The Association of Disposable Device Manufacturers Says: FDA Chooses Expediency Over Patient Safety; Agency Again Delays Enforcement On Reprocessed Single Use Devices.

Business Editors, Health/Medical Writers

WASHINGTON--(BW HealthWire)--Aug. 16, 2001

The following is a statement by The Association of Disposable Device Manufacturers:

Just as a needless death occurs due to reuse of a single device, FDA again demonstrates a complete disregard for both patient safety and commitments made to Congress by failing to follow through with the enforcement plan announced one year ago for reprocessed single use medical devices. Last week the British press reported that a nine-year-old boy has died as a direct result of disposable device reuse. Tony Clowes entered the hospital for a minor operation after falling from his bicycle and died when a blocked reused oxygen tube failed to deliver enough oxygen to him. Because of FDA's apparent support of reprocessing, this incident could easily be repeated in a U.S. hospital.

August 14, 2001 - the date on which FDA was to begin actively enforcing the premarket requirements for reprocessed Class III devices and the Quality System Regulation for all reprocessed devices - has passed. Rather than enforce the law, however, FDA has quietly told reprocessors and hospitals that both deadlines will be extended. This action is the latest in a series of FDA retreats signaling the agency's unwillingness to enforce the law on reprocessors. Below is a snapshot of recent FDA actions regarding reuse:

December 13, 2000: During a hospital training videobroadcast, FDA

incorrectly instructed hospitals that they may report some adverse

events which occur with a reprocessed device to the original

equipment manufacturer (OEM) rather than the reprocessor. FDA

admitted the error but refused to adequately correct it and

continued to broadly distribute copies of the tape, further

thwarting efforts to identify adverse events associated with

reprocessing.

March 31, 2001: Forty-five days after receiving reprocessor PMAs

which did not contain sufficient clinical information to permit

substantive review, FDA failed to follow its own policy and issue

"refusal to file" letters which would have required reprocessors

to stop marketing those devices.

June 1, 2001: In a draft guidance document FDA noted that it will

permit entities who intend to reprocess a device multiple times,

for use on multiple patients, to misbrand that device by labeling

it "single use only" over and over again, thereby avoiding the

more rigorous premarket requirements associated with multiple use

devices.

June 28, 2001: FDA refused to even initiate the regulatory process

necessary to determine whether premarket data should be required

for reprocessed single use biopsy forceps, despite the agency's

prior determination that such devices are high risk and its

commitment to revoke premarket exemptions for high risk

reprocessed devices on a case-by-case basis.

August 4, 2001: FDA signaled that it will permit reprocessed

devices to bear the OEM trademark despite the fact that such

labeling misbrands the device and implies, at a minimum, that

there exists a cooperative relationship between the OEM and the

reprocessor, and that the reprocessed device continues to be

backed by the OEM.

August 14, 2001: Without conducting an investigation into whether

OEMs could meet increased demand if hospitals discontinue

reprocessing in-house, FDA granted a request from the American

Hospital Association to stay enforcement of the post-market

requirements for hospitals because such enforcement could lead to

device shortages.

August 14, 2001: Contrary to its typical 6+ month review time for

petitions, FDA responded to a reprocessor petition submitted only

six days earlier agreeing to extend the approval deadline for

reprocessor PMAs despite FDA's determination that the data in the

PMAs are not sufficient for approval.

The medical device provisions of the Federal Food, Drug, and Cosmetic Act (the FDC Act) are designed to ensure that unsafe medical devices do not reach U.S. patients. The FDA is an enforcement agency obligated to enforce the FDC Act and remove such devices from the market. As to reprocessed single use devices, however, FDA is inexplicably unwilling to do so. If reprocessors cannot manufacture safe and effective devices in accordance with good manufacturing practices, then they must not be permitted to sell those devices for use on U.S. patients. It is this very basic element of the law that appears troubling to FDA. To the extent that enforcement would threaten the existence or extent of reprocessing, FDA would rather extend deadlines and find exceptions than take action.

The agency entrusted with ensuring the safety of medical devices has spent enormous sums of taxpayer dollars to draft reuse policies and has sent its spokespeople from Texas to Spain - even Japan - to announce and explain those policies. But when the time comes to turn words into action - to enforce - to actually protect the public health - FDA retreats.

This pattern of activity can lead to a number of unwelcome outcomes - some involving legislation, some involving litigation, but the most troubling involving more deaths like that of Tony Clowes.

ADDM is a national trade association representing manufacturers of single use medical devices. ADDM's mission is to provide information and industry perspectives on the reuse of these devices.