Senators ponder single-use device reprocessing

At a hearing of the U.S. Senate Health, Education, Labor and Pensions Committee yesterday, senators agreed that regulations covering the reprocessing of single-use medical devices are inadequate, and that further FDA oversight is needed, according to Josephine Torrente, president of the Association of Disposable Device Manufacturers.

Senators heard testimony from the FDA, the General Accounting Office, and trade associations regarding a new GAO report that examines the suitability of reprocessing single-use devices for reuse in patients. The senators agreed with the report's conclusion stating that such devices are not always safe for reuse, Torrente said.

The FDA said it intends to more fully implement current law to ensure that the devices are safe, releasing final guidance documents on the subject in July. Torrente described the FDA's measures as "fundamentally flawed," in that they will allow high-risk devices to be processed without FDA approval, and confer the FDA's approval on devices that are not safe for reuse.

By AuntMinnie.com staff writers
June 29, 2000

Copyright © 2000 AuntMinnie.com

Page 1 of 14
Next Page