Hospital Buyer

The Associated Press reports on the latest about the recycling of single use devices, a topic Hospital Buyer last covered in December last year. A federal law taking effect tomorrow will require medical device reprocessors to put their company name on recycled devices and their packaging. Devices too small to mark will come with detachable stickers to be pu on patient charts.

A number of incidents involving reprocessed devices have been reported over the years, some fatal. In many cases there was no evidence to single out reprocessing as the cause of the outcome, as opposed to the device itself even if it had been new, or other factors. Larry Spears, Chief of the FDA’s Office of Compliance was quoted as saying: “it is as safe and effective as a new device if they meet our requirements.” Spears said six years ago that manufacturers were sending mixed signals on which products were not fit for reprocessing.

Rep. Tom Davis (D-VA), Chairman of the House Committee on Government Reform, said on Friday he planned a committee hearing to examine the issue in the fall, stating that: “it is unclear to us at this time whether FDA is able to accurately track how often something goes wrong because a device meant to be used once was instead re-used.” This follows a letters (pdf) sent in December 2005 to then FDA Acting Commisioner Andrew von Eschenbach and to GAO chief David Walker. Device manufacturers and reprocessors are carrying a lobbying battle in several states through their trade associations. The Association of Medical Device Reprocessors is bringing forward arguments against legislation that device manufacturers are asking for in several states. Issues include whether the informed consent of patients should be sought before using reprocessed products on them, and who is liable in case such a product fails.

July 31, 2006 Related topics: Legal & legislative, Medical Devices & Products, Cost savings