Third-Party Medical Device Reprocessors Say Newspaper Investigation of Reprocessed Devices Unable to Find Link Between the Practice of Reprocessing and an Increase in Risk to Patients


WASHINGTON, D.C. -- A year-long Washington Post investigation into the widely used practice of reprocessing of medical devices has found no evidence that patients are put at an increased risk from the practice, according to the Association of Medical Device Reprocessors (AMDR). The group says that 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 new or original equipment. The group adds that a review of the Food and Drug Administration (FDA)'s adverse event reporting database will uncover many times more examples of adverse events using original equipment than reprocessed equipment.  Based on the 30 million-plus devices that have been reprocessed, the practice has been found to be every bit as safe, if not more safe than original equipment, the AMDR asserts.

The AMDR says that the Post article pointed to several anecdotal reports, mostly from years ago before stringent regulations were in place or from overseas, where FDA has no authority over the practice. It adds that 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 a new device been used.

The group also asserts that the article also fails to inform readers that FDA has in place a stringent set of reprocessing-related regulations that protects the patient. Instead, the group says, readers are exposed to graphic, tragic cases of patients who were treated before these regulations existed or outside the US, where these regulations don't apply. Furthermore, the AMDR says the article presents a "mishmash" of different types of problems, with no clear demonstration whether the problem was caused by original manufacturing or reprocessing.

For Vanguard Medical Concepts, SterilMed, and Alliance Medical, the three companies that comprise the AMDR, safety comes first. The companies  emphasize that no device is ever reprocessed if the reprocessor cannot establish and validate that the device can be cleaned, made sterile and made functional. The AMDR adopted a strict "Commitment to Patient Safety," which requires its members to meet or exceed all federal standards for safety.

Source: Association of Medical Device Reprocessors

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