Recent reports in the Las Vegas Review-Journal about a physician’s (Dr. Michael Kaplan) reuse of single-use needle guides have brought attention to the fact that many healthcare professionals routinely reuse medical devices originally labeled by the manufacturer for “single-use.” The Association of Medical Device Reprocessors (AMDR), or the association that represents the third-party companies that reprocess (i.e., clean, remanufacture, test, sterilize) medical devices for a majority of hospitals in the U.S., would like to clarify the important distinction between the improper reuse of “single-use” devices and the legal, regulated reprocessing of “single-use” devices.
In the local press, Dr. Dale Carrison of University Medical Center and State Epidemiologist Dr. Ihsan Azzam have made comments regarding the “single-use” label, including, “if it says it’s for single use, that’s what it means – single use.” However, this view is not accurate.
What patients need to know is that FDA has been regulating reprocessing for more than a decade. The “single-use” label is chosen at the discretion of the original manufacturer – not FDA – and often that decision has nothing to do with patient safety or device design. In many cases, it is possible to clean, remanufacture, test, repackage and sterilize a “single-use” device for an additional use. For example, external titanium clamps (i.e., devices used to stabilize arm or leg bones during/after surgery) are marketed as “single-use” and cost $400 per new clamp. In reality, these are durable devices that are capable of being safely reprocessed.
Since 2000, the FDA has reviewed and cleared hundreds of so-called “single-use” devices for reprocessing by a handful of third-party vendors. These reprocessors meet all the same FDA requirements as the original manufacturers, and by obtaining clearance from FDA, the reprocessor has demonstrated to the agency that its reprocessed “single-use” device is as safe and effective as its original counterpart.
There is no evidence, from any source, indicating that FDA-regulated reprocessed devices are any less safe than original equipment. In fact, AMDR’s members serve a majority of U.S. hospitals including ALL of the nation’s Honor Roll hospitals as listed by U.S. News and World Report. Moreover, the independent evidence – such as the Government Accountability Office’s 2008 report and the peer-reviewed literature – has shown that FDA-regulated reprocessing is safe, stringently regulated, financially and environmentally responsible, and poses no increased risk to patients.
Most importantly, nothing that has been reported in the Las Vegas media thus far implicates FDA-regulated reprocessed devices as being a threat to patient safety. Dr. Kaplan’s improper reuse of needle guides is entirely separate from FDA-regulated reprocessing. In fact, needle guides have not been cleared by FDA for reprocessing, and any reuse of such “single-use” devices is prohibited. The doctor’s inappropriate reuse, without meeting FDA’s requirements, should in no way be used as evidence to denounce the legitimate, FDA-regulated reprocessing industry.
Time will tell what happens to Dr. Kaplan. But patients should know that AMDR’s members do not reprocess needles or any other “single-use” device that has not been cleared or approved by FDA. If your health provider or hospital contracts with an FDA-regulated third-party reprocessor, it is using the same safe and effective devices as at America’s top hospitals.
Dan Vukelich
President