A Medical Device Daily

Perhaps one of the hardest challenges faced by medical device reprocessors is one of perception.

Following its board meeting last month, the Association of Medical Device Reprocessors (AMDR; Washington) issued a list of items which outline and reemphasize, it said, its commitment to patient safety.

The association's "Commitment to Patient Safety and Hospital Customers" is an initiative to educate patients and the medical community. AMDR's message is that the reprocessing of medical devices, when following FDA requirements, is safe and can help hospitals control costs and reduce their medical waste while at the same time maintaining quality patient care.

AMDR released a list of items as part of its plan. The association said its members would:

  • provide hospitals and patients with reprocessed devices that "meet or exceed all regulatory requirements and inspect each device to ensure safety and functional integrity;"
  • monitor devices so that hospitals and patients can be certain that no device is reprocessed more times than the number that has been demonstrated through strict validation studies appropriate for the device model in question;
  • conduct manufacturing operations in conformance with the FDA's manufacturing and quality assurance requirements;
  • comply with all FDA adverse event reporting requirements.

The association said it also plans to educate hospital customers through an evidence-based campaign demonstrating how reprocessing can reduce hospital costs and medical waste. This includes clarification of "single-use" labels used on many devices.

AMDR wants to emphasize that the label is used at the discretion of the original equipment manufacturer, it said, and that the FDA does not require devices to be labeled for single use.

Manufacturers frequently choose to label their products this way because they make more money if the hospital throws out each device after one use, AMDR said.

About 95% of the third-party reprocessing in the U.S. is performed by three companies – Vanguard Medical Concepts (Lakeland, Florida), Alliance Medical (Phoenix) and SterilMed (Minneapolis) – the three comprising the membership of AMDR.