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At least 19 recordsLinked to original sources
PubMed1995

Performance standards for medical device approvals.

As a result of the controversy concerning the safety of silicone and other permanent implants, the Food and Drug Administration's Center for Drug Evaluation and Research has conducted a rereview of a small sample of applications by manufacturers. The Food and Drug Administration's "Final Report of the Committee for Clinical Review" found that clinical trials were carried out with little planning or attention to the purpose of the study. It is urged that the medical profession assist in the establishment of complication rates associated with each type of implant and surgical procedure and that surgeons and professional societies need to be more critically involved in the setting up of performance standards for implants prior to their approval by the Food and Drug Administration. To avoid a repeat of the silicone gel-filled breast implant problem, scientists and clinicians are urged to take a more proactive position on the development of performance standards for implants currently being used.

Device Approval↗
PubMed1985

New obstacles in the path of marketing new medical devices.

Approval of a new medical device's safety and effectiveness by the Food and Drug Administration (FDA) is only one step in the typical device's passage into the marketplace. A review of 10 new Class II and III devices found an average of 62 months elapsing between the beginning of FDA-approved clinical trials and the device's final approval for general marketing. However, FDA marketing approval does not mean a new device can be sold because, for many new devices, the Health Care Financing Administration (HCFA) requests a technology assessment from the Office of Health Technology Assessment (OHTA) in order to determine whether the device's use is "reasonable and necessary" and thus appropriate for Medicare payment. The Medicare decision often guides other third parties. OHTA assessments of 93 devices and procedures required an average of 26 months to complete; of 16 FDA-approved Class III devices, OHTA reported to HCFA that insufficient data existed to recommend coverage for 12 (75 percent). Under the Medicare prospective payment system (PPS) for hospital care, a third step has been added to the process, consideration by the Prospective Payment Assessment Commission (ProPAC) and HCFA of the new device's impact on PPS payment rates. Further, under recent legislation, OHTA is mandated also to consider a device's cost effectiveness. Duplicative reviews of new devices should be eliminated, and until they are, medical equipment developers must recognize that delays and conflicting payment rulings may have serious impacts on the ability to market a new device.

Centers for Medicare and Medicaid Services, U.S.↗
PubMed1980

[Testing of medical devices (author's transl)].

The French regulation of medical devices is already old. it gradually begins since 1940 firstly for the need of safety in radiology. In 1952, an Interministerial Commission (Health, Welfare, Defense, Interior, etc.) was instituted for the medical devices approval: the anaesthesiological devices were examinated since 1956. But this regulation is weak because there is no effective penalty. Nevertheless it is efficient: it had allowed the collection of important documents especially in the fields of radiology, anaesthesiology and intensive care, and recently in hemodialysis. During the last ten years all medical devices in this fields were examinated by the French essay laboratories and their performances were registraded. If the compliance of a device is not effective the approval is not gived. For anaesthesiological and intensive care devices, the approval is give, after clinical testing, only for five years. This approval is not renewed if there are complaints about the device during this time. But medical devices are not easy to define and to test. The best definition seems the American one: "There is a new definition of "device". In broad terms, a device is a health-care product that does not achieve any of its principal intended purposes by chemical action within or on the body or by being metabolized. There is specific recognition that a device may diagnose "conditions" that are not necessarily "diseases" (Medical device Amendment, 1976)." The french regulation is of course not perfect: we suffer of a lack of a law on medical device thus this regulation is appliable only if the public health is envolved. Nevertheless a rather good protection of the patients is assured and the efficiency is gradually better as the international exchanges give technical and clinical informations.

Anesthesiology↗
PubMed1986

General hospital and personal use devices; premarket approval of the infant radiant warmer--FDA. Proposed rule.

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the infant radiant warmer, a medical device. The agency is also summarizing its proposed findings regarding: (1) the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and (2) the benefits to the public from the use of the device. In addition, FDA is announcing an opportunity for interested persons to request the agency to change the classification of the device based on new information.

Equipment Safety↗
PubMedDate not supplied

Assessment and approval of medical devices used in diagnostic imaging in the United States.

Development of new and improved medical imaging technology has been increasing rapidly over the past two decades. While media attention has focused on the revolutionary advances, such as computed tomography, magnetic resonance imaging and metabolic assessment by positron emission tomography, important progress has also been made in the more conventional modalities, including contrast radiography, ultrasound, scintigraphy and mammography. These evolutionary developments have produced fundamental changes in the character of imaging information and in the methods of its acquisition, storage, manipulation, analysis and display. The assessment process-vis-à-vis safety, effectiveness, efficacy or cost-has moved from a previously well-defined physical and engineering evaluation to one of assessing quality, relevance and appropriateness of the "information." A regulatory scheme has evolved in the U.S., whereby the Food and Drug Administration (FDA) is responsible for assuring that new medical devices be approved for commercial distribution only if their safety and effectiveness can be assured. Clear distinctions should be drawn between the FDA "approval" process, assessment of clinical efficacy, and planning for health care delivery.

Certificate of Need↗
PubMed2026

An impact assessment of the European medical device regulations implementation - the current status quo.

BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.

Equipment and Supplies↗
PubMed1991

Evaluation and treatment of erectile dysfunction following spinal cord injury: a review.

The majority of spinal cord injured (SCI) men with upper motor neuron lesions have reflex erections. However, these erections are often not adequately sustained making it difficult if not impossible to have intercourse. The majority of SCI men with lower motor neuron lesions do not have erections. Penile implants are effective in producing erections following SCI. However, they have the disadvantages of being a surgical procedure and of having the risk of infections and erosion of the implant through the skin. Intracavernous injections of papaverine and phentolamine and vacuum erection devices have recently been added to our armamentarium of ways to treat erectile dysfunction. A major concern particularly in SCI men is that papaverine and phentolamine may cause prolonged erections in SCI men. We presently have little data on the use of vacuum devices in SCI men, but preliminary reports on those who are using FDA-approved devices appear promising.

Equipment Design↗
PubMed1997

Catheter closure of secundum atrial septal defects.

Catheter occlusion of atrial septal defects has its roots in the 1950s, with early devices being implanted during closed-heart surgery without cardiopulmonary bypass. For the past 20 years, various catheter-delivered devices have undergone testing and refinement. Designs have included single- and double-disk prostheses, with a variety of materials, delivery systems, and techniques. In this monograph, the history of atrial septal defect occluders and their evaluation, results, and prognoses will be outlined. The early work of King and Mills has been advanced in the forms of the Rashkind and Lock-USCI Clamshell occluders (USCI; Billerica, Mass), the "buttoned" device (custom made by E.B. Sideris), the Babic atrial septal defect occlusion system (Osypka, GmbH; Grenzach-Wyhlen, Germany), the Das-Angel Wings atrial septal defect occlusion device (Microvena Corporation; White Bear Lake, Minn), and others. The future holds promise for approved devices in the treatment of selected secundum atrial septal defects.

Cardiac Catheterization↗
PubMed1993

Results using the biofragmentable anastomotic ring for colon anastomosis.

The Biofragmentable Anastomotic Ring (BAR) (Valtrac, Davis & Geck, Inc.) is a newly approved device intended for colonic anastomosis. We have used the device in 47 patients to date. These patients were studied to determine the effectiveness, uses and limitations of this new device. The BAR is similar in concept to the older Murphy "Button" used circa World War I, but it's constructed of polyglycolic acid rather than metal. Anastomosis is effected by placing the two bowel lumens over the device, tying the purse-string sutures snugly, and "clicking" the device closed. The BAR fragments and is passed 2 to 3 weeks postoperatively. The patients ranged from 14 to 82 years of age. Thirty-nine patients were operated on for cancer, four for diverticulitis, and four for colostomy closure. One transverse colectomy (THC), 15 left hemicolectomies (LHC), 23 sigmoid colectomies (SC), two low anterior resections (LAR), four colostomy closures, and two right hemicolectomies were performed. There were no anastomotic leaks and no complications. We found that because of the need to have access distally to "click" the device closed, BAR anastomosis after LAR is rarely feasible. Because of the small lumenal size of the distal ileum, the BAR is seldom usable for ileocolonic anastomosis after right hemicolectomy (RHC). The newly approved 25-mm BAR may change this. We found that the time required to perform an anastomosis with the BAR is equivalent to stapled techniques. At our hospital, the cost of the device is equivalent to one intestinal stapler. Since multiple staplers are used in most colon anastomotic techniques, there is a modest cost advantage for the BAR.(ABSTRACT TRUNCATED AT 250 WORDS)

Adolescent↗