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Results for “Device Approval”

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At least 19 recordsLinked to original sources
PubMed2001

Similarities and differences in distortion-product otoacoustic emissions among four FDA-approved devices.

Similarities and differences in distortion-product otoacoustic emissions (DPOAEs) among four Food and Drug Administration (FDA) approved devices were assessed quantitatively. DPOAEs were recorded from 42 adult subjects (84 ears) ranging in age from 19 to 40 years. All subjects had hearing thresholds of 20 dB HL or better for the test frequencies from 0.25 to 8.0 kHz and normal acoustic immittance findings. DPOAEs were collected in a quiet non-sound-treated room. DPOAE measurement parameters included an f2/f1 ratio of approximately 1.2, with f1 at 65 dB SPL (L1) and f2 at 55 dB SPL (L2). There were no significant differences in the mean emissions levels among the four devices. This investigation showed that validity criteria, pass criteria, and strategies for DPOAE measurements interact to produce varying pass and refer results. However, when DPOAEs are obtained with consistent validity criteria, pass criteria, and strategies for measurement, the results are remarkably consistent.

Adult↗
PubMed2002

Drug and device approval highlights from 2001.

The U.S. Food and Drug Administration approved more than 100 drugs and devices in 2001. This article discusses several of the new approvals, including ophthalmic drugs, contraceptive therapies, mental health medications, and medical devices.

Amides↗
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↗
PubMed2002

Introduction of endovascular aneurysm repair into community practice: initial results with a new Food and Drug Administration-approved device.

PURPOSE: The purpose of this study was to determine the outcome of endovascular aneurysm repair in a defined geographic region during the first 2 years after Food and Drug Administration approval of a new endovascular device. METHOD: Clinical results of all attempted endovascular aneurysm repairs from 1999 to 2001 with the AneuRx stent graft in the northern California/Nevada region were reviewed. All cases performed in 23 hospitals by 21 endovascular treatment teams were included on an intent-to-treat basis. Community physician training, proctoring, and assistance in case selection was provided by the manufacturer, with outcome monitored by external physician observers and clinical vascular specialists. Results in 22 community hospitals were compared with concurrent results in the regional university hospital training center and with results from the controlled, multicenter AneuRx clinical trial. RESULTS: Endovascular aneurysm repair was attempted in 257 patients by 20 endovascular teams working in 22 community hospitals. The mean number of cases per team was 13 +/- 2 (range, 1 to 36). Patient age was 74.1 +/- 6.5 years (89% men and 11% women), and 29% of patients were not candidates for open surgical repair because of multiple medical comorbidities. Mean aneurysm diameter was 5.7 +/- 0.8 cm. The endoluminal stent graft was successfully deployed in 254 patients (98.8%). In two patients, iliac access could not be obtained, and in one case, the iliac limb was misdeployed and the patient underwent successful open surgical repair. The surgical conversion rate was two of 257 patients (0.8%). The 30-day mortality rate was 1.2%, with one patient dying of stroke, one of multisystem organ failure, and one of cerebral hemorrhage. No device-related deaths occurred. Secondary procedures were performed in 8% of patients. Primary graft patency rate was 98%, and secondary graft patency rate was 100%. Concurrent university training center experience with 100 patients with similar characteristics and aneurysm size was not statistically different (deployment success rate, 100%; 30-day mortality rate, 0%; surgical conversion rate, 0%; secondary procedure rate, 8%). No aneurysm ruptures and no late surgical conversions have been seen in either the community or university experience, with follow-up periods extending to 2 years. CONCLUSION: Early results of endovascular aneurysm repair introduced into community practice are favorable. Initial community experience, with clinical support from the manufacturer, does not appear to differ significantly from concurrent results in the university training center or from results reported from the multicenter controlled clinical trial with the same device.

Aged↗
PubMed2002

Regulatory and medical-legal aspects of intraoperative monitoring.

Public policies are in place for health care to insure high quality, organized delivery of care to patients. Public policy issues for intraoperative monitoring include billing, coding, reimbursement, staffing, device approval, and liability. Staffing issues include privileging, credentialing, certifying, training, and professionalism. Those staffing processes provide ways that the profession passes judgment on individual's skills, knowledge, abilities, and training relevant to monitoring. These issues are reviewed here, along with a discussion of the respective roles of physicians and non-physicians in monitoring. Various billing codes for intraoperative monitoring are reviewed along with the circumstances in which they are to be used. Policy on the use of non-approved devices is also presented.

Credentialing↗