Statement From the Association of Medical Device Reprocessors

Editor's Note: The following is an updated version of a statement that previously ran on washingtonpost.com Sunday, Dec. 11 and Monday, Dec. 12.

(Washington, D.C.) December 12, 2005 -- A year-long Washington Post investigation into the widely-used practice of reprocessing medical devices found no evidence that patients are put at an increased risk from the practice. The article was irresponsible in avoiding a basic fact: that no surgery is without risk, and that hundreds of surgical incident reports are filed every year as a result of unreprocessed or "original" devices. Any article that discusses failures of reprocessed devices and neglects to put that information in the context of the failure rate of their alternative -- original devices-- is deliberately misleading and unfairly disparages an industry that is doing good for patients, hospitals, and the environment.

A simple review of FDA's adverse event reporting database will uncover many times more examples of failures or problems involving original devices than failures or problems involving reprocessed devices. Over 30 million devices have been reprocessed, and the practice of reprocessing has been found to be every bit as safe, if not more safe than original devices.

Post Article Misinforms Readers About U.S. FDA Regulation

The article pointed to several anecdotal reports, mostly from years before stringent regulations were in place, or from overseas, where FDA's regulatory authority does not apply. The article does not demonstrate that the risk faced by a patient when a reprocessed device is used during surgery is any greater than the risk that would have been faced by that same patient had an original device been used.

The article also misleads readers by omitting the fact that FDA has in place stringent reprocessing-related regulations that protect the patient. Instead, The Post emphasizes graphic, tragic cases of two children who were injured by devices that were not reprocessed by commercial reprocessors but rather by hospitals before hospitals were subject to these regulations, or by entities outside the USA. Furthermore, the article presents a "mishmash" of different types of problems, with no clear explanation whether a given problem was caused by original manufacturing of the device or by reprocessing.

For Vanguard Medical Concepts, SterilMed, and Alliance Medical -- the three companies that comprise the Association of Medical Device Reprocessors (AMDR) -- safety comes first. No device is ever reprocessed if the reprocessor cannot establish and validate that the device can be cleaned, made sterile and made functional. AMDR adopted a strict "Commitment to Patient Safety," which requires its members to meet or exceed all federal standards for safety. More information can be found at http://www.amdr.org/news.html

The Post Fails to Identify That It Is the Original Manufacturers' Concern for Profits, Not Concern for Patient Safety, That Fuels This Controversy

Is it any wonder that some of the nation's largest original equipment manufacturers have tried to use the legislative and regulatory processes to drive the reprocessing industry out of existence? AMDR members pose a serious threat to the profits of the original equipment manufacturers. Because the original equipment manufacturers were unable to convince Congress or the FDA to eliminate the reprocessing industry, they've sought and found reporters willing to publicize their distorted views of the industry and misrepresentations of the facts.

The Post Ignores The Growing Numbers of Reports of Faulty Original Devices

From our first interview, we explained to The Post that no procedure that uses a medical device is without risk. Original equipment - new devices -- fails on occasion. FDA has received thousands of reports of injuries and patient deaths resulting from the use of original equipment, and we need only look at last week's news to see the latest instance of an original device manufacturer recalling tens of thousands of original devices because of an unacceptable failure rate. So it should come as no surprise that reprocessed devices, on rare occasion, also may fail. But the ways in which reprocessed devices fail are similar to the ways in which original devices fail. For example, both original and reprocessed catheter tips sometimes break if a surgeon puts excessive pressure on a catheter tip, but such a failure cannot fairly be said to be due to reprocessing.

The Post was unable to find any evidence that reprocessing results in an increased risk to patient safety. This isn't surprising, given that neither FDA nor the U.S. Government Accountability Office has identified an increased risk to patient safety from properly reprocessed devices.