos; Mc Caffery, Fergal; McDaid, Kevin; Flood, Derek
peer-reviewed Traceability of requirements through the software development lifecycle (including supporting processes such as risk management and change management) is a difficult and expensive task. The implementation of effective traceability allows organizations to leverage its many advantages, such as im-pact analysis, product verification and validation, and facilitation of code maintenance. Traceability is conducive to producing quality software. Within the medical device domain, ...
Bernard A; Vaneau M; Fournel I; Galmiche H; Nony P; Dubernard JM
Alain Bernard,1 Michel Vaneau,2 Isabelle Fournel,3 Hubert Galmiche,2 Patrice Nony,4,5 Jean Michel Dubernard6 1Department of Thoracic Surgery CHU Bocage, Dijon, France; 2Department for Assessment of Medical Devices, HAS (French National Authority of Health), Saint-Denis La Plaine, France; 3Centre of Epidemiology of the Populations, Burgundy University, Dijon, France; 4Department of Clinical Pharmacology, Lyon University CNRS, Lyon, France; 5Laboratory of Biometry and Biology, CNRS, Lyon, Franc...
Integration ” at Society of Critical Care Medicine Annual Congress, San Francisco, CA January 21-22 2014 – Chaired Meetings for US TAG ISO TC 121 on...Award Number: W81XWH-12-C-0154 TITLE: “Enabling Medical Device Interoperability for the Integrated Clinical Environment” PRINCIPAL INVESTIGATOR...Julian M. Goldman, MD CONTRACTING ORGANIZATION: Massachusetts General Hospital Boston, MA 02114 REPORT DATE: December 2016 TYPE OF REPORT : Final
Trippoli, Sabrina; Caccese, Erminia; Marinai, Claudio; Messori, Andrea
In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. The present study explored how complex pharmacoeconomic models that evaluate effectiveness and cost can be incorporated into the in-hospital procurement of thrombectomy devices. As regards clinical modeling, we extracted outcomes at three months from randomized trials conducted for four thrombectomy devices, and we projected long-term results using standard Markov modeling. In estimating QALYs, the same model was run for the four devices. As regards economic modeling, we firstly estimated for each device the net monetary benefit (NMB) per patient (threshold = $60,000 per QALY); then, we simulated a competitive tender across the four products by determining the tender-based score (on a 0-to-100 scale). Prices of individual devices were obtained from manufacturers. Extensive sensitivity testing was applied to our analyses. For the four devices (Solitaire, Trevo, Penumbra, Solumbra), QALYs were 1.86, 1.52, 1,79, 1.35, NMB was $101,824, $83,546, $101,923, $69,440, and tender-based scores were 99.70, 43.43, 100, 0, respectively. Sensitivity analysis confirmed findings from base-case. Our results indicate that, in the field of thrombectomy devices, incorporating the typical tools of cost-effectiveness into the processes of tenders and procurement is feasible. Bridging the methodology of cost-effectiveness with the every-day practice of in-hospital procurement can contribute to maximizing the health returns that are generated by in-hospital expenditures for medical devices. Copyright © 2018 Elsevier B.V. All rights reserved.
Wang, Yue; Li, Tianping; Liang, Ningxia
A series of laws and regulations are the essential legal requirement in the field of clinical trial of medical device currently in China, especially the Provision for Clinical Trial of Medical Device. On the basis of current situation of medical device clinical trial, systemic analysis on the hot spot topics in the regulations was conducted to explore the way of improving the control system of clinical trial of medical device in China, which will provide the reference for medical device industry and the investigators of the clinical trial of medical device.
Full Text Available Estudio de caso del Centro de Cardioestimuladores del Uruguay - CCC Medical Devices preparado a solicitud de Ingenio en el marco del proyecto financiado por la Iniciativa para Incubadoras de InfoDev - Grupo Banco Mundial. Este estudio detalla los pasos seguidos por una empresa nacional con un fuerte factor de innovación y los cambios producidos en el entorno de los negocios de la empresa. El comienzo de una pequeña empresa de marcapasos que tras pasar por diferentes etapas hoy gana mercados en el área de ingeniería para dispositivos médicos para diferentes empresas de investigación biomédica a nivel internacional.AbstractCase study of the Centro de Cardioestimuladores del Uruguay - CCC Medical Devices prepared on behalf of Ingenio within the project financed by de Incubator Initiative of InfoDev-World Bank Group. This study refers to the steps followed by a highly innovative local company and to the changes in its business environment. The start up of a small pacemakers company that after going through different stages is presently increasing its market share in the area of engineering of medical devices for biomedic research companies worldwide.
Full Text Available A Cardiac Implantable Medical device (IMD is a device, which is surgically implanted into a patient's body, and wirelessly configured using an external programmer by prescribing physicians and doctors. A set of lethal attacks targeting these devices can be conducted due to the use of vulnerable wireless communication and security protocols, and the lack of security protection mechanisms deployed on IMDs. In this paper, we propose a system for postmortem analysis of lethal attack scenarios targeting cardiac IMDs. Such a system reconciles in the same framework conclusions derived by technical investigators and deductions generated by pathologists. An inference system integrating a library of medical rules is used to automatically infer potential medical scenarios that could have led to the death of a patient. A Model Checking based formal technique allowing the reconstruction of potential technical attack scenarios on the IMD, starting from the collected evidence, is also proposed. A correlation between the results obtained by the two techniques allows to prove whether a potential attack scenario is the source of the patient's death.
Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.
Campaign to gather medical devices containing radium: results. On December 1, 1999, at the request of the French Health Ministry, OPRI and ANDRA launched a campaign to gather medical devices containing radium, formerly used in brachytherapy. This campaign addressed a public health issue because of the risks actually involved in a careless handling of these objects. Moreover the growing number of reported scattered radium medical devices in the last few years reinforced the necessity of the campaign. The gathering was initiated by a call of the owners (hospitals, caring centers, retired doctors or their heirs) to a toll free number. OPRI or ANDRA then appreciated the situation urgency. Priority was given to private people because most of them did not have suitable storage facilities. OPRI teams operated according a strict protocol guaranteeing their own safety, proper procedures and compliance with transport regulations for radioactive materials. 517 objects amounting to an activity of 1.32 x 10 11 Bq have been gathered in 90 operations. Properly packaged they were transported to and safely stored at the CEA Saclay site before their permanent storage in the ANDRA facilities. (author)
Bahamondes, Luis; Brache, Vivian; Meirik, Olav; Ali, Moazzam; Habib, Ndema; Landoulsi, Sihem
Is there any difference in the clinical performance of the 3-year one-rod etonogestrel (ENG)- and the 5-year two-rod levonorgestrel (LNG)-releasing contraceptive implants during 3 years of insertion, and between implant and intrauterine device (IUD) contraception, in particular complaints possibly related to hormonal contraceptives? The cumulative contraceptive effectiveness after 3 years and method continuation through 2.5 years were not significantly different between ENG and LNG implants, but both outcomes were significantly worse in the non-randomized age-matched group of IUD users than in the combined implant group. ENG- and LNG-releasing implants are safe and highly efficacious contraceptives with pregnancy rates reported to be 0.0-0.5 per 100 women-years (W-Y). No head-to-head comparative study of the two implants has been undertaken, and little information is available on comparisons of complaints of side effects of implant and copper IUD users. This was an open parallel group RCT with 1:1 allocation ratio of the ENG and the LNG implants with non-randomized control group of women choosing TCu380A IUD to address lack of reliable data on common side effects typically attributed to the use of progestogen-only contraceptives. After device(s) placement, follow-ups were at 2 weeks, 3 and 6 months, and semi-annually thereafter for 3 years or until pregnancy, removal or expulsion of the implant/IUD occurred. The study took place in family planning clinics in Brazil, Chile, Dominican Republic, Hungary, Thailand, Turkey and Zimbabwe. Women seeking long-term contraception were enlisted after an eligibility check and informed consent, and 2982 women were enrolled: 1003, 1005 and 974 in the ENG-implant, LNG-implant and IUD groups, respectively; 995, 997 and 971, respectively, were included in the per protocol analysis reported here. ENG and LNG implants each had the same 3-year cumulative pregnancy rate of 0.4 per 100 W-Y [95% confidence interval (CI) 0.1-1.4]. A weight
Intussusception is a known complication of Meckel's diverticulum. However, intrauterine intussusception secondary to Meckel's diverticulum has unknown incidence. Our case describes the medical and surgical management of a newborn with intrauterine intussusception of a Meckel's diverticulum as a cause of the vascular ...
In the 'Regulations for the State Evaluation and Registration of Medical Equipment' force (Hereinafter Rules) set forth in Chapter VII, Articles 79 and 86, the monitoring activity as one of the programs necessary for evaluating the safety and effectiveness of medical monitoring equipment. In the years 2008 and 2011 were approved and implemented by the Center for State Control of Medical Equipment (CCEEM) Regulations and -1.1 ER and ER-1 that support and regulatory requirements 'Control and monitoring of pacemakers and implantable defibrillators' and 'Assessment, recording and control after market surgical silicone implants,' which are specific to these products and have provided a useful result for the performance of the activity. Given the number and diversity of high-risk medical devices as implantable or sustain human life that are brought into our National Health System (SNS), a regulation establishing control over the behavior becomes necessary safety and effectiveness of this equipment during use, which provide inputs to risk management. The objective of this regulation is to establish the regulatory requirements for tracking medical equipment introduced in the NHS. The provisions of this Regulation is aimed at health institutions, to CECMED as manufacturers, suppliers, distributors and importers of medical equipment.
Background. One of the strategies to reduce maternal mortality includes accessible and appropriate contraceptive services to all women. The intrauterine contraceptive device (IUCD) has been identified as a cheap and effective means of contraception by the South African National Department of Health. Objective.
Background: In the past, the use of intrauterine contraceptive device (IUCD), in particular, Dalkon Shield was found to be associated with increased risk of pelvic infection. Recent literature illustrates that the risk of pelvic infection after insertion of an IUCD is low and that the risk peaks in the 1st month after insertion. We set ...
... Cycle; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop...), is announcing a public workshop entitled ``Medical Device Quality System Regulation Educational Forum... information about FDA's Medical Device Quality Systems Regulation (QSR) to the regulated industry...
Full Text Available Utilization of biodegradable polymers for controlled drug delivery has gained immense attention in the pharmaceutical and medical device industry to administer various drugs, proteins and other bio-molecules both systematically and locally to cure several diseases. The efficacy and toxicity of this local therapeutics depends upon drug release kinetics, which will further decide drug deposition, distribution, and retention at the target site. Drug Eluting Stent (DES presently possesses clinical importance as an alternative to Coronary Artery Bypass Grafting due to the ease of the procedure and comparable safety and efficacy. Many models have been developed to describe the drug delivery from polymeric carriers based on the different mechanisms which control the release phenomenon from DES. Advanced characterization techniques facilitate an understanding of the complexities behind design and related drug release behavior of drug eluting stents, which aids in the development of improved future drug eluting systems. This review discusses different drug release mechanisms, engineering principles, mathematical models and current trends that are proposed for drug-polymer coated medical devices such as cardiovascular stents and different analytical methods currently utilized to probe diverse characteristics of drug eluting devices.
Lenz, S; Lindenberg, S; Sundberg, K
Treatment of 26 women with tubal infertility was attempted using intrauterine capsules loaded with oocytes and spermatozoa. The stimulation protocol was as used for in vitro fertilization and embryo transfer and consisted of short-term use of Buserelin, human menopausal gonadotropin, and human...... and piston from an intrauterine device. Six complete capsules and parts of two other capsules were expelled. None of the women became pregnant, compared with a pregnancy rate of 21% per aspiration following in vitro fertilization and embryo transfer during the same period....
Both provider organizations and medical device vendors have made significant, if slow-going, progress over the last several years to network their digitally-enabled medical devices. Recent strides in both the regulatory and standards arenas have provided renewed impetus on the part of both stakeholder groups to bring more interoperability to disparate medical devices, resulting in better security and quality of patient data.
... IUI) Overview Intrauterine insemination ( IUI ) — a type of artificial insemination — is a procedure for treating infertility. Sperm that ... more eggs to be fertilized. Older types of artificial insemination placed the sperm in the vagina. While this ...
Donovan, Aine; Kaplan, Aaron V
The past fifty years has witnessed dramatic progress in the understanding and treatment of patients suffering from cardiovascular disease leading to symptomatic relief and impressive increases in longevity. These advances have been due in large part to the development, study and implementation of new technology. Within interventional cardiology in particular, these advances have been driven by the availability of new technology in the form of medical devices. Successful device development efforts require close collaboration among basic scientist, clinician-inventors/entrepreneurs, clinician-investigators and corporations. Though the role of the clinician is central to this process, these activities present important conflicts-of-interest (COIs). The purpose of this paper is to 1) characterize these conflicts, 2) provide a context from which to approach their management and 3) recommend management strategies. Copyright © 2012 Elsevier Inc. All rights reserved.
... children may be long-term device users--bringing new concerns about device longevity and long- term...] Pediatric Medical Devices; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS... announcing a public workshop entitled ``Using Scientific Research Data to Support Pediatric Medical Device...
Goldman, Julian M
.... The three-day workshop drew 145 participants from academia, industry, government, and health care, including researchers, developers, regulators, users, and manufacturers of medical devices, as well...
...) Implementation: Online Repository of Medical Device Labeling, Including Photographs; Public Meeting AGENCY: Food... of an Online Repository of Medical Device Labeling and of Making Device Photographs Available in a... public comment on the following topics: FDA's plans to establish an online public repository of medical...
... commodities, medicine, and medical devices. 560.533 Section 560.533 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices, provided that the sale and exportation or...
... commodities, medicine, and medical devices. 538.526 Section 538.526 Money and Finance: Treasury Regulations... Brokering sales of agricultural commodities, medicine, and medical devices. (a) General license for... agricultural commodities, medicine, and medical devices to the Government of Sudan, to any individual or entity...
Ruzalina Baharin; Hasan Sham; Ahsanulkhaliqin Abdul Wahab
This paper explains the work done during product dose mapping in order to get the correlation between doses at MINTec-Sinagama plant. Product used was medical devices in aluminium tubes packaged in cardboard kegs packaging with average weight of 12 kg per carton. 12 cartons were loaded in every one tote to give 0.2 g/ cm 3 of density. Ceric cerous dosimeters were placed at specific locations as indicated in SP14: Product Dose Mapping, QMS of MINTec-Sinagama around three planes. Three processes were made at different days as a three replicates to show the reproducibility of measurements. (author)
Roohpour, Nima; Moshaverinia, Alireza; Wasikiewicz, Jaroslaw M; Paul, Deepen; Vadgama, Pankaj; Wilks, Mark; Millar, Michael
Polyurethanes have been widely used in medicine for coating and packaging implantable and other medical devices. Polyether-urethanes, in particular, have superior mechanical properties and are biocompatible, but in common with other medical materials they are susceptible to microbial film formation. In this study, polyether-urethane was end-capped with silver lactate and silver sulfadiazine functional groups to produce a bacterially resistant polymer without sacrificing the useful mechanical properties of the polyether-polyurethane. The silver ions were covalently incorporated into the polymer during chain extension of the prepolymer. The functionalized polymers were structurally characterized by light scattering, electron microscopy, NMR, FTIR and Raman spectroscopy. Mechanical properties, hydrophilicity, in vitro stability and antibacterial action of polymers were also investigated. Results indicate that both silver salts were successfully incorporated into the polymer structure without significant effect on mechanical properties, whilst conferring acceptable bacterial resistance.
Kelly Farrah, MLIS, AHIP
Full Text Available Objective: The study tested the performance of adverse effects search filters when searching for safety information on medical devices, procedures, and diagnostic tests in MEDLINE and Embase. Methods: The sensitivity of 3 filters was determined using a sample of 631 references from 131 rapid reviews related to the safety of health technologies. The references were divided into 2 sets by type of intervention: drugs and nondrug health technologies. Keyword and indexing analysis were performed on references from the nondrug testing set that 1 or more of the filters did not retrieve. Results: For all 3 filters, sensitivity was lower for nondrug health technologies (ranging from 53%– 87% than for drugs (88%–93% in both databases. When tested on the nondrug health technologies set, sensitivity was lower in Embase (ranging from 53%–81% than in MEDLINE (67%–87% for all filters. Of the nondrug records that 1 or more of the filters missed, 39% of the missed MEDLINE records and 18% of the missed Embase records did not contain any indexing terms related to adverse events. Analyzing the titles and abstracts of nondrug records that were missed by any 1 filter, the most commonly used keywords related to adverse effects were: risk, complications, mortality, contamination, hemorrhage, and failure. Conclusions: In this study, adverse effects filters were less effective at finding information about the safety of medical devices, procedures, and tests compared to information about the safety of drugs.
Konkani, Avinash; Oakley, Barbara; Bauld, Thomas J
Increasing noise in hospital environments, especially in intensive care units (ICUs) and operating rooms (ORs), has created a formidable challenge for both patients and hospital staff. A major contributing factor for the increasing noise levels in these environments is the number of false alarms generated by medical devices. This study focuses on discovering best practices for reducing the number of false clinical alarms in order to increase patient safety and provide a quiet environment for both work and healing. The researchers reviewed Pub Med, Web of Knowledge and Google Scholar sources to obtain original journal research and review articles published through January 2012. This review includes 27 critically important journal articles that address different aspects of medical device alarms management, including the audibility, identification, urgency mapping, and response time of nursing staff and different solutions to such problems. With current technology, the easiest and most direct method for reducing false alarms is to individualize alarm settings for each patient's condition. Promoting an institutional culture change that emphasizes the importance of individualization of alarms is therefore an important goal. Future research should also focus on the development of smart alarms.
Based on the theories of the Government Regulation and Administrative Licensure, aiming at the current situations of medical device registration system in China, some policy suggestions for future reform and improvement were provided as follows. (1) change the concepts of medical device registration administration. (2) perfect the regulations of medical device registration administration. (3) reform the medical device review organizational system. (4) Optimize the procedure of review and approval. (5) set up and maintain a professional team of review and approval staff. (6) reinforce the post-marketing supervision of medical devices. (7) foster and bring into play of the role of non-government organizations.
Aubourg, R; Putzolu, J; Bouche, S; Galmiche, H; Denis, C; d'Andon, A; Maitrot, D; Partensky, C
Surgical hemostatic agents are indicated to improve hemostasis when conventional techniques (compression, sutures or electrocoagulation) are inadequate. The National French Authority for Health (Haute Autorité de santé [HAS]) set out to assess these products (medical devices and agents) to determine their optimal utility. This evaluation included one class of products containing some form of human fibrinogen and thrombin and eight classes of medical devices and automated devices to prepare autologous fibrin. The assessment was based on a systematic review of the literature and expert opinion of health care professionals. The main measures of effectiveness of hemostatic agents were the success rate as expressed in terms of the time necessary to obtain adequate hemostasis, the volume of intra and/or postoperative blood loss, the need for blood transfusions, complication rate, duration of operations and hospital stay. A meta-analysis and 52 controlled randomized studies were selected involving cardiac or vascular surgery (19), ENT surgery (11), gastrointestinal surgery (5), urology (4), orthopedic surgery (4). Approximately half of the studies retained in this analysis evaluated blood derived agents (fibrin sealants) while the other half evaluated medical devices. The working group considered that there is not any evidence that these surgical hemostatic agents decrease the rates of transfusion, complications, reoperation, mortality, duration of operation and/or hospital stay. The working group considered that the use of surgical hemostatic agents to improve the safety of hemostasis in the absence of identified bleeding as an alternative to adequate conventional hemostasis was not justified. Surgical hemostatic agents can be used in ad hoc settings, as a complement to conventional methods to control persistent bleeding after conventional hemostatic techniques, or when abundant bleeding has led to biologic hemostatic disorders. The working group also distinguished
Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus
Nowadays, only closed and proprietary integrated operating room systems (IORS) from big manufacturers are available on the market. Hence, the interconnection of components from third-party vendors is only possible with increased time and costs. In the context of the German Federal Ministry of Education and Research (BMBF)-funded project OR.NET (2012-2016), the open integration of medical devices from different manufacturers was addressed. An integrated operating theater based on the open communication standard IEEE 11073 shall give clinical operators the opportunity to choose medical devices independently of the manufacturer. This approach would be advantageous especially for hospital operators and small- and medium-sized enterprises (SME) of medical devices. Actual standards and concepts regarding technical feasibility and the approval process do not cope with the requirements for a modular integration of medical devices in the operating room (OR), based on an open communication standard. Therefore, innovative approval strategies and corresponding certification and test procedures, which cover actual legal and normative standards, have to be developed in order to support the future risk management and the usability engineering process of open integrated medical devices in the OR. The use of standardized device and service profiles and a three-step testing procedure, including conformity, interoperability and integration tests are described in this paper and shall support the manufacturers to integrate their medical devices without disclosing the medical devices' risk analysis and related confidential expertise or proprietary information.
This paper provides an overview of the United States Food and Drug Administration's (FDA) role as a regulatory agency in medical device clinical studies involving human subjects. The FDA's regulations and responsibilities are explained and the device application process discussed. The specific medical device regulatory authorities are described as they apply to the development and clinical study of retinal visual prosthetic devices. The FDA medical device regulations regarding clinical studies of human subjects are intended to safeguard the rights and safety of subjects. The data gathered in pre-approval clinical studies provide a basis of valid scientific evidence in order to demonstrate the safety and effectiveness of a medical device. The importance of a working understanding of applicable medical device regulations from the beginning of the device development project is emphasized particularly for novel, complex products such as implantable visual prosthetic devices.
Pashkov, Vitalii; Harkusha, Andrii; Bytiak, Oleksii
Chosen European foreign policy vector for Ukraine establishes its obligation to enforce the process of adaptation of the EU law regulations in the internal legal policy. The approximation of Ukrainian law to the European Union (EU) "acquis communautaire" is not only the instrument for deepening our economic cooperation with the European Union, but also the important measure to enhance further development of Ukraine in general. National legislation, which regulate advertising and promotion of medical devices (MD), is not an exception. Some key points on legal regulation of abovementioned sphere is a base of this study. Ukrainian legislation, European Union`s Law Acts, EU's member-states law, WHO Acts and Recommendations, European Medical Technology Industry Association (EUCOMED) Acts. Article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. In accordance with Ukrainian legislation, there is no special law that concerns advertising on MD in Ukraine, this sphere is regulated by general law that named ≪About advertisement≫, but it doesn't take into account even main characteristics of such a special object as medical devices (MD). Moreover, the law ≪About advertisement≫ contain discrepancies in terms that are used, these contradictions, in our opinion, must be eliminated by appropriate law reforms. The advertising and promotion of MD in EU is regulated by a combination of EU and national legislation of EU Member States, national advertising and promotion of MD are not harmonized with the EU MDD for now, resulting in a fragmented legal landscape that differs from one EU Member State to the other. Practice of adopting different codes and guides that regulate advertising, including advertising of MD, is widespread in EU and EU Member States and thus must be used in Ukraine with appropriate reformation of national law.
Sriram Thirumalai; Kingshuk K. Sinha
Medical devices play an increasingly significant role in the delivery of health care today. However, persistent quality problems with medical devices and the associated recalls present potential health risks to patients and personnel using these devices. This study addresses three key issues in this regard. First, it empirically assesses the financial implications of medical device recalls to understand if these consequences are severe enough to deter firms from introducing potentially hazard...
Meshkov Aleksandr S.
Full Text Available With the ever-increasing volume of applications of various kinds of electric drives in all spheres of human activity, the issues in improving the efficiency of the electromechanical converters of electric energy, one of the most important components of the electric drive (ED, are becoming increasingly important. Such issues include reducing their weight and size, improving the functional characteristics of these devices to increase their operational life and reducing the cost of manufacture. Taking full advantage of these opportunities relates to the AC and DC single-phase commutator motor (SCM, which is widely used in regulated and high-speed motor drives in medical electric hand tools. The SCM is used in machinery where the load torque has a hyperbolic dependence on the rotational speed and the need to work with a large motor overload due to the “soft” mechanical characteristics of such motors.
Nevoux, Jérôme; Coez, Arnaud; Truy, Éric
The management of deafness has become a major public health issue as their lack of detection has a deleterious effect in children and increases the risk factors for aggravation of other pathologies in adults. The detection of deafness remains a real challenge: in the newborn, systematic screening at birth is a good strategy, in adults, much remains to be done. The functional rehabilitation of deafness is based on the use of hearing aids by aerial or bone conduction or of auditory implants. There are three types of auditory implants available: bone anchored hearing implants, middle ear implants and cochlear implants. Many actors, in particular social organizations, can intervene in the financial management of these medical devices. Copyright © 2017 Elsevier Masson SAS. All rights reserved.
Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke
The rule for re-usage of medical single-use devices was established in US in 2000 based on the concept of Managed Care (total management of medicare on cost, quality and patients' satisfaction) and 20-30% of those devices are re-used at present. The re-usage is conducted in not only US but also Canada, Denmark, UK, India, China etc. Standing on the viewpoint, this paper described and discussed the possibility of re-usage of the single-use devices now prohibited in Japan, possible re-sterilization, possible re-usage of hollow fiber-type hemodialyzer following γ-ray sterilization with consideration for D-values against bacteria and viruses, cost estimation of electron beam sterilization for re-usage, and radiation sterilization of waste water and plastic materials. Radiation sterilization for re-usage of medical devices was concluded possible if their materials and records for their usage processes are proper, and should be conducted in a large scale after sufficient examinations by industries/government/academia. (N.I.)
... manufacturers can bring their safe and effective devices to the American people at an earlier time, and to...] Medical Device User Fee Act; Public Meeting; Request for Comments AGENCY: Food and Drug Administration... (FDA) is announcing a public meeting on the reauthorization of the medical device user fee program. The...
The use of medical devices is an increasingly important element of a healthcare professional's role. It is crucial that users receive regular teaching and education to ensure that they are competent in the use of devices. This is particularly relevant in the increasingly litigious society in which we live. This article focuses upon the importance of a medical device education.
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; Spanish-language version of....16 Medical devices; Spanish-language version of certain required statements. If devices restricted to prescription use only are labeled solely in Spanish for distribution in the Commonwealth of Puerto Rico where...
... Devices in the Treatment of Obesity and Metabolic Diseases: How To Estimate and Reward True Patient... ``Changing Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Obesity and... medical devices for the treatment of morbid obesity and other metabolic diseases and evolving approaches...
Beaussier, H; Junot, H; Lancrenon, S; Faure, P
Since 2003, the AP-HP medical devices committee (CODIMS) assess the therapeutic relevance of innovated medical device (MD) for the French AP-HP hospitals' group. To accomplish this task, the CODIMS asks manufacturers to bring out clinical arguments to justify the use of their MD in hospital. This work analyses retrospectively after 8years, all assessed MD until March 2011 and the scientific quality of the clinical data submitted by manufacturers to the CODIMS to purchase their MD. All MD were classed according to their certification's level (I, IIa, IIb, III, DMIA). The quality of available clinical studies (CS) provided by manufacturers for each case was assessed and classed according to five clinical relevance levels based on the evidence-based medecine standards (1-2: high methodology; 3-5: low methodology). One hundred and three MD files (80 % of class IIb and III MD) were analysed by the CODIMS (630CS). Our results highlight the lack of relevance of files that are provided to assess innovated MD: 29 files without any CS; concerning class IIb (32DMS, 221CS) and III (50, 342CS) MD, only 6 % of CS presented a correct clinical relevance level. And the situation did not get better during this assessment period. The CODIMS deplore the poor clinical relevance of files provided to assess MD (wrong comparator, inappropriate ends-points, insufficient follow-up to assess long-term security, small population studied). Future legislative developments for MD assessment are expected to improve this situation. Copyright Â© 2011 Elsevier Masson SAS. All rights reserved.
Larsen, Sandra; Dobbin, Joanna; McCallion, Oliver; Eskild, Anne
Vaginal delivery is recommended after intrauterine fetal death. However, little is known about the risk of shoulder dystocia in these deliveries. We studied whether intrauterine fetal death increases the risk of shoulder dystocia at delivery. In this population-based register study using the Medical Birth Registry of Norway, we included all singleton pregnancies with vaginal delivery of offspring in cephalic presentation in Norway during the period 1967-2012 (n = 2 266 118). Risk of shoulder dystocia was estimated as absolute risk (%) and odds ratio with 95% confidence interval. Adjustment was made for offspring birthweight (in grams). We performed sub-analyses within categories of birthweight (Shoulder dystocia occurred in 1.1% of pregnancies with intrauterine fetal death and in 0.8% of pregnancies without intrauterine fetal death (p shoulder dystocia occurred in 14.6% of pregnancies with intrauterine fetal death and in 2.8% of pregnancies without intrauterine fetal death (p shoulder dystocia occurred in 57.1% of pregnancies with intrauterine fetal death and 9.6% of pregnancies without intrauterine fetal death (p shoulder dystocia at delivery, and the absolute risk of shoulder dystocia was particularly high if offspring birthweight was high and the mother had diabetes. © 2016 Nordic Federation of Societies of Obstetrics and Gynecology.
Wallace, G G; Higgins, M J; Moulton, S E; Wang, C
The nexus of any bionic device can be found at the electrode-cellular interface. Overall efficiency is determined by our ability to transfer electronic information across that interface. The nanostructure imparted to electrodes plays a critical role in controlling the cascade of events that determines the composition and structure of that interface. With commonly used conductors: metals, carbon and organic conducting polymers, a number of approaches that promote control over structure in the nanodomain have emerged in recent years with subsequent studies revealing a critical dependency between nanostructure and cellular behaviour. As we continue to develop our understanding of how to create and characterise electromaterials in the nanodomain, this is expected to have a profound effect on the development of next generation bionic devices. In this review, we focus on advances in fabricating nanostructured electrodes that present new opportunities in the field of medical bionics. We also briefly evaluate the interactions of living cells with the nanostructured electromaterials, in addition to highlighting emerging tools used for nanofabrication and nanocharacterisation of the electrode-cellular interface.
Full Text Available Beverley D GlassSchool of Pharmacy and Molecular Sciences, James Cook University, Townsville, QLD, AustraliaAbstract: The World Health Organization has reported that counterfeit medicines potentially make up more than 50% of the global drug market, with a significant proportion of these fake products being encountered in developing countries. This occurrence is attributed to a lack of effective regulation and a weak enforcement capacity existing in these countries, with an increase in this trade resulting from the growing size and sophistication of drug counterfeiters. In addition, due to both cost and lack of availability of medicines, consumers in developing countries are more likely to seek out these inexpensive options. The World Health Organization is mindful of the impact of counterfeit drugs on consumer confidence in health care systems, health professionals, the supply chain, and genuine suppliers of medicines and medical devices. Antibiotics, antituberculosis drugs, and antimalarial and antiretroviral drugs are frequently targeted, with reports of 60% of the anti-infective drugs in Asia and Africa containing active pharmaceutical ingredients outside their pharmacopoeial limits. This has obvious public health implications of increasing drug resistance and negating all the efforts that have already gone into the provision of medicines to treat these life threatening conditions in the developing world. This review, while focusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world. The complexity of the problem will also be highlighted in terms of the definition of counterfeit and substandard medicines, including gray pharmaceuticals. Although this issue presents as a global public health problem, outcomes in developing countries where counterfeit
Juan Francisco Márquez-Peiró
Full Text Available Objective: To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. Method: The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. Results: SIVIPS was developed using Acces®. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. Conclusions: SIVIPS® is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS.
Márquez-Peiró, Juan Francisco; Gaspar-Carreño, Marisa; Jiménez-Torres, José; Selva-Otaolaurruchi, Juan
To describe the features of computer program to support the activity of the responsible for surveillance of medical devices. To evaluate their use after one year of implementation in a hospital. The stages of the process were: description of the activities of medical devices surveillance and implant registration, definition of functionality and data processing, creation of databases, implementation in a private hospital which manages PS, validation of the program and analysis of their usefulness. SIVIPS was developed using Acces. Main variables were described for all the activities of the responsible for medical device surveillance (implants, alert, medical device incidents, including for in vitro diagnostics) and all the functionalities of the computer program. SIVIPS was introduced in a pharmacy service with one pharmacist for the management of medical devices. One year after its implementation we had registered 564 implants with a description by type of implant, 31 alerts and 6 incidents. SIVIPS allow monitoring of the actions taken in these cases. SIVIPS is the first tool to support the activity of medical device surveillance. It is an easy tool that allows the registration of alerts and medical device related incidents, and registration of implants performed in the center, which will improve the traceability of the PS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.
...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... transport devices commonly known as stairlifts. These devices are used to assist transfers of a mobility... behalf of Bruno Independent Living Aids, Inc., for powered patient transport devices (commonly known as...
...] Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator AGENCY: Food and Drug... elevator devices commonly known as inclined platform lifts and vertical platform lifts. These devices are... behalf of Bruno Independent Living Aids, Inc., for wheelchair elevator devices (commonly known as...
Mattei, Eugenio; Censi, Federica; Triventi, Michele; Bartolini, Pietro; Calcagnini, Giovanni
The number and the types of electromagnetic emitters to which patients with active implantable medical devices (AIMD) are exposed to in their daily activities have proliferated over the last decade. Radiofrequency identification (RFID) is an example of wireless technology applied in many fields. The interaction between RFID emitters and AIMD is an important issue for patients, industry and regulators, because of the risks associated with such interactions. The different AIMDs refer to different standards that address the electromagnetic immunity issue in different ways. Indeed, different test setups, immunity levels and rationales are used to guarantee that AIMDs are immune to electromagnetic nonionizing radiation. In this article, the regulatory framework concerning electromagnetic compatibility between RFID systems and AIMDs is analyzed to understand whether and how the application of the current AIMD standards allows for the effective control of the possible risks associated with RFID technology.
Sivin, I; Alvarez, F; Diaz, J; Diaz, S; el Mahgoub, S; Coutinho, E; Brache, V; Diaz, M M; Faundes, A; Pavez, M
First year results of a randomized study of 1509 users of the Copper T380Ag with a silver core or of an IUD releasing 20 mcg day of levonorgestrel are reported. The cumulative gross pregnancy rate for each device was 0.3 per 100 at one year, with more than 490 women having one year of use with each device. The levonorgestrel-releasing device was associated with significantly fewer bleeding days and significantly increased hemoglobin levels when compared with pre-admission values or the one year values observed among users of the TCu380Ag. Terminations attributable to amenorrhea were significantly more frequent among users of the levonorgestrel-releasing device. The TCu 380Ag was associated with increased frequency and severity of dysmenorrhea compared with pre-admission levels or with the steroid-releasing device. Hemoglobin levels were somewhat reduced among users of the TCu 380Ag device. Terminations attributable to pain were, however, not significantly different by device. Continuation rates at the end of the first year were not significantly different by device.
... for decontamination and resterilization. The emergence of new materials and sterilization methods, and the increasing costs of health care, resulted in the development of medical single-use devices and the practice of reprocessing the devices...
Shokouh-Amiri, Ali; Kjaergaard, Niels
A case of intrauterine pregnancy occurring after successful balloon thermal endometrial ablation is described. Although rare, pregnancy after endometrial ablation is possible, and use of a supplemental contraceptive method should be planned. In case of pregnancy after endometrial ablation......, the woman should be informed of the high risk of pregnancy complications, and termination of the pregnancy should be discussed. Udgivelsesdato: 2009-Feb-16...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food...
... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0478] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing an amendment to the notice of...
... HUMAN SERVICES Food and Drug Administration Ear, Nose and Throat Devices Panel of the Medical Devices... Federal Register about last minute modifications that impact a previously announced advisory committee... for the Nucleus Hybrid TM L24 Implant System sponsored by Cochlear Americas. The proposed Indications...
Full Text Available In order to provide for successful, safe and high quality medical services, health care institutions need to be equipped with adequate medical devices. For this reason, every medical institution is legally obliged to have relevant medical devices. In case a patient has been deprived of some medical service for the lack of necessary medical devices (which the institution has been obliged to provide, the medical institution is responsible for the damage and harm sustained by the patient. The responsibility implies non-contractual liability (in tort law or pre-contractual liability (in contract law. In both cases, the liability is based on the presumed culpability. In order to be excluded from liability, the medical institution has to prove that the patient has been deprived of medical service (or that the institution has refused to enter into a medical service provider agreement on justifiable grounds, i.e. due to the lack of necessary medical devices. On the other hand, in case the medial institutions fail to provide needed care or violate their obligation to use medical devices when necessary, it is regarded as medical negligence (professional error. In most cases, it implies the liability of medical institutions for damage, injury or harm caused to the patient by medical services provided without applying a relevant medical device, whose use has been medically indicated. The liability is even more substantial in cases where the medical device has been available but the medical institutions has not applied it in medial treatment (even though its use has been medically indicated; such conduct is qualified as gross negligence.
Neugebauer, Edmund A M; Rath, Ana; Antoine, Sunya-Lee
that the classical evidence hierarchy cannot be applied for medical devices, as randomised clinical trials are impossible to perform. This article aims to identify the barriers for randomised clinical trials on medical devices. METHODS: Systematic literature searches without meta-analysis and internal European...... of scientific advice, regulations and transparency. CONCLUSIONS: The present review offers potential solutions to break down the barriers identified, and argues for applying the randomised clinical trial design when assessing the benefits and harms of medical devices....
Liu, Wenbo; Shi, Xinli; Lu, Zhong; Wang, Lanming; Zhang, Kai; Zhang, Xingdong
The 4th US-China Joint Workshop on Regulation, Standards and Innovation of Biomaterials was held during the Annual Meeting of the Society for Biomaterials on April 5, 2017 at Minneapolis, MN. This series of joint workshops have become a unique platform for both the US and China to discuss and update what is new in the field of biomaterials and medical devices in terms of regulation, standards and innovation since 2013. China Food and Drug Administration and its affiliated agencies such as Center for Medical Device Evaluation presented at each of the workshop. With the implementation of Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council of the People's Republic of China, No. 650) since June 1, 2014, the regulatory changes and reform for medical devices in China have been hot topics in the workshops. This report captures the key information presented during the workshops, which includes major changes of the Chinese medical device regulation systems, reform of the review and approval system for medical devices in China, and the special procedures of review and approval for innovative medical devices. The market growth of medical devices along with demands for innovative technologies brings the ongoing regulatory changes and reform in China, which will certainly create positive impact on both the development of the Chinese healthcare system and the innovation of medical devices in China. © 2017 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2017. © 2017 Wiley Periodicals, Inc.
... or intermittent. While FDA has confidence that medical devices currently being marketed will continue... for open dialogue among stakeholders to share lessons learned and best practices for overcoming...
.... Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 standard certification for medical device manufacturing in terms of quality control...
Goldman, Julian M
Partial support was requested from TATRC, with joint funding from NSF, for a joint workshop to bring together the synergistic efforts and communities of the High Confidence Medical Devices, Software, and Systems (HCMDSS...
Full Text Available The focus of Peta Bush’s work is to create wearable medical devices that address all qualities of the individual, including physical, mental, emotional, and psychosocial aspects. Peta is completing a practice-based research PhD titled “Therapeutic jewelry: The craft of people-centric devices for wellbeing.” Her passion for creating wearable medical devices that are multi-dimensional stems from her personal experiences, as she has Ehlers-Danlos syndrome. In addition, she uses her knowledge of well-being and the biopsychosocial model when creating her wearable medical devices. Peta currently uses technology, such as 3D printing, as one method to fabricate her collection. Her aspirations are for this concept of wearable medical devices to become mainstream, similar to glasses, and to remove the stigma associated with wearable medical devices.
Crouzel, C.; Le Poec, C.; Jarry, E.; Knipper, R.; Comar, D.
The authors describe an irradiation device set up beside a compact medical cyclotron (520.CGR-MeV cyclotron). The variable energy machine can accelerate 3-22 MeV protons, 3-13 MeV deuterons, 6-26 MeV alpha particles and 5-31 MeV helium-3 particles, the currents extracted at the maximum energies reaching 50 μA for 4 He and 3 He, 70 μA for protons and deuterons. The essential characteristics demanded of the apparatus in order to produce a regular and abundant supply of short-lived radioisotopes were as follows: - Flexibility of use or the possibility of fast, completely non-manual target changing. - Simplicity of operation: the target-holder components must be easily interchangeable and the transfer of radioisotopes from the irradiation point to the chemical laboratory must be rapid. - Working safety: the automatic target-holder cooling controls must be duplicated by manual controls. - Target cooling efficiency: these targets, whether gaseous, liquid or solid, must be able to support a high particle current. (Auth.)
Internet crowdfunding, a new and increasingly popular method of raising capital to develop products and businesses, has recently come into conflict with the Food and Drug Administration's (FDA's) regulation of medical devices. This Article examines the issues that arise when companies pre-sell medical devices via crowdfunding campaigns before gaining FDA approval of the devices. Because Internet crowdfunding has only been in use for a few years, little has been written about it academically, particularly about its interaction with FDA regulations. The rising interest in crowdfunding, coupled with the downturn in investment in the American medical device industry, make this a salient issue that is ripe for FDA review. This Article uses the crowdfunding campaign Scanadu, a medical device company, conducted in 2013 to raise money to develop its in-home diagnostic device, the "Scout," as a starting point for this analysis. Because it is extremely costly to develop a device and obtain FDA approval, medical device companies should be able to utilize crowdfunding to raise the necessary capital. However, because of the possible dangers medical devices pose, FDA needs to review the risks created by allowing companies to crowdfund medical devices and should issue guidance to help companies comply with FDA regulations while still allowing them to take advantage of the benefits of crowdfunding. This guidance should ensure the continued commitment to consumer safety that is at the core of FDA regulation.
Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil
The high quality of public health improves not only healthy life expectancy, but also the productivity of labor. The most important part of the health care sector is the medical technology industry. The aim of this study is to analyze the current situation in the medical device industry in Europe, its potential strengths and weaknesses in the context of topical economic and demographic development. The contribution specifies an analysis of the economic state of the medical device industry in the context of demographic development of European Union's macroeconomic indicators and views of experts in the field of medical device development, concerning the opportunities for entities involved in the medical device market. There is fierce competition on the European market. The innovative activity is stable and well regulated by responsible authorities. Worldwide, the medical device market is expected to grow.
Demiris, George; Marek, Karen D.
Introduction Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults’ perceptions of a telehealth medication dispensing device as part of a clinical trial involving home health care clients, nurse coordination and use of the medication dispensing device. Methods Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Results Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. Conclusion The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research. Trial Registration clinicaltrials.gov identifier: NCT01321853 PMID:23323721
Reeder, Blaine; Demiris, George; Marek, Karen D
Older adults with multiple chronic conditions face the complex task of medication management involving multiple medications of varying doses at different times. Advances in telehealth technologies have resulted in home-based devices for medication management and health monitoring of older adults. We examined older adults' perceptions of a telehealth medication dispensing device as part of a clinical trial involving home healthcare clients, nurse coordination and use of the medication dispensing device. Ninety-six frail older adult participants who used the medication dispensing device for 12 months completed a satisfaction survey related to perceived usefulness and reliability. Results were analyzed and grouped by themes in the following areas: Ease of Use, Reliability, Medication Management Assistance, Routine Task Performance and Acceptability. Nearly all participants perceived the medication dispensing device as very easy to use, very reliable and helpful in the management of their medications. Eighty-four percent of participants expressed a desire to use the machine in the future. The technology-enhanced medication management device in this study is an acceptable tool for older adults to manage medication in collaboration with home care nurses. Improved usability and cost models for medication dispensers are areas for future research.
for the past 3 years and cyclical haematuria for the past 6 months. Menstrual cycles were regular. She had undergone puerperal sterilisation 20 years ago. Vaginal speculum examination revealed threads of an intrauterine contraceptive device (IUCD). The threads snapped during attempts to remove the device. The patient ...
Intrauterine contraceptive device (IUCD) is a commonly utilized reversible contraceptive technique especially in the developing world. Though effective, it is not immune to complications. Migration of the device is a rare but serious complication which may be symptomatic or asymptomatic. We report a case of a 45yr old ...
Muniz Janaína Barbosa
Full Text Available Asthma results from a combination of three essential features: airflow obstruction, hyperresponsiveness of airways to endogenous or exogenous stimuli and inflammation. Inadequacy of the techniques to use different inhalation devices is one of the causes of therapeutic failure. The main purpose of this study was to evaluate how 20 medical students, 36 resident physicians of Internal Medicine/Pediatrics, and 40 asthma patients used three devices for inhalation therapy containing placebo. All patients were followed at the Pulmonary Outpatient Service of Botucatu Medical School and had been using inhaled medication for at least six months. The following devices were evaluated: metered dose inhalers (MDI, dry powder inhalers (DPI, and MDI attached to a spacer device. A single observer applied a protocol containing the main steps necessary to obtain a good inhaler technique to follow and grade the use of different devices. Health care professionals tested all three devices and patients tested only the device being used on their management. MDI was the device best known by doctors and patients. MDI use was associated with errors related to the coordination between inspiration and device activation. Failure to exhale completely before inhalation of the powder was the most frequent error observed with DPI use. In summary, patients did not receive precise instruction on how to use inhaled medication and health care professionals were not well prepared to adequately teach their patients.
Mantus, David; Pisano, Douglas J
...: A Guide for Prescription Drugs, Medical Devices, and Biologics, Second Edition are covered in a straightforward format. It is a compilation and commentary of selected laws and regulations pertaining to the development and approval of drugs, biologics, and medical devices in the United States. It is not intended to take the place of an actual r...
The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal - a safe product - but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force. (author)
de Mol, Bastian A.
Patient health often depends on medical devices and implants. Thanks to these advancements, trust in and expectations of medical technology are high. But history shows critical device failures of heart valves, breast implants, hip prostheses and heart stimulators occurring under the regulatory
The purpose of this article is to give a short overview of some different regulations in Europe and the United States with regard to the clearance of medical devices and to give an outlook of what the Agreements on Mutual Recognition will bring in terms of Global Harmonization. Recent European legislation, the Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (Medical Device Directive, MDD), requires that all medical devices placed on the European market bear the CE marking. From 14 June 1998, medical devices fall under the scope of this European Medical Device Directive and there is a harmonization within the European market. Similar to this, but for another market, are the USA FDA requirements, Premarket Approval (PMA) and Premarket notification (510(k)). The same medical device, the same goal — a safe product — but different legislation and thus duplication of registration procedures. The European Commission is presently discussing a series of agreements with third countries, Australia, New Zealand, USA, Canada, Japan and Eastern European countries wishing to join the EU, concerning the mutual acceptance of inspection bodies and, ultimately, proof of conformity (for example reports on examination, certificates, licenses and marks of conformity) in connection with medical devices. Meanwhile agreements with Australia, New Zealand, USA and Canada came into force.
...] Food and Drug Administration/Xavier University Global Medical Device Conference AGENCY: Food and Drug... ``FDA/Xavier University Global Medical Device Conference.'' This 3-day public conference includes.... Combination Products Panel. Update on Quality System Regulations. Warning Letter and Enforcement Action Trends...
..., radiological, or nuclear agent. For the exception to apply, it is necessary for the investigator and an.... FDA-2003-N-0212; (formerly Docket No. 2003N-0355)] Medical Devices; Exception From General... interim final rule (IFR) entitled ``Medical Devices; Exception From General Requirements for Informed...
...] Medical Device Epidemiology Network 2011: Second Annual Public Workshop AGENCY: Food and Drug... public workshop entitled ``Medical Device Epidemiology Network (MDEpiNet) 2011: Second Annual Public... and to facilitate discussion among FDA and all stakeholders with expertise in epidemiology and health...
Römer, GertWillem R.B.E.; Stuyt, Harry J.A.
Medical devices produced by manufacturers are subject to regulatory review by authorities. Usually, medical devices are developed at universities and other research institutes. This implies that regulatory activities are to be carried out by the designer at these organizations also. And as early as
...] Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of Meeting... comment period for the notice announcing a meeting of the Molecular and Clinical Genetics Panel (the panel... Clinical Genetics Panel of the Medical Devices Advisory Committee, and the opening of a public docket to...
... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for use in teaching, law enforcement, research, and analysis. 801.125 Section 801.125 Food and Drugs FOOD AND DRUG ADMINISTRATION... Directions for Use § 801.125 Medical devices for use in teaching, law enforcement, research, and analysis. A...
Schmettow, Martin; Schnittker, Raphaela; Schraagen, Jan Maarten
This paper proposes and demonstrates an extended protocol for usability validation testing of medical devices. A review of currently used methods for the usability evaluation of medical devices revealed two main shortcomings. Firstly, the lack of methods to closely trace the interaction sequences