An overview of the raging debates and trends surrounding medical reprocessing devices

Reprocessing medical devices for ‘single use’ has been standard practice in U.S hospitals for several years and has now given rise to a booming APAC Reprocessed Medical Devices Market as well. This concept is two decades old and emerged when original equipment manufacturers (OEMs) began to change a few device labels from ‘reusable’ to ‘single use’ without making too many significant structural changes. Hospitals became aware that the ‘single use’ term was more of an economic motivation than one brought about by patient safety concerns. That is why hospitals began to reprocess devices instead of discarding them after a single use. Third-party reprocessing device companies began to enter the market as hospitals wished to outsource this work. Reprocessing became an effective way to cut costs without any compromise on patient safety.

Devices that are reprocessed are chosen as they are durable enough to be reused. Highly-trained mechanical, electrical and chemical engineers employed by device reprocessors analyse devices to determine the materials they are made of, their functional characteristics, and the sterilisation and cleaning effect on device performance. Reprocessors gather a large volume of ‘validation’ data to prove that the reprocessed device is clean, sterile and will function properly. All reprocessing stages are subject to comprehensive and stringent guidelines by regulatory bodies such as the FDA.

Reprocessed devices that clear FDA requirements are as safe to use as original devices and the FDA considers the two to be at par. In fact, original devices that fail during original use are not reprocessed. Hence, every reprocessed device has essentially worked correctly at least once before. Thus, some health care providers are occasionally even more confident about reprocessed devices than their original counterparts. Reprocessors inspect and rigorously test each device before it resumes service and they are also cognizant of the fact that every device must not be reprocessed. In reality, only a small percentage of ‘single use’ devices are actually reprocessed. The main advantage of reprocessed devices is that they are usually half the cost of original devices. As health care costs continue to exponentially rise, reprocessing is an effective method to cut costs for hospitals. The savings can then be used to hire a larger nursing staff, expand indigent care, invest in new technology, or make improvements in patient support. The widespread availability of reprocessing devices has compelled OEMs to drop the prices of original devices.

A few original equipment manufacturers argue that third party reprocessing companies are unable to access original specifications of the device and therefore, their assessment of a device reprocessing is simply ‘guesswork’. They believe that these devices are not built to take repeated use which is why OEMs label them as ‘single use’. OEMs opine that third party reprocessing is potentially dangerous. Third party companies strongly deny these allegations. The companies claim they use a comprehensive, time-consuming and rigorous scientific testing and analysis system to ensure that they fully understand how a device is manufactured and how it functions before they begin reprocessing it.

As previously stated, all reprocessing process stages are subject to FDA oversight. In most cases, reprocessors get their information from OEM data made public (through sales and marketing material), through Patent Office or FDA records or even via OEM agreement. This data is helpful in corroborating reverse-engineering reprocessor findings. Reprocessors also rely on independent third party laboratories to back up their findings.

OEM claims that their device design is not meant to be reprocessed or withstand reprocessing is disproved by data showing that a greater number of OEMs are reprocessing their own ‘single use’ devices. Third party processor companies have unearthed evidence that a few OEMs have reprocessed their own devices for hospital customers; some OEMs have outsourced reprocessing; and others have tied up with third party reprocessor companies. There are also cases where OEMs have changed labels on ‘reusable’ devices to ‘single’ use without substantially changing the device structurally. Lastly, hospitals have seen that OEMs give instructions on how the former can reprocess OEM ‘single use’ devices.