The Re-Emergence of Device Reprocessing

Article preview from Medtech Insight - September, 2010

The single-use device reprocessing and remanufacturing market is an estimated $200+ million business and growing fast thanks to cost containment pressures and the waning of early controversy surrounding the practice. By nearly any measure--including the number of facilities, number of approved products, and dollars both spent and saved--the SUD reprocessing industry is making a noteworthy impact on health care delivery in the US.

The Re-Emergence of Device Reprocessing

Article preview from Medtech Insight - September, 2010

Up until the early 1990s, seemingly a lifetime ago, it wasn't unusual to see nurses and doctors casually throw away items labeled for single-use after using that product to treat a patient. Opened, but unused devices met the same fate, scrapped with little or no regard for the price the facility paid for it or whether it might retain any further use. And it didn't seem to matter much whether a $30 pulse oximetry device or an $800 coronary catheter in near mint condition ended up in a landfill.

After all, things were going pretty well for hospitals. The dollars were flowing in and the nation's economy was perched on the edge of what became unprecedented boom times. The environment was another story, however, and articles about needles washing up on the shores of New Jersey, dangerous medical waste filling landfills, and smokestacks choking the air with medical waste not only disturbed the citizenry, but prompted legislative action.

That landscape, along with clinicians' attitudes toward these unwanted devices, began to change when money became scarcer and saving it began to count. What the combined scenario added up to was the perfect storm for a nascent medical device reprocessing industry to take hold. All that was needed was the blessing of regulators to move private reprocessing operations aboveground. Some hospitals had already begun (quietly) reprocessing a limited number of items in their central sterile operation, usually located in their basement.

In June 2000, a report from the then Government Accounting Office (GAO) helped move SUD reprocessing up from the basement when it announced there was "little evidence of harm from reuse" of single-use devices or SUDs. An even bigger moment came later that summer in August when the US Food & Drug Administration (FDA), in a landmark ruling, decreed that hospitals and third parties that reprocess SUDs were to be regulated in the same way as original equipment manufacturers (OEMs).

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