Intrauterin Device Migration to the Bladder and Endoscopic Treatment; Case Report

Directory of Open Access Journals (Sweden)

Ižsmail Nalbant

2014-08-01

Full Text Available An intrauterine device (IUD is a long term, efficient, reversible and common method of contraception. IUD migration into the bladder is a rarely observed complication. Chronic pelvic pain, vaginal discharge, resistant urinary tract infections and bladder irritative voiding symptoms in the presence of IUD migration should be considered. This study aimed to report cases of bladder petrified IUD.

Synthesis of copolymers suitable for the storage and slow release of reactants. Cases of copper salts for intra-uterine devices

International Nuclear Information System (INIS)

Gaussens, Gilbert; Duchemin-Berthet, Jeanne.

1976-01-01

This research has been carried out to determine whether a grafted poly(ethylene-vinyl acetate) matrix could be prepared which would release useful amounts of copper salts when used in intra-uterine devices. Intra-uterine devices were prepared by grafting hydroxyethyl acrylate onto ethylene-vinylacetate copolymers (EVA). The kinetics of the grafting reaction were studied. The grafting reaction was initiated by cobalt 60 gamma rays using the simultaneous method. The conditions of copper salts absorption by the grafted copolymers were selected. The average quantity of copper salts released daily from the intra-uterine device was meaured as a function of grafting ratio and the amount of copper salt initially incorporated in the grafted polymeric matrix. In vitro experiments samples showed constant release rates during a period of 18 months

Use of a levonorgestrel-releasing intrauterine device in the treatment of adenomyosis associated heavy menstrual bleeding

International Nuclear Information System (INIS)

Uysal, A.; Taner, C.E.; Mun, S.; Celimli, F.H.; Uysal, F.

2013-01-01

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)

Endometrial cancer treated with levonorgestrel-releasing intrauterine device for almost three years in an elderly woman with comorbidity

DEFF Research Database (Denmark)

Andreasen, Lisbeth Anita; Antonsen, Sofie Leisby; Settnes, Annette

2016-01-01

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...

Vesical Calculus 10 Years Post Missing Intrauterine Contraceptive ...

African Journals Online (AJOL)

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 ...

Three-Dimensional Printed PCL-Based Implantable Prototypes of Medical Devices for Controlled Drug Delivery

DEFF Research Database (Denmark)

Hollander, Jenny; Genina, Natalja; Jukarainen, Harri

2016-01-01

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...... prototypes were dependent on the amount of drug loading. The drug release profiles from the printed devices were faster than from the corresponding filaments due to a lower degree of the drug crystallinity in IUS in addition to the differences in the external/internal structure and geometry between...

Conservative management in ureteric hydronephrosis due to deep endometriosis: Could the levonorgestrel-intrauterine device be an option?

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Simón, Elisa; Tejerizo, Álvaro; Muñoz, José Luis; Álvarez, Carmen; Marqueta, Laura; Jiménez, Jesús S

2017-07-01

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.

The levonorgestrel-releasing intrauterine device potentiates stress reactivity.

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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

2017-06-01

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) (Pcontraception 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.

Empty-bladder (hysterographic) view on US for evaluation of intrauterine devices. Work in progress.

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Carroll, R; Gombergh, R

1987-06-01

Ultrasound scanning of the pelvis with an empty bladder permits a true frontal view of the uterus to be easily obtained. This view is comparable to the en face view seen at hysterography performed with contrast material. Good definition both of the endometrium and the uterine wall makes this the optimal method for the evaluation of an intrauterine contraceptive device.

Intrauterine devices and other forms of contraception: thinking outside the pack.

Science.gov (United States)

Allen, Caitlin; Kolehmainen, Christine

2015-05-01

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.

Structure of a radiate pseudocolony associated with an intrauterine contraceptive device

International Nuclear Information System (INIS)

O'Brien, P.K.; Lea, P.J.; Roth-Moyo, L.A.

1985-01-01

Transmission electron microscopy of a radiate pseudocolony associated with an intrauterine contraceptive device (IUCD) showed central bundles of extracellular fibers averaging 35 nm in diameter, surrounded by layered mantles of electron-dense, amorphous granular material. No bacterial, viral, or fungal structures were present. X-ray microanalysis revealed copper, sulfur, chloride, iron, and phosphorus; no calcium was found. It is postulated that these structures and histologically identical non-IUCD-associated granules from the female genital tract, as well as similar structures from other body locations, including those reported in colloid cysts of the third ventricle, are of lipofuscin origin

Social media and the intrauterine device: a YouTube content analysis.

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Nguyen, Brian T; Allen, Allison J

2017-11-23

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.

Combined Laparoscopic and Cystoscopic Retrieval of Forgotten Translocated Intrauterine Contraceptive Device

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Taiwo O Alabi

2018-01-01

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.

Use of frameless intrauterine devices and systems in young nulliparous and adolescent women: results of a multicenter study

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Wildemeersch D

2014-08-01

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

Colonoscopic Removal of an Intrauterine Device That Had Perforated the Rectosigmoid Colon

Science.gov (United States)

Huh, Jin Myeong; Kim, Ki Seok; Cho, Yong Seok; Lee, Jae Uk; Baek, Seong Deuk; Moon, Sin Kil

2018-01-01

The intrauterine device (IUD) is a widely used contraceptive method. One of the most serious and rare complications of using an IUD is colon perforation. We report a case of colonoscopic removal of an IUD that had perforated into the rectosigmoid colon in a 42-year-old woman who presented with no symptoms. Colonoscopy showed that the IUD had penetrated into rectosigmoid colon wall and that an arm of the IUD was embedded in the colon wall. We were able to remove the IUD easily by using colonoscopy. The endoscopic approach may be considered the first choice therapy for selected patients. PMID:29742863

Serum copper levels in users of multiload intra-uterine contraceptive devices.

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Arowojolu, A O; Otolorin, E O; Ladipo, O A

1989-12-01

The systemic absorption of copper incorporated into multiload intra-uterine contraceptive devices (IUDs), as indicated by serum copper levels in users of such devices, was assessed in a prospective longitudinal study. One hundred and ten healthy Nigerian women using either multiload copper 250 (MLCU 250) or multiload copper 375 (MLCU 375) IUDs participated in the study. Their serum copper levels were estimated serially during 12 months of continuous use of the devices. The mean (+/- s.e.m.) pre-insertion serum copper levels of our subjects using MLCU 250 (17.0 +/- 3 mumol/l) and MLCU 375 (16.7 +/- 0.5 mumol/l) were found to be lower than those reported in Americans (22.2 mumol/l) and in Germans (20.2 mumol/l), although similar to levels in Indians (17.0 mumol/l). There was no significant difference in the mean serum copper levels estimated before and after 1 month of continuous use of the device. Serial estimations of the serum copper levels in users showed that there was no alteration in these levels after a period of 12 months of continuous IUD use. We therefore conclude that the copper incorporated into multiload IUDs appears not to influence the concentration of serum copper of users.

Clinical characteristic and intraoperative findings of uterine perforation patients in using of intrauterine devices (IUDs).

Science.gov (United States)

Sun, Xin; Xue, Min; Deng, Xinliang; Lin, Yun; Tan, Ying; Wei, Xueli

2018-01-01

Intrauterine devices (IUDs) are the most popular form of contraception used worldwide; however, IUD is not risk-free. IUD migrations, especially uterine perforations, were frequently occurred in patients. The aim of this study was to investigate the clinical characteristics and intraoperative findings in patients with migrated IUDs. 29 cases of uterine perforation associated with migrated IUDs and 69 control patients were followed between January 2008 to March 2015. Patients who used IUDs within first 6 months from the last delivery experienced a characteristically high rate of the perforation of the uterine wall. A significantly larger number of IUD insertion associated with uterine perforation were performed in rural hospitals or operated at a lower level health care system. There was no clear difference in the age and presented symptoms in patients between two groups. Majority of contraceptive intrauterine devices was the copper-releasing IUDs. Furthermore, patients who used V-shaped IUD showed significantly higher incidence of pelvic adhesions when compared with the users of O-shaped IUDs. Unique clinical characteristics of IUD migration were identified in patients with uterine perforation. Hysteroscopy and/or laparoscopy were the effective approaches to remove the migrated IUDs. Improving operating skills is required at the lower level of health care system.

Treatment of Women With an Endometrial Polyp and Heavy Menstrual Bleeding: A Levonorgestrel-Releasing Intrauterine Device or Hysteroscopic Polypectomy?

NARCIS (Netherlands)

van Dijk, Myrthe M.; van Hanegem, Nehalennia; de Lange, Maria E.; Timmermans, Anne

2015-01-01

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

Effect of copper intrauterine device vs. injectable contraceptive on serum hormone levels and cell mitotic activity in endometrium

Directory of Open Access Journals (Sweden)

Ebtesam Moustafa Kamal

2013-09-01

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.

Medical Device Safety

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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

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Fitzpatrick, Dennis

2014-01-01

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

Implantable Medical Devices

Science.gov (United States)

... Artery Disease Venous Thromboembolism Aortic Aneurysm More Implantable Medical Devices Updated:Sep 16,2016 For Rhythm Control ... a Heart Attack Introduction Medications Surgical Procedures Implantable Medical Devices • Life After a Heart Attack • Heart Attack ...

A reanalysis of the Cu-7 intrauterine contraceptive device clinical trial and the incidence of pelvic inflammatory disease: a paradigm for assessing intrauterine contraceptive device safety.

Science.gov (United States)

Roy, S; Azen, C

1994-06-01

We calculated and compared the incidence of pelvic inflammatory disease in a 10% random sample of the Cu-7 intrauterine contraceptive device (G.D. Searle & Co., Skokie, Ill.) clinical trial with the rates reported to the Food and Drug Administration and those in subsequent trials published in the world literature. A 10% random sample of the Cu-7 clinical trial was examined because calculations had demonstrated this random sample to be sufficient in size (n = 1614) to detect a difference in rates of pelvic inflammatory disease from those reported to the Food and Drug Administration. An audit of a subset of the patient files, compared with the original files in Skokie, Illinois, confirmed that the files available for analysis were complete. Standard definitions were used to identify cases of pelvic inflammatory disease and to calculate rates of pelvic inflammatory disease. The world literature on Cu-7 clinical trials was reviewed. The calculated crude and Pearl index rates of pelvic inflammatory disease were consistent with those rates previously reported to the Food and Drug Administration and published in the medical literature. Life-table pelvic inflammatory disease rates were not different between nulliparous and parous women and pelvic inflammatory disease did not differ from basal annual rates in fecund women. On the basis of the analysis of this 10% sample, the pelvic inflammatory disease patient rates reported to the Food and Drug Administration for the entire Cu-7 clinical trial are accurate and are similar to those published in the world literature.

Pyometra caused by carrying of an intrauterine device for a period of forty years and chronic endometritis

Directory of Open Access Journals (Sweden)

Todorović Nada 1

2002-01-01

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

Copper intrauterine device for emergency contraception: clinical practice among contraceptive providers.

Science.gov (United States)

Harper, Cynthia C; Speidel, J Joseph; Drey, Eleanor A; Trussell, James; Blum, Maya; Darney, Philip D

2012-02-01

The copper intrauterine device (IUD) is the most effective emergency contraceptive available but is largely ignored in clinical practice. We examined clinicians' recommendations of the copper IUD for emergency contraception in a setting with few cost obstacles. 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. 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. Although more than 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. 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. III.

Mechanisms of action of intrauterine devices.

Science.gov (United States)

Ortiz, M E; Croxatto, H B; Bardin, C W

1996-12-01

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.

Intrauterine Morcellator Devices: The Icon of Hysteroscopic Future or Merely a Marketing Image? A Systematic Review Regarding Safety, Efficacy, Advantages, and Contraindications.

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Noventa, Marco; Ancona, Emanuele; Quaranta, Michela; Vitagliano, Amerigo; Cosmi, Erich; D'Antona, Donato; Gizzo, Salvatore

2015-10-01

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.

Foreign body granuloma in the anterior abdominal wall mimicking an acute appendicular lump and induced by a translocated copper-T intrauterine contraceptive device: a case report

Directory of Open Access Journals (Sweden)

Ansari Maulana Mohammed

2009-04-01

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.

Class 1 devices case studies in medical devices design

CERN Document Server

Ogrodnik, Peter J

2014-01-01

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...

Pain from copper intrauterine device insertion: randomized trial of prophylactic ibuprofen.

Science.gov (United States)

Hubacher, David; Reyes, Veronica; Lillo, Sonia; Zepeda, Ana; Chen, Pai-Lien; Croxatto, Horacio

2006-11-01

This study was undertaken to determine whether 400 mg of prophylactic ibuprofen can alleviate pain from insertion of an intrauterine device (IUD) and to measure level of pain with improved techniques. We conducted a randomized, double-blind, placebo-controlled trial of 2019 first-time IUD users: 1008 women received placebo and 1011 women received 400 mg of ibuprofen. Participants took the single tablet at least 45 minutes before IUD insertion. Immediately after insertion, participants recorded level of pain by using a 10-cm visual analog scale, with the value of 10 meaning "worst imaginable pain." Median level of pain was 1.0 for both ibuprofen and placebo participants; rank test statistics confirmed no difference. Some subgroups of women experienced higher pain (eg, nulliparous women), but ibuprofen still had no important impact on level of pain. Even among first-time users, pain from IUD insertion is generally low. Prophylactic ibuprofen as used in this protocol does not reduce IUD insertion pain.

Invading of intrauterine contraceptive device into the sigmoid colon through uterine perforation caused by a blunt trauma.

Science.gov (United States)

Davoodabadi, Abdoulhossein; Mohammadzadeh, Mahdi; Amirbeigi, Mahdieh; Jazayeri, Hoda

2015-01-01

Intrauterine contraceptive device (IUCD) is relatively safe but still with some serious risks. Uterus perforation is rare and would be fatal. A case of Cu-7 IUCD invading into the sigmoid colon through uterine perforation caused by a pelvic blunt trauma was presented. Our case showed that uterus perforation by an IUCD could induce utero-sigmoid fistula which is likely to be missed. Imaging is required when the patients with IUCD present abdominal pain, particularly with a history of trauma.

Intravesical Migration of a Failed and Forgotten Intrauterine ...

African Journals Online (AJOL)

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 ...

Levonorgestrel-releasing intrauterine device versus dydrogesterone for management of endometrial hyperplasia without atypia.

Science.gov (United States)

El Behery, Manal M; Saleh, Hend S; Ibrahiem, Moustafa A; Kamal, Ebtesam M; Kassem, Gamal A; Mohamed, Mohamed El Sayed

2015-03-01

To compare the efficacy and safety of the levonorgestrel-releasing intrauterine device (LNG-IUD) with dydrogesterone applied for the same duration in patients having endometrial hyperplasia (EH) without atypia. One hundred thirty eight women aged between 30 and 50 years with abnormal uterine bleeding and diagnosed as EH by transvaginal ultrasound were randomized to receive either LNG-IUD or dydrogesterone for 6 months. Primary outcome measures were regression of hyperplasia after 6 months of therapy. Secondary outcome measures were occurrence of side effects during treatment or recurrence of hyperplasia during follow-up period. After 6 months of treatment, regression of EH occurs in 96% of women in the levonorgestrel-releasing intrauterine system (LNG-IUS) group versus 80% of women in the oral group (P < .001). Adverse effects were relatively common with minimal differences between the 2 groups. Intermenstrual vaginal spotting and amenorrhea were more common in the LNG-IUD group (P value .01 and .0001). Patient satisfaction was significantly higher in the LNG-IUS group (P value .0001). Hysterectomy rates were lower in the LNG-IUS group than in the oral group (P = .001). Recurrence rate was 0% in the LNG-IUD group compared to 12.5% in the oral group. In management of EH without atypia, LNG-IUS achieves a higher regression and a lower hysterectomy rate than oral progesterone and could be used as a first-line therapy. © The Author(s) 2014.

Case outsourcing medical device reprocessing.

Science.gov (United States)

Haley, Deborah

2004-04-01

IN THE INTEREST OF SAVING MONEY, many hospitals are considering extending the life of some single-use medical devices by using medical device reprocessing programs. FACILITIES OFTEN LACK the resources required to meet the US Food and Drug Administration's tough quality assurance standards. BY OUTSOURCING, hospitals can reap the benefits of medical device reprocessing without assuming additional staffing and compliance burdens. OUTSOURCING enables hospitals to implement a medical device reprocessing program quickly, with no capital investment and minimal effort.

Hysteroscopic Management Of Intrauterin Adhesion

Directory of Open Access Journals (Sweden)

Ayşegül Dikmen

2013-03-01

Full Text Available Objective: Assessment of preoperative and postoperative outcomes of patients that were performed hysterescopic intrauterine adhesiolysis. Material and method: We reviewed 24 patients that underwent hysterescopy with the complaints of amenorrhea, hypomenorrhea, recurrent pregnancy loss between 2004-2008. The most complaints of patients were infertilty amenorrhea. Results: Adhesions occurs mainly as a result of trauma to the gravid uterine cavity in 14 patients. When classifying patients with their intrauterine adhesions, Grade 3 was the most frequently seen. Adhesiolisis was performed with hysteresopic scissors in all patients. In postoperative period following synechiolysis, 10 patients were treated with estrogen and progestogen, 11 of them used intrauterine device with estrogen and progestogen therapy, foley catheter was used in 3 patients. Hysterescopy was performed in 5 patients for second time because of adhesion suspicions. The re-adhesiolysis performed to 3 patients because of determined to mild adhesion. Conclusion: After hysterescopic adhesiolysis, all patients with the complaint of amenorrhea had regular menstruation. Pregnancy after treatment occured in 4 patients but live birth rate was 75%.

Comparison of genital microbial isolates between intrauterine ...

African Journals Online (AJOL)

Background:In the past, the use of intrauterine contraceptive device (IUCD), in particular, Dalkon Shield was found to be associated with ... of these residing in Asia. .... to air dry, labeled and transferred to the laboratory for Gram staining.

Medical device-related pressure ulcers

Directory of Open Access Journals (Sweden)

Black JM

2016-08-01

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

Human Factors and Medical Devices

International Nuclear Information System (INIS)

Dick Sawyer

1998-01-01

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

Attitudes of physicians providing family planning services in Egypt about recommending intrauterine device for family planning clients.

Science.gov (United States)

Aziz, Mirette; Ahmed, Sabra; Ahmed, Boshra

2017-12-01

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.

Unprotected intercourse in the 2 weeks prior to requesting emergency intrauterine contraception.

Science.gov (United States)

Sanders, Jessica N; Howell, Laura; Saltzman, Hanna M; Schwarz, E Bimla; Thompson, Ivana S; Turok, David K

2016-11-01

Previous emergency contraception studies have excluded women who report >1 episode of unprotected or underprotected intercourse. Thus, clinical recommendations are based on exposure to a single episode of underprotected intercourse. We sought to assess the prevalence and timing of underprotected intercourse episodes among women requesting emergency contraception and to examine the probability of pregnancy following an emergency contraception regimen including placement of either a copper intrauterine device or a levonorgestrel intrauterine device with simultaneous administration of an oral levonorgestrel pill in women reporting multiple underprotected intercourse episodes, including episodes beyond the Food and Drug Administration-approved emergency contraception time frame (6-14 days). Women seeking emergency contraception who had a negative pregnancy test and desired either a copper intrauterine device or levonorgestrel emergency contraception regimen enrolled in this prospective observational study. At enrollment, participants reported the number and timing of underprotected intercourse episodes in the previous 14 days. Two weeks later, participants reported the results of a self-administered home pregnancy test. Of the 176 women who presented for emergency contraception and received a same-day intrauterine device, 43% (n = 76) reported multiple underprotected intercourse episodes in the 14 days prior to presenting for emergency contraception. Women with multiple underprotected intercourse episodes reported a median of 3 events (range 2-20). Two-week pregnancy data were available for 172 (98%) participants. Only 1 participant had a positive pregnancy test. Pregnancy occurred in 0 of 97 (0%; 95% confidence interval, 0-3.7%) women with a single underprotected intercourse episode and 1 of 75 (1.3%; 95% confidence interval, 0-7.2%) women reporting multiple underprotected intercourse episodes; this includes 1 of 40 (2.5%; 95% confidence interval, 0-13.2%) women

[Medical Devices Law for pain therapists].

Science.gov (United States)

Regner, M; Sabatowski, R

2016-08-01

Medical Devices Law is a relatively new legal system, which has replaced the Medical Devices Regulations still well-known in Germany. German Medical Devices Law is based on European directives, which are, in turn, incorporated into national law by the Medical Devices Act. The Medical Devices Act is a framework law and covers a number of regulations that address specific topics within Medical Devices Law. In turn, in individual regulations, reference is made to guidelines, recommendations, etc. from other sources that provide detailed technical information on specific topics. Medical Devices Law is a very complex legal system, which needs to be permanently observed due to constant updating and adjustment. In the current article, the design and the structure of the system will be described, but special emphasis will be laid on important problem areas that need to be considered when applying and operating medical products, in this case by pain therapists in particular.

Surgical removal of intra-abdominal intrauterine devices at one center in a 20-year period.

Science.gov (United States)

Ertopcu, Kenan; Nayki, Cenk; Ulug, Pasa; Nayki, Umit; Gultekin, Emre; Donmez, Aysegul; Yildirim, Yusuf

2015-01-01

To review 20 years of experience of the removal of intra-abdominal intrauterine devices (IUDs) and to compare the surgical methods used. In a retrospective study, charts dating from between September 1, 1992, and August 31, 2012, were reviewed. Patients were eligible for inclusion when they had an IUD surgically removed by minilaparotomy or laparoscopy at a tertiary referral center in Izmir, Turkey. Among the 36 eligible women, 18 (50%) had undergone laparoscopy and 18 (50%) had undergone minilaparotomy. Mean operation length was 55.3±6.3 minutes in the laparoscopy group and 29.1±4.2 minutes in the minilaparotomy group (P=0.008). Conversion to full laparotomy was necessary in 4 (22%) women in the laparoscopy group and 1 (6%) in the minilaparotomy group (P=0.02). Perioperative complications were observed in 5 (14%) women, with no difference in frequency between groups (P=0.09). Total cost of medical/surgical procedures was US$436.4±35.4 for the laparoscopy group and $323.4±21.3 for the minilaparotomy group (P=0.04). Minilaparotomy seems to be an important alternative to laparoscopy for the removal of intra-abdominal IUDs. This procedure should be an integral part of gynecologic surgical training. Copyright © 2014 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

Reducing barriers to the use of the intrauterine contraceptive device ...

African Journals Online (AJOL)

AJRH Managing Editor

The use of the IUD as a LARC method is increasing in many developed and developing countries. New technology should .... Margules spiral(Gynecoil). Copper T (TCu200 ..... health benefit to an intrauterine system, not just an improvement in ...

Trichomonas vaginalis clinical isolates: cytoadherence and adherence to polystyrene, intrauterine device, and vaginal ring.

Science.gov (United States)

Dos Santos, Odelta; Rigo, Graziela Vargas; Macedo, Alexandre José; Tasca, Tiana

2017-12-01

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.

Halo and spillover effect illustrations for selected beneficial medical devices and drugs

Directory of Open Access Journals (Sweden)

Brent D. Kerger

2016-09-01

Full Text Available Abstract Background Negative news media reports regarding potential health hazards of implanted medical devices and pharmaceuticals can lead to a ‘negative halo effect,’ a phenomenon whereby judgments about a product or product type can be unconsciously altered even though the scientific support is tenuous. To determine how a ‘negative halo effect’ may impact the rates of use and/or explantation of medical products, we analyzed the occurrence of such an effect on three implanted medical devices and one drug: 1 intrauterine contraceptive devices (IUDs; 2 silicone gel-filled breast implants (SGBI; 3 metal-on-metal hip implants (MoM; and 4 the drug Tysabri. Methods Data on IUD use from 1965 to 2008 were gathered from the Department of Health and Human Services Vital and Health Statistics and peer-reviewed publications. Data regarding SGBI implant and explantation rates from 1989 to 2012 were obtained from the Institute of Medicine and the American Society of Plastic Surgeons. MoM implant and explantation data were extracted from the England and Wales National Joint Registry and peer-reviewed publications. Tysabri patient data were reported by Elan Corporation or Biogen Idec Inc. Data trends for all products were compared with historical recall or withdrawal events and discussed in the context of public perceptions following such events. Results We found that common factors altered public risk perceptions and patterns of continued use. First, a negative halo effect may be driven by continuing patient anxiety despite positive clinical outcomes. Second, negative reports about one product can spill over to affect the use of dissimilar products in the same category. Third, a negative halo effect on an entire category of medical devices can be sustained regardless of the scientific findings pertaining to safety. Fourth, recovery of a product’s safety reputation and prevalent use may take decades in the U.S., even while these products may

Intrauterine fetal death and risk of shoulder dystocia at delivery.

Science.gov (United States)

Larsen, Sandra; Dobbin, Joanna; McCallion, Oliver; Eskild, Anne

2016-12-01

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 (dystocia occurred in 1.1% of pregnancies with intrauterine fetal death and in 0.8% of pregnancies without intrauterine fetal death (p dystocia occurred in 14.6% of pregnancies with intrauterine fetal death and in 2.8% of pregnancies without intrauterine fetal death (p dystocia occurred in 57.1% of pregnancies with intrauterine fetal death and 9.6% of pregnancies without intrauterine fetal death (p 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.

Levonorgestrel-releasing intrauterine system vs. usual medical treatment for menorrhagia: an economic evaluation alongside a randomised controlled trial.

Directory of Open Access Journals (Sweden)

Sabina Sanghera

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.

Non-contraceptive benefits of hormonal and intrauterine reversible contraceptive methods.

Science.gov (United States)

Bahamondes, Luis; Valeria Bahamondes, M; Shulman, Lee P

2015-01-01

Most contraceptive methods present benefits beyond contraception; however, despite a large body of evidence, many healthcare professionals (HCPs), users and potential users are unaware of those benefits. This review evaluates the evidence for non-contraceptive benefits of hormonal and non-hormonal contraceptive methods. We searched the medical publications in PubMed, POPLINE, CENTRAL, EMBASE and LILACS for relevant articles, on non-contraceptive benefits of the use of hormonal and intrauterine reversible contraceptive methods, which were published in English between 1980 and July 2014. Articles were identified using the following search terms: 'contraceptive methods', 'benefits', 'cancer', 'anaemia', 'heavy menstrual bleeding (HMB)', 'endometrial hyperplasia', 'endometriosis' and 'leiomyoma'. We identified, through the literature search, evidence that some combined oral contraceptives have benefits in controlling HMB and anaemia, reducing the rate of endometrial, ovarian and colorectal cancer and ectopic pregnancy as well as alleviating symptoms of premenstrual dysphoric disorder. Furthermore, the use of the levonorgestrel-releasing intrauterine system also controls HMB and anaemia and endometrial hyperplasia and cancer, reduces rates of endometrial polyps in users of tamoxifen and alleviates pain associated with endometriosis and adenomyosis. Depot medroxyprogesterone acetate controls crises of pain associated with sickle cell disease and endometriosis. Users of the etonogestrel-releasing contraceptive implant have the benefits of a reduction of pain associated with endometriosis, and users of the copper intrauterine device have reduced rates of endometrial and cervical cancer. Despite the high contraceptive effectiveness of many hormonal and intrauterine reversible contraceptive methods, many HCPs, users and potential users are concerned mainly about side effects and safety of both hormonal and non-hormonal contraceptive methods, and there is scarce information

Levonorgestrel Intrauterine Device Placement in a Premenopausal Breast Cancer Patient with a Bicornuate Uterus.

Science.gov (United States)

Eskew, Ashley M; Crane, Erin K

2016-01-01

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.

Medical device software: defining key terms.

Science.gov (United States)

Pashkov, Vitalii; Gutorova, Nataliya; Harkusha, Andrii

one of the areas of significant growth in medical devices has been the role of software - as an integral component of a medical device, as a standalone device and more recently as applications on mobile devices. The risk related to a malfunction of the standalone software used within healthcare is in itself not a criterion for its qualification or not as a medical device. It is therefore, necessary to clarify some criteria for the qualification of stand-alone software as medical devices Materials and methods: Ukrainian, European Union, United States of America legislation, Guidelines developed by European Commission and Food and Drug Administration's, recommendations represented by international voluntary group and scientific works. This article is based on dialectical, comparative, analytic, synthetic and comprehensive research methods. the legal regulation of software which is used for medical purpose in Ukraine limited to one definition. In European Union and United States of America were developed and applying special guidelines that help developers, manufactures and end users to difference software on types standing on medical purpose criteria. Software becomes more and more incorporated into medical devices. Developers and manufacturers may not have initially appreciated potential risks to patients and users such situation could have dangerous results for patients or users. It is necessary to develop and adopt the legislation that will intend to define the criteria for the qualification of medical device software and the application of the classification criteria to such software, provide some illustrative examples and step by step recommendations to qualify software as medical device.

Medical devices regulations, standards and practices

CERN Document Server

Ramakrishna, Seeram; Wang, Charlene

2015-01-01

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

21 CFR 892.2040 - Medical image hardcopy device.

Science.gov (United States)

2010-04-01

... 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...

[Consideration of Mobile Medical Device Regulation].

Science.gov (United States)

Peng, Liang; Yang, Pengfei; He, Weigang

2015-07-01

The regulation of mobile medical devices is one of the hot topics in the industry now. The definition, regulation scope and requirements, potential risks of mobile medical devices were analyzed and discussed based on mobile computing techniques and the FDA guidance of mobile medical applications. The regulation work of mobile medical devices in China needs to adopt the risk-based method.

Surgical tools and medical devices

CERN Document Server

Jackson, Mark

2016-01-01

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...

Comparing the Effect of Mefenamic Acid and Vitex Agnus on Intrauterine Device Induced Bleeding

Directory of Open Access Journals (Sweden)

Parisa Yavarikia

2013-08-01

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.

Comparing the effect of mefenamic Acid and vitex agnus on intrauterine device induced bleeding.

Science.gov (United States)

Yavarikia, Parisa; Shahnazi, Mahnaz; Hadavand Mirzaie, Samira; Javadzadeh, Yousef; Lutfi, Razieh

2013-09-01

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.

Medical device development.

Science.gov (United States)

Panescu, Dorin

2009-01-01

The development of a successful medical product requires not only engineering design efforts, but also clinical, regulatory, marketing and business expertise. This paper reviews items related to the process of designing medical devices. It discusses the steps required to take a medical product idea from concept, through development, verification and validation, regulatory approvals and market release.

Intrauterine fertilization capsules--a clinical trial

DEFF Research Database (Denmark)

Lenz, S; Lindenberg, S; Sundberg, K

1991-01-01

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....... chorionic gonadotropin. Oocytes were collected by ultrasonically guided transvaginal aspiration, and spermatozoa were prepared by swim-up technique. The gametes were placed in agar capsules 4 hr after oocyte collection, and the capsules were introduced to the uterine fundus using an insertion tube...

International Standards for Radiation Sterilization of Medical Devices

International Nuclear Information System (INIS)

Miller, A.

2007-01-01

For a terminally sterilized medical device to be designated '' STERILE '', probability of finding the viable micro-organisms in the device shall be equal to or less than 1 x 10 -6 (EN 556-1:2001: Sterilization of medical devices - Requirements for medical devices to be designated '' STERILE '' - Part 1: Requirements for terminally sterilized medical devices). Author presents the main legal aspects of the international standards for radiation sterilization of medical devices

Body Implanted Medical Device Communications

Science.gov (United States)

Yazdandoost, Kamya Yekeh; Kohno, Ryuji

The medical care day by day and more and more is associated with and reliant upon concepts and advances of electronics and electromagnetics. Numerous medical devices are implanted in the body for medical use. Tissue implanted devices are of great interest for wireless medical applications due to the promising of different clinical usage to promote a patient independence. It can be used in hospitals, health care facilities and home to transmit patient measurement data, such as pulse and respiration rates to a nearby receiver, permitting greater patient mobility and increased comfort. As this service permits remote monitoring of several patients simultaneously it could also potentially decrease health care costs. Advancement in radio frequency communications and miniaturization of bioelectronics are supporting medical implant applications. A central component of wireless implanted device is an antenna and there are several issues to consider when designing an in-body antenna, including power consumption, size, frequency, biocompatibility and the unique RF transmission challenges posed by the human body. The radiation characteristics of such devices are important in terms of both safety and performance. The implanted antenna and human body as a medium for wireless communication are discussed over Medical Implant Communications Service (MICS) band in the frequency range of 402-405MHz.

Vesical Calculus 10 Years Post Missing Intrauterine Contraceptive ...

African Journals Online (AJOL)

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 ...

Effects of intrauterine contraception on the vaginal microbiota.

Science.gov (United States)

Bassis, Christine M; Allsworth, Jenifer E; Wahl, Heather N; Sack, Daniel E; Young, Vincent B; Bell, Jason D

2017-09-01

There have been conflicting reports of altered vaginal microbiota and infection susceptibility associated with contraception use. The objectives of this study were to determine if intrauterine contraception altered the vaginal microbiota and to compare the effects of a copper intrauterine device (Cu-IUD) and a levonorgestrel intrauterine system (LNG-IUS) on the vaginal microbiota. DNA was isolated from the vaginal swab samples of 76 women using Cu-IUD (n=36) or LNG-IUS (n=40) collected prior to insertion of intrauterine contraception (baseline) and at 6 months. A third swab from approximately 12 months following insertion was available for 69 (Cu-IUD, n=33; LNG-IUS, n=36) of these women. The V4 region of the bacterial 16S rRNA-encoding gene was amplified from the vaginal swab DNA and sequenced. The 16S rRNA gene sequences were processed and analyzed using the software package mothur to compare the structure and dynamics of the vaginal bacterial communities. The vaginal microbiota from individuals in this study clustered into 3 major vaginal bacterial community types: one dominated by Lactobacillus iners, one dominated by Lactobacillus crispatus and one community type that was not dominated by a single Lactobacillus species. Changes in the vaginal bacterial community composition were not associated with the use of Cu-IUD or LNG-IUS. Additionally, we did not observe a clear difference in vaginal microbiota stability with Cu-IUD versus LNG-IUS use. Although the vaginal microbiota can be highly dynamic, alterations in the community associated with the use of intrauterine contraception (Cu-IUD or LNG-IUS) were not detected over 12 months. We found no evidence that intrauterine contraception (Cu-IUD or LNG-IUS) altered the vaginal microbiota composition. Therefore, the use of intrauterine contraception is unlikely to shift the composition of the vaginal microbiota such that infection susceptibility is altered. Copyright © 2017 Elsevier Inc. All rights reserved.

Medical Devices

NARCIS (Netherlands)

Verkerke, Gijsbertus Jacob; Mahieu, H.F.; Geertsema, A.A.; Hermann, I.F.; van Horn, J.R.; Hummel, J. Marjan; van Loon, J.P.; Mihaylov, D.; van der Plaats, A.; Schraffordt Koops, H.; Schutte, H.K.; Veth, R.P.H.; de Vries, M.P.; Rakhorst, G.; Shi, Donglu

2004-01-01

The development of new medical devices is a very time-consuming and costly process. Besides the time between the initial idea and the time that manufacturing and testing of prototypes takes place, the time needed for the development of production facilities, production of test series, marketing,

Classification and evaluation of medical devices

Directory of Open Access Journals (Sweden)

Edina Vranić

2003-05-01

Full Text Available Medical devices and medical disposables contribute significantly to the quality and effectiveness of the health care system. It is necessary to commit scientifically sound regulatory environment that will provide consumers with the best medical care. This includes continued services to small manufacturers, readily available guidance on FDA requirements, predictable and reasonable response times on applications for marketing, and equitable enforcement. But in the public interest, this commitment to the industry must be coupled with a reciprocal commitment: that medical device firms will meet high standards in the design, manufacture, and evaluation of their products. The protections afforded our consumer, and the benefits provided the medical device industry, cannot be underestimated.

Vaginal flora changes on Pap smears after insertion of levonorgestrel-releasing intrauterine device.

Science.gov (United States)

Donders, Gilbert G G; Berger, Judith; Heuninckx, Hélène; Bellen, Gert; Cornelis, Ann

2011-04-01

The levonorgestrel intrauterine system (LNG-IUS) combines a uterine foreign body and the continuous release of low-dose levonorgestrel for contraception. Its influence on the rate of vulvovaginal infections and flora disturbance is insufficiently known, but important for contraceptive advice in women, especially those who develop recurrent vaginosis or Candida vulvovaginitis. Slides of 286 women who had a Pap smear taken before and 1 to 2 years after placement of a LNG-IUS were blindly reviewed for the presence of abnormal vaginal flora (AVF), bacterial vaginosis (BV), aerobic vaginitis (AV) and Candida vaginitis (CV). Prior to insertion, there were no differences in vaginal flora abnormalities between women using different kinds of contraception. LNG-IUS users did not have different rates of AVF, BV, AV or CV, but the general risk to develop any infection was increased. Uterine bleeding after insertion did not seem to predict a different flora type. We found that Pap smears suggested more vaginal infections after 1 year of LNG-IUS use than prior to insertion of the device. Copyright © 2011 Elsevier Inc. All rights reserved.

The T 380A intrauterine device: a retrospective 5-year evaluation.

Science.gov (United States)

de Araujo, Fabio Fernando; Barbieri, Márcia; Guazzelli, Cristina Aparecida Falho; Lindsey, Prescilla Chow

2008-12-01

The undue resistance to intrauterine device (IUD) use seen in several settings does not seem to occur in the Family Planning Unit of UNIFESP-EPM (São Paulo Federal University, Brazil). In fact, the Copper T 380A IUD in this clinic has reached an outstanding importance and this motivated us to present our differing experience. The prevalence of this method in this clinic is as high as 40%. This contrasts to the low use in the rest of the country, where tubal ligation is by far the most used contraceptive method (40%) and where IUD is inexpressive (1.1%). This is a retrospective study of the records of 118 users of Copper T 380A IUD inserted at the clinic and who were followed during 5 years. The cumulative pregnancy rate was 0.8%. The main cause for discontinuation of the study was loss to follow-up (21.3%). Other reasons for the withdrawal of the device were personal option (13.6%), dislocation (11.7%) and pregnancy wish (3.4%). There was no withdrawal by pelvic inflammatory disease. Bleeding (0.8%) was not an important cause for withdrawal, and there were no withdrawals due to pain. The continuation rate at 5 years was 46.7%. The structured service and an adequate educative program perhaps could explain at least partially the good performance of IUD use in this clinic. There was an amazing prevalence of the components of the metabolic syndrome. This could represent contraindications for hormonal contraception, and, in consequence, it could influence the increased option for and continuation of the IUD. These data show a good performance of the IUD for long duration, in relation to other studies, and this should be considered as a reliable alternative to the high prevalence of female sterilization in this country.

Contextual inquiry for medical device design

CERN Document Server

Privitera, Mary Beth

2015-01-01

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

Medical device market in China.

Science.gov (United States)

Boyer, Philip; Morshed, Bashir I; Mussivand, Tofy

2015-06-01

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.

An evaluation of the simultaneous use of the levonorgestrel-releasing intrauterine device (LNG-IUS, Mirena®) combined with endometrial ablation in the management of menorrhagia.

LENUS (Irish Health Repository)

Vaughan, D

2012-05-01

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.

Patient knowledge about and intention to use the intrauterine ...

African Journals Online (AJOL)

The intrauterine contraceptive device (IUCD) is a highly effective and safe method of ... A prospective cross-sectional study was conducted at Pelonomi Tertiary Hospital. A total ... Overall qualitative knowledge was poor, even among those aware of the ..... Nine percent of the 53 women who had heard about the IUCD in the.

Legislative aspects of the development of medical devices.

Science.gov (United States)

Marešová, Petra; Klímová, Blanka; Krejcar, Ondřej; Kuča, Kamil

2015-09-01

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.

Mobile medical device connectivity: real world solutions.

Science.gov (United States)

Pettus, Dan

2004-01-01

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

Analytical Chemistry in the Regulatory Science of Medical Devices.

Science.gov (United States)

Wang, Yi; Guan, Allan; Wickramasekara, Samanthi; Phillips, K Scott

2018-06-12

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.

Experience and levels of satisfaction with the levonorgestrel-releasing intrauterine system in China: a prospective multicenter survey

Directory of Open Access Journals (Sweden)

Zhao S

2014-10-01

Full Text Available Shuping Zhao,1 Jihong Deng,2 Yan Wang,3 Shiliang Bi,4 Xiaoye Wang,5 Wen Qin,6 Zirong Huang,7 Li Li,8 Xin Mi,9 Liping Han,10 Qing Chang,11 Jian Li12 1The Affiliated Hospital of the Medical College Qingdao University, Qingdao, 2Kunming Maternal and Child Health Hospital, Kunming, 3Hubei Maternity and Child Health Hospital, Wuhan, 4West China Second University Hospital, Sichuan University, Chengdu, 5Peking University Third Hospital, Beijing, 6Changzhou Maternity and Child Health Hospital, Affiliated to Nanjing Medical University, Jiangsu, 7The Affiliated Women’s Hospital of Fudan University, Shanghai, 8Guangzhou Women and Children’s Medical Center, Guangzhou, 9Maternity and Child Health Care Hospital, Shunyi District, Beijing, 10The First Affiliated Hospital of Zhengzhou University, Zhengzhou City, Henan, 11Southwest Hospital, Chongqing City, Chongqing, 12Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, People’s Republic of China Background: Although surveys conducted in Western countries have shown that the levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena® is well accepted by European women, its acceptance by Chinese women is not yet clearly known. The purpose of this study was to analyze the experiences and levels of satisfaction with Mirena among Chinese women living in 12 different cities. Methods: In total, 1,021 women who attended 21 medical centers for insertion of Mirena were invited to complete a questionnaire regarding their contraceptive decision at baseline (preinsertion, and two further questionnaires on their experience and satisfaction with Mirena at 3–6 months and 1 year after insertion. Results: At baseline, 36% of women self-reported heavy or very heavy menstrual bleeding, while 41% reported normal bleeding. The majority of women (98% were satisfied with the preinsertion counseling, during which contraceptive reliability was identified as the most important reason for

A double-blind trial of ethamsylate in the treatment of primary and intrauterine-device menorrhagia.

Science.gov (United States)

Harrison, R F; Cambell, S

1976-08-07

22 patients complaining of primary menorrhagia or menorrhagia associated with an intrauterine device (I.U.C.D.) were studied in a double blind trial with crossover of ethamsylate and placebo. Acutal menstrual blood-losses were calculated from the iron content of used sanitary material during one pre-trail menstrual period and four trial menstrual periods, during which patients received ethamsylate ("Dicynene") treatment during two menstrual cycles and placebo during two cycles. During ethamsylate treatment the mean menstrual blood-loss was reduced by 50% in patients with primary menorrhagia and by 19% in patients with an I.U.C.D. This difference between the two groups is probably accounted for by the differing values of initial blood-loss which was significantly higher in the group with primary menorrhagia. Tampon usage and the duration of bleeding were not significantly altered by ethamsylate treatment. Reported side-effects, which were not serious, were equally common during ethamsylate and placebo treatment.

An update on mobile phones interference with medical devices.

Science.gov (United States)

Mahmoud Pashazadeh, Ali; Aghajani, Mahdi; Nabipour, Iraj; Assadi, Majid

2013-10-01

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.

An update on mobile phones interference with medical devices

International Nuclear Information System (INIS)

Pashazadeh, A. M.; Aghajani, M.; Nabipour, I.; Assadi, M.

2013-01-01

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)

Medical devices and human engineering

CERN Document Server

Bronzino, Joseph D

2014-01-01

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

ACR Appropriateness Criteria® growth disturbances - risk of intrauterine growth restriction.

Science.gov (United States)

Zelop, Carolyn M; Javitt, Marcia C; Glanc, Phyllis; Dubinsky, Theodore; Harisinghani, Mukesh G; Harris, Robert D; Khati, Nadia J; Mitchell, Donald G; Pandharipande, Pari V; Pannu, Harpreet K; Podrasky, Ann E; Shipp, Thomas D; Siegel, Cary Lynn; Simpson, Lynn; Wall, Darci J; Wong-You-Cheong, Jade J

2013-09-01

Fetal growth disturbances include fetuses at risk for intrauterine growth restriction. These fetuses may have an estimated fetal weight at less than the 10% or demonstrate a plateau of fetal growth with an estimated fetal growth greater than the 10%. Uteroplacental insufficiency may play a major role in the etiology of intrauterine growth restriction. Fetuses at risk for intrauterine fetal growth restriction are susceptible to the potential hostility of the intrauterine environment leading to fetal hypoxia and fetal acidosis. Fetal well-being can be assessed using biophysical profile, Doppler velocimetry, fetal heart rate monitoring, and fetal movement counting.Fetal growth disturbances include fetuses at risk for intrauterine growth restriction. These fetuses may have an estimated fetal weight at less than the 10% or demonstrate a plateau of fetal growth with an estimated fetal growth greater than the 10%. Uteroplacental insufficiency may play a major role in the etiology of intrauterine growth restriction. Fetuses at risk for intrauterine fetal growth restriction are susceptible to the potential hostility of the intrauterine environment leading to fetal hypoxia and fetal acidosis. Fetal well-being can be assessed using biophysical profile, Doppler velocimetry, fetal heart rate monitoring, and fetal movement counting.The ACR Appropriateness Criteria® are evidence-based guidelines for specific clinical conditions that are reviewed every two years by a multidisciplinary expert panel. The guideline development and review include an extensive analysis of current medical literature from peer reviewed journals and the application of a well-established consensus methodology (modified Delphi) to rate the appropriateness of imaging and treatment procedures by the panel. In those instances where evidence is lacking or not definitive, expert opinion may be used to recommend imaging or treatment.

Medical device reliability and associated areas

National Research Council Canada - National Science Library

Dhillon, Balbir S

2000-01-01

.... 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...

[ANTITHROMBOTIC MEDICATION IN PREGNANT WOMEN WITH PREVIOUS INTRAUTERINE GROWTH RESTRICTION].

Science.gov (United States)

Neykova, K; Dimitrova, V; Dimitrov, R; Vakrilova, L

2016-01-01

To analyze pregnancy outcome in patients who were on antithrombotic medication (AM) because of previous pregnancy with fetal intrauterine growth restriction (IUGR). The studied group (SG) included 21 pregnancies in 15 women with history of previous IUGR. The patients were on low dose aspirin (LDA) and/or low molecular weight heparin (LMWH). Pregnancy outcome was compared to the one in two more groups: 1) primary group (PG) including the previous 15 pregnancies with IUGR of the same women; 2) control group (CG) including 45 pregnancies of women matched for parity with the ones in the SG, with no history of IUGR and without medication. The SG, PG and CG were compared for the following: mean gestational age (g.a.) at birth, mean birth weight (BW), proportion of cases with early preeclampsia (PE), IUGR (total, moderate, and severe), intrauterine fetal death (IUFD), neonatal death (NND), admission to NICU, cesarean section (CS) because of chronic or acute fetal distress (FD) related to IUGR, PE or placental abruption. Student's t-test was applied to assess differences between the groups. P values < 0.05 were considered statistically significant. The differences between the SG and the PG regarding mean g. a. at delivery (33.7 and 29.8 w.g. respectively) and the proportion of babies admitted to NICU (66.7% vs. 71.4%) were not statistically significant. The mean BW in the SG (2114,7 g.) was significantly higher than in the PG (1090.8 g.). In the SG compared with the PG there were significantly less cases of IUFD (14.3% and 53.3% respectively), early PE (9.5% vs. 46.7%) moderate and severe IUGR (10.5% and 36.8% vs. 41.7% and 58.3%). Neonatal mortality in the SG (5.6%) was significantly lower than in the PG (57.1%), The proportion of CS for FD was not significantly different--53.3% in the SG and 57.1% in the PG. On the other hand, comparison between the SG and the CG demonstrated significantly lower g.a. at delivery in the SG (33.7 vs. 38 w.g.) an lower BW (2114 vs. 3094 g

Ethylene vinyl acetate (EVA) as a new drug carrier for 3D printed medical drug delivery devices

DEFF Research Database (Denmark)

Genina, Natalja; Hollander, Jenny; Jukarainen, Harri

2016-01-01

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...... affected the drug release profiles from the filaments and printed prototype products: faster release from the prototypes over 30 days in the in vitro tests. To conclude, this study indicates that certain grades of EVA were applicable feedstock material for 3D printing to produce drug-loaded implantable...

Model-based engineering for medical-device software.

Science.gov (United States)

Ray, Arnab; Jetley, Raoul; Jones, Paul L; Zhang, Yi

2010-01-01

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.

[Ethic review on clinical experiments of medical devices in medical institutions].

Science.gov (United States)

Shuai, Wanjun; Chao, Yong; Wang, Ning; Xu, Shining

2011-07-01

Clinical experiments are always used to evaluate the safety and validity of medical devices. The experiments have two types of clinical trying and testing. Ethic review must be done by the ethics committee of the medical department with the qualification of clinical research, and the approval must be made before the experiments. In order to ensure the safety and validity of clinical experiments of medical devices in medical institutions, the contents, process and approval criterions of the ethic review were analyzed and discussed.

A concept ideation framework for medical device design.

Science.gov (United States)

Hagedorn, Thomas J; Grosse, Ian R; Krishnamurty, Sundar

2015-06-01

Medical device design is a challenging process, often requiring collaboration between medical and engineering domain experts. This collaboration can be best institutionalized through systematic knowledge transfer between the two domains coupled with effective knowledge management throughout the design innovation process. Toward this goal, we present the development of a semantic framework for medical device design that unifies a large medical ontology with detailed engineering functional models along with the repository of design innovation information contained in the US Patent Database. As part of our development, existing medical, engineering, and patent document ontologies were modified and interlinked to create a comprehensive medical device innovation and design tool with appropriate properties and semantic relations to facilitate knowledge capture, enrich existing knowledge, and enable effective knowledge reuse for different scenarios. The result is a Concept Ideation Framework for Medical Device Design (CIFMeDD). Key features of the resulting framework include function-based searching and automated inter-domain reasoning to uniquely enable identification of functionally similar procedures, tools, and inventions from multiple domains based on simple semantic searches. The significance and usefulness of the resulting framework for aiding in conceptual design and innovation in the medical realm are explored via two case studies examining medical device design problems. Copyright © 2015 Elsevier Inc. All rights reserved.

Power Approaches for Implantable Medical Devices

Directory of Open Access Journals (Sweden)

Achraf Ben Amar

2015-11-01

Full Text Available Implantable medical devices have been implemented to provide treatment and to assess in vivo physiological information in humans as well as animal models for medical diagnosis and prognosis, therapeutic applications and biological science studies. The advances of micro/nanotechnology dovetailed with novel biomaterials have further enhanced biocompatibility, sensitivity, longevity and reliability in newly-emerged low-cost and compact devices. Close-loop systems with both sensing and treatment functions have also been developed to provide point-of-care and personalized medicine. Nevertheless, one of the remaining challenges is whether power can be supplied sufficiently and continuously for the operation of the entire system. This issue is becoming more and more critical to the increasing need of power for wireless communication in implanted devices towards the future healthcare infrastructure, namely mobile health (m-Health. In this review paper, methodologies to transfer and harvest energy in implantable medical devices are introduced and discussed to highlight the uses and significances of various potential power sources.

Towards sustainable design for single-use medical devices.

Science.gov (United States)

Hanson, Jacob J; Hitchcock, Robert W

2009-01-01

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.

Intrauterine nutrition: long-term consequences for vascular health

Directory of Open Access Journals (Sweden)

Szostak-Wegierek D

2014-07-01

Full Text Available Dorota Szostak-WegierekDepartment of Human Nutrition, Medical University of Warsaw, Warsaw, Poland Abstract: There is a growing body of evidence that improper intrauterine nutrition may negatively influence vascular health in later life. Maternal malnutrition may result in intrauterine growth retardation and, in turn, metabolic disorders such as insulin resistance, diabetes, hypertension, and dyslipidemia, and also enhanced risk of atherosclerosis and cardiovascular death in the offspring. Energy and/or protein restriction is the most critical determinant for fetal programming. However, it has also been proposed that intrauterine n-3 fatty acid deficiency may be linked to later higher blood pressure levels and reduced insulin sensitivity. Moreover, it has been shown that inadequate supply of micronutrients such as folate, vitamin B12, vitamin A, iron, magnesium, zinc, and calcium may contribute to impaired vascular health in the progeny. In addition, hypertensive disorders of pregnancy that are linked to impaired placental blood flow and suboptimal fetal nutrition may also contribute to intrauterine growth retardation and aggravated cardiovascular risk in the offspring. On the other hand, maternal overnutrition, which often contributes to obesity and/or diabetes, may result in macrosomia and enhanced cardiometabolic risk in the offspring. Progeny of obese and/or diabetic mothers are relatively more prone to develop obesity, insulin resistance, diabetes, and hypertension. It was demonstrated that they may have permanently enhanced appetites. Their atheromatous lesions are usually more pronounced. It seems that, particularly, a maternal high-fat/junk food diet may be detrimental for vascular health in the offspring. Fetal exposure to excessive levels of saturated fatty and/or n-6 fatty acids, sucrose, fructose and salt, as well as a maternal high glycemic index diet, may also contribute to later enhanced cardiometabolic risk. Keywords: maternal

78 FR 21129 - Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-04-09

... radiofrequency band ranging between 13 megahertz to 27.12 megahertz and is intended for the treatment of medical...] Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting... the public. Name of Committee: Orthopaedic and Rehabilitation Devices Panel of the Medical Devices...

Anti-malware software and medical devices.

Science.gov (United States)

2010-10-01

Just as much as healthcare information systems, medical devices need protection against cybersecurity threats. Anti-malware software can help safeguard the devices in your facility-but it has limitations and even risks. Find out what steps you can take to manage anti-malware applications in your devices.

Practice of Regulatory Science (Development of Medical Devices).

Science.gov (United States)

Niimi, Shingo

2017-01-01

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.

INTRAUTERINE FETAL DEATH CASES AT TERTIARY CENTER

Directory of Open Access Journals (Sweden)

Babu Lal Bishnoi

2018-01-01

Full Text Available BACKGROUND Intrauterine fetal death is a tragic event for the parents and a great cause of stress for the caregiver. It is an important indicator of maternal and perinatal health of a given population. This study was undertaken to study the maternal and fetal factors associated with intrauterine fetal death. Aim and Objective- This was an Analytical study aimed to evaluate and understand the prevalence, socio-epidemiological and etiological factors of IUFD methodology should not be mixed with aims and objectives MATERIALS AND METHODS The study was carried out at March 2017 to June 2017 (4 months study which was conducted at Dr. S. N. Medical College, Jodhpur, Rajasthan. The details were entered in a preformed proforma. IUD is defined as fetal death beyond 20 weeks of gestation and/or birth weight >500g. The details of complaints at admission, obstetrics history, menstrual history, examination findings, per vaginal examination findings, mode and method of delivery and fetal outcomes and investigation reports were recorded. RESULTS A total of 227 intrauterine fetal deaths were reported amongst 6264 deliveries conducted during the study period. The incidence rate of intrauterine fetal death was 36/1000 live births. 192 (84.56% deliveries were unbooked and unsupervised and 133 (58.59% belonged to rural population and 126 (55.5% were preterm and 221 (97.55% were singleton pregnancy. Among the identifiable causes hypertensive disorders (24.22% and severe anemia (13.10% were most common followed by placental causes (9.97%. Congenital malformations were responsible for 12.39% and unidentifiable causes were 11.01%. Induction was done in 103 patients, 94 patients had spontaneous onset of labour and caesarean section was done in 30 patients. Incidence of intrauterine foetal demise gradually decreased as parity advanced. CONCLUSION Institutional deliveries should be promoted to prevent intrapartum fetal deaths. Decrease in the incidence of IUD would

MDR (Medical Device Reporting)

Data.gov (United States)

U.S. Department of Health & Human Services — This database allows you to search the CDRH's database information on medical devices which may have malfunctioned or caused a death or serious injury during the...

78 FR 68714 - Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug

Science.gov (United States)

2013-11-15

... amendments), as ``preamendments devices.'' FDA classifies these devices after the Agency takes the following.... FDA-2012-N-1238] Medical Devices; Ophthalmic Devices; Classification of the Scleral Plug AGENCY: Food... scleral plugs in order to provide a reasonable assurance of safety and effectiveness of the device. The...

Use of mobile devices for medical imaging.

Science.gov (United States)

Hirschorn, David S; Choudhri, Asim F; Shih, George; Kim, Woojin

2014-12-01

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.

77 FR 72924 - Taxable Medical Devices

Science.gov (United States)

2012-12-07

... in hospitals, doctors offices and other medical institutions, such as x-ray machines, magnetic... the medical device context include sales to hospitals and other medical service providers. Although... of a taxable article to charity constitutes a taxable use under section 4218. However, the IRS and...

Development of Implantable Medical Devices: From an Engineering Perspective

Directory of Open Access Journals (Sweden)

Yeun-Ho Joung

2013-09-01

Full Text Available 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.

Preventing medical device recalls

CERN Document Server

Raheja, Dev

2014-01-01

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

78 FR 26786 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-08

... 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...

76 FR 48871 - Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-08-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Immunology Devices Panel of the Medical Devices Advisory Committee. General Function of the Committee: To...

Product-based Safety Certification for Medical Devices Embedded Software.

Science.gov (United States)

Neto, José Augusto; Figueiredo Damásio, Jemerson; Monthaler, Paul; Morais, Misael

2015-01-01

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP).

On the impact of medical device regulations on software architecture

DEFF Research Database (Denmark)

Hansen, Klaus Marius; Manikas, Konstantinos

2016-01-01

Compliance to regulations and regulatory approval are requirements for many medical device software systems. In this paper, we investigate the implications of medical device software regulations to the design of software systems. We do so by focusing on the American and European regulatory author...... of the device. Moreover, we review software modularity in the implementation of software medical device and propose a set of preliminary principles for architectural design of software medical device based on a set of constrains identified from the reviewed regulations....

[Industry regulation and its relationship to the rapid marketing of medical devices].

Science.gov (United States)

Matsuoka, Atsuko

2012-01-01

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").

76 FR 7220 - Medical Device Innovation Initiative; Request for Comments

Science.gov (United States)

2011-02-09

... medical device innovation. 6. Other actions CDRH should take to facilitate the development, assessment...] Medical Device Innovation Initiative; Request for Comments AGENCY: Food and Drug Administration, HHS... availability of a document for public comment entitled ``Medical Device Innovation Initiative'' (the report...

78 FR 68853 - International Medical Device Regulators Forum; Medical Device Single Audit Program International...

Science.gov (United States)

2013-11-15

... its inaugural meeting in Singapore in 2012, identified a Work Group (WG) to develop specific documents... Assessment Method for the Recognition and Monitoring of Medical Device Auditing Organizations;'' and IMDRF...

The current situation and development of medical device testing institutes in China.

Science.gov (United States)

Yang, Xiaofang; Mu, Ruihong; Fan, Yubo; Wang, Chunren; Li, Deyu

2017-04-01

This article analyses the current situation and development of Chinese medical device testing institutes from the perspectives of the two most important functions - testing functions and medical device standardization functions. Areas Covered: The objective of the Chinese government regulations for medical device industry is to ensure the safety and effectiveness of medical devices for Chinese patients. To support the regulation system, the Chinese government has established medical device testing institutes at different levels for example, the national, provincial, and municipal levels. These testing institutes also play an important role in technical support during medical device premarket registration and post market surveillance, they are also the vital practitioners of Chinese medical device standardization. Expert Commentary: Chinese medical device testing institutes are technical departments established by government, and serve the regulatory functions of government agency. In recent years, with the rapid development of medical device industry as well as constantly increasing international and domestic medical device market, the importance of medical device testing institute is more prominent, However, there are still some problems unsolved, such as their overall capacity remains to be improved, construction of standardization is to be strengthened, etc.

Medical devices for the anesthetist: current perspectives

Directory of Open Access Journals (Sweden)

Ingrande J

2014-03-01

Full Text Available Jerry Ingrande, Hendrikus JM LemmensDepartment of Anesthesiology, Perioperative and Pain Medicine, Stanford University School of Medicine, Stanford, CA, USAAbstract: Anesthesiologists are unique among most physicians in that they routinely use technology and medical devices to carry out their daily activities. Recently, there have been significant advances in medical technology. These advances have increased the number and utility of medical devices available to the anesthesiologist. There is little doubt that these new tools have improved the practice of anesthesia. Monitoring has become more comprehensive and less invasive, airway management has become easier, and placement of central venous catheters and regional nerve blockade has become faster and safer. This review focuses on key medical devices such as cardiovascular monitors, airway equipment, neuromonitoring tools, ultrasound, and target controlled drug delivery software and hardware. This review demonstrates how advances in these areas have improved the safety and efficacy of anesthesia and facilitate its administration. When applicable, indications and contraindications to the use of these novel devices will be explored as well as the controversies surrounding their use.Keywords: catheters, echocardiography, ultrasound, fiberoptic bronchoscope, laryngeal mask airway, closed-loop anesthesia

77 FR 18829 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2012-03-28

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0001] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

76 FR 71983 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-11-21

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory...

Intrauterine contraception: the role of general practitioners in four Dutch general practices.

NARCIS (Netherlands)

Vos, A.A.; Veldhuis, H.M.; Lagro-Janssen, A.L.M.

2004-01-01

The intrauterine device (IUD) use in the Netherlands and the United States is limited to a small group of women, though the risk of infection and pregnancy is small. Therefore, it was of interest to investigate the characteristics of women who choose an IUD as contraceptive method and the influence

42 CFR 410.36 - Medical supplies, appliances, and devices: Scope.

Science.gov (United States)

2010-10-01

... 42 Public Health 2 2010-10-01 2010-10-01 false Medical supplies, appliances, and devices: Scope... Services § 410.36 Medical supplies, appliances, and devices: Scope. (a) Medicare Part B pays for the following medical supplies, appliances and devices: (1) Surgical dressings, and splints, casts, and other...

75 FR 57968 - Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-09-23

...] Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY... public. Name of Committee: Gastroenterology and Urology Devices Panel of the Medical Devices Advisory... committee will discuss, make recommendations, and vote on information related to the PMA for the LAP-BAND...

76 FR 55398 - Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of...

Science.gov (United States)

2011-09-07

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0002] Immunology Devices Panel of the Medical Devices Advisory Committee: Notice of Postponement of Meeting AGENCY... postponing the meeting of the Immunology Devices Panel of the Medical Devices Advisory Committee scheduled...

A Medical Delivery Device

DEFF Research Database (Denmark)

2010-01-01

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...

Medical Device Integration Model Based on the Internet of Things

Science.gov (United States)

Hao, Aiyu; Wang, Ling

2015-01-01

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

Handbook of materials for medical devices

National Research Council Canada - National Science Library

Davis, J. R

2003-01-01

... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii Introduction Chapter 1 Overview of Biomaterials and Their Use in Medical Devices . . . . . . . . . . . . . . . . 1 Uses for Biomaterials...

Cybersecurity and the Medical Device Product Development Lifecycle.

Science.gov (United States)

Jones, Richard W; Katzis, Konstantinos

2017-01-01

Protecting connected medical devices from evolving cyber related threats, requires a continuous lifecycle approach whereby cybersecurity is integrated within the product development lifecycle and both complements and re-enforces the safety risk management processes therein. This contribution reviews the guidance relating to medical device cybersecurity within the product development lifecycle.

Antiepileptic drugs and intrauterine death

DEFF Research Database (Denmark)

Tomson, Torbjörn; Battino, Dina; Bonizzoni, Erminio

2015-01-01

) after prenatal AED exposure. Using EURAP data, we prospectively monitored pregnancies exposed to the 6 most common AED monotherapies and to polytherapy. Intrauterine death (spontaneous abortion and stillbirth combined) was the primary endpoint. RESULTS: Of 7,055 pregnancies exposed to monotherapy...... with lamotrigine (n = 1,910), carbamazepine (n = 1,713), valproic acid (n = 1,171), levetiracetam (n = 324), oxcarbazepine (n = 262), or phenobarbital (n = 260), and to polytherapy (n = 1,415), 632 ended in intrauterine deaths (592 spontaneous abortions and 40 stillbirths). Rates of intrauterine death were similar...... that the risk was greater with polytherapy vs monotherapy (risk ratio [RR] 1.38; 95% CI 1.14-1.66), parental history of MCMs (RR 1.92; 1.20-3.07), maternal age (RR 1.06; 1.04-1.07), and number of previous intrauterine deaths (RR 1.09; 1.00-1.19). The risk was greater with early enrollment and decreased...

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

OpenAIRE

A. Yu. Galkin; A. G. Komar; A. A. Grigorenko

2015-01-01

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...

75 FR 61507 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2010-10-05

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the..., FDA announced that a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices...

Medical device risk management and its economic impact

Directory of Open Access Journals (Sweden)

Katerina Krsteva Jakimovska

2013-10-01

Full Text Available The importance of medical devices in everyday users/patients lives is imensse. This is the reason why emphasis must be put on safety during their use. Satisfactory safety level can be achived by implementation of quality and risk management standards. Medical device manufacturers must learn to deal with the potential risks by using theoretical and practical examples and measures in order to protect their users/patients and themselves from suffering huge losses arising from adverse events or recall of their products. The best moment for implementation of risk management methods and analysis begins from the device design and development through manufacturing, sales and distribution. These way medical device manufacturers will succseed in protecting their users/patients from serious adverse events and at the same time protect their brand and society status, while minimizing economic losses.

75 FR 47606 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-08-06

... 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... General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee scheduled for August...

[Design and application of implantable medical device information management system].

Science.gov (United States)

Cao, Shaoping; Yin, Chunguang; Zhao, Zhenying

2013-03-01

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.

Influences on women's decision making about intrauterine device use in Madagascar.

Science.gov (United States)

Gottert, Ann; Jacquin, Karin; Rahaivondrafahitra, Bakoly; Moracco, Kathryn; Maman, Suzanne

2015-04-01

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.

78 FR 16684 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-03-18

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

77 FR 20642 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2012-04-05

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 14415 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-03-16

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 62419 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-10-07

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

75 FR 49940 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2010-08-16

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

78 FR 30928 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2013-05-23

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

76 FR 39882 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-07-07

... 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... the public. Name of Committee: General and Plastic Surgery Devices Panel of the Medical Devices...

Design considerations for medical devices in the home environment.

Science.gov (United States)

Kaufman-Rivi, Diana; Collins-Mitchell, Janette; Jetley, Raoul

2010-01-01

Patient demographics, economic forces, and technological advancements contribute to the rise in home care services. Advanced medical devices and equipment originally designed for use by trained personnel in hospitals and clinics are increasingly migrating into the home. Unlike the clinical setting, the home is an uncontrolled environment with additional hazards. The compatibility of the device with the recipient's knowledge, abilities, lifestyle, and home environment plays a significant role in their therapy and rehabilitation. The advent of new device technologies such as wireless devices and interoperability of systems lends a new and complex perspective for medical device use in the home that must also be addressed. Adequately assessing and matching the patient and their caregiver with the appropriate device technology while considering the suitability of the home environment for device operation and maintenance is a challenge that relies on good human factors principles. There is a need to address these challenges in the growing home care sector In this article, the authors take a look at some important considerations and design issues for medical devices used in the home care environment.

Maternal hyperthyroidism after intrauterine insemination due to hypertrophic action of human chorionic gonadotropin: a case report.

Science.gov (United States)

Bakas, P; Tzouma, C; Creatsa, M; Boutas, I; Hassiakos, D

2016-01-01

To report a rare case of maternal hyperthyroidism after intrauterine insemination due to hypertrophic action of hCG. A 36-year-old woman after successful intrauterine insemination and triplet pregnancy, developed hyperthyroidism with resistance to medical treatment. All signs of hyperthyroidism resolved and the results of thyroid function tests returned to normal without any medication after embryo meiosis. De novo maternal hyperthyroidism may develop during pregnancy as a result of pathological stimulation of the thyroid gland from the high levels of hCG hormone that can be seen in multiple pregnancies. The risk of hyperthyroidism is related to the number of fetuses. Reversibility of symptomatology can be seen after fetal reduction of multiple pregnancies.

Implantable Medical Devices; Networking Security Survey

Directory of Open Access Journals (Sweden)

Siamak Aram

2016-08-01

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.

MedMon: securing medical devices through wireless monitoring and anomaly detection.

Science.gov (United States)

Zhang, Meng; Raghunathan, Anand; Jha, Niraj K

2013-12-01

Rapid advances in personal healthcare systems based on implantable and wearable medical devices promise to greatly improve the quality of diagnosis and treatment for a range of medical conditions. However, the increasing programmability and wireless connectivity of medical devices also open up opportunities for malicious attackers. Unfortunately, implantable/wearable medical devices come with extreme size and power constraints, and unique usage models, making it infeasible to simply borrow conventional security solutions such as cryptography. We propose a general framework for securing medical devices based on wireless channel monitoring and anomaly detection. Our proposal is based on a medical security monitor (MedMon) that snoops on all the radio-frequency wireless communications to/from medical devices and uses multi-layered anomaly detection to identify potentially malicious transactions. Upon detection of a malicious transaction, MedMon takes appropriate response actions, which could range from passive (notifying the user) to active (jamming the packets so that they do not reach the medical device). A key benefit of MedMon is that it is applicable to existing medical devices that are in use by patients, with no hardware or software modifications to them. Consequently, it also leads to zero power overheads on these devices. We demonstrate the feasibility of our proposal by developing a prototype implementation for an insulin delivery system using off-the-shelf components (USRP software-defined radio). We evaluate its effectiveness under several attack scenarios. Our results show that MedMon can detect virtually all naive attacks and a large fraction of more sophisticated attacks, suggesting that it is an effective approach to enhancing the security of medical devices.

Risk evaluation of medical and industrial radiation devices

International Nuclear Information System (INIS)

Jones, E.D.; Cunningham, R.E.; Rathbun, P.A.

1994-03-01

In 1991, the NRC, Division of Industrial and Medical Nuclear Safety, began a program to evaluate the use of probabilistic risk assessment (PRA) in regulating medical devices. This program represents an initial step in an overall plant to evaluate the use of PRA in regulating the use of nuclear by-product materials. The NRC envisioned that the use of risk analysis techniques could assist staff in ensuring that the regulatory approach was standardized, understandable, and effective. Traditional methods of assessing risk in nuclear power plants may be inappropriate to use in assessing the use of by-product devices. The approaches used in assessing nuclear reactor risks are equipment-oriented. Secondary attention is paid to the human component, for the most part after critical system failure events have been identified. This paper describes the risk methodology developed by Lawrence Livermore National Laboratory (LLNL), initially intended to assess risks associated with the use of the Gamma Knife, a gamma stereotactic radiosurgical device. For relatively new medical devices such as the Gamma Knife, the challenge is to perform a risk analysis with very little quantitative data but with an important human factor component. The method described below provides a basic approach for identifying the most likely risk contributors and evaluating their relative importance. The risk analysis approach developed for the Gamma Knife and described in this paper should be applicable to a broader class of devices in which the human interaction with the device is a prominent factor. In this sense, the method could be a prototypical model of nuclear medical or industrial device risk analysis

Value-based purchasing of medical devices.

Science.gov (United States)

Obremskey, William T; Dail, Teresa; Jahangir, A Alex

2012-04-01

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.

Medical instruments and devices principles and practices

CERN Document Server

Schreiner, Steven; Peterson, Donald R

2015-01-01

Medical Instruments and Devices: Principles and Practices originates from the medical instruments and devices section of The Biomedical Engineering Handbook, Fourth Edition. Top experts in the field provide material that spans this wide field. The text examines how biopotential amplifiers help regulate the quality and content of measured signals. It includes instruments and devices that span a range of physiological systems and the physiological scale: molecular, cellular, organ, and system. The book chronicles the evolution of pacemakers and their system operation and discusses oscillometry, cardiac output measurement, and the direct and indirect methods of measuring cardiac output. The authors also expound on the mechanics and safety of defibrillators and cover implantable stimulators, respiration, and the structure and function of mechanical ventilators. In addition, this text covers in depth: Anesthesia Delivery Electrosurgical Units and Devices Biomedical Lasers Measuring Cellular Traction Forces Blood G...

Knowledge and attitudes of Latin American obstetricians and gynecologists regarding intrauterine contraceptives

Directory of Open Access Journals (Sweden)

Bahamondes L

2015-07-01

Full Text Available Luis Bahamondes,1 Maria Y Makuch,1 Ilza Monteiro,1 Victor Marin,2 Richard Lynen3 1Department of Obstetrics and Gynecology, School of Medical Sciences, University of Campinas, Campinas, Brazil; 2Department of Obstetrics and Gynecology, Hospital Central, Petróleos Mexicanos, México City, Mexico; 3Bayer HealthCare, Newark, NJ, USA Background: Intrauterine contraceptives (IUCs, including the copper intrauterine device and the levonorgestrel-releasing intrauterine system (LNG-IUS, are among the reversible contraceptive methods with high effectiveness. However, use is low in many settings, including some Latin American countries, mainly due to the influences of myths, fears, and negative attitudes, not only of users and potential users, but also of different cadres of health care professionals. The purpose of this study was to assess the knowledge and attitudes of a group of Latin American obstetricians and gynecologists regarding IUCs.Methods: A survey was conducted during a scientific meeting organized in Chile in 2014 to present and discuss updated information about contraception. Obstetricians and gynecologists from 12 Latin American countries, who reported that they provide daily contraception services in both the public and private sectors, participated in the meeting. Participants who agreed to take part in the survey responded to a multiple-choice questionnaire on issues regarding knowledge, use, and attitudes about IUCs.Results: Of the 210 obstetricians and gynecologists participating in the meeting, the respondents to each question varied from 168 (80.0% to 205 (97.6%. Almost 50% recognized that the failure rate of combined oral contraceptives, patches, and vaginal rings is 8%–10%. Furthermore, 10% of the participants did not recognize the high contraceptive effectiveness of long-acting reversible contraceptive methods. Additionally, almost 80% of the respondents answered that they did not offer IUCs to nulligravidas and almost 10% did

Instructions included? Make safety training part of medical device procurement process.

Science.gov (United States)

Keller, James P

2010-04-01

Before hospitals embrace new technologies, it's important that medical personnel agree on how best to use them. Likewise, hospitals must provide the support to operate these sophisticated devices safely. With this in mind, it's wise for hospitals to include medical device training in the procurement process. Moreover, purchasing professionals can play a key role in helping to increase the amount of user training for medical devices and systems. What steps should you take to help ensure that new medical devices are implemented safely? Here are some tips.

The potential of medical device industry in technological and economical context.

Science.gov (United States)

Maresova, Petra; Penhaker, Marek; Selamat, Ali; Kuca, Kamil

2015-01-01

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.

77 FR 14272 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-03-09

... 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... AND MICROBIOLOGY DEVICES 0 1. The authority citation for 21 CFR part 866 continues to read as follows...

Regulatory affairs for biomaterials and medical devices

CERN Document Server

Amato, Stephen F; Amato, B

2015-01-01

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

INTERFACE ELECTRONIC MEDICAL CARD ON MOBILE DEVICE

Directory of Open Access Journals (Sweden)

Y. L. Nechyporenko

2013-05-01

Full Text Available The concept designed by electronic medical card for heterogeneous environment of medical information systems at various levels. Appropriate model and technical solution. Done evaluating operating systems for mobile devices. Designed and produced by the project mobile application on Android OS as an electronic medical record on a Tablet PC Acer.

Healthcare Provider Attitudes of Safety of Intrauterine Devices in the Postpartum Period.

Science.gov (United States)

Rauh-Benoit, Lisa A; Tepper, Naomi K; Zapata, Lauren B; Whiteman, Maura K; Curtis, Kathryn M; Mandel, Michele G; Marchbanks, Polly A; Jamieson, Denise J

2017-07-01

Immediate postpartum intrauterine devices (IUDs) have been underutilized in the United States despite their known safety. Understanding how providers' attitudes contribute to underutilization is important in improving access. Our objective was to examine healthcare providers' perceptions of the safety of immediate postpartum IUDs before publication of United States contraceptive guidelines. We analyzed survey data collected from December 2009 to March 2010 from 635 office-based physicians and 1368 Title X clinic providers (overall response rate of 64.8%). Providers were asked how safe they thought copper and levonorgestrel (LNG) IUDs were in postpartum women (very safe, safe, unsafe, very unsafe, and unsure). Multivariable logistic regression was used to calculate adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs) for characteristics associated with considering immediate and delayed postpartum IUDs to be safe. Less than 40% of respondents considered immediate or delayed IUD insertion to be safe. Providers with postpartum IUD insertion to be safe compared with unsafe/unsure (aOR 0.18, 95% CI 0.04-0.84 for copper IUD and aOR 0.17, 95% CI 0.04-0.81 for LNG-IUD). Providers without training in postpartum or interval copper IUD insertion had decreased odds of considering immediate postpartum copper IUD insertion (aOR 0.40, 95% CI 0.16-0.79) and delayed postpartum insertion for both IUD types to be safe (aOR 0.34, 95% CI 0.18-0.66 for copper IUD and aOR 0.41, 95% CI 0.21-0.77 for LNG-IUD). Before United States contraceptive guidelines, a majority of providers perceived immediate postpartum IUDs to be unsafe.

Growing pains: medical device interoperability. Regulators and new standards are helping to bring about the convergence of medical devices and information management systems on IT networks.

Science.gov (United States)

Degaspari, John

2011-07-01

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.

Screening, diagnosis, and management of intrauterine growth restriction.

Science.gov (United States)

Lausman, Andrea; McCarthy, Fergus P; Walker, Melissa; Kingdom, John

2012-01-01

To provide comprehensive background knowledge relevant to the SOGC Maternal-Fetal Medicine Committee-approved guideline entitled "Intrauterine Growth Restriction: Screening, Diagnosis, and Management." Publications in English were retrieved through searches of PubMed or Medline, CINAHL, and the Cochrane Library in January 2011 using appropriate controlled vocabulary via MeSH terms (fetal growth restriction and small for gestational age) and any key words (fetal growth, restriction, growth retardation, intrauterine growth restriction [IUGR], low birth weight, small for gestational age). Results were restricted to systematic reviews, randomized controlled trials or controlled clinical trials, and high-quality prospective and retrospective observational studies. Grey (unpublished) literature was identified through searching the websites of health technology assessment and health technology assessment-related agencies, clinical practice guideline collections, clinical trial registries, and national and international medical specialty societies. Evidence obtained from at least one properly randomized controlled trial, Cochrane Reviews, and high quality cohort data have been combined to provide clinicians with evidence to optimize their practice for screening, diagnosis, and management of intrauterine growth restriction. Considerable advances have been made to improve clinicians' ability to screen, diagnose, and manage pregnancies with suspected IUGR more effectively, including several properly randomized controlled trials. Pregnancies with late-onset IUGR may be managed equally effectively by early delivery or delayed delivery (with increased surveillance) anticipating favourable outcomes. By contrast, many aspects of the management of early-onset IUGR require further clinical trials.

78 FR 18233 - Medical Devices; Technical Amendment

Science.gov (United States)

2013-03-26

... human environment. Therefore, neither an environmental assessment nor an environmental impact statement..., Confidential business information, Medical devices, Medical research, Reporting and recordkeeping requirements... revising the second sentence in paragraph (a) to read as follows: Sec. 870.3600 External pacemaker pulse...

76 FR 65200 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee: Notice of...

Science.gov (United States)

2011-10-20

... 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... Administration (FDA) is postponing the meeting of the General and Plastic Surgery Devices Panel of the Medical...

Pre-sterilization contamination of disposable medical products and the choice of minimum sterilization dose

International Nuclear Information System (INIS)

Horakova, V.; Buriankova, E.

1975-01-01

The bacterial contamination was assessed on randomly taken samples of blood-transfusion devices, donor sets, intra-uterine contraceptive devices and inserters, surgical gloves and dressing material prior to sterilization. The quantitative and qualitative efficiency of six nutrient media was compared. The best results were obtained with the enriched ''Universal'' medium. It was confirmed that the contamination of plastic products was low compared with dressing material. Most frequently, Gram-positive aerobic spore-forming rods and Gram-positive cocci were found on non-sterile medical disposable products. A method was tested to obtain a general informative picture of the resistance of bacteria on products. The methods used for choosing the dose for radiation sterilization of medical products are discussed. (author)

Prospects of radiation sterilization of medical devices

International Nuclear Information System (INIS)

Hosobuchi, Kazunari

1992-01-01

Since radiation sterilization was first introduced in the United States in 1956 in the field of disposable medical devices, it has become an indispensable technique for sterilization because of the following reasons: (1) introduction into dialyzers, (2) introduction in medical device makers, (3) development of disposable medical devices associated with developing both high molecular chemistry and cool sterilization, (4) rationality of sterilization process, and (5) problems of sterilization with ethylene oxide gas. To promote the further development of radiation sterilization, the following items are considered necessary: (1) an increase in the number of facilities for radiation sterilization, (2) recommendation of the international standardization of sterilization method, (3) decrease in radiation doses associated with sterilization, (4) development of electron accelerators and bremsstrahlung equipments for radiation sources, and (5) simplification of sterilization process management. Factors precluding the development of radiation sterilization are: (1) development of other methods than radiation sterilization, (2) development of technique for sterile products, (3) high facility cost, (4) high irradiation cost, (5) benefits and limits of sterilization markets, and (6) influences of materials. (N.K.)

Assurance Cases for Medical Devices

Science.gov (United States)

2011-04-28

the patient, and the hospital setting. Some pumps allow the patient to control part of the injection process (e.g. to inject more painkiller ...overdose, incorrect therapy, etc.   Design and development decisions that bear on safety and effectiveness http://www.fda.gov/MedicalDevices

Features of newborns with intrauterine growth restriction (according to the data of perinatal center of the Saratov region

Directory of Open Access Journals (Sweden)

Chernenkov Yu.V.

2017-03-01

Full Text Available Objective: to identify risk factors that adversely affect the development of fetus and child small for gestational age; to assess the incidence of the intrauterine development of fetus and newborn; to analyze the health indicators of these children. Material and Methods. Cases of 226 children (6.6% with diagnosed intrauterine growth restriction of the fetus were examined, including 134 of prematurity (59%. Results. The most common risk factors for the intrauterine development of the fetus were: violation of the utero-placental circulation — 196 cases, the uterine scar — 78 women, urinary tract infection — 94. Extragenital pathology was found in all women, the threat of termination of pregnancy in 109 cases, medical history of abortions in 106 women and 83 anaemia in women. Birth asphyxia was observed in 102 children (45%, prematurity in 71 cases (31.4%. Asphyxia of severe degree accounted 1 (0.5% premature and 1 (0.45% full-term baby. Asphyxia of moderate severity (4-6 points accounted 70 (30.9% preterm and 31 (13.7% full-term infants. The most common form of the intrauterine development of the fetus asymmetrical revealed 178 cases (79.1%. Conclusion: Perinatal factors such as medical abortion, urinary tract infection, extragenital pathology are preventable. The predominant form of the intrauterine development of the fetus is asymmetric form, symmetric and dysplastic revealed to a greater degree in premature infants. Children with low weight for gestational age should be adequately provided with the necessary nutrients, fortifiers, vitamins and in the process of rehabilitation — cerebropro-tective therapy.

Successful Intrauterine Pregnancy following salpingostomy; Case ...

African Journals Online (AJOL)

by salpingostomy, after which she had spontaneous abortion of the associated intrauterine pregnancy. Result: Initial marital disharmony, followed by an uneventful intrauterine pregnancy carried to term with caesarean delivery of a live female baby. Conclusion: In well-selected cases, conservative tubal surgeries should be ...

Electronic medical devices: a primer for pathologists.

Science.gov (United States)

Weitzman, James B

2003-07-01

Electronic medical devices (EMDs) with downloadable memories, such as implantable cardiac pacemakers, defibrillators, drug pumps, insulin pumps, and glucose monitors, are now an integral part of routine medical practice in the United States, and functional organ replacements, such as the artificial heart, pancreas, and retina, will most likely become commonplace in the near future. Often, EMDs end up in the hands of the pathologist as a surgical specimen or at autopsy. No established guidelines for systematic examination and reporting or comprehensive reviews of EMDs currently exist for the pathologist. To provide pathologists with a general overview of EMDs, including a brief history; epidemiology; essential technical aspects, indications, contraindications, and complications of selected devices; potential applications in pathology; relevant government regulations; and suggested examination and reporting guidelines. Articles indexed on PubMed of the National Library of Medicine, various medical and history of medicine textbooks, US Food and Drug Administration publications and product information, and specifications provided by device manufacturers. Studies were selected on the basis of relevance to the study objectives. Descriptive data were selected by the author. Suggested examination and reporting guidelines for EMDs received as surgical specimens and retrieved at autopsy. Electronic medical devices received as surgical specimens and retrieved at autopsy are increasing in number and level of sophistication. They should be systematically examined and reported, should have electronic memories downloaded when indicated, will help pathologists answer more questions with greater certainty, and should become an integral part of the formal knowledge base, research focus, training, and practice of pathology.

Wearable Devices in Medical Internet of Things: Scientific Research and Commercially Available Devices.

Science.gov (United States)

Haghi, Mostafa; Thurow, Kerstin; Stoll, Regina

2017-01-01

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.

The Style Evolution of Glasses: Acknowledging Well-being for Wearable Medical Device

Directory of Open Access Journals (Sweden)

Lydia Royeen

2015-10-01

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.

78 FR 12329 - Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft...

Science.gov (United States)

2013-02-22

... medical devices to take timely action to correct violative devices or remove them from the marketplace...] Distinguishing Medical Device Recalls From Product Enhancements; Reporting Requirements; Draft Guidance for... draft guidance entitled ``Distinguishing Medical Device Recalls From Product Enhancements; Reporting...

[Thoughts on the Witnessed Audit in Medical Device Single Audit Program].

Science.gov (United States)

Wen, Jing; Xiao, Jiangyi; Wang, Aijun

2018-02-08

Medical Device Single Audit Program is one of the key projects in International Medical Device Regulators Forum, which has much experience to be used for reference. This paper briefly describes the procedures and contents of the Witnessed Audit in Medical Device Single Audit Program. Some revelations about the work of Witnessed Audit have been discussed, for reference by the Regulatory Authorities and the Auditing Organizations.

Medical device development: managing conflicts of interest encountered by physicians.

Science.gov (United States)

Baim, Donald S; Donovan, Aine; Smith, John J; Briefs, Nancy; Geoffrion, Richard; Feigal, David; Kaplan, Aaron V

2007-04-01

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

75 FR 68200 - Medical Devices; Radiology Devices; Reclassification of Full-Field Digital Mammography System

Science.gov (United States)

2010-11-05

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 892 [Docket No. FDA-2008-N-0273] Medical Devices; Radiology Devices; Reclassification of Full- Field Digital... and Drugs, 21 CFR part 892 is amended as follows: PART 892--RADIOLOGY DEVICES 0 1. The authority...

Identification of Bodies by Unique Serial Numbers on Implanted Medical Devices.

Science.gov (United States)

Blessing, Melissa M; Lin, Peter T

2018-05-01

Visual identification is the most common identification method used by medical examiners but is not always possible. Alternative methods include X-ray, fingerprint, or DNA comparison, but these methods require additional resources. Comparison of serial numbers on implanted medical devices is a rapid and definitive method of identification. To assess the practicality of using this method, we reviewed 608 consecutive forensic autopsies performed at a regional medical examiner office. Of these, 56 cases required an alternative method of identification due to decomposition (n = 35), gunshot wound (n = 9), blunt trauma (n = 6), or charring (n = 6). Of these 56 cases, eight (14.3%) were known to have an implanted medical device. Of these eight cases, five (63%) could be positively identified by comparing serial numbers. If an implanted medical device is known to be present, and medical records are available, identification by medical device serial number should be a first-line method. © 2017 American Academy of Forensic Sciences.

MEDIC: medical embedded device for individualized care.

Science.gov (United States)

Wu, Winston H; Bui, Alex A T; Batalin, Maxim A; Au, Lawrence K; Binney, Jonathan D; Kaiser, William J

2008-02-01

Presented work highlights the development and initial validation of a medical embedded device for individualized care (MEDIC), which is based on a novel software architecture, enabling sensor management and disease prediction capabilities, and commercially available microelectronic components, sensors and conventional personal digital assistant (PDA) (or a cell phone). In this paper, we present a general architecture for a wearable sensor system that can be customized to an individual patient's needs. This architecture is based on embedded artificial intelligence that permits autonomous operation, sensor management and inference, and may be applied to a general purpose wearable medical diagnostics. A prototype of the system has been developed based on a standard PDA and wireless sensor nodes equipped with commercially available Bluetooth radio components, permitting real-time streaming of high-bandwidth data from various physiological and contextual sensors. We also present the results of abnormal gait diagnosis using the complete system from our evaluation, and illustrate how the wearable system and its operation can be remotely configured and managed by either enterprise systems or medical personnel at centralized locations. By using commercially available hardware components and software architecture presented in this paper, the MEDIC system can be rapidly configured, providing medical researchers with broadband sensor data from remote patients and platform access to best adapt operation for diagnostic operation objectives.

Medical applications for pharmacists using mobile devices.

Science.gov (United States)

Aungst, Timothy Dy

2013-01-01

Mobile devices (eg, smartphones, tablet computers) have become ubiquitous and subsequently there has been a growth in mobile applications (apps). Concurrently, mobile devices have been integrated into health care practice due to the availability and quality of medical apps. These mobile medical apps offer increased access to clinical references and point-of-care tools. However, there has been little identification of mobile medical apps suitable for the practice of pharmacy. To address the shortage of recommendations of mobile medical apps for pharmacists in daily practice. Mobile medical apps were identified via the iTunes and Google Play Stores via the "Medical" app categories and key word searches (eg, drug information, medical calculators). In addition, reviews provided by professional mobile medical app review websites were used to identify apps. Mobile medical apps were included if they had been updated in the previous 3 months, were available in the US, used evidence-based information or literature support, had dedicated app support, and demonstrated stability. Exclusion criteria included apps that were not available in English, had advertisement bias, used nonreferenced sources, were available only via an institution-only subscription, and were web-based portals. Twenty-seven mobile apps were identified and reviewed that involved general pharmacy practice, including apps that involved drug references, clinical references, medical calculators, laboratory references, news and continuing medical education, and productivity. Mobile medical apps have a variety of features that are beneficial to pharmacy practice. Individual clinicians should consider several characteristics of these apps to determine which are suitable to incorporate into their daily practice.

Developing medical device software in compliance with regulations.

Science.gov (United States)

Zema, M; Rosati, S; Gioia, V; Knaflitz, M; Balestra, G

2015-08-01

In the last decade, the use of information technology (IT) in healthcare has taken a growing role. In fact, the adoption of an increasing number of computer tools has led to several benefits related to the process of patient care and allowed easier access to social and health care resources. At the same time this trend gave rise to new challenges related to the implementation of these new technologies. Software used in healthcare can be classified as medical devices depending on the way they are used and on their functional characteristics. If they are classified as medical devices they must satisfy specific regulations. The aim of this work is to present a software development framework that can allow the production of safe and high quality medical device software and to highlight the correspondence between each software development phase and the appropriate standard and/or regulation.

21 CFR 801.122 - Medical devices for processing, repacking, or manufacturing.

Science.gov (United States)

2010-04-01

....122 Medical devices for processing, repacking, or manufacturing. A device intended for processing... act if its label bears the statement “Caution: For manufacturing, processing, or repacking”. ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices for processing, repacking, or...

Handheld Diagnostic Device Delivers Quick Medical Readings

Science.gov (United States)

2014-01-01

To monitor astronauts' health remotely, Glenn Research Center awarded SBIR funding to Cambridge, Massachusetts-based DNA Medical Institute, which developed a device capable of analyzing blood cell counts and a variety of medical biomarkers. The technology will prove especially useful in rural areas without easy access to labs.

The intrauterine device as emergency contraception: how much do young women know?

Science.gov (United States)

Goodman, Suzan R; El Ayadi, Alison M; Rocca, Corinne H; Kohn, Julia E; Benedict, Courtney E; Dieseldorff, Jessica R; Harper, Cynthia C

2018-04-18

Unprotected intercourse is common, especially among teens and young women. Access to intrauterine device (IUD) as emergency contraception (EC) can help interested patients more effectively prevent unintended pregnancy and can also offer ongoing contraception. This study evaluated young women's awareness of IUD as EC and interest in case of need. We conducted a secondary analysis of data from young women aged 18-25 years, not desiring pregnancy within 12 months, and receiving contraceptive counseling within a cluster-randomized trial in 40 US Planned Parenthood health centers in 2011-2013 (n=1500). Heath centers were randomized to receive enhanced training on contraceptive counseling and IUD placement, or to provide standard care. The intervention did not focus specifically on IUD as EC. We assessed awareness of IUD as EC, desire to learn more about EC and most trusted source of information of EC among women in both intervention and control groups completing baseline and 3- or 6-month follow-up questionnaires (n=1138). At follow-up, very few young women overall (7.5%) visiting health centers had heard of IUD as EC. However, if they needed EC, most (68%) reported that they would want to learn about IUDs in addition to EC pills, especially those who would be very unhappy to become pregnant (adjusted odds ratio [aOR], 1.3; 95% confidence interval, 1.0-1.6, pContraceptive education should explicitly address IUD as EC. Few young women know that the IUD can be used for EC or about its effectiveness. However, if they needed EC, most reported that they would want to learn about IUDs in addition to EC pills, especially those very unhappy to become pregnant. Contraceptive education should explicitly address IUD as EC. Copyright © 2018 Elsevier Inc. All rights reserved.

Medical device problem reporting for the betterment of healthcare.

Science.gov (United States)

1998-08-01

Given that there are nearly 5,000 individual classes of medical devices, tens of thousands of medical device suppliers, and millions of healthcare providers around the world, device-related problems are bound to happen. But effective problem reporting can help reduce or eliminate many of these problems--not only within an institution, but also potentially around the world. In this article, we trace the problem reporting process from its beginnings in the hospital to its global impact in making critical information available throughout the healthcare community.

One-year continuation of copper or levonorgestrel intrauterine devices initiated at the time of emergency contraception.

Science.gov (United States)

Sanders, J N; Turok, D K; Royer, P A; Thompson, I S; Gawron, L M; Storck, K E

2017-08-01

This study compares 1-year intrauterine device (IUD) continuation among women presenting for emergency contraception (EC) and initiating the copper (Cu T380A) IUD or the levonorgestrel (LNG) 52 mg IUD plus 1.5 mg oral LNG. This cohort study enrolled 188 women who presented at a single family planning clinic in Utah between June 2013 and September 2014 and selected either the Cu T380A IUD or LNG 52 mg IUD plus oral LNG for EC. Trained personnel followed participants by phone, text or e-mail for 12 months or until discontinuation occurred. We assessed reasons for discontinuation and used Cox proportional hazard models, Kaplan-Meier estimates and log-rank tests to assess differences in continuation rates between IUDs. One hundred seventy-six women received IUDs; 66 (37%) chose the Cu T380A IUD and 110 (63%) chose the LNG 52 mg IUD plus oral LNG. At 1 year, we accounted for 147 (84%) participants, 33 (22%) had requested removals, 13 (9%) had an expulsion and declined reinsertion, 3 (2%) had a pregnancy with their IUD in place and 98 (67%) were still using their device. Continuation rates did not differ by IUD type; 60% of Cu T380A IUD users and 70% of LNG 52 mg IUD plus oral LNG users were still using their device at 12 months (adjusted hazard ratio 0.72, 95% confidence interval 0.40-1.3). Two-thirds of women who chose IUD placement at the EC clinical encounter continued use at 1 year. Women initiating Cu T380A IUD and LNG 52 mg IUD had similar 1-year continuation rates. These findings support same-day insertion of IUDs for women who are seeking EC and would like to use a highly effective reversible method going forward. Providing IUD options for EC users presents an opportunity to increase availability of highly effective contraception. Copyright © 2017. Published by Elsevier Inc.

Home Healthcare Medical Devices: A Checklist

Science.gov (United States)

... not using it. Contact your doctor and home healthcare team often to review your health condition. * Check ... assurance of their safety and effectiveness. A home healthcare medical device is any product or equipment used ...

Radiation sterilization of medical devices

International Nuclear Information System (INIS)

Kaluska, I.; Stuglik, Z.

1996-01-01

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

77 FR 19534 - Medical Devices; Immunology and Microbiology Devices; Classification of Norovirus Serological...

Science.gov (United States)

2012-04-02

... 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...

Magnetic Field Interactions of Copper-Containing Intrauterine Devices in 3.0-Tesla Magnetic Resonance Imaging: In Vivo Study

Energy Technology Data Exchange (ETDEWEB)

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)

2013-07-01

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.

Magnetic Field Interactions of Copper-Containing Intrauterine Devices in 3.0-Tesla Magnetic Resonance Imaging: In Vivo Study

International Nuclear Information System (INIS)

Berger-Kulemann, Vanessa; Einspieler, Henrik; Hachemian, Nilouparak; Prayer, Daniela; Trattnig, Siegfried; Weber, Michael; Ba-Ssalamah, Ahmed

2013-01-01

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

Attitudes towards and knowledge about intrauterine contraceptive devices among women in the reproductive age group in a resourceconstrained setting

Directory of Open Access Journals (Sweden)

Pierre Monji Builu

2015-01-01

Full Text Available 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. To explore knowledge about the IUCD among women using the public health sector and identify any misconceptions.Methods. A sample of 150 women attending antenatal/postnatal clinics were interviewed using a structured questionnaire.Results. Forty-six percent (n=69 had some experience with the injectable form of contraception, and 2.7% (n=4 had used the IUCD; 70.7% (n=106 knew that the device does not prevent HIV transmission, 40.7% (n=61 knew that HIV-positive women can use the IUCD, 75.3% (n=113 believed that the IUCD causes heavy bleeding, 36.7% (n=55 knew that the device does not stop fertility indefinitely, 33.3% (n=50 knew that the IUCD can be inserted in the immediate postpartum period, and 26.7% (n=40 knew that the duration of use is 10 years. In terms of attitudes, 40.0% (n=60 expressed concern about the pain during insertion, 33.3% (n=50 believed the IUCD can cause cancer, and 32.0% (n=48 believed that the device interferes with normal sexual activities. Most participants 77.3% (n=116 acquired the information they had about the IUCD from the clinic during teaching and counselling sessions.Conclusion. This survey documented poor knowledge about the IUCD among women using the public health sector. However, the fact that there are few misconceptions and that clients rely on the clinic information should be seen as an opportunity to improve the situation. 

BIOANALYTICAL STANDARDIZING FOR SEROLOGICAL DIAGNOSTIC MEDICAL DEVICES

Directory of Open Access Journals (Sweden)

A. Yu. Galkin

2015-04-01

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.

Liability for damage caused by shortage and failure to use necessary medical devices

Directory of Open Access Journals (Sweden)

Cvetković Mihajlo

2014-01-01

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.

Evaluation of quality of life and sexual functioning of women using levonorgestrel-releasing intrauterine contraceptive system--Mirena.

Science.gov (United States)

Skrzypulec, Violetta; Drosdzol, Agnieszka

2008-12-01

The advantages ensuing from the high contraceptive efficacy, positive effect on the parameters of the menstrual cycle as well as other values of the levonorgestrel-releasing intrauterine system may play an important role in women's sexual life. The aim of the study was to evaluate the effect of the levonorgestrel-releasing intrauterine system on the quality of life and sexual functioning of women. The research encompassed 200 women aged between 30 and 45. 52 women using the levonorgestrel-releasing intrauterine system were qualified to the study as the research group (Mirena Group). The control groups consisted of 48 women using a different type of intrauterine device (Control Group I--Other IUD) and 50 women using no contraception (Control Group II). A specific questionnaire with a general part concerning socio-demographic conditions, a part dealing with contraception and Polish version of self-evaluation inventories: Short Form-36 Health Survey, Female Sexual Function Index and Mell-Krat Scale was used as a research tool. Quality of life parameters for women using the Mirena system were higher than for the control groups, especially in the aspect of general health, energy/fatigue and emotional well-being. A significant beneficial effect of the levonorgestrel-releasing intrauterine system on sexual functioning (sexual desire and arousal) was also revealed in the study. Sexual dysfunctions were diagnosed in 20.8% of Other IUD, 34.7% of Control Group II and 9.6% of Mirena Group. Levonorgestrel-releasing intrauterine system increases female quality of life and sexual functioning parameters.

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2017-10-01

Award Number: W81XWH-09-1-0705 TITLE: “Medical Device Plug-and-Play Interoperability Standards and Technology Leadership” PRINCIPAL INVESTIGATOR...Sept 2016 – 20 Sept 2017 4. TITLE AND SUBTITLE “Medical Device Plug-and-Play Interoperability 5a. CONTRACT NUMBER Standards and Technology ...efficiency through interoperable medical technologies . We played a leadership role on interoperability safety standards (AAMI, AAMI/UL Joint

Transmitting patient and device data via GSM--central management for decentral mobile medical devices.

Science.gov (United States)

Bachmor, T; Schöchlin, J; Bolz, A

2002-01-01

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.

Medical device integration: CIOs must bridge the digital divide between devices and electronic medical records.

Science.gov (United States)

Raths, David

2009-02-01

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.

Cybersecurity and medical devices: A practical guide for cardiac electrophysiologists

Science.gov (United States)

Kramer, Daniel B.; Foo Kune, Denis; Auto de Medeiros, Julio; Yan, Chen; Xu, Wenyuan; Crawford, Thomas; Fu, Kevin

2017-01-01

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

Cardiovascular adaptation to extrauterine life after intrauterine growth restriction.

Science.gov (United States)

Rodriguez-Guerineau, Luciana; Perez-Cruz, Miriam; Gomez Roig, María D; Cambra, Francisco J; Carretero, Juan; Prada, Fredy; Gómez, Olga; Crispi, Fátima; Bartrons, Joaquim

2018-02-01

Introduction The adaptive changes of the foetal heart in intrauterine growth restriction can persist postnatally. Data regarding its consequences for early circulatory adaptation to extrauterine life are scarce. The aim of this study was to assess cardiac morphometry and function in newborns with late-onset intrauterine growth restriction to test the hypothesis that intrauterine growth restriction causes cardiac shape and functional changes at birth. A comprehensive echocardiographic study was performed in 25 neonates with intrauterine growth restriction and 25 adequate-for-gestational-age neonates. Compared with controls, neonates with intrauterine growth restriction had more globular ventricles, lower longitudinal tricuspid annular motion, and higher left stroke volume without differences in the heart rate. Neonates with intrauterine growth restriction also showed subclinical signs of diastolic dysfunction in the tissue Doppler imaging with lower values of early (e') diastolic annular peak velocities in the septal annulus. Finally, the Tei index in the tricuspid annulus was higher in the intrauterine growth restriction group. Neonates with history of intrauterine growth restriction showed cardiac remodelling and signs of systolic and diastolic dysfunction. Overall, there was a significant tendency to worse cardiac function results in the right heart. The adaptation to extrauterine life occurred with more globular hearts, higher stroke volumes but a similar heart rate compared to adequate-for-gestational-age neonates.

Routine counseling about intrauterine contraception for women seeking emergency contraception.

Science.gov (United States)

Schwarz, E Bimla; Papic, Melissa; Parisi, Sara M; Baldauf, Erin; Rapkin, Rachel; Updike, Glenn

2014-07-01

To compare contraceptive knowledge and use among women seeking emergency contraception (EC) before and after an inner-city clinic began providing structured counseling and offering same-day intrauterine device (IUD) or implant placement to all women seeking EC. For 8 months before and 21 months after this change in clinic policy, women aged 15-45 who wanted to avoid pregnancy for at least 6 months were asked to complete surveys immediately, 3 and 12 months after their clinic visit. In addition, we abstracted electronic medical record (EMR) data on all women who sought EC (n=328) during this period. We used chi-squared tests to assess pre/post differences in survey and EMR data. Surveys were completed by 186 women. After the clinic began offering structured counseling, more women had accurate knowledge of the effectiveness of IUDs, immediately and 3 months after their clinic visit. In addition, more women initiated IUD or implant use (survey: 40% vs. 17% preintervention, p=0.04; EMR: 22% vs. 10% preintervention, p=0.01), and fewer had no contraceptive use (survey: 3% vs. 17% preintervention, pcontraceptives with the option of same-day contraceptive placement. Copyright © 2014 Elsevier Inc. All rights reserved.

Medical device registration, agreements on mutual recognition - a step forward to global harmonization?

International Nuclear Information System (INIS)

Eidenberger, R.Reiner

2000-01-01

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)

The potential of medical device industry in technological and economical context

Directory of Open Access Journals (Sweden)

Maresova P

2015-10-01

Full Text Available Petra Maresova,1 Marek Penhaker,1,2 Ali Selamat,1,3 Kamil Kuca1,41Faculty of Informatics and Management, University of Hradec Králové, Hradec Králové, Czech Republic; 2Department of Cybernetics and Biomedical Engineering, Faculty of Electrical Engineering and Computer Science, Technical University of Ostrava, Poruba, Czech Republic; 3Faculty of Computing, Universiti Teknologi Malaysia, Johor Bahru, Johor, Malaysia; 4Center for Biomedical Research, University Hospital Hradec Králové, Hradec Králové, Czech RepublicAbstract: 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.Keywords: technology context, medical device, Europe, expenditure, review

77 FR 4252 - Additional Spectrum for the Medical Device Radiocommunication Service

Science.gov (United States)

2012-01-27

... licensed users in these frequency bands to continue providing service. Medical Micro-Power Networks (MMNs...). Under this approach, medical devices would operate in the band on a shared, non-exclusive basis with...Radio Service rules for devices operating in the 413-457 MHz band. These definitions were for a Medical...

Optical tests for using smartphones inside medical devices

Science.gov (United States)

Bernat, Amir S.; Acobas, Jennifer K.; Phang, Ye Shang; Hassan, David; Bolton, Frank J.; Levitz, David

2018-02-01

Smartphones are currently used in many medical applications and are more frequently being integrated into medical imaging devices. The regulatory requirements in existence today however, particularly the standardization of smartphone imaging through validation and verification testing, only partially cover imaging characteristics with a smartphone. Specifically, it has been shown that smartphone camera specifications are of sufficient quality for medical imaging, and there are devices which comply with the FDA's regulatory requirements for a medical device such as a device's field of view, direction of viewing and optical resolution and optical distortion. However, these regulatory requirements do not call specifically for color testing. Images of the same object using automatic settings or different light sources can show different color composition. Experimental results showing such differences are presented. Under some circumstances, such differences in color composition could potentially lead to incorrect diagnoses. It is therefore critical to control the smartphone camera and illumination parameters properly. This paper examines different smartphone camera settings that affect image quality and color composition. To test and select the correct settings, a test methodology is proposed. It aims at evaluating and testing image color correctness and white balance settings for mobile phones and LED light sources. Emphasis is placed on color consistency and deviation from gray values, specifically by evaluating the ΔC values based on the CIEL*a*b* color space. Results show that such standardization minimizes differences in color composition and thus could reduce the risk of a wrong diagnosis.

Laser direct writing of micro- and nano-scale medical devices

Science.gov (United States)

Gittard, Shaun D; Narayan, Roger J

2010-01-01

Laser-based direct writing of materials has undergone significant development in recent years. The ability to modify a variety of materials at small length scales and using short production times provides laser direct writing with unique capabilities for fabrication of medical devices. In many laser-based rapid prototyping methods, microscale and submicroscale structuring of materials is controlled by computer-generated models. Various laser-based direct write methods, including selective laser sintering/melting, laser machining, matrix-assisted pulsed-laser evaporation direct write, stereolithography and two-photon polymerization, are described. Their use in fabrication of microstructured and nanostructured medical devices is discussed. Laser direct writing may be used for processing a wide variety of advanced medical devices, including patient-specific prostheses, drug delivery devices, biosensors, stents and tissue-engineering scaffolds. PMID:20420557

Open-source hardware for medical devices.

Science.gov (United States)

Niezen, Gerrit; Eslambolchilar, Parisa; Thimbleby, Harold

2016-04-01

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.

Consequences in Infants That Were Intrauterine Growth Restricted

Directory of Open Access Journals (Sweden)

Erich Cosmi

2011-01-01

Full Text Available Intrauterine growth restriction is a condition fetus does not reach its growth potential and associated with perinatal mobility and mortality. Intrauterine growth restriction is caused by placental insufficiency, which determines cardiovascular abnormalities in the fetus. This condition, moreover, should prompt intensive antenatal surveillance of the fetus as well as follow-up of infants that had intrauterine growth restriction as short and long-term sequele should be considered.

Evaluating and Predicting Patient Safety for Medical Devices With Integral Information Technology

Science.gov (United States)

2005-01-01

323 Evaluating and Predicting Patient Safety for Medical Devices with Integral Information Technology Jiajie Zhang, Vimla L. Patel, Todd R...errors are due to inappropriate designs for user interactions, rather than mechanical failures. Evaluating and predicting patient safety in medical ...the users on the identified trouble spots in the devices. We developed two methods for evaluating and predicting patient safety in medical devices

Modelling degradation of bioresorbable polymeric medical devices

CERN Document Server

Pan, J

2015-01-01

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.

77 FR 8260 - Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device...

Science.gov (United States)

2012-02-14

... will be used to evaluate risks associated with medical devices which will enable FDA to take...] Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Device Reporting... comment in response to the notice. This notice solicits comments on medical device reporting (MDR...

Intrauterine temperature during intrapartum amnioinfusion: a prospective observational study.

Science.gov (United States)

Tomlinson, T M; Schaecher, C; Sadovsky, Y; Gross, G

2012-07-01

To determine the influence of routine intrapartum amnioinfusion (AI) on intrauterine temperature. Prospective observational study. Maternity unit, Barnes Jewish Hospital, St Louis, MO, USA. Forty women with singleton gestations and an indication for intrapartum intrauterine pressure catheter placement. Using a temperature probe, we digitally recorded intrauterine temperature every 10 minutes during labour. Amnioinfusion was administered according to a standard protocol using saline equilibrated to the ambient temperature. Mean intrauterine temperature during labour. Participants were monitored for a mean of 280 minutes (range 20-820). A total of 164 intrauterine temperature readings in the AI cohort were compared with 797 control measurements. When compared with controls, we observed a lower intrauterine temperature in the AI cohort (36.4 versus 37.4°C, P<0.01). More measurements in the AI cohort were recorded in the presence of intrapartum fever (40% versus 30%). A subgroup analysis of measurements recorded in afebrile parturients revealed an even greater effect of AI (1.5°C decrease, 37.3 versus 35.8°C, P<0.01). Routine intrapartum AI using saline equilibrated to a mean ambient temperature of 25.0°C reduces intrauterine temperature and may thereby affect fetal core temperature. © 2012 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2012 RCOG.

Use-related risk analysis for medical devices based on improved FMEA.

Science.gov (United States)

Liu, Long; Shuai, Ma; Wang, Zhu; Li, Ping

2012-01-01

In order to effectively analyze and control use-related risk of medical devices, quantitative methodologies must be applied. Failure Mode and Effects Analysis (FMEA) is a proactive technique for error detection and risk reduction. In this article, an improved FMEA based on Fuzzy Mathematics and Grey Relational Theory is developed to better carry out user-related risk analysis for medical devices. As an example, the analysis process using this improved FMEA method for a certain medical device (C-arm X-ray machine) is described.

Home Use Devices: How to Prepare for and Handle Power Outages for Medical Devices That Require Electricity

Science.gov (United States)

... to Create a Personal Emergency File My personal emergency file contains: □ Instructions for using the medical device and all device manuals. □ First aid kit □ Medical records □ Insurance cards □ Current home care doctor’s orders □ Plan of treatment □ What a family ...

Extended device profiles and testing procedures for the approval process of integrated medical devices using the IEEE 11073 communication standard.

Science.gov (United States)

Janß, Armin; Thorn, Johannes; Schmitz, Malte; Mildner, Alexander; Dell'Anna-Pudlik, Jasmin; Leucker, Martin; Radermacher, Klaus

2018-02-23

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.

Strategies in intrauterine growth restriction at term

NARCIS (Netherlands)

Boers, Kim Esther

2012-01-01

To establish consensus and to collect evidence on the best management policy in intrauterine growth restriction (IUGR) at term, the DIGITAT-trial (Disproportionate Intrauterine Growth Intervention Trial At Term) was designed. The aim of the DIGITAT study was to compare the effect of induction of

The copper intrauterine device for emergency contraception: an opportunity to provide the optimal emergency contraception method and transition to highly effective contraception.

Science.gov (United States)

Dermish, Amna I; Turok, David K

2013-07-01

Worldwide, 40% of all pregnancies are unintended. Widespread, over-the-counter availability of oral emergency contraception (EC) has not reduced unintended pregnancy rates. The EC visit presents an opportunity to initiate a highly effective method of contraception in a population at high risk of unintended pregnancy who are actively seeking to avoid pregnancy. The copper intrauterine device (IUD), the most effective method of EC, continues to provide contraception as effective as sterilization for up to 12 years, and it should be offered as the first-line method of EC wherever possible. Increased demand for and supply of the copper IUD for EC may have an important role in reducing rates of unintended pregnancy. The EC visit should include access to the copper IUD as optimal care but should ideally include access to all highly effective methods of contraception.

76 FR 22322 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-04-21

... 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...

Just a piece of equipment? The importance of medical device education.

Science.gov (United States)

Brand, Darren

2012-12-01

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.

Contraception in women with medical problems

Science.gov (United States)

Dhanjal, Mandish K

2008-01-01

Women with medical disease have a higher incidence of maternal mortality compared with healthy women, with cardiac disease now being the most common cause of maternal death in the UK. A handful of medical conditions exist where pregnancy is not recommended due to mortality rates approaching 50%. It is imperative that such women have the most reliable methods of contraception available. Contraceptive agents may themselves affect medical disease, or may interact with medications used by such women. There may be a range of contraceptive agents suitable for each medical condition. The contraceptive selected should be tailored to suit the individual. The following points should be considered when deciding on the most appropriate contraceptive agent: efficacy, thrombotic risk (oestrogen containing contraceptives), arterial risks (oestrogen containing contraceptives), infective risk (e.g. insertion of intrauterine device [IUD]), vagal stimulation (e.g. insertion of IUD, ESSURE®), bleeding risks with patients on anticoagulants, interaction with concomitant drugs, effects of anaesthesia and ease of use. This review aims to cover the different contraceptive agents available and the best ones to use for certain medical illnesses. PMID:27582790

Intrauterine neuromuscular blockade in fetus.

Science.gov (United States)

Fan, S Z; Huang, F Y; Lin, S Y; Wang, Y P; Hsieh, F J

1990-03-01

Antenatal intrauterine fetal therapy has now become the target of numerous invasive diagnostic and therapeutic maneuvers. Fetal motion during intrauterine fetal therapy not only makes these procedures technically more difficult but also increases the likelihood of trauma to the umbilical vessels and the fetus. Combination of high doses of sedatives, tranquilizers, and narcotics rarely results in adequate suppression of fetal movement. Such medication puts the mother at risk of respiratory depression, regurgitation and aspiration. The use of pancuronium or atracurium to temporarily arrest fetal movement in ten fetus is reported. After an initial ultrasound assessment of fetal lie, placental location, and umbilical cord insertion site, the fetal weight was calculated by the ultrasound parameters of biparietal diameter and abdominal circumference. Under ultrasound guidance, we injected pancuronium 0.15 mg/kg or atracurium 1.0 mg/kg using a 23-gauge spinal needle into the fetal gluteal muscle. Short-term paralysis of the fetus was induced in all cases. Fetal movement stopped by sonographic observation within 5.8 +/- 2.3 min in the pancuronium group and 4.7 +/- 1.8 min in the atracurium group. Fetal movements returned both to maternal sensation or ultrasonic observation by 92 +/- 23 min in the first group and 36 +/- 11 min in the second group. No adverse effect of the relaxant has been observed in any of the mothers. There was no evidence of local soft tissue, nerve or muscle damage at the site of injection on initial examination of the neonates after delivery. The use of neuromuscular relaxant in fetus was a safe and useful method.

Accuracy of information about the intrauterine device on the Internet.

Science.gov (United States)

Madden, Tessa; Cortez, Sarah; Kuzemchak, Marie; Kaphingst, Kimberly A; Politi, Mary C

2016-04-01

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

New IEEE 11073 Standards for interoperable, networked Point-of-Care Medical Devices.

Science.gov (United States)

Kasparick, Martin; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2015-08-01

Surgical procedures become more and more complex and the number of medical devices in an operating room (OR) increases continuously. Today's vendor-dependent solutions for integrated ORs are not able to handle this complexity. They can only form isolated solutions. Furthermore, high costs are a result of vendor-dependent approaches. Thus we present a service-oriented device communication for distributed medical systems that enables the integration and interconnection between medical devices among each other and to (medical) information systems, including plug-and-play functionality. This system will improve patient's safety by making technical complexity of a comprehensive integration manageable. It will be available as open standards that are part of the IEEE 11073 family of standards. The solution consists of a service-oriented communication technology, the so called Medical Devices Profile for Web Services (MDPWS), a Domain Information & Service Model, and a binding between the first two mechanisms. A proof of this concept has been done with demonstrators of real world OR devices.

Protecting computer-based medical devices: defending against viruses and other threats.

Science.gov (United States)

2005-07-01

The increasing integration of computer hardware has exposed medical devices to greater risks than ever before. More and more devices rely on commercial off-the-shelf software and operating systems, which are vulnerable to the increasing proliferation of viruses and other malicious programs that target computers. Therefore, it is necessary for hospitals to take steps such as those outlined in this article to ensure that their computer-based devices are made safe and continue to remain safe in the future. Maintaining the security of medical devices requires planning, careful execution, and a commitment of resources. A team should be created to develop a process for surveying the security status of all computerized devices in the hospital and making sure that patches and other updates are applied as needed. These patches and updates should be approved by the medical system supplier before being implemented. The team should consider using virtual local area networks to isolate susceptible devices on the hospital's network. All security measures should be carefully documented, and the documentation should be kept up-to-date. Above all, care must be taken to ensure that medical device security involves a collaborative, supportive partnership between the hospital's information technology staff and biomedical engineering personnel.

Prevalence of genital tract infection with Entamoeba gingivalis among copper T 380A intrauterine device users in Egypt.

Science.gov (United States)

Foda, Ashraf A; El-Malky, Mohamed M

2012-01-01

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.

Provision of intrauterine contraception in association with first trimester induced abortion reduces the need of repeat abortion: first-year results of a randomized controlled trial.

Science.gov (United States)

Pohjoranta, Elina; Mentula, Maarit; Gissler, Mika; Suhonen, Satu; Heikinheimo, Oskari

2015-11-01

Can the need of subsequent abortion be reduced by providing intrauterine contraception as a part of the abortion service? Provision of intrauterine devices (IUDs) in association with first trimester abortion more than halved the incidence of repeat abortion during the first year of follow-up. Following abortion, the incidence of subsequent abortion is high, up to 30-40%. In cohort studies, intrauterine contraception has reduced the need of repeat abortion by 60-70%. A randomized controlled trial. The main outcome measure was the incidence of subsequent induced abortions during the follow-up. Altogether 751 women seeking first trimester induced abortion were recruited and randomized into two groups. Randomization was accomplished by computer-assisted permuted-block randomization with random block sizes of four to six. The investigators did not participate in randomization, which was done before commencing the study. The participants were recruited between 18 October 2010 and 21 January 2013. The inclusion criteria were age ≥18 years, duration of pregnancy ≤12 weeks, accepting intrauterine contraception, residence in Helsinki and signing the informed consent form. Women with contraindications to intrauterine contraception, such as uterine anomaly, acute genital infection or pap-smear change requiring surgical treatment were ineligible to participate.This study was conducted in collaboration between the Department of Obstetrics and Gynaecology, University of Helsinki and Helsinki University Hospital, and Centralized family planning of the City of Helsinki.The intervention group (n = 375) was provided with intrauterine contraception (either the levonorgestrel-releasing intrauterine system or copper-releasing intrauterine device) immediately following surgical abortion (18.1%) or at a follow-up 2-4 weeks after medical abortion (81.9%). Women in the control group were prescribed oral contraceptives and advised to contact their primary healthcare unit for a follow

21 CFR 892.2010 - Medical image storage device.

Science.gov (United States)

2010-04-01

... 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...

[Impact of an automated dispensing system for medical devices in cardiac surgery department].

Science.gov (United States)

Clou, E; Dompnier, M; Kably, B; Leplay, C; Poupon, E; Archer, V; Paul, M

2018-01-01

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved.

[Regulatory Program for Medical Devices in Cuba: experiences and current challenges].

Science.gov (United States)

Pereira, Dulce María Martínez; Rodríguez, Yadira Álvarez; Valdés, Yamila Cedeño; Ribas, Silvia Delgado

2016-05-01

Regulatory control of medical devices in Cuba is conducted through a system based on the Regulatory Program for Medical Devices as a way to ensure the safety, efficacy, and effectiveness of these technologies, which are in use by the National Health System. This program was launched in 1992, when the Regulations for State Evaluation and Registration of Medical Devices were approved. Its successive stages and the merging of regulatory activities for drugs and medical equipment have meant progress toward stronger, more transparent strategies and greater control of industry and the National Health System. Throughout its course the Cuban program has met with challenges and difficulties that it has addressed by drawing on its own experiences. During the new period, the greatest challenges revolve around ensuring that regulatory systems incorporate scientific evaluation, risk levels, maximum rigor through the use of technical standards, and the implementation of international recommendations, together with the application of the ISO 13485 certification scheme, enhanced market monitoring, and classification of medical devices in accordance with their relevance to the country's national health policies. From the regional standpoint, the greatest challenge lies in working toward regulatory convergence. The Collaborating Centre for the Regulation of Health Technologies will support the proposed regulatory strategy and established regional priorities, in particular in connection with the implementation of actions involving medical devices.

76 FR 16292 - Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian Adnexal Mass...

Science.gov (United States)

2011-03-23

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 866 [Docket No. FDA-2011-N-0026] Medical Devices; Immunology and Microbiology Devices; Classification of Ovarian... of Food and Drugs, 21 CFR part 866 is amended as follows: PART 866--IMMUNOLOGY AND MICROBIOLOGY...

Safety evaluation in the development of medical devices and combination products

CERN Document Server

Gad, Shayne C

2008-01-01

Capturing the growth of the global medical device market in recent years, this practical new guide is essential for all who are responsible for ensuring safety in the use and manufacture of medical devices. It has been extensively updated to reflect significant advances, incorporating combination products and helpful case examples of current real-life problems in the field.The Third Edition explores these key current trends:global device marketscontinually advancing technologythe increasing harmonization of device safety regulation worldwideEach aspect of safety evaluation is considered in ter

Inhaled medication for asthma management: evaluation of how asthma patients, medical students, and doctors use the different devices

Directory of Open Access Journals (Sweden)

Muniz Janaína Barbosa

2003-01-01

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.

Methodological considerations in observational comparative effectiveness research for implantable medical devices: an epidemiologic perspective.

Science.gov (United States)

Jalbert, Jessica J; Ritchey, Mary Elizabeth; Mi, Xiaojuan; Chen, Chih-Ying; Hammill, Bradley G; Curtis, Lesley H; Setoguchi, Soko

2014-11-01

Medical devices play a vital role in diagnosing, treating, and preventing diseases and are an integral part of the health-care system. Many devices, including implantable medical devices, enter the market through a regulatory pathway that was not designed to assure safety and effectiveness. Several recent studies and high-profile device recalls have demonstrated the need for well-designed, valid postmarketing studies of medical devices. Medical device epidemiology is a relatively new field compared with pharmacoepidemiology, which for decades has been developed to assess the safety and effectiveness of medications. Many methodological considerations in pharmacoepidemiology apply to medical device epidemiology. Fundamental differences in mechanisms of action and use and in how exposure data are captured mean that comparative effectiveness studies of medical devices often necessitate additional and different considerations. In this paper, we discuss some of the most salient issues encountered in conducting comparative effectiveness research on implantable devices. We discuss special methodological considerations regarding the use of data sources, exposure and outcome definitions, timing of exposure, and sources of bias. © The Author 2014. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

[Study on the reform and improvement of the medical device registration system in China].

Science.gov (United States)

Wang, Lanming

2012-11-01

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.

75 FR 70112 - Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered Suction...

Science.gov (United States)

2010-11-17

.... FDA-2010-N-0513] Medical Devices; General and Plastic Surgery Devices; Classification of Non-Powered... risks. Adverse tissue reaction Material degradation Improper function of suction apparatus (e.g., reflux.... Material degradation Section 8. Stability and Shelf Life. [[Page 70113

Campaign to gather medical devices containing radium: results

International Nuclear Information System (INIS)

Pierre, J.P.; Vidal, J.P.; Martin, J.C.; Pasquier, J.L.

2002-01-01

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)

Drugs and Medical Devices: Adverse Events and the Impact on Women's Health.

Science.gov (United States)

Carey, Jennifer L; Nader, Nathalie; Chai, Peter R; Carreiro, Stephanie; Griswold, Matthew K; Boyle, Katherine L

2017-01-01

A large number of medications and medical devices removed from the market by the US Food and Drug Administration over the past 4 decades specifically posed greater health risks to women. This article reviews the historical background of sex and gender in clinical research policy and describes several approved drugs and devices targeted for use in women that have caused major morbidity and mortality. The intended population for the medications and devices, population affected, approval process, and the basic and legal actions taken against the medication/drug company are also discussed. It is recognized that women are still at risk for harm from unsafe medications and devices, and continued improvements in legislation that promotes inclusion of sex and gender into the design and analysis of research will improve safety for both men and women. Copyright © 2017 Elsevier HS Journals, Inc. All rights reserved.

76 FR 71982 - Advancing Regulatory Science for Highly Multiplexed Microbiology/Medical Countermeasure Devices...

Science.gov (United States)

2011-11-21

... Multiplexed Microbiology Devices: Their clinical application and public health/clinical needs; inclusion of...] 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...

Electromagnetic compatibility of WLAN adapters with life-supporting medical devices.

Science.gov (United States)

Calcagnini, G; Mattei, E; Censi, F; Triventi, M; Lo Sterzo, R; Marchetta, E; Bartolini, P

2011-05-01

This paper investigates the electromagnetic compatibility of 45 critical care medical devices (infusion pumps, defibrillators, monitors, lung ventilators, anesthesia machines and external pacemakers) with various types of wireless local area network (WLAN, IEEE 802.11 b/g, 2.45 GHz, 100 mW) adapters. Interference is evaluated by performing ad-hoc tests according to the ANSI C63.18 recommended practice. The behavior of the devices during the tests was monitored using patient simulators/device testers specific for each device class. Electromagnetic interference cases were observed in three of 45 devices at a maximum distance of 5 cm. In two cases the interference caused malfunctions that may have clinical consequences for the patient. The authors' findings show that the use of these wireless local area network adapters can be considered reasonably safe, although interference may occur if they are operated at very close distance (<10 cm) to the medical devices.

77 FR 6028 - Taxable Medical Devices

Science.gov (United States)

2012-02-07

... sold as part of an x-ray system. Commentators also requested information on the tax treatment of..., mitigation, treatment, or prevention of disease; or intended to affect the structure or any function of the... subject to an IDE is not a ``taxable medical device'' under the proposed regulations. VI. Dental...

Levonorgestrel Intrauterine System

Science.gov (United States)

... removed during the first 7 days of your menstrual period, you should start using your new form of birth control 7 days before your intrauterine system is removed.Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

78 FR 33849 - Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request...

Science.gov (United States)

2013-06-05

... after the public workshop on the Internet at http://www.fda.gov/MedicalDevices/NewsEvents/Workshops..., compact, and mobile, the number of battery-powered medical devices will continue to increase. While many...] Battery-Powered Medical Devices Workshop: Challenges and Opportunities; Public Workshop; Request for...

The anchor of the frameless intrauterine device does not migrate over time: an analysis in over 300 women

Directory of Open Access Journals (Sweden)

Wildemeersch D

2014-12-01

Full Text Available Dirk Wildemeersch,1 Ansgar Pett,2 Sohela Jandi,2 Kilian Nolte,3 Wolfgang Albrecht4 1Gynecological Outpatient Clinic and IUD Training Centre, Ghent, Belgium; 2Gynecological Outpatient Clinic, Berlin, Germany; 3Gynecological Outpatient Clinic, Uetze, Germany; 4Gynecological Outpatient Clinic, Feldkirchen, Austria Objective: To evaluate the correct position of the anchor at insertion and follow-up and assess if migration of the anchor occurs over time. Materials and methods: This was an insertion-related, prospective, postmarketing study in 309 women. Following insertion, women were followed up at 4–6 weeks, 6 months, and yearly thereafter. The position of the visualized anchor in the fundus of the uterus was evaluated using ultrasound by measuring its distance from the serosal surface of the uterus (SA-distance. Results: A total of 309 parous (n=115 and nulliparous (n=194 women were fitted with the frameless GyneFix 200 or the GyneFix 330 intrauterine device for contraception. The mean SA-distance in 306 parous and nulliparous women was 6.0 mm (range 2.0–24.0 mm at insertion in the parous group and 5.4 mm (range 1.3–11.0 mm in the nulliparous group. At the first follow-up in 281 women, the SA-distance was 6.0 mm (range 2.0–12.0 mm in the parous group and 5.5 mm (range 1.1–11.0 mm in the nulliparous group. The SA-distance was not significantly different. One patient had an exceptionally large SA-distance of 24 mm, probably due to insertion in the posterior wall. No follow-up could be done in this patient. In 77 women, the SA-distance was measured up to 42 months. The mean SA-distance at insertion in the parous group was 5.2 mm (range 3.0–8.5 mm and 4.8 mm (range 1.3–7.0 mm in the nulliparous group. At the last follow-up up to 36 months or longer, the SA-distance was 5.1 mm (range 3.0–8.5 mm in the parous group and 4.9 mm (range 1.3–7.0 mm in the nulliparous group. The SA-distance was not significantly different. The visualized

75 FR 68972 - Medical Devices; General and Plastic Surgery Devices; Classification of Tissue Adhesive With...

Science.gov (United States)

2010-11-10

.... FDA-2010-N-0512] Medical Devices; General and Plastic Surgery Devices; Classification of Tissue... running to unintended areas, etc. B. Wound dehiscence C. Adverse tissue reaction and chemical burns D..., Clinical Studies, Labeling. Adverse tissue reaction and chemical Biocompatibility Animal burns. Testing...

77 FR 32644 - Medical Devices; Exemption From Premarket Notification: Wheelchair Elevator

Science.gov (United States)

2012-06-01

...] 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...

Views of patients and professionals about electronic multicompartment medication devices: a qualitative study.

Science.gov (United States)

Hall, Jill; Bond, Christine; Kinnear, Moira; McKinstry, Brian

2016-10-17

To explore the perceived acceptability, advantages and disadvantages of electronic multicompartment medication devices. Qualitative study using 8 focus groups and 10 individual semistructured interviews. Recordings were transcribed and analysed thematically. Strategies were employed to ensure the findings were credible and trustworthy. Community pharmacists (n=11), general practitioners (n=9), community nurses (n=12) and social care managers (n=8) were recruited from the National Health Service (NHS) and local authority services. Patients (n=15) who were current conventional or electronic multicompartment medication device users or had medication adherence problems were recruited from community pharmacies. 3 informal carers participated. Electronic multicompartment medication devices which prompt the patient to take medication may be beneficial for selected individuals, particularly those with cognitive impairment, but who are not seriously impaired, provided they have a good level of dexterity. They may also assist individuals where it is important that medication is taken at fixed time intervals. These are likely to be people who are being supported to live alone. No single device suited everybody; smaller/lighter devices were preferred but their usefulness was limited by the small number/size of storage compartments. Removing medications was often challenging. Transportability was an important factor for patients and carers. A carer's alert if medication is not taken was problematic with multiple barriers to implementation and no consensus as to who should receive the alert. There was a lack of enthusiasm among professionals, particularly among pharmacists, due to concerns about responsibility and funding for devices as well as ensuring devices met regulatory standards for storage and labelling. This study provides indicators of which patients might benefit from an electronic multicompartment medication device as well as the kinds of features to consider when

Left to their own devices: medical learners' use of mobile technologies.

Science.gov (United States)

Ellaway, Rachel H; Fink, Patricia; Graves, Lisa; Campbell, Alanna

2014-02-01

Although many medical learners and teachers are using mobile technologies within medical education, there has been little evidence presented describing how they use mobile devices across a whole curriculum. The Northern Ontario School of Medicine (NOSM) introduced a new mobile device program in 2010. Incoming undergraduate medical learners received a laptop and an iPad and learners entering year three of the four-year program received a laptop and an iPhone. A survey was sent to all learners to gather information on their use of and attitudes toward these devices. A combination of quantitative and qualitative methods was used to analyze the data and to generate a series of themes that synthesized student behaviors, perceptions and attitudes. Context and learner autonomy were found to be important factors with learners using multiple devices for different purposes and adopting strategic approaches to learning using these devices. The expectation that school-issued devices would be regularly and enthusiastically used to replace more traditional study media was not reflected in practice. Learners' approaches to using mobile devices are heterogeneous as is the extent to which they use them. Learners adapt their use of mobile devices to the learning cultures and contexts they find themselves in.

Advancing medical device innovation through collaboration and coordination of structured data capture pilots: Report from the Medical Device Epidemiology Network (MDEpiNet) Specific, Measurable, Achievable, Results-Oriented, Time Bound (SMART) Think Tank.

Science.gov (United States)

Reed, Terrie L; Drozda, Joseph P; Baskin, Kevin M; Tcheng, James; Conway, Karen; Wilson, Natalia; Marinac-Dabic, Danica; Heise, Theodore; Krucoff, Mitchell W

2017-12-01

The Medical Device Epidemiology Network (MDEpiNet) is a public private partnership (PPP) that provides a platform for collaboration on medical device evaluation and depth of expertise for supporting pilots to capture, exchange and use device information for improving device safety and protecting public health. The MDEpiNet SMART Think Tank, held in February, 2013, sought to engage expert stakeholders who were committed to improving the capture of device data, including Unique Device Identification (UDI), in key electronic health information. Prior to the Think Tank there was limited collaboration among stakeholders beyond a few single health care organizations engaged in electronic capture and exchange of device data. The Think Tank resulted in what has become two sustainable multi-stakeholder device data capture initiatives, BUILD and VANGUARD. These initiatives continue to mature within the MDEpiNet PPP structure and are well aligned with the goals outlined in recent FDA-initiated National Medical Device Planning Board and Medical Device Registry Task Force white papers as well as the vision for the National Evaluation System for health Technology.%. Published by Elsevier Inc.

Consequences of intrauterine growth restriction for the kidney

NARCIS (Netherlands)

M.F. Schreuder; A. van Wijk (Ans); H.A. Delemarre-van de Waal (Henriette)

2006-01-01

textabstractLow birth weight due to intrauterine growth restriction is associated with various diseases in adulthood, such as hypertension, cardiovascular disease, insulin resistance and end-stage renal disease. The purpose of this review is to describe the effects of intrauterine growth restriction

Possibilities of radiation sterilization for re-usage of medical devices in the medical management

International Nuclear Information System (INIS)

Tabei, Masae; Kudo, Hisaaki; Katsumura, Yosuke

2004-01-01

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.)

Third-year medical students' knowledge of privacy and security issues concerning mobile devices.

Science.gov (United States)

Whipple, Elizabeth C; Allgood, Kacy L; Larue, Elizabeth M

2012-01-01

The use of mobile devices are ubiquitous in medical-care professional settings, but information on privacy and security concerns of mobile devices for medical students is scarce. To gain baseline information about third-year medical students' mobile device use and knowledge of privacy and security issues concerning mobile devices. We surveyed 67 third-year medical students at a Midwestern university on their use of mobile devices and knowledge of how to protect information available through mobile devices. Students were also presented with clinical scenarios to rate their level of concern in regards to privacy and security of information. The most used features of mobile devices were: voice-to-voice (100%), text messaging (SMS) (94%), Internet (76.9%), and email (69.3%). For locking of one's personal mobile phone, 54.1% never physically lock their phone, and 58% never electronically lock their personal PDA. Scenarios considering definitely privacy concerns include emailing patient information intact (66.7%), and posting de-identified information on YouTube (45.2%) or Facebook (42.2%). As the ease of sharing data increases with the use of mobile devices, students need more education and training on possible privacy and security risks posed with mobile devices.

Low power signal processing electronics for wearable medical devices.

Science.gov (United States)

Casson, Alexander J; Rodriguez-Villegas, Esther

2010-01-01

Custom designed microchips, known as Application Specific Integrated Circuits (ASICs), offer the lowest possible power consumption electronics. However, this comes at the cost of a longer, more complex and more costly design process compared to one using generic, off-the-shelf components. Nevertheless, their use is essential in future truly wearable medical devices that must operate for long periods of time from physically small, energy limited batteries. This presentation will demonstrate the state-of-the-art in ASIC technology for providing online signal processing for use in these wearable medical devices.

Stakeholder challenges in purchasing medical devices for patient safety.

Science.gov (United States)

Hinrichs, Saba; Dickerson, Terry; Clarkson, John

2013-03-01

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.

[Software as medical devices/medical apps : Tasks, requirements, and experiences from the point of view of a competent authority].

Science.gov (United States)

Terhechte, Arno

2018-03-01

Software can be classified as a medical device according to the Medical Device Directive 93/42/EEC. The number of software products and medical apps is continuously increasing and so too is the use in health institutions (e. g., in hospitals and doctors' surgeries) for diagnosis and therapy.Different aspects of standalone software and medical apps from the perspective of the authority responsible are presented. The quality system implemented to establish a risk-based systematic inspection and supervision of manufacturers is discussed. The legal framework, as well as additional standards that are the basis for inspection, are outlined. The article highlights special aspects that occur during inspection like verification of software and interfaces, and the clinical evaluation of software. The Bezirksregierung, as the local government authority responsible in North Rhine-Westphalia, is also in charge of inspection of health institutions. Therefore this article is not limited to the manufacturers placing the software on the market, but in addition it describes the management and use of software as a medical device in hospitals.The future legal framework, the Medical Device Regulation, will strengthen the requirements and engage notified bodies more than today in the conformity assessment of software as a medical device.Manufacturers, health institutions, notified bodies and the authorities responsible are in charge of intensifying their efforts towards software as a medical device. Mutual information, improvement of skills, and inspections will lead to compliance with regulatory requirements.

Research on dose setting for radiation sterilization of medical device

International Nuclear Information System (INIS)

Zhang Tongcheng; Liu Qingfang; Zhong Hongliang; Mi Zhisu; Wang Chunlei; Jiang Jianping

2002-01-01

Objective: To establish the radiation sterilization dose for medical devices using data of bioburden on the medical device. Methods: Firstly determination of recovery ratio and correction coefficient of the microbiological test method was used according to ISO11737 standard, then determination of bioburden on the products, finally the dose setting was completed based on the Method 1 in ISO11137 standard. Results: Fifteen kinds of medical devices were tested. Bioburden range was from 8.6-97271.2 CFU/device, recovery ration range 54.6%-100%, correction co-efficiency range 1.00-1.83, D 10 distribution from 1.40 to 2.82 kGy, verification dose (dose at SAL = 10 -2 ) range 5.1-17.6 kGy and sterilization dose (dose at SAL 10 -6 ) range 17.5-32.5 kGy. Conclusion: One hundred samples of each kind of product were exposed to the pre-determined verification dose and then the sterility test was performed. Each sterility test showed positive number was not greater than two. This indicated that the sterilization dose established for each kind of product was statistically acceptable

77 FR 32642 - Medical Devices; Exemption From Premarket Notification: Powered Patient Transport

Science.gov (United States)

2012-06-01

...] Medical Devices; Exemption From Premarket Notification: Powered Patient Transport AGENCY: Food and Drug... received a petition requesting exemption from the premarket notification requirements for powered patient... necessary to provide a reasonable assurance of safety and effectiveness. Under the Medical Device Amendments...

76 FR 14414 - Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2011-03-16

... 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...

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2010-10-01

American Telemedicine Association), we demonstrated how continuous monitoring of the patient’s SpO2 and respiratory rate could detect the onset of...designed to monitor sepsis infection sounded its alarm continually, day and night. The device was built with an innovative algorithm to detect sepsis, but...transport Figure 3. This medical device has misread its sensors and inserted false data into patient’s permanent medical record. SPECIal FEaTuRE October

Relationship between in utero sonographic evaluation and subcutaneous plicometry after birth in infants with intrauterine growth restriction: an exploratory study

Directory of Open Access Journals (Sweden)

Giannì Maria L

2010-10-01

Full Text Available Abstract Background Intrauterine growth restriction (IUGR is associated with several medical complications before and after delivery. The aim of this study was to evaluate the concordance between the fetal ultrasonographic measurement of subcutaneous tissue thicknesses and the skinfold thicknesses assessment in intrauterine growth restricted newborns. Methods We designed an exploratory study. Fetal ultrasonographic measurement of subcutaneous tissue thicknesses, according to Bernstein's and Galan's method, and neonatal skinfold thicknesses were evaluated in 13 intrauterine growth restricted newborns within 4 hours before delivery and on the first day of life, respectively. Concordance between fetal and neonatal measurements was assessed using the Lin's correlation coefficient and the Bland-Altman method. Results The data obtained by the measurements of neonatal skinfold thicknesses was significantly correlated with the prenatal measurements (Lin's coefficients, arm: 0.60; subscapular: 0.72; abdomen: 0.51. Bland-Altman analysis showed moderate agreement between the fetal ultrasonographic measurement of subcutaneous tissue thicknesses and the neonatal skinfold thicknesses assessment. Conclusions The present study provides preliminary evidence that fetal sonographic measurements may represent additional indices of intrauterine growth restriction.

21 CFR 801.16 - Medical devices; Spanish-language version of certain required statements.

Science.gov (United States)

2010-04-01

... 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...

Determinants of Method Switching among Social Franchise Clients Who Discontinued the Use of Intrauterine Contraceptive Device.

Science.gov (United States)

Hameed, Waqas; Azmat, Syed Khurram; Ali, Moazzam; Hussain, Wajahat; Mustafa, Ghulam; Ishaque, Muhammad; Ali, Safdar; Ahmed, Aftab; Temmerman, Marleen

2015-01-01

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.

A survey on abnormal uterine bleeding among radiographers with frequent MRI exposure using intrauterine contraceptive devices.

Science.gov (United States)

Huss, A; Schaap, K; Kromhout, H

2018-02-01

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.

Determinants of Method Switching among Social Franchise Clients Who Discontinued the Use of Intrauterine Contraceptive Device

Directory of Open Access Journals (Sweden)

Waqas Hameed

2015-01-01

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.

[Intrauterine intestinal volvulus].

Science.gov (United States)

Gawrych, Elzbieta; Chojnacka, Hanna; Wegrzynowski, Jerzy; Rajewska, Justyna

2009-07-01

Intrauterine intestinal volvulus is an extremely rare case of acute congenital intestinal obstruction. The diagnosis is usually possible in the third trimester of a pregnancy. Fetal midgut volvulus is most likely to be recognized by observing a typical clockwise whirlpool sign during color Doppler investigation. Multiple dilated intestinal loops with fluid levels are usually visible during the antenatal ultrasound as well. Physical and radiographic findings in the newborn indicate intestinal obstruction and an emergency surgery is required. The authors describe intrauterine volvulus in 3 female newborns in which surgical treatment was individualized. The decision about primary or delayed anastomosis after resection of the gangrenous part of the small bowel was made at the time of the surgery and depended on the general condition of the newborn, as well as presence or absence of meconium peritonitis. Double loop jejunostomy was performed in case of two newborns, followed by a delayed end-to-end anastomosis. In case of the third newborn, good blood supply of the small intestine after untwisting and 0.25% lignocaine injections into mesentery led to the assumption that the torsion was not complete and ischemia was reversible. In the two cases of incomplete rotation the cecum was sutured to the left abdominal wall to prevent further twisting. The postoperative course was uneventful and oral alimentation caused no problems. Physical development of all these children has been normal (current age: 1-2 years) and the parents have not observed any disorders or problems regarding passage of food through the alimentary canal. Prompt antenatal diagnosis of this surgical emergency and adequate choice of intervention may greatly reduce mortality due to intrauterine volvulus.

Health Care: Reprocessed Medical Single-Use Devices in DoD

National Research Council Canada - National Science Library

2002-01-01

... 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...

Management information system of medical equipment using mobile devices

Science.gov (United States)

Núñez, C.; Castro, D.

2011-09-01

The large numbers of technologies currently incorporated into mobile devices transform them into excellent tools for capture and to manage the information, because of the increasing computing power and storage that allow to add many miscellaneous applications. In order to obtain benefits of these technologies, in the biomedical engineering field, it was developed a mobile information system for medical equipment management. The central platform for the system it's a mobile phone, which by a connection with a web server, it's capable to send and receive information relative to any medical equipment. Decoding a type of barcodes, known as QR-Codes, the management process is simplified and improved. These barcodes identified the medical equipments in a database, when these codes are photographed and decoded with the mobile device, you can access to relevant information about the medical equipment in question. This Project in it's actual state is a basic support tool for the maintenance of medical equipment. It is also a modern alternative, competitive and economic in the actual market.

Experimental intrauterine growth retardation.

Science.gov (United States)

van Marthens, E; Harel, S; Zamenshof, S

1975-01-01

The effects of experimental intrauterine growth retardation on subsequent fetal development, especially with respect to brain development, were studied in a new animal model. The rabbit was chosen since it has a perinatal pattern of brain development similar to that of the human. Experimental ischemia was induced during the last trimester by ligation of spiral arterioles and the differential effects on fetal development at term (30th gestational day) are reported. Specific brain regions were examined for wet weight, total cell number (DNA) and total protein content. Highly significant decreases in all these parameters were found in both the cortex and cerebellum following experimental intrauterine growth retardation; these two organs were differentially affected. The prospects and advantages of using this animal model for the study of the postnatal "catch-up growth" are discussed.

Regulatory Science in Practice (Pharmaceuticals and Medical Devices Agency).

Science.gov (United States)

Hojo, Taisuke

2017-01-01

Review, safety, and relief services of the Pharmaceuticals and Medical Devices Agency are primarily focused on scientifically evaluating pharmaceuticals, medical devices, and cellular and tissue-based products referring to their quality, efficacy, and safety, which requires a variety of scientific knowledge and methods. Pharmaceutical regulation should be established based on the most advanced scientific expertise at all times. In order to evaluate products that use cutting-edge technology such as induced pluripotent stem cells and information and communication technology adequately, since fiscal year 2012 the Science Committee has been established as a platform to exchange opinions among members from top-ranking domestic and international academia and to enhance personnel exchanges through the Initiative to Facilitate Development of Innovative Drugs. In addition, the Regulatory Science Center will be established in 2018 to increase the integrity of our services for product reviews and safety measures. In particular, requiring electronic data submissions for clinical trial applications followed by an advanced approach to analysis should not only enhance the quality of reviews of individual products but should also support the development of pharmaceuticals and medical devices by providing pharmaceutical affairs consultations on research and development strategies with various guidelines based on new insights resulting from product-bridging data analysis. Moreover, a database including electronic health records with comprehensive medical information collected mainly from 10 cooperating medical institutions will be developed with the aim of developing safety measures in a more timely manner using methods of pharmacoepidemiological analysis.

31 CFR 595.513 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine...-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

Pricing and reimbursement of drugs and medical devices in Hungary.

Science.gov (United States)

Gulácsi, L; Dávid, T; Dózsa, Cs

2002-01-01

Similarly to other countries of Central and Eastern Europe, Hungary has witnessed massive diffusion of healthcare technology such as drugs and medical devices since 1990. While substantial new pharmaceuticals, medical devices, and procedures have been liberalized, there has been no proper evaluation or training in their use. Healthcare providers have come to find themselves as entrepreneurs in private practice, while patients are acquiring an increasing awareness as customers of healthcare,demanding services in return for their taxes and contributions. This has led to extremely irrational patterns of investment in technology, with most an obvious waste of resources, while leaving basic needs unmet. Both the National Health Insurance Fund and the Ministry of Finance believe that the current pharmaceutical and medical device bill is too high. However, introducing a more transparent and flexible pricing and reimbursement framework may enable a more efficient allocation of the limited resources to be achieved.

Care quality following intrauterine death in Spanish hospitals: results from an online survey.

Science.gov (United States)

Cassidy, Paul Richard

2018-01-10

The objective of the study was to evaluate practices in Spanish hospitals after intrauterine death in terms of medical/ technical care and bereavement support care. A cross-sectional descriptive study using an online self-completion questionnaire. The population was defined as women who had experienced an intrauterine fetal death between sixteen weeks and birth, either through spontaneous late miscarriage/stillbirth or termination of pregnancy for medical reasons. Respondents were recruited through an online advertisement on a stillbirth charity website and social media. The analysis used Pearson's chi-squared (p ≤ 0.05) test of independence to cross-analyse for associations between objective measures of care quality and independent variables. Responses from 796 women were analysed. Half of the women (52.9%) had postmortem contact with their baby. 30.4% left the hospital with a least one linking object or a photograph. In 35.8% of cases parents weren't given any option to recover the body/remains. 22.9% of births ≥26 weeks gestation were by caesarean, with a significant (p < 0.001) difference between public hospitals (16.8%) and private hospitals (41.5%). 29.3% of respondents were not accompanied during the delivery. 48.0% of respondents recalled being administered sedatives at least once during the hospital stay. The autopsy rate in stillbirth cases (≥ 20 weeks) was 70.5% and 44.4% in cases of termination of pregnancy (all gestational ages). Consistent significant (p < 0.05) differences in care practices were found based on gestational age and type of hospital (public or private), but not to other variables related to socio-demographics, pregnancy history or details of the loss/death. Intrauterine deaths at earlier gestational ages received poorer quality care. Supportive healthcare following intrauterine death is important to women's experiences in the hospital and beneficial to the grief process. Many care practices that are standard in

SU-D-BRF-05: A Novel System to Provide Real-Time Image-Guidance for Intrauterine Tandem Insertion and Placement

Energy Technology Data Exchange (ETDEWEB)

Price, M; Fontenot, J [pF Biomedical Solutions LLC, Baton Rouge, LA (United States)

2014-06-01

Purpose: To develop a system that provides real-time image-guidance for intrauterine tandem insertion and placement for brachytherapy. Methods: The conceptualized system consists of an intrauterine tandem with a transparent, lensed tip, a flexible miniature fiber optic scope, light source and interface for CCD coupling. The tandem tip was designed to act as a lens providing a wide field-of-view (FOV) with minimal image distortion and focus length appropriate for the application. The system is designed so that once inserted, the image-guidance component of the system can be removed and brachytherapy can be administered without interfering with source transport or disturbing tandem placement. Proof-of-principle studies were conducted to assess the conceptualized system's (1) lens functionality (clarity, focus and FOV) (2) and ability to visualize the cervical os of a female placed in the lithotomy position. Results: A prototype of this device was constructed using a commercial tandem modified to incorporate a transparent tip that internally coupled with a 1.9mm diameter fiber optic cable. The 900mm-long cable terminated at an interface that provided illumination as well as facilitated visualization of patient anatomy on a computer. The system provided a 23mm FOV with a focal length of 1cm and provided clear visualization of the cervix, cervical fornix and cervical os. The optical components of the system are easily removed without perturbing the position of a tandem placed in a common fixation clamp. Conclusion: Clinicians frequently encounter difficulty inserting an intrauterine tandem through the cervical os, circumventing fibrotic tissue or masses within the uterus, and positioning the tandem without perforating the uterus. To mitigate these challenges, we have designed and conducted proof-of- principle studies to discern the utility of a prototype device that provides real-time image-guidance for intrauterine tandem placement using fiber optic components.

75 FR 1395 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2010-01-11

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0606] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice...) is announcing an amendment to the notice of a meeting of the General and Plastic Surgery Devices...

Towards automated assistance for operating home medical devices.

Science.gov (United States)

Gao, Zan; Detyniecki, Marcin; Chen, Ming-Yu; Wu, Wen; Hauptmann, Alexander G; Wactlar, Howard D

2010-01-01

To detect errors when subjects operate a home medical device, we observe them with multiple cameras. We then perform action recognition with a robust approach to recognize action information based on explicitly encoding motion information. This algorithm detects interest points and encodes not only their local appearance but also explicitly models local motion. Our goal is to recognize individual human actions in the operations of a home medical device to see if the patient has correctly performed the required actions in the prescribed sequence. Using a specific infusion pump as a test case, requiring 22 operation steps from 6 action classes, our best classifier selects high likelihood action estimates from 4 available cameras, to obtain an average class recognition rate of 69%.

Recent advances in medical device triage technologies for chemical, biological, radiological, and nuclear events.

Science.gov (United States)

Lansdowne, Krystal; Scully, Christopher G; Galeotti, Loriano; Schwartz, Suzanne; Marcozzi, David; Strauss, David G

2015-06-01

In 2010, the US Food and Drug Administration (Silver Spring, Maryland USA) created the Medical Countermeasures Initiative with the mission of development and promoting medical countermeasures that would be needed to protect the nation from identified, high-priority chemical, biological, radiological, or nuclear (CBRN) threats and emerging infectious diseases. The aim of this review was to promote regulatory science research of medical devices and to analyze how the devices can be employed in different CBRN scenarios. Triage in CBRN scenarios presents unique challenges for first responders because the effects of CBRN agents and the clinical presentations of casualties at each triage stage can vary. The uniqueness of a CBRN event can render standard patient monitoring medical device and conventional triage algorithms ineffective. Despite the challenges, there have been recent advances in CBRN triage technology that include: novel technologies; mobile medical applications ("medical apps") for CBRN disasters; electronic triage tags, such as eTriage; diagnostic field devices, such as the Joint Biological Agent Identification System; and decision support systems, such as the Chemical Hazards Emergency Medical Management Intelligent Syndromes Tool (CHEMM-IST). Further research and medical device validation can help to advance prehospital triage technology for CBRN events.

31 CFR 594.515 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine....515 In-kind donations of medicine, medical devices, and medical services. (a) Effective July 6, 2006, nongovernmental organizations that are U.S. persons are authorized to provide in-kind donations of medicine...

31 CFR 597.511 - In-kind donations of medicine, medical devices, and medical services.

Science.gov (United States)

2010-07-01

... 31 Money and Finance: Treasury 3 2010-07-01 2010-07-01 false In-kind donations of medicine... Licensing Policy § 597.511 In-kind donations of medicine, medical devices, and medical services. (a... incident to the provision by nongovernmental organizations that are U.S. persons of in-kind donations of...

ANSTO and CSIRO: supporting the medical devices and sensors industry in Australia

International Nuclear Information System (INIS)

Triani, Gerry; Doe, Simon

2005-01-01

The Australian Nuclear Science and Technology Organisation (ANSTO) and the Commonwealth Scientific and Industrial Research Organisation (CSIRO) have provided support to the Medical Devices and Sensors Industry in Australia for many years. In particular the Institute of Materials and Engineering Science at ANSTO and CSIRO Manufacturing and Infrastructure Technology have worked independently and jointly on a number of projects to provide technical services and support to small to medium sized companies. A recent venture to capture their capabilities in the WTIA's Medical Devices and Sensors Industry Sectoral Project, part of the WTIA National Diffusion Networks Project, has produced substantial technical and financial gains for its participants. The aim of this article is to highlight the infrastructure and capabilities that ANSTO and CSIRO can provide to component manufacturers and industry clusters that offer a range of manufacturing processes needed for medical devices and sensors. Several case studies illustrate how ANSTO and CSIRO have provided support to the medical devices industry

Sterilization and reprocessing of materials and medical devices--reusability.

Science.gov (United States)

Jayabalan, M

1995-07-01

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.

Intrauterine growth restriction

Directory of Open Access Journals (Sweden)

Bernardita Donoso Bernales

2012-07-01

Full Text Available It is estimated that the true prevalence of intrauterine growth restriction is 3-10% of all pregnancies, making this fetal condition one of the most frequent obstetric problems, together with premature labor and premature rupture of membranes. The article stresses the importance of early diagnosis because of the associated risks.

Home Healthcare Medical Devices: Infusion Therapy - Getting the Most Out of Your Pump

Science.gov (United States)

... Medical Procedures Home Health and Consumer Devices Brochure - Home Healthcare Medical Devices: Infusion Therapy - Getting the Most ... if needed. What is the role of your home healthcare provider and supplier in your infusion therapy? ...

76 FR 42713 - General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of...

Science.gov (United States)

2011-07-19

...] General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee; Amendment of Notice... announcing an amendment to the notice of meeting of the General and Plastic Surgery Devices Panel of the... INFORMATION: In the Federal Register of July 7, 2011, FDA announced that a meeting of the General and Plastic...

OR.NET: a service-oriented architecture for safe and dynamic medical device interoperability.

Science.gov (United States)

Kasparick, Martin; Schmitz, Malte; Andersen, Björn; Rockstroh, Max; Franke, Stefan; Schlichting, Stefan; Golatowski, Frank; Timmermann, Dirk

2018-02-23

Modern surgical departments are characterized by a high degree of automation supporting complex procedures. It recently became apparent that integrated operating rooms can improve the quality of care, simplify clinical workflows, and mitigate equipment-related incidents and human errors. Particularly using computer assistance based on data from integrated surgical devices is a promising opportunity. However, the lack of manufacturer-independent interoperability often prevents the deployment of collaborative assistive systems. The German flagship project OR.NET has therefore developed, implemented, validated, and standardized concepts for open medical device interoperability. This paper describes the universal OR.NET interoperability concept enabling a safe and dynamic manufacturer-independent interconnection of point-of-care (PoC) medical devices in the operating room and the whole clinic. It is based on a protocol specifically addressing the requirements of device-to-device communication, yet also provides solutions for connecting the clinical information technology (IT) infrastructure. We present the concept of a service-oriented medical device architecture (SOMDA) as well as an introduction to the technical specification implementing the SOMDA paradigm, currently being standardized within the IEEE 11073 service-oriented device connectivity (SDC) series. In addition, the Session concept is introduced as a key enabler for safe device interconnection in highly dynamic ensembles of networked medical devices; and finally, some security aspects of a SOMDA are discussed.

El Centro de Cardioestimuladores del Uruguay. CCC Medical Devices

Directory of Open Access Journals (Sweden)

Pablo Darscht

2011-05-01

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.

Current status of the regulation for medical devices

OpenAIRE

Shah Anuja; Goyal R

2008-01-01

In the light of escalating use of medical devices, stringent regulatory standards are required to ensure that the devices are safe, well studied and have least adverse reactions. Recently introduced guidelines and the amendment in the law will provide adequate guidance for both the manufacturers and competent authorities to manage cases efficiently and appropriately. India has emerged as one of the leaders in pharmaceutical industry. Like many other amendments in Drugs and Cosmetics Act that ...

Intrauterin graviditet efter Cavatermbehandling

DEFF Research Database (Denmark)

Shokouh-Amiri, Ali; Kjaergaard, Niels

2009-01-01

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...

Alteration of placental haemostatic mechanisms in idiopathic intrauterine growth restriction

Directory of Open Access Journals (Sweden)

Jaime Eduardo Bernal Villegas

2012-08-01

Full Text Available Intrauterine growth restriction is a complication of pregnancy with a high probability of perinatal morbidity and mortality. It appears tobe caused by abnormal development of placental vasculature. Haemostatic processes are important for the development of the placenta,and an imbalance between procoagulant and anticoagulant factors has been associated with risk of intrauterine growth restriction.Objective. To evaluate coagulation abnormalities in placenta of pregnancies complicated with idiopathic intrauterine growth restriction.Materials and methods. Five placentas from pregnancies with idiopathic intrauterine growth restriction were compared to 19 controls.We performed gross and histological examination of the placenta. Analysis was made of both mRNA expression by real-time PCRand protein by ELISA of tissue factor and thrombomodulin in placental tissue. Results. Results based on histological evaluation wereconsistent with an increased prothrombotic state in placentas from pregnancies with idiopathic intrauterine growth restriction, andthrombosis of chorionic vessels was the most important finding. The study showed an increased expression of tissue factor protein(p=0.0411 and an increase in the ratio of tissue factor/thrombomodulin mRNA (p=0.0411 and protein (p=0.0215 in placentas frompregnancies with idiopathic intrauterine growth restriction. There were no statistically significant differences neither between cases andcontrols in the mRNA levels of tissue factor or thrombomodulin nor at the protein level of thrombomodulin. Conclusion. Evidence ofalteration of local haemostatic mechanisms at the level of the placenta, including abnormal expression of tissue factor and tissue factor/thrombomodulin ratio, in pregnancies that occur with idiopathic intrauterine growth restriction is presented.

Post market surveillance in the german medical device sector - current state and future perspectives.

Science.gov (United States)

Zippel, Claus; Bohnet-Joschko, Sabine

2017-08-01

Medical devices play a central role in the diagnosis and treatment of diseases but also bring the potential for adverse events, hazards or malfunction with serious consequences for patients and users. Medical device manufacturers are therefore required by law to monitor the performance of medical devices that have been approved by the competent authorities (post market surveillance). Conducting a nationwide online-survey in the German medical device sector in Q2/2014 in order to explore the current status of the use of post market instruments we obtained a total of 118 complete data sets, for a return rate of 36%. The survey included manufacturers of different sizes, producing medical devices of all risk classes. The post market instruments most frequently reported covered the fields of production monitoring and quality management as well as literature observation, regulatory vigilance systems, customer knowledge management and market observation while Post Market Clinical Follow-up and health services research were being used less for product monitoring. We found significant differences between the different risk classes of medical devices produced and the intensity of use of post market instruments. Differences between company size and the intensity of instruments used were hardly detected. Results may well contribute to the development of device monitoring which is a crucial element of the policy and regulatory system to identify device-related safety issues. Copyright © 2017 Elsevier B.V. All rights reserved.

Image Quality Characteristics of Handheld Display Devices for Medical Imaging

Science.gov (United States)

Yamazaki, Asumi; Liu, Peter; Cheng, Wei-Chung; Badano, Aldo

2013-01-01

Handheld devices such as mobile phones and tablet computers have become widespread with thousands of available software applications. Recently, handhelds are being proposed as part of medical imaging solutions, especially in emergency medicine, where immediate consultation is required. However, handheld devices differ significantly from medical workstation displays in terms of display characteristics. Moreover, the characteristics vary significantly among device types. We investigate the image quality characteristics of various handheld devices with respect to luminance response, spatial resolution, spatial noise, and reflectance. We show that the luminance characteristics of the handheld displays are different from those of workstation displays complying with grayscale standard target response suggesting that luminance calibration might be needed. Our results also demonstrate that the spatial characteristics of handhelds can surpass those of medical workstation displays particularly for recent generation devices. While a 5 mega-pixel monochrome workstation display has horizontal and vertical modulation transfer factors of 0.52 and 0.47 at the Nyquist frequency, the handheld displays released after 2011 can have values higher than 0.63 at the respective Nyquist frequencies. The noise power spectra for workstation displays are higher than 1.2×10−5 mm2 at 1 mm−1, while handheld displays have values lower than 3.7×10−6 mm2. Reflectance measurements on some of the handheld displays are consistent with measurements for workstation displays with, in some cases, low specular and diffuse reflectance coefficients. The variability of the characterization results among devices due to the different technological features indicates that image quality varies greatly among handheld display devices. PMID:24236113

"Joint Workshop on High Confidence Medical Devices, Software, and Systems (HCMDSS) and Medical Device Plug-and-Play (MD PnP) Interoperability"

National Research Council Canada - National Science Library

Goldman, Julian M

2008-01-01

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...

Value driven innovation in medical device design: a process for balancing stakeholder voices.

Science.gov (United States)

de Ana, F J; Umstead, K A; Phillips, G J; Conner, C P

2013-09-01

The innovation process has often been represented as a linear process which funnels customer needs through various business and process filters. This method may be appropriate for some consumer products, but in the medical device industry there are some inherent limitations to the traditional innovation funnel approach. In the medical device industry, there are a number of stakeholders who need to have their voices heard throughout the innovation process. Each stakeholder has diverse and unique needs relating to the medical device, the needs of one may highly affect the needs of another, and the relationships between stakeholders may be tenuous. This paper describes the application of a spiral innovation process to the development of a medical device which considers three distinct stakeholder voices: the Voice of the Customer, the Voice of the Business and the Voice of the Technology. The process is presented as a case study focusing on the front-end redesign of a class III medical device for an orthopedics company. Starting from project initiation and scope alignment, the process describes four phases, Discover, Envision, Create, and Refine, and concludes with value assessment of the final design features.

Global health indicators and maternal health futures: The case of Intrauterine Growth Restriction.

Science.gov (United States)

Erikson, Susan L

2015-01-01

Public health indicators generally operate in the world as credible, apolitical and authoritative. But indicators are less stable than they appear. Clinical critiques of Intrauterine Growth Restriction (IUGR) criteria have been forthcoming for decades. This article, though, takes up the measuring and calculation gradients of IUGR in the ultrasound machine itself, including the software algorithms that identify IUGR. One hospital where research was conducted incorrectly predicted pathological birth outcomes 14 of 14 times. We are at a historical moment when the global use of prenatal diagnostic ultrasound for the express purpose of assessing IUGR is set to escalate. Medical imaging device corporations like Siemens, Toshiba, General Electric and Phillips are quite literally banking on it, and new forms of ultrasound technology and diagnostic software are increasingly available on smartphones, tablets and laptops. Clinical guidelines for IUGR--assumed to be authoritative and evidence-based--are evolving right along with the installation throughout the world of the technology capable of diagnosing it. Maternal malnutrition remains the single strongest predictive factor for IUGR, regardless of the technological investments currently amassing to identify the indicator, which is cause for a reassessment of priority spending and investment.

New after-loading intrauterine packing device: ten years experience

International Nuclear Information System (INIS)

Sklaroff, D.M.; Baker, A.S.; Tasbas, M.

1985-01-01

A new variation of the uterine packing device for the treatment of endometrial carcinoma is described. It combines the advantages of the Holter technique with the after-loading method described by Simon. This device has been in use for more than 10 years and has been found most satisfactory

Pelvic actinomycosis with abundant ascites, pleural effusion, and lymphadenopathy diagnosed with endometrial biopsy and treated with medication only

Directory of Open Access Journals (Sweden)

Myounghwan Kim

2014-12-01

Conclusion: Pelvic actinomycosis should always be considered in patients with a pelvic mass and peritoneal infiltration, especially in the presence of intrauterine device use, despite the fact that abundant ascites, pleural effusion, and lymphadenopathy almost never accompany pelvic actinomycosis. Endometrial/endocervical biopsy may yield a diagnosis without an invasive procedure and should be performed. Because of the excellent response to penicillin, medical treatment alone is an effective method to eradicate pelvic actinomycosis without the need for surgical intervention.

ISO 13485 a complete guide to quality management in the medical device industry

CERN Document Server

Abuhav, Itay

2011-01-01

Although complex and lengthy, the process of certification for the ISO 13485 can be easily mastered using the simple method outlined in ISO 13485: A Complete Guide to Quality Management in the Medical Device Industry. Written by an experienced industry professional, this practical book provides a complete guide to the ISO 13485 Standard certification for medical device manufacturing. Filled with examples drawn from the author's experience and spanning different sectors and fields of the medical device industry, the book translates the extra ordinary requirements and objectives of the standard

Stretchable bioelectronics for medical devices and systems

CERN Document Server

Ghaffari, Roozbeh; Kim, Dae-Hyeong

2016-01-01

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.

A model of user engagement in medical device development.

Science.gov (United States)

Grocott, Patricia; Weir, Heather; Ram, Mala Bridgelal

2007-01-01

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.

How can cardiothoracic and vascular medical devices stay in the market?

Science.gov (United States)

Wong, Kathie A; Hodgson, Luke; Garas, George; Malietzis, George; Markar, Sheraz; Rao, Christopher; von Segesser, Ludwig K; Athanasiou, Thanos

2016-12-01

Surgeons, as the consumers, must engage in commercial activity regarding medical devices since it directly has impacts on surgical practice and patient outcomes. Unique features defy traditional economic convention in this specific market partly because consumers do not usually pay directly. Greater involvement with commercial activity means better post-market surveillance of medical devices which leads to improved patient safety. The medical device industry has exhibited astonishing levels of growth and profitability reaching $398 billion on a global scale with new product development focusing on unmet clinical need. The industry has rapidly emerged within the context of an ageing population and a global surge in healthcare spending. But the market remains fragmented. The split of consumer, purchaser and payer leads to clinical need driving demand for new product development. This demand contributes to potentially large profit margins mainly contained by regulatory burden and liability issues. Demographic trends, prevalence of diseases and a huge capacity to absorb technology have sustained near unparalleled growth. To stay in the market, incremental development over the short term is essentially aided by responsiveness to demand. Disruptive product development is now more likely to come from multinational companies, in an increasingly expensive, regulated industry. Understanding healthcare organization can help explain the highly complex process of diffusion of innovations in healthcare that include medical devices. The time has come for surgeons to become actively involved with all aspects of the medical device life cycle including commercial activity and post-market surveillance. This is vital for improving patient care and ensuring patient safety. © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.

Effects of Medical Device Regulations on the Development of Stand-Alone Medical Software: A Pilot Study.

Science.gov (United States)

Blagec, Kathrin; Jungwirth, David; Haluza, Daniela; Samwald, Matthias

2018-01-01

Medical device regulations which aim to ensure safety standards do not only apply to hardware devices but also to standalone medical software, e.g. mobile apps. To explore the effects of these regulations on the development and distribution of medical standalone software. We invited a convenience sample of 130 domain experts to participate in an online survey about the impact of current regulations on the development and distribution of medical standalone software. 21 respondents completed the questionnaire. Participants reported slight positive effects on usability, reliability, and data security of their products, whereas the ability to modify already deployed software and customization by end users were negatively impacted. The additional time and costs needed to go through the regulatory process were perceived as the greatest obstacles in developing and distributing medical software. Further research is needed to compare positive effects on software quality with negative impacts on market access and innovation. Strategies for avoiding over-regulation while still ensuring safety standards need to be devised.

Barriers and enablers to adoption of intrauterine device as a contraceptive method: A multi-stakeholder perspective

Directory of Open Access Journals (Sweden)

Namita Mishra

2017-01-01

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.

78 FR 66941 - Design Considerations for Pivotal Clinical Investigations for Medical Devices; Guidance for...

Science.gov (United States)

2013-11-07

.... 66, rm. 2110, Silver Spring, MD 20993-0002, 301- 796-5750. For devices regulated by CBER: Stephen... the best clinical and statistical practices for investigational medical device studies. A medical...

Expression profiles of antimicrobial peptides in the genital tract of women using progesterone intrauterine devices versus combined oral contraceptives.

Science.gov (United States)

Introini, Andrea; Kaldensjö, Tove; Hirbod, Taha; Röhl, Maria; Tjernlund, Annelie; Andersson, Sonia; Broliden, Kristina

2014-11-01

Sex hormones can influence the immune defenses of the female genital tract (FGT) and its susceptibility to infections. Here we investigated the effect of different hormonal contraceptives on the production of antimicrobial peptides (AMPs) in different compartments of the female genital mucosa (FGM), secretions and tissue. Cervicovaginal secretions (CVS) and ectocervical tissue samples obtained from women using progesterone intrauterine devices (pIUD) (n = 23) and combined oral contraceptives (COC) (n = 23) were analyzed for the expression and in situ localization of HNP1-3, BD-2, LL-37, SLPI and trappin-2 by ELISA, real-time PCR and immunohistochemistry. Women using COC had significantly lower mRNA levels of BD-2 and trappin-2 in ectocervical tissue than pIUD users. The two groups showed no differences in CVS concentration, as well as similar in situ expression patterns in ectocervical tissue, of all five AMPs. The use of hormonal contraceptives influences AMP expression differently in genital secretions compared to ectocervical tissue. This suggests that the impact of sex hormones on local immune defenses varies in different compartments of the FGM, and likely in different locations across the FGT. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

OR.NET RT: how service-oriented medical device architecture meets real-time communication.

Science.gov (United States)

Pfeiffer, Jonas H; Kasparick, Martin; Strathen, Benjamin; Dietz, Christian; Dingler, Max E; Lueth, Tim C; Timmermann, Dirk; Radermacher, Klaus; Golatowski, Frank

2018-02-23

Today's landscape of medical devices is dominated by stand-alone systems and proprietary interfaces lacking cross-vendor interoperability. This complicates or even impedes the innovation of novel, intelligent assistance systems relying on the collaboration of medical devices. Emerging approaches use the service-oriented architecture (SOA) paradigm based on Internet protocol (IP) to enable communication between medical devices. While this works well for scenarios with no or only soft timing constraints, the underlying best-effort communication scheme is insufficient for time critical data. Real-time (RT) networks are able to reliably guarantee fixed latency boundaries, for example, by using time division multiple access (TDMA) communication patterns. However, deterministic RT networks come with their own limitations such as tedious, inflexible configuration and a more restricted bandwidth allocation. In this contribution we overcome the drawbacks of both approaches by describing and implementing mechanisms that allow the two networks to interact. We introduce the first implementation of a medical device network that offers hard RT guarantees for control and sensor data and integrates into SOA networks. Based on two application examples we show how the flexibility of SOA networks and the reliability of RT networks can be combined to achieve an open network infrastructure for medical devices in the operating room (OR).

Scouting For Approval: Lessons on Medical Device Regulation in an Era of Crowdfunding from Scanadu's "Scout".

Science.gov (United States)

Smith, Colleen

2015-01-01

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.

Contraception: Everyone's responsibility | Patel | South African ...

African Journals Online (AJOL)

The intrauterine contraceptive device, the levonorgestrel intrauterine system and the injectable progestogen contraceptives form part of this group of contraceptives. The most recently launched LARC is Implanon NXT. A comprehensive guideline to assess suitability of the various contraceptive methods in various medical ...

Monitoring of Vital Signs with Flexible and Wearable Medical Devices.

Science.gov (United States)

Khan, Yasser; Ostfeld, Aminy E; Lochner, Claire M; Pierre, Adrien; Arias, Ana C

2016-06-01

Advances in wireless technologies, low-power electronics, the internet of things, and in the domain of connected health are driving innovations in wearable medical devices at a tremendous pace. Wearable sensor systems composed of flexible and stretchable materials have the potential to better interface to the human skin, whereas silicon-based electronics are extremely efficient in sensor data processing and transmission. Therefore, flexible and stretchable sensors combined with low-power silicon-based electronics are a viable and efficient approach for medical monitoring. Flexible medical devices designed for monitoring human vital signs, such as body temperature, heart rate, respiration rate, blood pressure, pulse oxygenation, and blood glucose have applications in both fitness monitoring and medical diagnostics. As a review of the latest development in flexible and wearable human vitals sensors, the essential components required for vitals sensors are outlined and discussed here, including the reported sensor systems, sensing mechanisms, sensor fabrication, power, and data processing requirements. © 2016 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states

Directory of Open Access Journals (Sweden)

Howard JJ

2014-11-01

Full Text Available Jason J Howard Division of Paediatric Orthopaedics, Department of Surgery, Sidra Medical and Research Center, Doha, Qatar Abstract: With some of the richest economies in the world, the Gulf Cooperation Council (GCC is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states. Keywords: medical devices, regulation, reimbursement, Middle East 

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information*

Science.gov (United States)

Boruff, Jill T.; Storie, Dale

2014-01-01

Objectives: The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. Methods: An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. Results: The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Conclusions: Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Implications: Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes. PMID:24415916

Mobile devices in medicine: a survey of how medical students, residents, and faculty use smartphones and other mobile devices to find information.

Science.gov (United States)

Boruff, Jill T; Storie, Dale

2014-01-01

The research investigated the extent to which students, residents, and faculty members in Canadian medical faculties use mobile devices, such as smartphones (e.g., iPhone, Android, Blackberry) and tablet computers (e.g., iPad), to answer clinical questions and find medical information. The results of this study will inform how health libraries can effectively support mobile technology and collections. An electronic survey was distributed by medical librarians at four Canadian universities to medical students, residents, and faculty members via departmental email discussion lists, personal contacts, and relevant websites. It investigated the types of information sought, facilitators to mobile device use in medical information seeking, barriers to access, support needs, familiarity with institutionally licensed resources, and most frequently used resources. The survey of 1,210 respondents indicated widespread use of smartphones and tablets in clinical settings in 4 Canadian universities. Third- and fourth-year undergraduate students (i.e., those in their clinical clerkships) and medical residents, compared to other graduate students and faculty, used their mobile devices more often, used them for a broader range of activities, and purchased more resources for their devices. Technological and intellectual barriers do not seem to prevent medical trainees and faculty from regularly using mobile devices for their medical information searches; however, barriers to access and lack of awareness might keep them from using reliable, library-licensed resources. Libraries should focus on providing access to a smaller number of highly used mobile resources instead of a huge collection until library-licensed mobile resources have streamlined authentication processes.

Implantable Medical Devices; Networking Security Survey

OpenAIRE

Siamak Aram; Rouzbeh A. Shirvani; Eros G. Pasero; Mohamd F. Chouikha

2016-01-01

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...

Framework conditions and requirements to ensure the technical functional safety of reprocessed medical devices.

Science.gov (United States)

Kraft, Marc

2008-09-03

Testing and restoring technical-functional safety is an essential part of medical device reprocessing. Technical functional tests have to be carried out on the medical device in the course of the validation of reprocessing procedures. These ensure (in addition to the hygiene tests) that the reprocessing procedure is suitable for the medical device. Functional tests are, however, also a part of reprocessing procedures. As a stage in the reprocessing, they ensure for the individual medical device that no damage or other changes limit the performance. When determining which technical-functional tests are to be carried out, the current technological standard has to be taken into account in the form of product-specific and process-oriented norms. Product-specific norms primarily define safety-relevant requirements. The risk management method described in DIN EN ISO 14971 is the basis for recognising hazards; the likelihood of such hazards arising can be minimised through additional technical-functional tests, which may not yet have been standardised. Risk management is part of a quality management system, which must be bindingly certified for manufacturers and processors of critical medical devices with particularly high processing demands by a body accredited by the competent authority.

77 FR 3781 - Pediatric Medical Devices; Public Workshop; Reopening of Comment Period

Science.gov (United States)

2012-01-25

... devices. DATES: Submit either electronic or written comments by March 5, 2012. ADDRESSES: Submit.... Designing pediatric medical devices can be challenging; children are often smaller and more active than adults; body structures and functions change throughout childhood, and children may be long-term device...

A Maturity Grid Assessment Tool for Environmentally Conscious Design in the Medical Device Industry

DEFF Research Database (Denmark)

Moultrie, James; Sutcliffe, Laura Francesca Rose; Maier, Anja

2016-01-01

. This intervention tool provides designers and product marketers with insights on how to improve the design of their medical devices and specifically allows consideration of the complex trade-offs between decisions that influence different life-cycle stages. Through the tool, actionable insight is created......The medical device industry is growing increasingly concerned about environmental impact of products. Whilst there are many tools aiming to support environmentally conscious design, they are typically complex to use, demand substantial data collection and are not tailored to the specific needs...... of the medical device sector. This paper reports on the development of a Maturity Grid to address this gap. This novel design tool was developed iteratively through application in five case studies. The tool captures principles of eco-design for medical devices in a simple form, designed to be used by a team...

Initiatives in the Australian Medical Devices Industry

International Nuclear Information System (INIS)

Whelan, Luke

2005-01-01

The medical device industry is as diverse as it is specialised and calls on the innovative use of design and components and utilises all facets of precision manufacturing from printed circuit boards, injection-moulded plastics to engineering, using a wide range of materials. It generally requires exacting standards, starting with design, particularly for devices that are invasive or have direct contact with the human body. Of course this brings the further consideration of sterilisation and whether it is for single or multiple use. There is an ever-present need to produce more accurate less invasive and cheaper devices. The driving motivation appears to be meeting clinical needs at a reduced cost. The push to treat people outside the hospital is growing, creating new demands and directions. The advent of the Internet and wireless technology has opened a whole new direction of research and development opportunities

78 FR 27971 - Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting

Science.gov (United States)

2013-05-13

...] Dental Products Panel of the Medical Devices Advisory Committee; Notice of Meeting AGENCY: Food and Drug...: Dental Products Panel of the Medical Devices Advisory Committee. General Function of the Committee: To... regulatory classification for dental devices known as Endosseous Dental Implants (Blade-form), one of the...

Antenatal taurine reduces cerebral cell apoptosis in fetal rats with intrauterine growth restriction.

Science.gov (United States)

Liu, Jing; Wang, Xiaofeng; Liu, Ying; Yang, Na; Xu, Jing; Ren, Xiaotun

2013-08-15

From pregnancy to parturition, Sprague-Dawley rats were daily administered a low protein diet to establish a model of intrauterine growth restriction. From the 12(th) day of pregnancy, 300 mg/kg rine was daily added to food until spontaneous delivery occurred. Brain tissues from normal neonatal rats at 6 hours after delivery, neonatal rats with intrauterine growth restriction, and neonatal rats with intrauterine growth restriction undergoing taurine supplement were obtained for further experiments. The terminal deoxyribonucleotidyl transferase (TdT)-mediated biotin-16-dUTP nick-end labeling assay revealed that the number of apoptotic cells in the brain tissue of neonatal rats with intrauterine growth restriction significantly increased. Taurine supplement in pregnant rats reduced cell apoptosis in brain tissue from neonatal rats with intrauterine growth restriction. nohistochemical staining revealed that taurine supplement increased glial cell line-derived neurotrophic factor expression and decreased caspase-3 expression in the cerebral cortex of intrauterine growth-restricted fetal rats. These results indicate that taurine supplement reduces cell apoptosis through the glial cell line-derived neurotrophic factor-caspase-3 signaling pathway, resulting in a protective effect on the intrauterine growth-restricted fetal rat brain.

Biomaterials and medical devices a perspective from an emerging country

CERN Document Server

Hermawan, Hendra

2016-01-01

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...

Additive Manufacturing for Robust and Affordable Medical Devices

OpenAIRE

Wolozny Gomez Robelo, Daniel Andre

2016-01-01

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...

An extended protocol for usability validation of medical devices : Research design and reference model

NARCIS (Netherlands)

Schmettow, M.; Schnittker, R.; Schraagen, J.M.

2017-01-01

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

Distribution of microorganisms in medical devices and their inactivation effects by gamma-irradiation

International Nuclear Information System (INIS)

Ito, Hitoshi; Ishigaki, Isao

1986-01-01

Radiation treatment is getting important position for sterilizing medical devices and for packaging films of foods. Recently, survey of bioburden is an important technique for evaluation of sterility doses for medical devices. However, many studies have been done mainly on the irradiation effects of spore-forming bacteria in medical devices. In this study, radiation sensitivity of spore-forming bacteria and fungi were examined after the survey on distribution of microorganisms in several kinds of medical devices. The main contaminant in disposable syringes, needles and conical flasks were consisted of Bacillus, with lesser amount of Micrococcus, Pseudomonas, Peptococcaceae and fungi as positive of 5 - 60 % in the medical devices which cultivated in thioglycolate broth. Bacillus group were identified as B. pumilus, B. sphaericus, B. coagulans, B. megaterium and etc. Fungi were isolated a lesser amounts compared with spore-forming bacteria and identified as Blastomyces, Penicillium, Haplosporangium, Euricoa and Audeobasidium. Peptococaceae were not isolated after irradiation with a dose of 0.1 Mrad even the samples were contaminated with high percentage. The D 10 values of dryed endospores of Bacillus-isolates which attached to the filter paper with pepton-glycerin were obtained to be 0.11 - 0.19 Mrad. The D 10 values of many isolates of fungi in dry condition were obtained below 0.08 Mrad. However, the isolate of Aureobasidium is radiation-resistant, and it's D 10 values was obtained as 0.28 Mrad under aerobic and anaerobic dry condition. (author)

Medical devices of the head, neck, and spine.

Science.gov (United States)

Hunter, Tim B; Yoshino, Mark T; Dzioba, Robert B; Light, Rick A; Berger, William G

2004-01-01

There are many medical devices used for head, neck, and spinal diseases and injuries, and new devices are constantly being introduced. Many of the newest devices are variations on a previous theme. Knowing the specific name of a device is not important. It is important to recognize the presence of a device and to have an understanding of its function as well as to be able to recognize the complications associated with its use. The article discusses the most common and important devices of the head, neck, and spine, including cerebrospinal fluid shunts and the Codman Hakim programmable valve; subdural drainage catheters, subdural electrodes, intracranial electrodes, deep brain stimulators, and cerebellar electrodes; coils, balloons, adhesives, particles, and aneurysm clips; radiation therapy catheters, intracranial balloons for drug installation, and carmustine wafers; hearing aids, cochlear implants, and ossicular reconstruction prostheses; orbital prostheses, intraocular silicone oil, and lacrimal duct stents; anterior and posterior cervical plates, posterior cervical spine wiring, odontoid fracture fixation devices, cervical collars and halo vests; thoracic and lumbar spine implants, anterior and posterior instrumentation for the thoracic and lumbar spine, vertebroplasty, and artificial disks; spinal column stimulators, bone stimulators, intrathecal drug delivery pumps, and sacral stimulators; dental and facial implant devices; gastric and tracheal tubes; vagus nerve stimulators; lumboperitoneal shunts; and temperature- and oxygen-sensing probes. Copyright RSNA, 2004

Metrological Reliability of Medical Devices

Science.gov (United States)

Costa Monteiro, E.; Leon, L. F.

2015-02-01

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.

Menstrual Concerns and Intrauterine Contraception Among Adolescent Bariatric Surgery Patients

Science.gov (United States)

Miller, Rachel J.; Inge, Thomas H.

2011-01-01

Abstract Objective Adolescent obesity has dramatically increased in recent decades, and along with that so have other medical comorbidities, such as hypertension, diabetes, hyperlipidemia, nonalcoholic steatohepatitis, polycystic ovary syndrome (PCOS), and pseudotumor cerebri. Obesity and related comorbidites may be contraindications to hormonal contraception, making contraception counseling of morbidly obese adolescents more challenging. Obese adolescent females seeking bariatric surgery need effective contraception in the postoperative period. This study is designed to determine the acceptance rate of the levonorgestrel-releasing intrauterine device (IUD) and describe common menstrual problems in obese adolescent bariatric surgery patients. Methods This is a historic cohort study of adolescent females who underwent bariatric surgery over a 2-year period at a tertiary referral center for pediatric obesity. Data were systematically abstracted. The percent of patients with menstrual problems and the acceptance rate for the levonorgestrel-releasing IUD were determined. Results Twenty-five adolescents met inclusion criteria. The mean age was 17.4 years (standard deviation [SD] 2.6), and the mean body mass index (BMI) was 51.4 (SD 6.3) kg/m2. Eighty-four percent were white. Twenty-eight percent had menorrhagia, 32% had oligomenorrhea, 40% had dysmenorrhea, and 36% had PCOS. Ninety-two percent (23 of 25) underwent IUD placement. Conclusions There was a high prevalence of menstrual problems among this sample of severely obese adolescent females. The majority accepted the IUD, indicating it is a viable option among this population. PMID:21413894

Early-stage valuation of medical devices: the role of developmental uncertainty.

Science.gov (United States)

Girling, Alan; Young, Terry; Brown, Celia; Lilford, Richard

2010-08-01

At the concept stage, many uncertainties surround the commercial viability of a new medical device. These include the ultimate functionality of the device, the cost of producing it and whether, and at what price, it can be sold to a health-care provider (HCP). Simple assessments of value can be made by estimating such unknowns, but the levels of uncertainty may mean that their operational value for investment decisions is unclear. However, many decisions taken at the concept stage are reversible and will be reconsidered later before the product is brought to market. This flexibility can be exploited to enhance early-stage valuations. To develop a framework for valuing a new medical device at the concept stage that balances benefit to the HCP against commercial costs. This is done within a simplified stage-gated model of the development cycle for new products. The approach is intended to complement existing proposals for the evaluation of the commercial headroom available to new medical products. A model based on two decision gates can lead to lower bounds (underestimates) for product value that can serve to support a decision to develop the product. Quantifiable uncertainty that can be resolved before the device is brought to market will generally enhance early-stage valuations of the device, and this remains true even when some components of uncertainty cannot be fully described. Clinical trials and other evidence-gathering activities undertaken as part of the development process can contribute to early-stage estimates of value.

75 FR 18219 - Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and...

Science.gov (United States)

2010-04-09

... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0142] Drug and Medical Device Forum on Food and Drug Administration Drug and Device Requirements and Supplier Controls; Public Educational Forum AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public...

Design of point-of-care (POC) microfluidic medical diagnostic devices

Science.gov (United States)

Leary, James F.

2018-02-01

Design of inexpensive and portable hand-held microfluidic flow/image cytometry devices for initial medical diagnostics at the point of initial patient contact by emergency medical personnel in the field requires careful design in terms of power/weight requirements to allow for realistic portability as a hand-held, point-of-care medical diagnostics device. True portability also requires small micro-pumps for high-throughput capability. Weight/power requirements dictate use of super-bright LEDs and very small silicon photodiodes or nanophotonic sensors that can be powered by batteries. Signal-to-noise characteristics can be greatly improved by appropriately pulsing the LED excitation sources and sampling and subtracting noise in between excitation pulses. The requirements for basic computing, imaging, GPS and basic telecommunications can be simultaneously met by use of smartphone technologies, which become part of the overall device. Software for a user-interface system, limited real-time computing, real-time imaging, and offline data analysis can be accomplished through multi-platform software development systems that are well-suited to a variety of currently available cellphone technologies which already contain all of these capabilities. Microfluidic cytometry requires judicious use of small sample volumes and appropriate statistical sampling by microfluidic cytometry or imaging for adequate statistical significance to permit real-time (typically medical decisions for patients at the physician's office or real-time decision making in the field. One or two drops of blood obtained by pin-prick should be able to provide statistically meaningful results for use in making real-time medical decisions without the need for blood fractionation, which is not realistic in the field.

#DDOD Use Case: Consolidated reporting of medical device recalls

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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...

A service protocol for post-processing of medical images on the mobile device

Science.gov (United States)

He, Longjun; Ming, Xing; Xu, Lang; Liu, Qian

2014-03-01

With computing capability and display size growing, the mobile device has been used as a tool to help clinicians view patient information and medical images anywhere and anytime. It is uneasy and time-consuming for transferring medical images with large data size from picture archiving and communication system to mobile client, since the wireless network is unstable and limited by bandwidth. Besides, limited by computing capability, memory and power endurance, it is hard to provide a satisfactory quality of experience for radiologists to handle some complex post-processing of medical images on the mobile device, such as real-time direct interactive three-dimensional visualization. In this work, remote rendering technology is employed to implement the post-processing of medical images instead of local rendering, and a service protocol is developed to standardize the communication between the render server and mobile client. In order to make mobile devices with different platforms be able to access post-processing of medical images, the Extensible Markup Language is taken to describe this protocol, which contains four main parts: user authentication, medical image query/ retrieval, 2D post-processing (e.g. window leveling, pixel values obtained) and 3D post-processing (e.g. maximum intensity projection, multi-planar reconstruction, curved planar reformation and direct volume rendering). And then an instance is implemented to verify the protocol. This instance can support the mobile device access post-processing of medical image services on the render server via a client application or on the web page.

A new after-loading intrauterine packing device: ten years experience.

Science.gov (United States)

Sklaroff, D M; Baker, A S; Tasbas, M

1985-12-01

A new variation of the uterine packing device for the treatment of endometrial carcinoma is described. It combines the advantages of the Holter technique with the after-loading method described by Simon. This device has been in use for more than 10 years and has been found most satisfactory.

[Hospital-based health technology assessment in France: how to proceed to evaluate innovative medical devices?].

Science.gov (United States)

Martelli, N; van den Brink, H; Denies, F; Dervaux, B; Germe, A F; Prognon, P; Pineau, J

2014-01-01

Innovative medical devices offer solutions to medical problems and greatly improve patients' outcomes. Like National Health Technology Assessment (HTA) agencies, hospitals face numerous requests for innovative and costly medical devices. To help local decision-makers, different approaches of hospital-based HTA (HB-HTA) have been adopted worldwide. The objective of the present paper is to explore HB-HTA models for adopting innovative medical devices in France and elsewhere. Four different models have been conceptualized: "ambassador" model, "mini-HTA" model, "HTA unit" model and "internal committee". Apparently, "HTA unit" and "internal committee" (or a mixture of both models) are the prevailing HB-HTA models in France. Nevertheless, some weaknesses of these models have been pointed out in previous works. Only few examples involving hospital pharmacists have been found abroad, except in France and in Italy. Finally, the harmonization of the assessment of innovative medical devices in France needs a better understanding of HB-HTA practices. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

Adverse Intrauterine Environment and Cardiac miRNA Expression

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Mitchell C. Lock

2017-12-01

Full Text Available Placental insufficiency, high altitude pregnancies, maternal obesity/diabetes, maternal undernutrition and stress can result in a poor setting for growth of the developing fetus. These adverse intrauterine environments result in physiological changes to the developing heart that impact how the heart will function in postnatal life. The intrauterine environment plays a key role in the complex interplay between genes and the epigenetic mechanisms that regulate their expression. In this review we describe how an adverse intrauterine environment can influence the expression of miRNAs (a sub-set of non-coding RNAs and how these changes may impact heart development. Potential consequences of altered miRNA expression in the fetal heart include; Hypoxia inducible factor (HIF activation, dysregulation of angiogenesis, mitochondrial abnormalities and altered glucose and fatty acid transport/metabolism. It is important to understand how miRNAs are altered in these adverse environments to identify key pathways that can be targeted using miRNA mimics or inhibitors to condition an improved developmental response.

Pediatric medical device development by surgeons via capstone engineering design programs.

Science.gov (United States)

Sack, Bryan S; Elizondo, Rodolfo A; Huang, Gene O; Janzen, Nicolette; Espinoza, Jimmy; Sanz-Cortes, Magdalena; Dietrich, Jennifer E; Hakim, Julie; Richardson, Eric S; Oden, Maria; Hanks, John; Haridas, Balakrishna; Hury, James F; Koh, Chester J

2018-03-01

There is a need for pediatric medical devices that accommodate the unique physiology and anatomy of pediatric patients that is increasingly receiving more attention. However, there is limited literature on the programs within children's hospitals and academia that can support pediatric device development. We describe our experience with pediatric device design utilizing collaborations between a children's hospital and two engineering schools. Utilizing the academic year as a timeline, unmet pediatric device needs were identified by surgical faculty and matched with an engineering mentor and a team of students within the Capstone Engineering Design programs at two universities. The final prototypes were showcased at the end of the academic year and if appropriate, provisional patent applications were filed. All twelve teams successfully developed device prototypes, and five teams obtained provisional patents. The prototypes that obtained provisional patents included a non-operative ureteral stent removal system, an evacuation device for small kidney stone fragments, a mechanical leech, an anchoring system of the chorio-amniotic membranes during fetal surgery, and a fetal oxygenation monitor during fetoscopic procedures. Capstone Engineering Design programs in partnership with surgical faculty at children's hospitals can play an effective role in the prototype development of novel pediatric medical devices. N/A - No clinical subjects or human testing was performed. Copyright © 2017 Elsevier Inc. All rights reserved.

Wireless communication with implanted medical devices using the conductive properties of the body.

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Ferguson, John E; Redish, A David

2011-07-01

Many medical devices that are implanted in the body use wires or wireless radiofrequency telemetry to communicate with circuitry outside the body. However, the wires are a common source of surgical complications, including breakage, infection and electrical noise. In addition, radiofrequency telemetry requires large amounts of power and results in low-efficiency transmission through biological tissue. As an alternative, the conductive properties of the body can be used to enable wireless communication with implanted devices. In this article, several methods of intrabody communication are described and compared. In addition to reducing the complications that occur with current implantable medical devices, intrabody communication can enable novel types of miniature devices for research and clinical applications.

Low Cost, Simple, Intrauterine Insemination Procedure

African Journals Online (AJOL)

AJRH Managing Editor

quite simple intrauterine insemination technique which may be performed in developing countries, without the need of sophisticated ... Cytoplasmic Sperm Injection (ICSI), are quite ... were administered only once by intramuscular injection ...

Premature delivery due to intrauterine Candida infection that caused neonatal congenital cutaneous candidiasis: a case report.

Science.gov (United States)

Ito, Fumitake; Okubo, Tomoharu; Yasuo, Tadahiro; Mori, Taisuke; Iwasa, Koichi; Iwasaku, Kazuhiro; Kitawaki, Jo

2013-01-01

Congenital cutaneous candidiasis is a very rare disease with less than 100 cases published in the medical literature. Neonates having this disease present with systemic skin lesions caused by intrauterine Candida infections. We present a case of threatened premature delivery due to Candida chorioamnionitis, which caused both maternal postpartum endometritis and neonatal congenital cutaneous candidiasis. A 34-year-old woman who was admitted for fetal membrane bulging at 20 weeks of gestation underwent McDonald cervical cerclage. We diagnosed threatened premature delivery due to intrauterine infection; therefore, we terminated the gestation by cesarean section at 24 weeks of gestation. Fungi-like yeast was detected in infantile gastric juice. Histopathological findings of the placenta revealed that Candida albicans mycelium invaded the placenta, chorioamniotic membrane and umbilical cord. © 2012 The Authors. Journal of Obstetrics and Gynaecology Research © 2012 Japan Society of Obstetrics and Gynecology.

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey.

Science.gov (United States)

Ross, Joseph S; Blount, Katrina L; Ritchie, Jessica D; Hodshon, Beth; Krumholz, Harlan M

2015-01-01

In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA) to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA) pathway. We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%), nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives.

78 FR 35940 - Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft...

Science.gov (United States)

2013-06-14

...] Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Draft Guidance for... draft guidance entitled ``Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.'' This guidance identifies cybersecurity issues that manufacturers should consider in preparing...

Maternal morbidity and mortality associated with delivery after intrauterine death

International Nuclear Information System (INIS)

Ifnan, F.; Jameel, M.B.

2006-01-01

To determine the maternal morbidity and mortality associated with delivery after intrauterine fetal death (IUFD) and to find out the place of fetal destructive procedures and cesarean section. All women were included in the present study who presented before the onset of labour pains, after intrauterine fetal death at 26 weeks or onward with singleton pregnancy. Assessment of maternal demographic characteristics, gestational age at fetal demise, delivery-IUFD interval, mode of delivery; vaginal with or without fetal destructive procedures/cesarean section and maternal complications were the main outcome measures. There were 1834 live birth and 63 deliveries with intrauterine fetal death. Mode of delivery was vaginal in 87.4% and cesarean section in 12.6% of the cases. Twelve (21%) of the vaginal deliveries were complicated by lower urogenital tract injuries in certain cases, whereas 75% (6/8) of patients delivered by cesarean section developed major postoperative complications like postpartum haemorrhage, shock, endometritis, peritonitis and wound dehiscence. No maternal death was identified. Rate of delivery with intrauterine fetal death was 34.3/1000 live-birth deliveries. (author)

Patient knowledge and intention to use the intrauterine contraceptive device IUCD at a tertiary level hospital

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Nadia van der Westhuizen

2016-12-01

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. 

Wireless energy transfer platform for medical sensors and implantable devices.

Science.gov (United States)

Zhang, Fei; Hackworth, Steven A; Liu, Xiaoyu; Chen, Haiyan; Sclabassi, Robert J; Sun, Mingui

2009-01-01

Witricity is a newly developed technique for wireless energy transfer. This paper presents a frequency adjustable witricity system to power medical sensors and implantable devices. New witricity resonators are designed for both energy transmission and reception. A prototype platform is described, including an RF power source, two resonators with new structures, and inductively coupled input and output stages. In vitro experiments, both in open air and using a human head phantom consisting of simulated tissues, are employed to verify the feasibility of this platform. An animal model is utilized to evaluate in vivo energy transfer within the body of a laboratory pig. Our experiments indicate that witricity is an effective new tool for providing a variety of medical sensors and devices with power.

BORDERLINE AND CLASSIFICATION IN THE COMMUNITY REGULATORY FRAMEWORK FOR MEDICAL DEVICES – BRIEF REVIEW ON SOME DENTISTRY PRODUCTS.

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Maya Lyapina

2015-02-01

Full Text Available Defining a given product as a medical device and interpretation of the application of the classification rules fall within the competence of the competent authorities of the Member States where the product is on the market. Different interpretations of Community legislation occur, and, can put public health at risk and distort the internal market. Borderline cases are considered to be those cases where it is not clear from the outset whether a given product is a medical device, an in vitro diagnostic medical device, an active implantable medical device or not. Classification cases can be described as those cases where there exists a difficulty in the uniform application of the classification rules as laid down in the Medical Devices Directive (MDD, or where for a given device, depending on interpretation of the rules, different classifications can occur. The aim of the present work is to make a brief review on discussion on classification in the community regulatory framework for medical devices of some dentistry products.

The Biological Responses to Magnesium-Based Biodegradable Medical Devices

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Lumei Liu

2017-11-01

Full Text Available The biocompatibility of Magnesium-based materials (MBMs is critical to the safety of biodegradable medical devices. As a promising metallic biomaterial for medical devices, the issue of greatest concern is devices’ safety as degrading products are possibly interacting with local tissue during complete degradation. The aim of this review is to summarize the biological responses to MBMs at the cellular/molecular level, including cell adhesion, transportation signaling, immune response, and tissue growth during the complex degradation process. We review the influence of MBMs on gene/protein biosynthesis and expression at the site of implantation, as well as throughout the body. This paper provides a systematic review of the cellular/molecular behavior of local tissue on the response to Mg degradation, which may facilitate a better prediction of long-term degradation and the safe use of magnesium-based implants through metal innovation.

Communication during pediatric asthma visits and child asthma medication device technique 1 month later.

Science.gov (United States)

Sleath, Betsy; Carpenter, Delesha M; Ayala, Guadalupe X; Williams, Dennis; Davis, Stephanie; Tudor, Gail; Yeatts, Karin; Gillette, Chris

2012-11-01

This study investigated how provider demonstration of and assessment of child use of asthma medication devices and certain aspects of provider-patient communication during medical visits is associated with device technique 1 month later. Two hundred and ninety-six children aged 8-16 years with persistent asthma and their caregivers were recruited at five North Carolina pediatric practices. All of the medical visits were audio-tape recorded. Children were interviewed 1 month later and their device technique was observed and rated. If the provider asked the child to demonstrate metered dose inhaler technique during the medical visit, then the child was significantly more likely to perform a greater percentage of inhaler steps correctly 1 month later. Children with higher asthma management self-efficacy scores were significantly more likely to perform a greater percentage of diskus steps correctly. Additionally, children were significantly more likely to perform a greater percentage of diskus steps correctly if the provider discussed a written action plan during the visit. Children were significantly more likely to perform a greater percentage of turbuhaler steps correctly if they asked more medication questions. Providers should ask children to demonstrate their inhaler technique during medical visits so that they can educate children about proper technique and improve child asthma management self-efficacy. Providers should encourage children to ask questions about asthma medication devices during visits and they should discuss asthma action plans with families.

French Sizing of Medical Devices is not Fit for Purpose

International Nuclear Information System (INIS)

Kibriya, Nabil; Hall, Rebecca; Powell, Steven; How, Thien; McWilliams, Richard G.

2013-01-01

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

77 FR 38177 - TRICARE; Off-Label Uses of Devices; Partial List of Examples of Unproven Drugs, Devices, Medical...

Science.gov (United States)

2012-06-27

... drugs, devices, and medical treatments or procedures and adding the TRICARE definition of unlabeled or... labeling. We are now modifying the definition of ``unlabeled or off-label drug'' to ``off-label use of a... reference back to the definition of the term in 199.2. ``Off-label uses of drugs and devices'' includes off...

75 FR 20854 - Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of...

Science.gov (United States)

2010-04-21

...] Medical Device Use in the Home Environment: Implications for the Safe and Effective Use of Medical Device... related to the safe and effective use of medical device technology in the home environment. The workshop... the home environment. FDA will solicit feedback on: 1. The agency's current working definition of...

Maternal determinants of intrauterine growth restriction in Goa, India: a case-control study

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DD Motghare

2014-01-01

Full Text Available Objective: To study the maternal determinants of intrauterine growth restriction. Methods: A case-control study was conducted at a tertiary care Hospital in the year 2009. Ninety eight cases of intrauterine growth restriction were compared to 98 controls, matched for newborns sex and type of delivery. Data was collected by interviewing the mother using a structured pretested schedule and perusal of antenatal records. Intrauterine growth restriction was defined as occurring if birth weight of the newborn is below 10th percentile for gestational age on the intrauterine growth curve. Data was analyzed using SPSS software version 17 package. Percentages, odds ratios with 95% CI and multiple logistic regression analysis were used wherever appropriate. Results: Maternal age, education, socioeconomic status and number of antenatal visits were found to be the significant socio-demographic factors associated with Intrauterine growth restriction while, maternal height, parity, previous spontaneous abortion, direct obstetric morbidity, indirect obstetric morbidity and anemia were the maternal biological factors found to be significantly associated on bivariate analysis. Multiple logistic regression analysis identified parity, previous spontaneous abortion, direct obstetric morbidity, indirect obstetric morbidity and antenatal visits as significant maternal determinants of intrauterine growth restriction. Conclusions: A focus on good antenatal care, especially on high risk pregnancies would go a long way in reducing the problem of intrauterine growth restriction in the community thereby ensuring a safe and healthy future for our youngest generation.

Effects of intrauterine infusion of Escherichia coli lipopolysaccharide on uterine health, resolution of purulent vaginal discharge, and reproductive performance of lactating dairy cows.

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Moraes, João G N; Silva, Paula R B; Mendonça, Luís G D; Scanavez, Alexandre A; Silva, Joseane C C; Chebel, Ricardo C

2017-06-01

The objectives of the current experiment were to evaluate the effects of intrauterine infusion of Escherichia coli lipopolysaccharide (LPS) in cows diagnosed with purulent vaginal discharge (PVD) on intrauterine cell population, resolution of PVD, uterine health, and reproductive performance. Jersey cows (n = 3,084) were examined using the Metricheck device to diagnose PVD at 35 ± 6 d postpartum. Purulent vaginal discharge was defined as the presence of purulent (≥50% pus) discharge detectable in the vagina. Of the 310 cows positive for PVD, 267 cows were enrolled in the current experiment. To ensure proper timing of treatment and collection of samples, only 9 PVD-positive cows were treated per day. Selected cows were balanced at 35 ± 6 d postpartum for lactation number, body condition score, and milk yield and were randomly assigned to receive an intrauterine infusion of 20 mL of phosphate-buffered saline (PBS; control, n = 87), 20 mL of PBS with 150 µg LPS (LPS150, n = 91), or 20 mL of PBS with 300 µg of LPS (LPS300, n = 89). Uterine cytology was performed immediately before treatment and 1, 2, and 7 d after treatment to evaluate the effect of LPS treatment on intrauterine cell population. Cows were examined with the Metricheck device at 7 and 28 d after treatment to evaluate the effects of treatment on resolution of PVD. Reproductive status was recorded up to 200 d postpartum. Cows diagnosed with PVD had greater incidence of twinning, dystocia, retained placenta, and metritis after calving than cows without PVD. Count of polymorphonuclear leukocytes (PMNL) in uterine cytology 1, 2, and 7 d after intrauterine infusion was not statistically different among treatments. From d 0 to 1, however, PMNL count in uterine cytology of PBS cows increased by 5%, whereas the PMNL count in uterine cytology of LPS150 and LPS300 cows increased by 54 and 48%, respectively. Treatment did not affect the likelihood of cows being diagnosed with PVD 7 and 28 d after intrauterine

Intrauterine adhesions as a risk factor for failed first-trimester pregnancy termination.

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Luk, Janelle; Allen, Rebecca H; Schantz-Dunn, Julianna; Goldberg, Alisa B

2007-10-01

Risk factors for failed first-trimester surgical abortion include endometrial distortion caused by leiomyomas, uterine anomalies and malposition and cervical stenosis. This report introduces intrauterine adhesions as an additional risk factor. A multiparous woman presented for pregnancy termination at 6 weeks' gestation. Three suction-curettage attempts failed to remove what appeared to be an intrauterine pregnancy. Rising beta-hCG levels and concern for an interstitial ectopic pregnancy prompted a diagnostic laparoscopy and exploratory laparotomy without the identification of an ectopic pregnancy. After methotrexate treatment failed, the patient underwent ultrasound-guided hysteroscopy and suction curettage using a cannula with a whistle-cut aperture for the successful removal of a pregnancy implanted behind intrauterine adhesions. Intrauterine adhesions are a cause of failed surgical abortion. Ultrasound-guided hysteroscopy may be required for diagnosis.

Medical devices and the Middle East: market, regulation, and reimbursement in Gulf Cooperation Council states.

Science.gov (United States)

Howard, Jason J

2014-01-01

With some of the richest economies in the world, the Gulf Cooperation Council (GCC) is undergoing rapid growth not only in its population but also in health care expenditure. Despite the GCC's abundance of hydrocarbon-based wealth, the drivers of the medical device industry in the GCC are still in flux, with gains yet to be made in areas of infrastructure, regulation, and reimbursement. However, the regional disease burden, expanding health insurance penetration, increasing privatization, and a desire to attract skilled expatriate health care providers have led to favorable conditions for the medical device market in the GCC. The purpose of this article is to investigate the current state of the GCC medical device industry, with respect to market, regulation, and reimbursement, paying special attention to the three largest medical device markets: Saudi Arabia, the United Arab Emirates, and Qatar. The GCC would seem to represent fertile ground for the development of medical technologies, especially those in line with the regional health priorities of the respective member states.

Medical Device-Associated Candida Infections in a Rural Tertiary Care Teaching Hospital of India

Directory of Open Access Journals (Sweden)

Sachin C. Deorukhkar

2016-01-01

Full Text Available Health care associated infections (HCAIs add incrementally to the morbidity, mortality, and cost expected of the patient’s underlying diseases alone. Approximately, about half all cases of HCAIs are associated with medical devices. As Candida medical device-associated infection is highly drug resistant and can lead to serious life-threatening complications, there is a need of continuous surveillance of these infections to initiate preventive and corrective measures. The present study was conducted at a rural tertiary care hospital of India with an aim to evaluate the rate of medical device-associated Candida infections. Three commonly encountered medical device-associated infections (MDAI, catheter-associated urinary tract infection (CA-UTI, intravascular catheter-related blood stream infections (CR-BSI, and ventilator-associated pneumonia (VAP, were targeted. The overall rate of MDAI in our hospital was 2.1 per 1000 device days. The rate of Candida related CA-UTI and CR-BSI was noted as 1.0 and 0.3, respectively. Untiring efforts taken by team members of Hospital Acquired Infection Control Committee along with maintenance of meticulous hygiene of the hospital and wards may explain the low MDAI rates in our institute. The present surveillance helped us for systematic generation of institutional data regarding MDAI with special reference to role of Candida spp.

Compiling a Medical Device File and a Proposal for an International Standard for Rehabilitation Robots

NARCIS (Netherlands)

Römer, GertWillem R.B.E.; Stuyt, Harry J.A.

2007-01-01

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

78 FR 56719 - Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of...

Science.gov (United States)

2013-09-13

...] Challenging Regulatory and Reimbursement Paradigms for Medical Devices in the Treatment of Metabolic Diseases... announcing a public workshop entitled ``Changing Regulatory and Reimbursement Paradigms for Medical Devices... registration information on the AGA Web site. If you need special accommodations due to a disability, please...

Medical Device Integrated Vital Signs Monitoring Application with Real-Time Clinical Decision Support.

Science.gov (United States)

Moqeem, Aasia; Baig, Mirza; Gholamhosseini, Hamid; Mirza, Farhaan; Lindén, Maria

2018-01-01

This research involves the design and development of a novel Android smartphone application for real-time vital signs monitoring and decision support. The proposed application integrates market available, wireless and Bluetooth connected medical devices for collecting vital signs. The medical device data collected by the app includes heart rate, oxygen saturation and electrocardiograph (ECG). The collated data is streamed/displayed on the smartphone in real-time. This application was designed by adopting six screens approach (6S) mobile development framework and focused on user-centered approach and considered clinicians-as-a-user. The clinical engagement, consultations, feedback and usability of the application in the everyday practices were considered critical from the initial phase of the design and development. Furthermore, the proposed application is capable to deliver rich clinical decision support in real-time using the integrated medical device data.

Intra-uterine hematoma in pregnancy

DEFF Research Database (Denmark)

Glavind, K; Nøhr, S; Nielsen, P H

1991-01-01

In 60 patients with a live fetus and an intra-uterine hematoma (IUH) proven by ultrasonic scanning the outcome of pregnancy was spontaneous abortion in 12% and premature delivery in 10%. No correlation between the outcome of the pregnancy and the maximum size of the hematoma or the week...

Radiation as a microbiological contamination control of drugs, cosmetics and medical devices

International Nuclear Information System (INIS)

Ishizeki, Chuichi

1985-01-01

This paper deals with current status of radiation sterilization or disinfection of drugs, cosmetics, their materials, and medical devices, and with quality control as a tool for securing microbiological safety, especially current status of sterilization tests. Ointment containing tetracyclin, steroid hormones, gelatin, and enzymes are presented as drug samples to be irradiated, and explanations for radiation sterilization of these drugs are provided. An outline of the application of radiation in cosmetics and medical devices is given. Issues are also provided from the viewpoint of safey and effectiveness of radiation sterilization. (Namekawa, K.)

Intrauterine Cannabis Exposure Affects Fetal Growth Trajectories: The Generation R Study

Science.gov (United States)

El Marroun, Hanan; Tiemeier, Henning; Steegers, Eric A. P.; Jaddoe, Vincent W. V.; Hofman, Albert; Verhulst, Frank C.; van den Brink, Wim; Huizink, Anja C.

2009-01-01

Objective: Cannabis is the most commonly consumed illicit drug among pregnant women. Intrauterine exposure to cannabis may result in risks for the developing fetus. The importance of intrauterine growth on subsequent psychological and behavioral child development has been demonstrated. This study examined the relation between maternal cannabis use…

Limited Awareness of the Essences of Certification or Compliance Markings on Medical Devices.

Science.gov (United States)

Foo, Jong Yong Abdiel; Tan, Xin Ji Alan

2017-06-01

Medical devices have been long used for odiagnostic, therapeutic or rehabilitation purposes. Currently, they can range from a low-cost portable device that is often used for personal health monitoring to high-end sophisticated equipment that can only be operated by trained professionals. Depending on the functional purposes, there are different certification or compliance markings on the device when it is sold. One common certification marking is the Conformité Européenne affixation but this has a range of certification mark numbering for a variety of functional purposes. While the regulators and medical device manufacturers understand the associated significance and clinical implications, these may not be apparent to the professionals (using or maintaining the device) and the general public. With portable healthcare devices and mobile applications gaining popularity, better awareness of certification marking will be needed. Particularly, there are differences in the allowed functional purposes and the associated cost derivations of devices with a seemingly similar nature. A preferred approach such as an easy-to-understand notation next to any certification marking on a device can aid in differentiation without the need to digest mountainous regulatory details.

Feasibility of energy harvesting techniques for wearable medical devices.

Science.gov (United States)

Voss, Thaddaeus J; Subbian, Vignesh; Beyette, Fred R

2014-01-01

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.

Dosimetric studies for gamma radiation validation of medical devices

International Nuclear Information System (INIS)

Soliman, Y.S.; Beshir, W.B.; Abdel-Fattah, A.A.; Abdel-Rehim, F.

2013-01-01

The delivery and validation of a specified dose to medical devices are key concerns to operators of gamma radiation facilities. The objective of the present study was to characterize the industrial gamma radiation facility and map the dose distribution inside the product-loading pattern during the validation and routine control of the sterilization process using radiochromic films. Cardboard phantoms were designed to achieve the homogeneity of absorbed doses. The uncertainty of the dose delivered during validation of the sterilization process was assessed. - Highlights: ► Using γ-rays for sterilization of hollow fiber dialyzers and blood tubing sets according to ISO 11137, 2006. ► Dosimetry studies of validations of γ-irradiation facility and sterilized medical devices. ► Places of D min and D max have been determined using FWT-60 films. ► Determining the target minimum doses required to meet the desired SAL of 10 −6 for the two products.

Methodological issues underlying multiple decrement life table analysis.

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Mode, C J; Avery, R C; Littman, G S; Potter, R G

1977-02-01

In this paper, the actuarial method of multiple decrement life table analysis of censored, longitudinal data is examined. The discussion is organized in terms of the first segment of usage of an intrauterine device. Weaknesses of the actuarial approach are pointed out, and an alternative approach, based on the classical model of competing risks, is proposed. Finally, the actuarial and the alternative method of analyzing censored data are compared, using data from the Taichung Medical Study on Intrauterine Devices.

Clinical and Demographic Characteristics of Women with Intrauterine Adhesion in Abuja, Nigeria

Directory of Open Access Journals (Sweden)

Efena R. Efetie

2012-01-01

Full Text Available Objective. Infertility menstrual abnormalities continue to constitute a significant bulk of gynecological consultation in Africa. Both of these problems are sometimes traced to intrauterine adhesions which are preventable in the majority of cases. Study Design. A retrospective analysis of intrauterine adhesions at the National Hospital Abuja, Nigeria, was carried out, covering the period from 1st September 1999 to 1st September 2004. A total of 72 cases were analyzed. Statical analysis was done using 2. Results. The incidence of intrauterine adhesions was 1.73% of new patients. Mean age ± SD was 29.97±4.82 years. Patients who were Para 0 to 1 constituted 81.9% of the total. Intrauterine adhesions significantly (<0.02 occurred in nulliparae. The majority (68% were educated only up to secondary level which was significant (<0.05. Menstrual abnormalities were present in 90.3%. The commonest predisposing factor identified was a history of dilatation and curettage or uterine evacuation. Conclusion. Intrauterine adhesions are associated with lower educational status and low parity. Increasing educational targets nationally, poverty alleviation, nationwide retraining in manual vacuum aspiration, and wider application of this technique are recommended.

Field Safety Notes in Product Problems of Medical Devices for Use in Pulmonology.

Science.gov (United States)

Hannig, Jürgen; Siekmeier, Rüdiger

2015-01-01

The current European system for medical devices is governed by three EC directives: the Medical Device Directive 93/42/EEC, the In-Vitro Diagnostic Directive 98/79/EC and the Active Implantable Medical Device Directive 90/385/EEC and regulates marketing and post-market surveillance of medical devices in the European Economic Area. In cases of incidents and field safety corrective actions (FSCA) manufacturers have to inform the responsible Competent Authority, which is the Federal Institute for Drugs and Medical Devices (BfArM) and the public by field safety notices (FSN). In this study we analyzed FSN of medical devices exclusively serving for diagnostics or treatment in pulmonology (e.g. nebulizers, oxygen concentrators, pulse oximeters, lung function analyzers, and non-active devices for treatment). FSCA and FSN publicized by BfArM in 2005-2013 were analyzed in respect to the MEDDEV 2.12-1 rev 8. In total 41 FSCA were publicized for the included products. German and English FSN were found in 36/35 cases, respectively. FSN were clearly characterized as FSN in 22/20 cases and declaration of the type of action was found in 27/26 cases, respectively. Product names were provided in all cases. Lot numbers or other information for product characterization were available in 7/8 and 26/24 cases, respectively. Detailed information regarding FSCA and product malfunction were found in 27/33 and 36/35 cases, respectively. Information on product related risks with previous use of the affected product was provided in 24/23 cases. In 34/34 cases manufacturers provided information to mitigate product related risks. Requests to pass FSN to persons needing awareness were found in 10/14 cases. Contact data were provided in 30/30 cases. Confirmation that the Competent Authority was informed was found in 12/14 cases and in 19/18 cases a customer confirmation was included. The obtained data suggest that there is an increasing annual number of FSCA and most FSN fulfill the criteria of

Carbamazepine

Science.gov (United States)

... Adasuve); certain medications to treat malaria such as chloroquine (Aralen) and mefloquine ; medications for anxiety or mental ... pills, patches, rings, injections, implants, or intrauterine devices). Use another form of birth control while taking carbamazepine. ...

Knowledge and perceptions of the intrauterine device among family planning providers in Nepal: a cross-sectional analysis by cadre and sector.

Science.gov (United States)

Chakraborty, Nirali M; Murphy, Caitlin; Paudel, Mahesh; Sharma, Sriju

2015-01-28

Nepal has high unmet need for family planning and low use of intrauterine devices (IUDs). While clients' attitudes toward the IUD are known in a variety of contexts, little is known about providers' knowledge and perceptions of the IUD in developing countries. Nepal's liberal IUD service provision policies allow the opportunity to explore provider knowledge and perceptions across cadres and sectors. This research contributes to an understanding of providers' IUD perceptions in low-resource environments, and increases evidence for IUD task-sharing and private sector involvement. A questionnaire was administered to 345 nurses and auxiliary nurse midwives (ANMs) affiliated with the private Mahila Swastha Sewa (MSS) franchise, public sector, or private non-franchise sector. All providers had been trained in TCu 380A IUD insertion and removal. The questionnaire captured providers' IUD experience, knowledge, and perceived barriers to recommendation. Descriptive, multivariate linear, and multinomial logistic regression was conducted, comparing providers between cadre and sector. On average, providers answered 21.5 of 35 questions correctly, for a score of 61.4%. Providers scored the lowest on IUD medical eligibility, answering 5.9 of 14 questions correctly. Over 50% of providers were able to name the four side effects most frequently associated with the IUD; however, one-third of all providers found at least one of these side effects unacceptable. Adjusted results show that cadre does not significantly impact provider's IUD knowledge scores or side effect perceptions. Public sector affiliation was associated with higher knowledge scores regarding personal characteristic eligibility and more negative perceptions of two normal IUD side effects. IUD knowledge is significantly associated with provider's recent training and employment at multiple facilities, and side effect perceptions are significantly associated with client volume, range of family planning methods, and

Intrauterine exposure to tobacco and executive functioning in high school.

Science.gov (United States)

Rose-Jacobs, Ruth; Richardson, Mark A; Buchanan-Howland, Kathryn; Chen, Clara A; Cabral, Howard; Heeren, Timothy C; Liebschutz, Jane; Forman, Leah; Frank, Deborah A

2017-07-01

Executive functioning (EF), an umbrella construct encompassing gradual maturation of cognitive organization/management processes, is important to success in multiple settings including high school. Intrauterine tobacco exposure (IUTE) correlates with negative cognitive/behavioral outcomes, but little is known about its association with adolescent EF and information from real-life contexts is sparse. We evaluated the impact of IUTE on teacher-reported observations of EF in urban high school students controlling for covariates including other intrauterine and adolescent substance exposures. A prospective low-income birth cohort (51% male; 89% African American/Caribbean) was followed through late adolescence (16-18 years old). At birth, intrauterine exposures to cocaine and other substances (52% cocaine, 52% tobacco, 26% marijuana, 26% alcohol) were identified by meconium and/or urine assays, and/or maternal self-report. High school teachers knowledgeable about the student and unaware of study aims were asked to complete the Behavior Rating Inventory of Executive Functioning-Teacher Form (BRIEF-TF) annually. Teachers completed at least one BRIEF-TF for 131 adolescents. Multivariable analyses included controls for: demographics; intrauterine cocaine, marijuana, and alcohol exposures; early childhood exposures to lead; and violence exposure from school-age to adolescence. IUTE was associated with less optimal BRIEF-TF Behavioral Regulation scores (p <0.05). Other intrauterine substance exposures did not predict less optimal BRIEF-TF scores, nor did exposures to violence, lead, nor adolescents' own substance use. IUTE is associated with offspring's less optimal EF. Prenatal counseling should emphasize abstinence from tobacco, as well as alcohol and illegal substances. Copyright © 2017 Elsevier B.V. All rights reserved.

BioInnovate Ireland--fostering entrepreneurial activity through medical device innovation training.

Science.gov (United States)

Bruzzi, M S; Linehan, J H

2013-09-01

In the midst of a rich environment for medical device development and manufacturing, universities can play a critical role by developing relevant training programs to produce entrepreneurs who can be efficient and successful in creating early stage companies by understanding deeply the issues involved in creating a useful device, how to raise money, designing early clinical studies and locating manufacturing partners.

Hacking medical devices a review - biomed 2013.

Science.gov (United States)

Frenger, Paul

2013-01-01

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.

Monitoring of biofilm formation on different material surfaces of medical devices using hyperspectral imaging method

Science.gov (United States)

Kim, Do-Hyun; Kim, Moon S.; Hwang, Jeeseong

2012-03-01

Contamination of the inner surface of indwelling (implanted) medical devices by microbial biofilm is a serious problem. Some microbial bacteria such as Escherichia coli form biofilms that lead to potentially lifethreatening infections. Other types of medical devices such as bronchoscopes and duodenoscopes account for the highest number of reported endoscopic infections where microbial biofilm is one of the major causes for these infections. We applied a hyperspectral imaging method to detect biofilm contamination on the surface of several common materials used for medical devices. Such materials include stainless steel, titanium, and stainless-steeltitanium alloy. Potential uses of hyperspectral imaging technique to monitor biofilm attachment to different material surfaces are discussed.

State of the art of medical devices featuring smart electro-rheological and magneto-rheological fluids

Directory of Open Access Journals (Sweden)

Jong-Seok Oh

2017-10-01

Full Text Available Recently, smart fluids have drawn significant attention and growing a great interest in a broad range of engineering applications such as automotive and medical areas. In this article, two smart fluids called electro-rheological (ER fluid and magneto-rheological (MR fluid are reviewed in terms of medical applications. Especially, this article describes the attributes and inherent properties of individual medical and rehabilitation devices. The devices surveyed in this article include multi-degree-of-freedom haptic masters for robot surgery, thin membrane touch panels for braille readers, sponge-like tactile sensors to feel human tissues such as liver, rehabilitation systems such as prosthetic leg, and haptic interfaces for dental implant surgery. The operating principle, inherent characteristics and practical feasibility of each medical device or system are fully discussed in details.

Practical design control implementation for medical devices

CERN Document Server

Justiniano, Jose

2003-01-01

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

Medical Device Plug-and-Play Interoperability Standards and Technology Leadership

Science.gov (United States)

2016-10-01

death,” The Boston Globe, April 3 2010. 27. Arney D, Pajic M, Goldman JM, Lee I, Mangharam R, Sokolsky O, “Toward Patient Safety in Closed - Loop Medical ...becoming increasingly clear. We have been providing medical device interoperability domain expertise to assist the Veterans Administration in a...15. Wallroth C, Goldman J, Manigel J, Osborn D, Roellike T, Weininger S, Westenskow D, “Development of a Standard for Physiologic Closed Loop

Cost-effectiveness of emergency contraception options over 1 year.

Science.gov (United States)

Bellows, Brandon K; Tak, Casey R; Sanders, Jessica N; Turok, David K; Schwarz, Eleanor B

2018-05-01

seeking emergency contraception, the model estimated direct medical costs of $1,228,000 and 137 unintended pregnancies with ulipristal acetate, compared to $1,279,000 and 150 unintended pregnancies with oral levonorgestrel, $1,376,000 and 61 unintended pregnancies with copper intrauterine devices, and $1,558,000 and 63 unintended pregnancies with oral levonorgestrel plus same-day levonorgestrel intrauterine device. The copper intrauterine device was the most cost-effective emergency contraception strategy in the majority (63.9%) of model iterations and, compared to ulipristal acetate, cost $1957 per additional pregnancy prevented. Model estimates were most sensitive to changes in the cost of the copper intrauterine device (with higher copper intrauterine device costs, oral levonorgestrel plus same-day levonorgestrel intrauterine device became the most cost-effective option) and the cost of a live birth (with lower-cost births, ulipristal acetate became the most cost-effective option). When the proportion of obese women in the population increased, the copper intrauterine device became even more most cost-effective. Over 1 year, the copper intrauterine device is currently the most cost-effective emergency contraception option. Policy makers and health care insurance companies should consider the potential for long-term savings when women seeking emergency contraception can promptly obtain whatever contraceptive best meets their personal preferences and needs; this will require removing barriers and promoting access to intrauterine devices at emergency contraception visits. Copyright © 2018 Elsevier Inc. All rights reserved.

Remote Access: A Vision for Mobile Medical Devices

Directory of Open Access Journals (Sweden)

Herbert Ernst

2005-11-01

Full Text Available During the Symposium for Remote Engineering and Virtual Instrumentation held at Brasov in early July 2005 an outlook was presented regarding the future potential of remote engineering for mobile medical devices. It is the intention of this article to recapitulate the content of the initiated discussions and to stimulate work in this complex and until now largely neglected field of application.

How does the knowledge environment shape procurement practices for orthopaedic medical devices in Mexico?

Science.gov (United States)

Lingg, Myriam; Wyss, Kaspar; Durán-Arenas, Luis

2016-07-08

In organisational theory there is an assumption that knowledge is used effectively in healthcare systems that perform well. Actors in healthcare systems focus on managing knowledge of clinical processes like, for example, clinical decision-making to improve patient care. We know little about connecting that knowledge to administrative processes like high-risk medical device procurement. We analysed knowledge-related factors that influence procurement and clinical procedures for orthopaedic medical devices in Mexico. We based our qualitative study on 48 semi-structured interviews with various stakeholders in Mexico: orthopaedic specialists, government officials, and social security system managers or administrators. We took a knowledge-management related perspective (i) to analyse factors of managing knowledge of clinical procedures, (ii) to assess the role of this knowledge and in relation to procurement of orthopaedic medical devices, and (iii) to determine how to improve the situation. The results of this study are primarily relevant for Mexico but may also give impulsion to other health systems with highly standardized procurement practices. We found that knowledge of clinical procedures in orthopaedics is generated inconsistently and not always efficiently managed. Its support for procuring orthopaedic medical devices is insufficient. Identified deficiencies: leaders who lack guidance and direction and thus use knowledge poorly; failure to share knowledge; insufficiently defined formal structures and processes for collecting information and making it available to actors of health system; lack of strategies to benefit from synergies created by information and knowledge exchange. Many factors are related directly or indirectly to technological aspects, which are insufficiently developed. The content of this manuscript is novel as it analyses knowledge-related factors that influence procurement of orthopaedic medical devices in Mexico. Based on our results we

Post-market clinical research conducted by medical device manufacturers: a cross-sectional survey

Directory of Open Access Journals (Sweden)

Ross JS

2015-05-01

Full Text Available Joseph S Ross, Katrina L Blount, Jessica D Ritchie, Beth Hodshon, Harlan M Krumholz Center for Outcomes Research and Evaluation, Yale-New Haven Hospital, New Haven, CT, USA Background: In the US, once a medical device is made available for use, several requirements have been established by the US Food and Drug Administration (FDA to ensure ongoing post-market surveillance of device safety and effectiveness. Our objective was to determine how commonly medical device manufacturers initiate post-market clinical studies or augment FDA post-market surveillance requirements for higher-risk devices that are most often approved via the FDA's pre-market approval (PMA pathway. Methods and results: We conducted a cross-sectional survey of 47 manufacturers with operations in California, Minnesota, and Massachusetts who market devices approved via the PMA pathway. Among 22 respondents (response rate =47%, nearly all self-reported conducting post-market clinical research studies, commonly between 1 and 5; only 1 respondent reported never conducting post-market clinical research studies. While manufacturers most often engaged in these studies to satisfy FDA requirements, other reasons were reported, including performance monitoring and surveillance and market acceptance initiatives. Risks of conducting and not conducting post-market clinical research studies were described through open-ended response to questions. Conclusion: Medical device manufacturers commonly initiate post-market clinical studies at the request of the FDA. Clinical data from these studies should be integrated into national post-market surveillance initiatives. Keywords: FDA, PMA pathway, post-market surveillance

21 CFR 801.125 - Medical devices for use in teaching, law enforcement, research, and analysis.

Science.gov (United States)

2010-04-01

... 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...

[Radiotherapy and implantable medical device: example of infusion pumps].

Science.gov (United States)

Abrous-Anane, S; Benhassine, S; Lopez, S; Cristina, K; Mazeron, J-J

2013-12-01

Indication for radiotherapy is often questioned for patients equipped with implantable medical devices like infusion pumps as the radiation tolerance is poor or not known. We report here on the case of a patient who we treated with pelvic radiotherapy for cervical cancer and who had an infusion pump in iliac fossa. We conducted a series of tests on five identical pumps that insured that the treatment protocol is harmless to the implanted device. Copyright © 2013 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

A prospective window into medical device-related pressure ulcers in intensive care.

Science.gov (United States)

Coyer, Fiona M; Stotts, Nancy A; Blackman, Virginia Schmied

2014-12-01

The aim of this study was to determine the prevalence, severity, location, aetiology, treatment and healing of medical device-related pressure ulcers (PUs) in intensive care patients for up to 7 days. A prospective repeated measures study design was used. Patients in six intensive care units of two major medical centres, one each in Australia and the USA, were screened 1 day per month for 6 months. Those with device-related ulcers were followed daily for up to 7 days. The outcome measures were device-related ulcer prevalence, pain, infection, treatment and healing. Fifteen of 483 patients had device-related ulcers and 9 of 15 with 11 ulcers were followed beyond screening. Their mean age was 60·5 years, and most were men, overweight and at increased risk of PU. Endotracheal (ET) and nasogastric (NG) tubes were the cause of most device-related ulcers. Repositioning was the most frequent treatment. Four of 11 ulcers healed within the 7-day observation period. In conclusion, device-related ulcer prevalence was 3·1%, similar to that reported in the limited literature available, indicating an ongoing problem. Systematic assessment and repositioning of devices are the mainstays of care. We recommend continued prevalence determination and that nurses remain vigilant to prevent device-related ulcers, especially in patients with NG and ET tubes. © 2013 The Authors. International Wound Journal © 2013 Medicalhelplines.com Inc and John Wiley & Sons Ltd.

On-line integration of computer controlled diagnostic devices and medical information systems in undergraduate medical physics education for physicians.

Science.gov (United States)

Hanus, Josef; Nosek, Tomas; Zahora, Jiri; Bezrouk, Ales; Masin, Vladimir

2013-01-01

We designed and evaluated an innovative computer-aided-learning environment based on the on-line integration of computer controlled medical diagnostic devices and a medical information system for use in the preclinical medical physics education of medical students. Our learning system simulates the actual clinical environment in a hospital or primary care unit. It uses a commercial medical information system for on-line storage and processing of clinical type data acquired during physics laboratory classes. Every student adopts two roles, the role of 'patient' and the role of 'physician'. As a 'physician' the student operates the medical devices to clinically assess 'patient' colleagues and records all results in an electronic 'patient' record. We also introduced an innovative approach to the use of supportive education materials, based on the methods of adaptive e-learning. A survey of student feedback is included and statistically evaluated. The results from the student feedback confirm the positive response of the latter to this novel implementation of medical physics and informatics in preclinical education. This approach not only significantly improves learning of medical physics and informatics skills but has the added advantage that it facilitates students' transition from preclinical to clinical subjects. Copyright © 2011 Associazione Italiana di Fisica Medica. Published by Elsevier Ltd. All rights reserved.

Innovative medical devices and hospital decision making: a study comparing the views of hospital pharmacists and physicians.

Science.gov (United States)

Billaux, Mathilde; Borget, Isabelle; Prognon, Patrice; Pineau, Judith; Martelli, Nicolas

2016-06-01

Objectives Many university hospitals have developed local health technology assessment processes to guide informed decisions about new medical devices. However, little is known about stakeholders' perceptions and assessment of innovative devices. Herein, we investigated the perceptions regarding innovative medical devices of their chief users (physicians and surgeons), as well as those of hospital pharmacists, because they are responsible for the purchase and management of sterile medical devices. We noted the evaluation criteria used to assess and select new medical devices and suggestions for improving local health technology assessment processes indicated by the interviewees. Methods We randomly selected 18 physicians and surgeons (nine each) and 18 hospital pharmacists from 18 French university hospitals. Semistructured interviews were conducted between October 2012 and August 2013. Responses were coded separately by two researchers. Results Physicians and surgeons frequently described innovative medical devices as 'new', 'safe' and 'effective', whereas hospital pharmacists focused more on economic considerations and considered real innovative devices to be those for which no equivalent could be found on the market. No significant difference in evaluation criteria was found between these groups of professionals. Finally, hospital pharmacists considered the management of conflicts of interests in local health technology assessment processes to be an issue, whereas physicians and surgeons did not. Conclusions The present study highlights differences in perceptions related to professional affiliation. The findings suggest several ways in which current practices for local health technology assessment in French university hospitals could be improved and studied. What is known about the topic? Hospitals are faced with ever-growing demands for innovative and costly medical devices. To help hospital management deal with technology acquisition issues, hospital

Determinants of Contraceptive Availability at Medical Facilities in the Department of Veterans Affairs

Science.gov (United States)

Cope, Jacqueline R; Yano, Elizabeth M; Lee, Martin L; Washington, Donna L

2006-01-01

OBJECTIVE To describe the variation in provision of hormonal and intrauterine contraception among Veterans Affairs (VA) facilities. DESIGN Key informant, cross-sectional survey of 166 VA medical facilities. Data from public use data sets and VA administrative databases were linked to facility data to further characterize their contextual environments. PARTICIPANTS All VA hospital-based and affiliated community-based outpatient clinics delivering services to at least 400 unique women during fiscal year 2000. MEASUREMENTS Onsite availability of hormonal contraceptive prescription and intrauterine device (IUD) placement. RESULTS Ninety-seven percent of facilities offered onsite prescription and management of hormonal contraception whereas 63% offered placement of IUDs. After adjusting for facility caseload of reproductive-aged women, 3 organizational factors were independently associated with onsite IUD placement: (1) onsite gynecologist (adjusted odds ratio [OR], 20.35; 95% confidence interval [CI], 7.02 to 58.74; Pwomen's health training to other clinicians (adjusted OR, 3.40; 95% CI 1.19 to 9.76; P=.02). CONCLUSIONS VA's provision of hormonal and intrauterine contraception is in accordance with community standards, although onsite availability is not universal. Although contraception is a crucial component of a woman's health maintenance, her ability to obtain certain contraceptives from the facility where she obtains her primary care is largely influenced by the availability of a gynecologist. Further research is needed to determine how fragmentation of women's care into reproductive and nonreproductive services impacts access to contraception and the incidence of unintended pregnancy. PMID:16637943

Intrauterine thrombosis of umbilical artery - case report

Directory of Open Access Journals (Sweden)

Gustavo Henrique de Oliveira

Full Text Available ABSTRACT: CONTEXT: Umbilical cord thrombosis is related to greater fetal and perinatal morbidity and mortality. It is usually associated with umbilical cord abnormalities that lead to mechanical compression with consequent vascular ectasia. Its correct diagnosis and clinical management remains a challenge that has not yet been resolved. CASE REPORT: This study reports a case of umbilical artery thrombosis that occurred in the second half of a pregnancy. The umbilical cord was long, thin and overly twisted and the fetus presented severe intrauterine growth restriction. The clinical and histopathological findings from this case are described. CONCLUSIONS: This case report emphasizes the difficulty in diagnosing and clinically managing abnormalities of intrauterine life with a high chance of perinatal complications.

Utilizing national and international registries to enhance pre-market medical device regulatory evaluation.

Science.gov (United States)

Yue, Lilly Q; Campbell, Gregory; Lu, Nelson; Xu, Yunling; Zuckerman, Bram

2016-01-01

Regulatory decisions are made based on the assessment of risk and benefit of medical devices at the time of pre-market approval and subsequently, when post-market risk-benefit balance needs reevaluation. Such assessments depend on scientific evidence obtained from pre-market studies, post-approval studies, post-market surveillance studies, patient perspective information, as well as other real world data such as national and international registries. Such registries provide real world evidence and are playing a more and more important role in enhancing the safety and effectiveness evaluation of medical devices. While these registries provide large quantities of data reflecting real world practice and can potentially reduce the cost of clinical trials, challenges arise concerning (1) data quality adequate for regulatory decision-making, (2) bias introduced at every stage and aspect of study, (3) scientific validity of study designs, and (4) reliability and interpretability of study results. This article will discuss related statistical and regulatory challenges and opportunities with examples encountered in medical device regulatory reviews.

[Customized and non-customized French intrauterine growth curves. II - Comparison with existing curves and benefits of customization].

Science.gov (United States)

Ego, A; Prunet, C; Blondel, B; Kaminski, M; Goffinet, F; Zeitlin, J

2016-02-01

Our aim is to compare the new French EPOPé intrauterine growth curves, developed to address the guidelines 2013 of the French College of Obstetricians and Gynecologists, with reference curves currently used in France, and to evaluate the consequences of their adjustment for fetal sex and maternal characteristics. Eight intrauterine and birthweight curves, used in France were compared to the EPOPé curves using data from the French Perinatal Survey 2010. The influence of adjustment on the rate of SGA births and the characteristics of these births was analysed. Due to their birthweight values and distribution, the selected intrauterine curves are less suitable for births in France than the new curves. Birthweight curves led to low rates of SGA births from 4.3 to 8.5% compared to 10.0% with the EPOPé curves. The adjustment for maternal and fetal characteristics avoids the over-representation of girls among SGA births, and reclassifies 4% of births. Among births reclassified as SGA, the frequency of medical and obstetrical risk factors for growth restriction, smoking (≥10 cigarettes/day), and neonatal transfer is higher than among non-SGA births (P<0.01). The EPOPé curves are more suitable for French births than currently used curves, and their adjustment improves the identification of mothers and babies at risk of growth restriction and poor perinatal outcomes. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Biofilm eradication and prevention: a pharmaceutical approach to medical device infections

National Research Council Canada - National Science Library

Shunmugaperumal, Tamilvanan

2010-01-01

"Biofilm Eradication and Preventions presents the basics of biofilm formation on medical devices, diseases related to this formation, and approaches pharmaceutical researchers need to take to limit this problem...

Predictive factors for pregnancy outcome following controlled ovarian stimulation and intrauterine insemination

International Nuclear Information System (INIS)

Yildrim, G.; Turkgeldi, L.S.; Koroglu, N.; Mervetalmac, A.

2017-01-01

To establish predictive factors for positive pregnancy outcome in cases of controlled ovarian stimulation and intrauterine insemination. Methods: The retrospective study was conducted at Kanuni Sultan Suleyman Training and Research Hospital and comprised subjects having undergone ovulation induction cycles and intrauterine insemination between June 2010 and June 2015. Data was analysed in terms of various parameters affecting clinical pregnancy rates. SPSS 23 was used for statistical analysis. Results: There were 475 patients having undergone a total of 923 cycles. Pregnancy was established in 133(28%) patients. Univariate analysis of biological/clinical variables revealed the presence of secondary infertility, high endometrial thickness, antral follicle number, post wash total motile sperm count and midluteal progesterone levels following intrauterine insemination to be associated with positive pregnancy outcomes (p<0.05 each). Multiple logistic regression analysis was performed to establish factors that affected the pregnancy rate. The aetiology and type of infertility and high midluteal progesterone levels following intrauterine insemination were found to be statistically significant predictors of pregnancy (p<0.05 each). Conclusion: The best chance of pregnancy was found in cases with anovulatory infertility, a history of prior pregnancy, and high midluteal progesterone levels following treatment with gonadotrophins and intrauterine insemination. (author)

Intra-uterine insemination for male subfertility

NARCIS (Netherlands)

Bensdorp, A. J.; Cohlen, B. J.; Heineman, M. J.; Vandekerckhove, P.

2007-01-01

BACKGROUND: Intra-uterine insemination (IUI) is one of the most frequently used fertility treatments for couples with male subfertility. Its use, especially when combined with ovarian hyperstimulation (OH) has been subject of discussion. Although the treatment itself is less invasive and expensive

Commercial viability of medical devices using Headroom and return on investment calculation

NARCIS (Netherlands)

Markiewicz, Katarzyna; van Til, Janine Astrid; Steuten, Lotte Maria Gertruda; IJzerman, Maarten Joost

2016-01-01

The market success of a medical product depends on its commercial viability, yet this may be hard to predict during the development process of medical devices. This paper aims to determine if applying the Headroom method combined with return on investment (ROI) analysis allows for estimation of the

Assessment of Risk Factors of Intrauterine Adhesions in Patients With Induced Abortion and the Curative Effect of Hysteroscopic Surgery.

Science.gov (United States)

Mo, Xiaoliang; Qin, Guirong; Zhou, Zhoulin; Jiang, Xiaoli

2017-10-03

To explore the risk factors for intrauterine adhesions in patients with artificial abortion and clinical efficacy of hysteroscopic dissection. 1500 patients undergoing artificial abortion between January 2014 and June 2015 were enrolled into this study. The patients were divided into two groups with or without intrauterine adhesions. Univariate and Multiple logistic regression were conducted to assess the effects of multiple factors on the development of intrauterine adhesions following induced abortion. The incidence rate for intrauterine adhesions following induced abortion is 17.0%. Univariate showed that preoperative inflammation, multiple pregnancies and suction evacuation time are the influence risk factors of intrauterine adhesions. Multiple logistic regression demonstrates that multiple pregnancies, high intrauterine negative pressure, and long suction evacuation time are independent risk factors for the development of intrauterine adhesions following induced abortion. Additionally, intrauterine adhesions were observed in 105 mild, 80 moderate, and 70 severe cases. The cure rates for these three categories of intrauterine adhesions by hysteroscopic surgery were 100.0%, 93.8%, and 85.7%, respectively. Multiple pregnancies, high negative pressure suction evacuation and long suction evacuation time are independent risk factors for the development of intrauterine adhesions following induced abortions. Hysteroscopic surgery substantially improves the clinical outcomes of intrauterine adhesions.

76 FR 34845 - Medical Devices; Ear, Nose, and Throat Devices; Classification of the Wireless Air-Conduction...

Science.gov (United States)

2011-06-15

... control by other users with a similar medical device. Exposure to non-ionizing radiation Wireless... relating to EMC and wireless technology and human exposure to non-ionizing radiation. Therefore, on March... electro magnetic compatibility (EMC) and safety of exposure to non-ionizing radiation; (2) Design...

Closed-loop approach for situation awareness of medical devices and operating room infrastructure

Directory of Open Access Journals (Sweden)

Rockstroh Max

2015-09-01

Full Text Available In recent years, approaches for information and control integration in the digital operating room have emerged. A major step towards an intelligent operating room and a cooperative technical environment would be autonomous adaptation of medical devices and systems to the surgical workflow. The OR staff should be freed from information seeking and maintenance tasks. We propose a closed-loop concept integrating workflow monitoring, processing and (semi-automatic interaction to bridge the gap between OR integration of medical devices and workflow-related information management.

Motor and cortico-striatal-thalamic connectivity alterations in intrauterine growth restriction.

Science.gov (United States)

Eixarch, Elisenda; Muñoz-Moreno, Emma; Bargallo, Nuria; Batalle, Dafnis; Gratacos, Eduard

2016-06-01

Intrauterine growth restriction is associated with short- and long-term neurodevelopmental problems. Structural brain changes underlying these alterations have been described with the use of different magnetic resonance-based methods that include changes in whole structural brain networks. However, evaluation of specific brain circuits and its correlation with related functions has not been investigated in intrauterine growth restriction. In this study, we aimed to investigate differences in tractography-related metrics in cortico-striatal-thalamic and motor networks in intrauterine growth restricted children and whether these parameters were related with their specific function in order to explore its potential use as an imaging biomarker of altered neurodevelopment. We included a group of 24 intrauterine growth restriction subjects and 27 control subjects that were scanned at 1 year old; we acquired T1-weighted and 30 directions diffusion magnetic resonance images. Each subject brain was segmented in 93 regions with the use of anatomical automatic labeling atlas, and deterministic tractography was performed. Brain regions included in motor and cortico-striatal-thalamic networks were defined based in functional and anatomic criteria. Within the streamlines that resulted from the whole brain tractography, those belonging to each specific circuit were selected and tractography-related metrics that included number of streamlines, fractional anisotropy, and integrity were calculated for each network. We evaluated differences between both groups and further explored the correlation of these parameters with the results of socioemotional, cognitive, and motor scales from Bayley Scale at 2 years of age. Reduced fractional anisotropy (cortico-striatal-thalamic, 0.319 ± 0.018 vs 0.315 ± 0.015; P = .010; motor, 0.322 ± 0.019 vs 0.319 ± 0.020; P = .019) and integrity cortico-striatal-thalamic (0.407 ± 0.040 vs 0.399 ± 0.034; P = .018; motor, 0.417 ± 0.044 vs 0

Mobile Devices, Learning and Clinical Workplaces: Medical Student Use of Smartphones in Parisian Hospitals

Science.gov (United States)

Phelps, Megan; Scott, Karen M.; Chauffeté-Manillier, Martine; Lenne, Frédéric; Le Jeunne, Claire

2017-01-01

Mobile devices are ubiquitous worldwide, including in hospitals. "Just in time" learning provided by these devices is important for students. We investigated current use of, and learning with, smartphones and other mobile devices by medical students in Parisian hospitals. A survey with quantitative and qualitative items previously used…

Microbiological Load Of Ethylene Oxide Sterilized Medical Devices And Its Elimination By Cobalt 60 Source

International Nuclear Information System (INIS)

Bashir, R.; Afroze, B.; Zulfiqar, H. F.; Saleem, R.; Saleem, F.; Aslam, F.; Naz, S.

2016-01-01

Objective: To determine the residing microbial flora of ethylene oxide (EtO) sterilized medical devices and optimization of safe dose of gamma radiation (Cobalt 60 source) for the complete elimination of microbial load. Study Design: Experimental study. Place and Duration of Study: Department of Biotechnology, Lahore College for Women University, Lahore, Pakistan from September 2014 to June 2015. Methodology: Thirty-six samples of EtO sterilized medical devices of same batch of three different companies were collected for this study. Isolation and enumeration of microbes were done by using different selective and differential media. Gram staining and biochemically characterization by API 20 (Bio Merieux, France) kit was done for identification of the microorganisms. The medical devices having high microbial load were sent to Pakistan Radiation Services (PARAS) for gamma irradiations at 3 different selected doses (20 KGy, 25 KGy, and 30 KGy). Result: Different types of Gram positive bacteria (Staphylococcus epidermidis, Staphylococcus aureus and Bacillus subtilis) were isolated from the EtO sterilized samples. Gram negative bacteria and fungi were not detected on these medical devices. Gamma irradiations Result showed that 30 KGy was optimized dose for complete elimination of microbial flora on endotracheal, Nelaton, and tracheostomy tubes. Conclusion: Gamma radiations (Co 60 source) effectively decontaminate the microbial flora on the equipment previously sterilized by the ethylene oxide gas; and 30 KGy is the optimized dose for all these medical devices. (author)

Characterization of Bacterial Etiologic Agents of Biofilm Formation in Medical Devices in Critical Care Setup

Directory of Open Access Journals (Sweden)

Sangita Revdiwala

2012-01-01

Full Text Available Background. Biofilms contaminate catheters, ventilators, and medical implants; they act as a source of disease for humans, animals, and plants. Aim. Critical care units of any healthcare institute follow various interventional strategies with use of medical devices for the management of critical cases. Bacteria contaminate medical devices and form biofilms. Material and Methods. The study was carried out on 100 positive bacteriological cultures of medical devices which were inserted in hospitalized patients. The bacterial isolates were processed as per microtitre plate. All the isolates were subjected to antibiotic susceptibility testing by VITEK 2 compact automated systems. Results. Out of the total 100 bacterial isolates tested, 88 of them were biofilm formers. A 16–20-hour incubation period was found to be optimum for biofilm development. 85% isolates were multidrug resistants and different mechanisms of bacterial drug resistance like ESBL, carbapenemase, and MRSA were found among isolates. Conclusion. Availability of nutrition in the form of glucose enhances the biofilm formation by bacteria. Time and availability of glucose are important factors for assessment of biofilm progress. It is an alarm for those who are associated with invasive procedures and indwelling medical devices especially in patients with low immunity.

Medical and welfare device session. Toward medical treatment and welfare of tomorrow; Iryo fukushi kiki session. Ashita no iryo fukushi ni mukete

Energy Technology Data Exchange (ETDEWEB)

NONE

2000-09-01

This paper is the material distributed in the medical and welfare device session held under the auspices of NEDO in September 2000. Diversification of needs in the medical and welfare areas and handling of age advancement are the growing issue. NEDO is putting efforts toward enhancement of quality of life (QOL) and realization of the nation with great life by providing high-quality and high-efficiency medical and welfare services. The NEDO's efforts cover the areas of treating adult diseases such as cancers and cardiac diseases whose seriousness is growing, early diagnoses of diseases, medical treatment with low invasion, elderly people helping, reduction of helpers' burden, reduction of handicaps to elderly people and mentally and physically handicapped persons, and assistance to participation in the society. To achieve these goals, NEDO is implementing the following four projects: research and development of medical and welfare device technologies, researches of medical science and engineering collaboration type, and promotion of developing welfare techno-systems and practical application of welfare appliances. Developments are being made toward practical application of medical and welfare devices with excellent safety and convenience, of low cost and high performance. The session gave the keynote addresses related to medical treatment and prevention of brain diseases; brain, the universe and MRI (the world of mind as seen in images), and high-tech medical treatments to protect brain (challenge to brain that starts now). (NEDO)

Two-dimensional ultrasonography in of medical abortion in the harem of residual experience%二维超声对药物流产后宫内残留的体会

Institute of Scientific and Technical Information of China (English)

原占国

2015-01-01

In recent years, medical abortion in wide clinical application, especially the menopause acuities were 49 days of pregnancy termination. But many patients use easy cause intrauterine residue after medical abortion. Now statistics from May 2009 to May 2011 among 420 patients with medical abortion of 50 cases of intrauterine residue analysis is as follows.

Analysis of liquid medication dose errors made by patients and caregivers using alternative measuring devices.

Science.gov (United States)

Ryu, Gyeong Suk; Lee, Yu Jeung

2012-01-01

Patients use several types of devices to measure liquid medication. Using a criterion ranging from a 10% to 40% variation from a target 5 mL for a teaspoon dose, previous studies have found that a considerable proportion of patients or caregivers make errors when dosing liquid medication with measuring devices. To determine the rate and magnitude of liquid medication dose errors that occur with patient/caregiver use of various measuring devices in a community pharmacy. Liquid medication measurements by patients or caregivers were observed in a convenience sample of community pharmacy patrons in Korea during a 2-week period in March 2011. Participants included all patients or caregivers (N = 300) who came to the pharmacy to buy over-the-counter liquid medication or to have a liquid medication prescription filled during the study period. The participants were instructed by an investigator who was also a pharmacist to select their preferred measuring devices from 6 alternatives (etched-calibration dosing cup, printed-calibration dosing cup, dosing spoon, syringe, dispensing bottle, or spoon with a bottle adapter) and measure a 5 mL dose of Coben (chlorpheniramine maleate/phenylephrine HCl, Daewoo Pharm. Co., Ltd) syrup using the device of their choice. The investigator used an ISOLAB graduated cylinder (Germany, blue grad, 10 mL) to measure the amount of syrup dispensed by the study participants. Participant characteristics were recorded including gender, age, education level, and relationship to the person for whom the medication was intended. Of the 300 participants, 257 (85.7%) were female; 286 (95.3%) had at least a high school education; and 282 (94.0%) were caregivers (parent or grandparent) for the patient. The mean (SD) measured dose was 4.949 (0.378) mL for the 300 participants. In analysis of variance of the 6 measuring devices, the greatest difference from the 5 mL target was a mean 5.552 mL for 17 subjects who used the regular (etched) dosing cup and 4

Biomaterials in medical devices: an interview with Jörg Vienken of Fresenius Medical Care, Germany.

Science.gov (United States)

Vienken, Jörg

2012-06-01

Biomaterial and biopolymer research have significant impact on the development as well as application of biotechnology. Biotechnology Journal recently attended the "Nanomaterials for Biomedical Technologies 2012" conference. We were privileged to have the opportunity to ask Prof. Dr. Jörg Vienken, VP of BioSciences at Fresenius Medical Care, a few questions relating to medical devices, the importance of publishing for industry, and also his advice for young scientists/engineers looking for a career in industry. Copyright © 2012 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.

Medical applications of superconducting quantum interference devices

International Nuclear Information System (INIS)

Uehara, Gen

2011-01-01

SQUIDs (Superconducting Quantum Interference Devices) are applied to clinical areas and basic medical science fields because of their potential for measuring a minute magnetic signal from the human body. Magnetoencephalography, one of their applications, is used for the functional mapping of the brain cortex before surgery and the localization of focus of epilepsy. Recently, their applications to the early-stage detection of dementia and the localization of brain ischemia are suggested. Another application of SQUIDs is magnetospinography, which detects the conduction block in spinal cord signal propagation. (author)

Design controls for the medical device industry

CERN Document Server

Teixeira, Marie B

2013-01-01

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

76 FR 18227 - Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee; Notice of...

Science.gov (United States)

2011-04-01

...] 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...

High-risk medical devices, children and the FDA: regulatory challenges facing pediatric mechanical circulatory support devices.

Science.gov (United States)

Almond, Christopher S D; Chen, Eric A; Berman, Michael R; Less, Joanne R; Baldwin, J Timothy; Linde-Feucht, Sarah R; Hoke, Tracey R; Pearson, Gail D; Jenkins, Kathy; Duncan, Brian W; Zuckerman, Bram D

2007-01-01

Pediatric mechanical circulatory support is a critical unmet need in the United States. Infant- and child-sized ventricular assist devices are currently being developed largely through federal contracts and grants through the National Heart, Lung, and Blood Institute (NHLBI). Human testing and marketing of high-risk devices for children raises epidemiologic and regulatory issues that will need to be addressed. Leaders from the US Food and Drug Administration (FDA), NHLBI, academic pediatric community, and industry convened in January 2006 for the first FDA Workshop on the Regulatory Process for Pediatric Mechanical Circulatory Support Devices. The purpose was to provide the pediatric community with an overview of the federal regulatory process for high-risk medical devices and to review the challenges specific to the development and regulation of pediatric mechanical circulatory support devices. Pediatric mechanical circulatory support present significant epidemiologic, logistic, and financial challenges to industry, federal regulators, and the pediatric community. Early interactions with the FDA, shared appreciation of challenges, and careful planning will be critical to avoid unnecessary delays in making potentially life-saving devices available for children. Collaborative efforts to address these challenges are warranted.

The efficacy of intrauterine devices for emergency contraception: a systematic review of 35 years of experience

Science.gov (United States)

Cleland, Kelly; Zhu, Haoping; Goldstuck, Norman; Cheng, Linan; Trussell, James

2012-01-01

BACKGROUND Intrauterine devices (IUDs) have been studied for use for emergency contraception for at least 35 years. IUDs are safe and highly effective for emergency contraception and regular contraception, and are extremely cost-effective as an ongoing method. The objective of this study was to evaluate the existing data to estimate the efficacy of IUDs for emergency contraception. METHODS The reference list for this study was generated from hand searching the reference lists of relevant articles and our own article archives, and electronic searches of several databases: Medline, Global Health, Clinicaltrials.gov, Popline, Wanfang Data (Chinese) and Weipu Data (Chinese). We included studies published in English or Chinese, with a defined population of women who presented for emergency contraception and were provided with an IUD, and in which the number of pregnancies was ascertained and loss to follow-up was clearly defined. Data from each article were abstracted independently by two reviewers. RESULTS The 42 studies (of 274 retrieved) that met our inclusion criteria were conducted in six countries between 1979 and 2011 and included eight different types of IUD and 7034 women. The maximum timeframe from intercourse to insertion of the IUD ranged from 2 days to 10 or more days; the majority of insertions (74% of studies) occurred within 5 days of intercourse. The pregnancy rate (excluding one outlier study) was 0.09%. CONCLUSIONS IUDs are a highly effective method of contraception after unprotected intercourse. Because they are safe for the majority of women, highly effective and cost-effective when left in place as ongoing contraception, whenever clinically feasible IUDs should be included in the range of emergency contraception options offered to patients presenting after unprotected intercourse. This review is limited by the fact that the original studies did not provide sufficient data on the delay between intercourse and insertion of the IUD, parity, cycle day

Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health.

Science.gov (United States)

Ronquillo, Jay G; Zuckerman, Diana M

2017-09-01

Policy Points: Medical software has become an increasingly critical component of health care, yet the regulation of these devices is inconsistent and controversial. No studies of medical devices and software assess the impact on patient safety of the FDA's current regulatory safeguards and new legislative changes to those standards. Our analysis quantifies the impact of software problems in regulated medical devices and indicates that current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market. New legislative changes will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients. Medical software has become an increasingly critical component of health care, yet the regulatory landscape for digital health is inconsistent and controversial. To understand which policies might best protect patients, we examined the impact of the US Food and Drug Administration's (FDA's) regulatory safeguards on software-related technologies in recent years and the implications for newly passed legislative changes in regulatory policy. Using FDA databases, we identified all medical devices that were recalled from 2011 through 2015 primarily because of software defects. We counted all software-related recalls for each FDA risk category and evaluated each high-risk and moderate-risk recall of electronic medical records to determine the manufacturer, device classification, submission type, number of units, and product details. A total of 627 software devices (1.4 million units) were subject to recalls, with 12 of these devices (190,596 units) subject to the highest-risk recalls. Eleven of the devices recalled as high risk had entered the market through the FDA review process that does not require evidence of safety or effectiveness, and one device was completely exempt from regulatory review

Real-time volume rendering of digital medical images on an iOS device

Science.gov (United States)

Noon, Christian; Holub, Joseph; Winer, Eliot

2013-03-01

Performing high quality 3D visualizations on mobile devices, while tantalizingly close in many areas, is still a quite difficult task. This is especially true for 3D volume rendering of digital medical images. Allowing this would empower medical personnel a powerful tool to diagnose and treat patients and train the next generation of physicians. This research focuses on performing real time volume rendering of digital medical images on iOS devices using custom developed GPU shaders for orthogonal texture slicing. An interactive volume renderer was designed and developed with several new features including dynamic modification of render resolutions, an incremental render loop, a shader-based clipping algorithm to support OpenGL ES 2.0, and an internal backface culling algorithm for properly sorting rendered geometry with alpha blending. The application was developed using several application programming interfaces (APIs) such as OpenSceneGraph (OSG) as the primary graphics renderer coupled with iOS Cocoa Touch for user interaction, and DCMTK for DICOM I/O. The developed application rendered volume datasets over 450 slices up to 50-60 frames per second, depending on the specific model of the iOS device. All rendering is done locally on the device so no Internet connection is required.

47 CFR 95.1119 - Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band.

Science.gov (United States)

2010-10-01

... devices operating in the 608-614 MHz band. For a wireless medical telemetry device operating within the... 47 Telecommunication 5 2010-10-01 2010-10-01 false Specific requirements for wireless medical telemetry devices operating in the 608-614 MHz band. 95.1119 Section 95.1119 Telecommunication FEDERAL...

Vasovagal response secondary to permanent contraception device in pulmonary arterial hypertension

Science.gov (United States)

Cope, Jessica; Alnuaimat, Hassan

2015-01-01

Abstract Adequate contraception is an essential component of managing pulmonary hypertension in women of childbearing age. Intrauterine devices are a popular contraceptive choice for many women but are associated with a risk of vagal response upon placement in certain patients with pulmonary hypertension, which may not be well tolerated. More recently, newer permanent contraception devices have emerged in the market, such as the Essure. We describe the first case, to our knowledge, of vagal-associated response due to an Essure device placement. PMID:26697184

Role of the levonorgestrel intrauterine system in effective contraception

Directory of Open Access Journals (Sweden)

Attia AM

2013-08-01

Full Text Available Abdelhamid M Attia,1 Magdy M Ibrahim,1 Ahmed M Abou-Setta21Department of Obstetrics and Gynecology, Cairo University, Cairo, Egypt; 2George and Fay Yee Centre for Healthcare Innovation, University of Manitoba/Winnipeg Regional Health Authority, Winnipeg, MB, CanadaAbstract: Norgestrel, a synthetic progestin chemically derived from 19-nortestosterone, is six times more potent than progesterone, with variable binding affinity to various steroid receptors. The levonorgestrel-releasing intrauterine system (LNG IUS provides a long-acting, highly effective, and reversible form of contraception, with a pearl index of 0.18 per 100 women-years. The locally released hormone leads to endometrial concentrations that are 200–800 times those found after daily oral use and a plasma level that is lower than that with other forms of levonorgestrel-containing contraception. The contraceptive effect of the LNG IUS is achieved mainly through its local suppressive effect on the endometrium, leading to endometrial thinning, glandular atrophy, and stromal decidualization without affecting ovulation. The LNG IUS is generally well tolerated. The main side effects are related to its androgenic activity, which is usually mild and transient, resolving after the first few months. Menstrual abnormalities are also common but well tolerated, and even become desirable (eg, amenorrhea, hypomenorrhea, and oligomenorrhea with proper counseling of the patient during the choice of the method of contraception. The satisfaction rates after 3 years of insertion are high, reaching between 77% and 94%. The local effect of the LNG IUS on the endometrium and low rates of systemic adverse effects have led to its use in other conditions rather than contraception, as for the treatment of endometrial hyperplasia, benign menorrhagia, endometriosis, adenomyosis, and uterine fibroids.Keywords: levonorgestrel, intrauterine device, contraception, family planning, Mirena, Skyla

OpenICE medical device interoperability platform overview and requirement analysis.

Science.gov (United States)

Arney, David; Plourde, Jeffrey; Goldman, Julian M

2018-02-23

We give an overview of OpenICE, an open source implementation of the ASTM standard F2761 for the Integrated Clinical Environment (ICE) that leverages medical device interoperability, together with an analysis of the clinical and non-functional requirements and community process that inspired its design.

Inherited thrombophilia in pregnant women with intrauterine growth restriction.

Science.gov (United States)

Coriu, Letitia; Copaciu, Elena; Tulbure, Dan; Talmaci, Rodica; Secara, Diana; Coriu, Daniel; Cirstoiu, Monica

2014-12-01

Intrauterine growth restriction (IUGR) is a major cause of fetal morbidity and mortality during pregnancy. The role of mutation in the factor V gene, prothrombin gene, MTHFR gene, as risk factors for intrauterine growth restriction during pregnancy, is not very well known so far. This is a retrospective study of 151 pregnant women with a history of complicated pregnancy: intrauterine growth restriction, preeclampsia, recurrent pregnancy loss or maternal venous thromboembolism, who were admitted in Bucharest Emergency University Hospital, during the period January 2010 to July 2014. Genetic testing was performed for all the cases to detect: factor V Leiden mutation, G20210A mutation in the prothrombin gene, C677T mutation and A1298C mutation in methylenetetrahydrofolate reductase (MTHFR) gene. Blood samples were obtained as soon as the diagnosis of intrauterine growth restriction was established with ultrasonography. The following gene mutations were associated with increased risk of IUGR: G20210A prothrombin gene mutation (OR 4.81, 95% CI 1.05 - 2.22, p= 0.043), G1691A factor V gene mutation (factor V Leiden) (OR 1.58, 95% CI 0.61 - 4.080, p= 0.347), C677T MTHFR gene mutation (OR 1.61, 95% CI 0.79 to 3.26, p= 0.186), compound heterozygous MTHFR C677T and A1298C (OR 1.66, 95% CI 0.81- 3.42, p= 0.169). Particularly, for G20210A prothrombin gene mutation we found statistically significant risk (p≤0.05) of IUGR.

Lessons learned: mobile device encryption in the academic medical center.

Science.gov (United States)

Kusche, Kristopher P

2009-01-01

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.

21 CFR 801.1 - Medical devices; name and place of business of manufacturer, packer or distributor.

Science.gov (United States)

2010-04-01

... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Medical devices; name and place of business of manufacturer, packer or distributor. 801.1 Section 801.1 Food and Drugs FOOD AND DRUG ADMINISTRATION... § 801.1 Medical devices; name and place of business of manufacturer, packer or distributor. (a) The...

The future of the pharmaceutical, biological and medical device industry

Directory of Open Access Journals (Sweden)

Burgess LJ

2011-09-01

Full Text Available Lesley J Burgess, Marli TerblancheTREAD Research/Cardiology Unit, Department of Internal Medicine, Tygerberg Hospital and University of Stellenbosch, Parow, South AfricaAbstract: Numerous factors contribute to the declining pharmaceutical industry on the one hand and the rapidly growing generic industry together with the growing importance of medical devices and biologicals on the other. It is clear that the pharmaceutical industry is going to undergo a change in the next decade in order to meet the current challenges facing it and ultimately sustain its profitability and growth. This paper aims to identify a number of fairly obvious trends that are likely to have a significant impact on the product development pipeline in the next decade. It is more than clear that the current production pipeline for pharmaceutical, biotechnology and medical device industries is no longer sustainable and that urgent interventions are required in order to maintain its current level of profitability.Keywords: pharmaceutical industry, personalized medicine, trends, generics, biotechnology

Hydrophilic Polymer Embolism: Implications for Manufacturing, Regulation, and Postmarket Surveillance of Coated Intravascular Medical Devices.

Science.gov (United States)

Mehta, Rashi I; Mehta, Rupal I

2018-03-19

Hydrophilic polymers are ubiquitously applied as surface coatings on catheters and intravascular medical technologies. Recent clinical literature has heightened awareness on the complication of hydrophilic polymer embolism, the phenomenon wherein polymer coating layers separate from catheter and device surfaces, and may be affiliated with a range of unanticipated adverse reactions. Significant system barriers have limited and delayed reporting on this iatrogenic complication, the full effects of which remain underrecognized by healthcare providers and manufacturers of various branded devices. In 2015, the United States Food and Drug Administration acknowledged rising clinical concerns and stated that the agency would work with stakeholders to further evaluate gaps that exist in current national and international device standards for coated intravascular medical technologies. The present article reviews current knowledge on this complication as well as factors that played a role in delaying detection and dissemination of information and new knowledge once hazards and clinical risks were identified. Furthermore, organ-specific effects and adverse reaction patterns are summarized, along with implications for device manufacturing, safety assurance, and regulation. Qualitative and quantitative particulate testing are needed to optimize coated intravascular device technologies. Moreover, general enhanced processes for medical device surveillance are required for timely adverse event management and to ensure patient safety.