The reprocessed medical devices market will rise from nearly $983 million in 2015 to $3.35 billion by 2024 for a 14.9 percent CAGR according to a report by the market research firm Transparency Market Research (TMP).

North America was the largest market for reprocessed medical devices in 2016 with 76.8 percent of the global reprocessed medical devices market, and is likely to remain so for the foreseeable future despite an appreciable growth rate in Europe.

Reprocessing of medical devices includes cleaning, disinfecting, testing, remanufacturing, sterilizing, and packaging. It also includes the labeling of used, expired, and undamaged devices for patient-ready use. 

Reprocessing offers a much-reduced supply cost for certain medical procedures. The report shows that vast demand for cardiovascular devices leads all other segments in both developing and developed countries. 

With the update of FDA reprocessing guidelines in 2015 that superseded its 1996 guidelines, the healthcare industry began to see a shift away from in-hospital reprocessing to outsourcing to qualified third-party providers. Those updated guidelines require validation data regarding cleaning, sterilization, and functional performance to show that the reprocessed device will remain “substantially equivalent” to the original device.

The major players in medical device reprocessing include Stryker Solutions, Ethicon (Johnson & Johnson), Centurion Medical Products, Hygia Health Services, Medline ReNewal, MidWest Reprocessing Center, ReNu Medical, SureTek Medical, and Vanguard AG.

TMP segments the reprocessed medical device market into orthopedic external fixation devices, laparoscopic, general surgery, gastroenterology biopsy forceps, and cardiovascular devices. Of these, cardiovascular reprocessing made up 61.5 percent of the overall market in 2016.

The growth in the cardio market segment is attributed to reduced pricing, high usage, and growing pressure to cut healthcare expenditure. Devices in this segment include blood pressure cuffs, cardiac stabilization and positioning devices, deep vein thrombosis compression sleeves, diagnostic electrophysiology catheters, and electrophysiology cables.

General surgery devices include balloon inflation devices and infusion pressure bags, while laparoscopic devices include endoscopic trocars and components and harmonic scalpels.

In addition to the need to reduce healthcare costs another driver of the growth in both North America and Europe is environmental concerns and the need to reduce the volume of medical waste disposal.

The report suggests that continuing negative perceptions about the safety of reprocessing remains a significant factor that may hamper growth.

The American Association of Medical Reprocessors also lists obstruction by original equipment manufactures as a threat to continued growth. They point to actions by OEMs to limit the savings from reprocessing by actively designing, marketing, and restrictive contracting, such as minimum purchase requirements, tying, bundling or similar arrangements, and by forced obsolescence for their medical devices.

Kapstone Medical has the experience and expertise to help navigate all phases of medical device development, regulatory acceptance, and marketing in a highly competitive environment. Visit our website or Call Us Today to learn more! Phone: (704) 843-7852 – email:



Sources: Press materials provided by PR Newswire, TMP , and the Association of Medical Reprocessors.


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