Printer Friendly

FDA PROPOSES STRENGTHENING MEDICAL DEVICE MANUFACTURING STANDARDS

 WASHINGTON, Nov. 18 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) today proposed to strengthen manufacturing standards for new medical devices -- a step that could prevent dozens of deaths and thousands of serious injuries each year believed caused by poor device design.
 Under the proposal, FDA would add design controls to the Good Manufacturing Practice (GMP) regulation. The current GMP regulation, issued in 1978, requires that quality standards be met in the methods, facilities and controls used in manufacturing, packing, storing and installing medical devices.
 "The public must have confidence that the medical devices used to treat them are properly designed," said FDA Commissioner David A. Kessler, M.D. "Appropriate design controls during the early stages of product development will help assure that the finished device is both safe and effective."
 An FDA review of medical device recalls from October 1983 through September 1989 found that some 44 percent of the quality problems that led to the recalls were attributable to errors or deficiencies inherent in the device and that could have been prevented with proper design controls.
 In addition to heart valves, catheters and defibrillators, design- related defects have been found in such products as pacemakers, ventilators, patient chair lifts, laboratory tests and medical device software.
 In some instances, manufacturers had failed to establish performance requirements for a device before production, failed to ensure that device components were compatible with each other, failed to select adequate packaging materials or failed to do a hazard analysis. All of these would be required under design controls.
 In addition to design controls, the revised GMP regulation would include new purchasing and servicing controls and clarify some of the requirements of the current regulation.
 The addition of design controls to the GMP regulation would make the U.S. standard for medical devices compatible with that adopted by the European Community this year.
 The public will have four months to comment on the proposed regulation, which will be published Nov. 23. The final regulation would take effect six months after it is published.
 FDA is one of eight Public Health Service agencies within the U.S. Department of Health and Human Services (HHS).
 -0- 11/18/93
 /NOTE TO EDITORS: Attention TV broadcasters: please use open caption for the hearing impaired./
 /CONTACT: Sharon Snider of the U.S. Food and Drug Administration, 301-443-3285, or home, 301-622-0977/


CO: U.S. Food and Drug Administration ST: District of Columbia IN: HEA SU: EXE

DT-MH -- DC015 -- 5957 11/18/93 10:55 EST
COPYRIGHT 1993 PR Newswire Association LLC
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1993 Gale, Cengage Learning. All rights reserved.

Article Details
Printer friendly Cite/link Email Feedback
Publication:PR Newswire
Date:Nov 18, 1993
Words:417
Previous Article:CRITEF-II PARTNERSHIP REPORTS THIRD QUARTER CASH FLOW FROM OPERATIONS OF 23 CENTS PER BAC
Next Article:CLOROX: CBS SERIES ON POULTRY CONTAMINATION: WIDESPREAD PROBLEMS, SOLUTIONS PENDING; WHAT CAN CONSUMERS DO TODAY?
Topics:

Terms of use | Copyright © 2017 Farlex, Inc. | Feedback | For webmasters