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Observations after 20 years of single-use device reprocessing

From the May 2019 issue of DOTmed HealthCare Business News magazine

By Dan Vukelich

The Association of Medical Device Reprocessors (AMDR) is celebrating 20 years promoting medical device reprocessing as a healthcare strategy that reduces costs and improves patient care without adding risk to the patient.
For 20 years, single-use device (SUD) reprocessing companies have been shaking up healthcare – adding new life to medical devices thereby reducing costs and waste. When I started working with AMDR back in 2000, the FDA had just begun regulating SUD reprocessing as a manufacturing activity.

Hospitals were prevented from reprocessing SUDs in-house, and a small band of startup companies got busy reverse engineering devices and obtaining FDA clearance for their devices – demonstrating that reprocessed SUDs were equivalent to their original device counterparts. In 2000, AMDR members estimated they saved hospitals about $20 million per year. In the U.S., reprocessed devices have typically cost about 30-50% the price of a new device. Today, analysts project SUD reprocessing to grow to between 2 and 4 billion dollars in the next five years. With this impact and forecasted growth, it’s no wonder reprocessing has shaken things up in the medical device industry.
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Reprocessing is a success story. But what’s next and what does it mean for healthcare delivery? In these last 20 years, I have learned a few things:
First, regulation has meant legitimization. When you’re in the business of reprocessing a device marketed by its original manufacturer as “single use”, you get a lot of extra scrutiny. Our biggest early opposition came from the manufacturers themselves. While hospitals had been reprocessing and reusing devices themselves, and consequently provided evidence of its safety to Congress and regulators, it’s rare for an industry to go to the government and ask to be regulated. However, that’s exactly what the reprocessing industry and AMDR did 20 years ago! We pursued FDA regulation of single use device (SUD) reprocessing to demonstrate that we knew what we were doing. This action was broadly viewed by medical device manufactures as suicidal – surely these reprocessors cannot meet the standards and requirements that were applied to medical device manufacturers – but we did.

It might surprise some readers that meeting the same standards as other medical device manufacturers was just the beginning. Since then, reprocessors have become experts in validating cleaning, disinfection, sterilization and medical device performance, and effectively help drive the device industry’s standard-setting in these areas. This is our niche, our expertise and contribution to healthcare. The increasingly sophisticated nature of professional reprocessing companies results in a positive impact on medical device quality (data shows certain reprocessed devices fail less than original equipment), lower prices (up to half the cost of buying a device new), more rapid adoption of new technologies, and less waste (every time a device is reprocessed, there is one less device that must be created, sold and disposed of).

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