Printer Friendly

FDA REQUIRES DEVICE PROBLEM REPORTING

 FDA REQUIRES DEVICE PROBLEM REPORTING
 WASHINGTON, Dec. 4 /PRNewswire/ -- The Food and Drug


Administration announced today that, as of Nov. 28, health care facilities are required to file reports to the agency on deaths and serious injuries or illnesses related to the use of medical devices.
 FDA Commissioner David A. Kessler, M.D., said, "These reports, mandated by the Safe Medical Devices Act of 1990, will alert FDA and manufacturers to significant problems and allow for quick action when needed. They will also improve our ability to protect the public health by helping to ensure that devices -- for example, heart valves, anesthesia machines or surgical equipment -- are safe."
 Early in November, FDA provided guidelines to hospitals, nursing homes, ambulatory surgical facilities and other outpatient facilities on how to prepare the reports. Physicians' offices are not subject to the reporting requirement.
 Although manufacturers have been required to report device- related injuries and deaths since 1984, Congress was concerned that manufacturers often did not receive information about serious device problems from physicians, nurses and other health professionals. As a result, the problems were not reported to FDA.
 A 1986 report by the General Accounting Office estimated that only about 50 percent of device problems occurring in hospitals were reported outside the hospital, and fewer than 1 percent were reported directly to FDA; the same study also found that the more serious the device problem, the less likely hospitals were to report the incident.
 The new law requires facilities to report device-related incidents within 10 working days. Deaths must be reported directly to FDA as well as to the manufacturer, and serious injuries or illnesses must be reported to the manufacturer or to FDA if the manufacturer is not known.
 The facilities are required to report only those incidents in which a medical device was probably the cause or a contributing factor. The reports need to include such information as the identity of the reporting facility, product name, model, serial number, name of manufacturer, if known, and a description of the event. To help FDA audit manufacturers' reporting, facilities must also submit summaries of all reports twice a year.
 The act required health care facilities to begin reporting on Nov. 28. Until final regulations are published, these tentative final regulations published in the Federal Register Nov. 26 may be relied upon by manufacturers in submitting their reports required by the new law.
 There is a 60-day comment period for hospitals and other health care facilities to suggest alternatives or make other comments. FDA will carefully consider any comments it receives and take them into consideration in preparing the final regulation. Comments may be sent to Dockets Management Branch, FDA-305, Room 1-23, 12420 Parklawn Dr., Rockville, Md. 20857.
 -0- 12/4/91
 /CONTACT: Susan Cruzan of FDA, 301-443-3285 or, after hours, 301-926-7081/ CO: Food and Drug Administration ST: District of Columbia IN: SU:


MK-MH -- DC004 -- 9094 12/04/91 10:16 EST
COPYRIGHT 1991 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1991 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Dec 4, 1991
Words:488
Previous Article:CN AND GRAND TRUNK CREATE NEW NORTH AMERICAN FREIGHT SERVICE
Next Article:THREE INTERNATIONAL UNITS OF MOBIL SET PRODUCTION RECORDS
Topics:


Related Articles
FDA ISSUES NEW GUIDELINES ON PATIENT RESTRAINTS
Food and Drug Administration: Data to Measure the Timeliness of Reviews of Medical Device Applications Are Limited.
Nation's Third-Party Medical Device Reprocessors: Washington Post Investigation of Reprocessed Devices Unable to Find Link Between the Safe...
Move to modernize.

Terms of use | Copyright © 2016 Farlex, Inc. | Feedback | For webmasters