Across the world, reprocessing of medical devices is a standard practice as a part of the lifecycle of medical devices. Reprocessing involves refurbishment of medical devices that are used and expired but are functionally faultless. The process involves cleansing, disinfecting, evaluating, remanufacturing, sanitizing, and packaging as well as marking medical devices to be utilizable for patients at a much reduced cost.
FDA Sets Standard Guidelines for Reprocessing of Medical Devices
The reprocessed medical devices market is primarily driven by the need to curb healthcare expenditures and the growing pressure from environmental agencies for reducing medical waste, which has resulted in increased refurbishment of medical devices. As per the Association of Medical Device Reprocessors (AMDR), typically, the use of reprocessed medical devices can result in savings of almost US$500,000 to US$2 mn for a hospital every year. Due to such high commercial benefits, the global reprocessed medical devices market will expand at a CAGR of 19.3% from 2014 to 2020, increasing from a valuation of US$0.8 bn in 2013 to US$2.6 bn by 2020.
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Nevertheless, in emerging nations, reprocessing of medical devices has received a negative perception, as it is solely being carried out for cost-cutting reasons. In these regions, lack of mandates that specify and control reprocessing techniques have interfered with patient safety, resulting in medical accidents using refurbished medical devices. Due to these incidents, presently, most large healthcare organizations engage third-party services for reprocessing of medical devices.
As suggested by research publications, until a decade ago, medical device reprocessing was performed by hospital staff within hospital premises, without adhering to proper guidelines and regulations. However, with the FDA’s guidelines for reprocessing of medical devices coming into effect, medical device reprocessing specifications have become a part of the standard practices of large hospital groups and healthcare organizations.
Cardiovascular Devices Register Highest Growth Rate in Reprocessed Medical Devices Market
The global reprocessed medical devices market has been segmented on the basis of device type and geography. Cardiovascular devices, laparoscopic devices, gastroenterology devices, general surgery devices, and orthopedic devices are the device type segments of the market. In the coming years, cardiovascular medical devices will exhibit the highest growth rate among all device types. The reasons for this are the increasing prevalence of cardiac conditions that need to be treated with specialty equipment for monitoring and diagnostics. Additionally, pressure from waste disposal departments to reduce the dumping of medical waste in landfills is contributing to the segment’s and the overall market’s growth.
North America is the largest market for reprocessed medical devices. The increasing rate of reprocessing of medical devices and favorable regulatory policies are the reasons for the same. In addition, the lower prices of reprocessing of medical devices, without compromising on the functionality of the product, are the reason for the dominant position of the North America reprocessed medical devices market.
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Europe will emerge as a significant market for reprocessed medical devices due to the savings in healthcare expenditures brought about by the usage of reprocessed medical devices. The increasing pressure from authorities in hospitals and healthcare facilities to keep budgets under control will bolster the growth of the reprocessed medical devices market in Europe.