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At least 37 records · Page 2Linked to original sources
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.↗
PubMed2006

The natural history of new orthopaedic devices.

Each year, hundreds of new devices and implants are introduced for orthopaedic surgeons. However, the proportion of new devices which ultimately will be successful is unknown. We investigated the natural history of new devices introduced to the orthopaedic market. From a list of all devices approved for use by the Food & Drug Administration 5 and 10 years before, a cohort of 100 devices was randomly selected using a random number list. Companies were contacted regarding the safety record and current availability of these devices. The company response rate was 93%. Forty-seven percent of devices approved 10 years ago and 25% of devices approved 5 years ago no longer were on the market. Of the 55 companies studied, 18 (33%) were out of business and their devices no longer were available. Devices approved 10 years ago were more likely to be unavailable than devices approved 5 years ago. Devices introduced by smaller companies were more likely to be unavailable. The majority of unavailable devices were discontinued not for clinical problems, but for poor market performance. Only 2% of devices studied had safety problems. Approximately 50% of devices approved for introduction to the orthopaedic marketplace no longer are available 10 years later. However, major device-related problems seem uncommon.

Device Approval↗
PubMed2004

FDA-approved neurologic devices intended for use in infants, children, and adolescents.

The US Food and Drug Administration (FDA) has approved several applications for the marketing of neurologic devices. Nineteen high risk Class III medical devices were approved for the central and peripheral nervous system for marketing between 1994 and 2003, and almost half (n = 8) include indications for use in children as well as adults. On July 24, 2003, the FDA Center for Devices and Radiologic Health released for public comment a draft guidance document entitled "Premarket Assessment of Pediatric Medical Devices," which included in its objectives, the types of information needed to provide reasonable assurance of the safety and effectiveness of medical devices intended for use in children. The draft guidance document is also relevant to the types of information needed to promote the safe and effective development of neurologic devices. We review risk assessment and ways to reduce risk for neurologic devices intended for use in children. We also discuss the deep brain stimulator, the cochlear implant, and the CSF shunt, and considerations for minimizing risks associated with brain development, physical growth, surgery, and human factors.

Adolescent↗
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↗
PubMedDate not supplied

How do regulatory agencies ensure the release of a safe medical device?

This article describes the current regulatory activities of the Food and Drug Administration (FDA), in particular the FDA techniques for regulating medical-device approvals, medical-device reporting, and medical-device-company inspections. Also discussed are the FDA Modernization Act and the methods the FDA is using to implement the act.

Device Approval↗
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↗
PubMed2006

The approval process for hyperthermic intraoperative intraperitoneal chemotherapy.

AIMS: To clarify the requirements for Food and Drug Administration approval in the United States for hyperthermic intraoperative intraperitoneal chemotherapy administration. Also, to review the status of the approval process in Europe. METHODS: The obstacles to be overcome for approval by the Food and Drug Administration for a new drug approval and for a new device approval were reviewed. Drugs approved in the past were examined for their potential for current application in this technology. RESULTS: The likelihood that the approval of a heater circulator along with the approval for specific chemotherapy agents for heated intraoperative intraperitoneal chemotherapy was judged to be remote. Rather, the continued use of "homemade heater circulators" and the off-label use of appropriate chemotherapy agents augmented by heat will continue to be the standard of care. The European community currently has several heater circulators approved for hyperthermic intraoperative intraperitoneal chemotherapy administration. These devices have been specifically approved for oncologic indications. CONCLUSIONS: Continued research and development of heated intraoperative intraperitoneal chemotherapy is necessary. As the requirement for prevention and treatment of the peritoneal surface component of gastrointestinal and gynecologic oncology expands, new investigations into the approval process in the United States will be necessary. Publication of results from institutions pioneering these new treatment strategies will, of necessity, continue.

Antineoplastic Agents↗
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↗
PubMed2005

Mechanical protection of cardiac microcirculation during percutaneous coronary intervention of saphenous vein grafts.

Saphenous vein bypass grafts permeability is one of the most important limitations of open heart surgery. The risks associated with surgical re-intervention are greater than those associated with the initial procedure. While native coronary arteries usually have fixed, fibrotic or calcified atherosclerotic plaques, the disease in the vein grafts contains soft material. When this material is compressed during percutaneous angioplasty, there is an unfavorable immediate outcome due to distal embolization of thrombus and plaque debris. In addition, the risk of post-procedure adverse events are higher when the grafts have a long time of implantation, due to a greater risk of branch occlusion or no-reflow at the adjacent microcirculation. The clinical consequence is a Non-Q-Wave Myocardial Infarction that is reflected in the increased serum cardiac enzymes. It is because of this complication that the distal protection devices were developed. The purpose of this paper is to review and discuss the current data on the distal protection devices available now for the treatment of degenerative saphenous vein graft disease. Currently, there are two distal protection devices approved in the United States: the Guardwire Balloon and Aspiration (Export) System and the Filter Wire EX. Other devices like the Triactiv System, Angioguard XP/ECW, DOW, MedNova Cardioshield, Medtronic-AVE DPD and the E-Trap Filter are still being studied. The first observational studies showed the safety and efficacy of the approved devices. A large randomized trial initially confirmed a significant decrease of in-hospital and 30-day cardiac adverse events, mainly Non-Q-Wave Myocardial Infarction, when angioplasty was performed with the assistance of the Guardwire System. Subsequently, another randomized study showed an equivalence between the Guardwire System and the Filter Wire EX. Distal protection devices have an acceptable performance, however, further technological improvements are warranted for a quick preparation, delivery and/or retrieval of these devices.

Angioplasty, Balloon, Coronary↗