The following was written by Gurmeet Singh, Product Director for EP and Cardiology products at Stryker Sustainability Solutions, for the ProtectOurSavings.com blog.
Today, the reprocessing industry is highly evolved. Single-use devices (SUDs) undergo complex and highly technical cleaning, testing, and validation methods. Gaining clearance from FDA to reprocess any SUD, such as an EP catheter, requires proving these devices are as safe and substantially equivalent as they were originally.
In the late 1990’s, reprocessing of diagnostic electrophysiology (EP) catheters became a practice many hospitals conducted in-house to reduce supply expenses. Few incidents of patient injury were reported, if any, but the OEMs began paying more attention. So it came as no surprise when the big manufacturers successfully lobbied Congress to enact legislation to regulate reprocessing. The result? Hospitals were forbidden to reprocess single-use devices in-house, and third-party reprocessors became tightly regulated. The reprocessors that survived were forced to invest fortunes to comply with new FDA guidelines…