Single-use medical device reprocessing is the concept of sterilizing, repackaging, testing, and manufacturing a used product. There is no clear definition for the term single-use device and it is entirely based upon the end user perception. Reprocessing of single-use device is acceptable, if the device is properly sterilized while keeping its physical and technological functionalities intact. Single-use medical device reprocessing is done in two ways: third party processing and in-hospital processing. Third party processing is considered to be a better option, as regulatory authorities are able to impose strict regulations for validation and quality assurance purpose.
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Single-use medical device reprocessing is gaining popularity as it helps to reduce hospital waste and allows for major cost savings. For instance, Kaiser Permanente, which is an integrated delivery network based in U.S., saved US$ 11 million on an annual basis by reprocessing of single-use devices. Reprocessing enables the hospitals to purchase the same device at a lower price in comparison to the cost of original equipment, which eventually leads to cost savings. Practice Green Health, an NGO providing environmental solutions to the healthcare sector, quoted that single-use medical device reprocessing prevented the entry of 10,000 tons of medical waste during 1997–2007, by processing an estimated 50 million devices. Single-use medical device reprocessing market is poised to grow significantly, as hospitals realize potential cost savings and its ability to reduce environmental hazards.
Cost constraints for Hospitals and positive environmental impact will drive growth of the single-use medical device reprocessing market
Hospitals across the globe are facing cost pressures due to rise in price of original medical equipment. In the U.S., Obamacare and its associated guidelines might get repealed with the change in government. This could lead to low third-party reimbursement for hospitals, in turn influencing them to adopt cost saving initiatives such as single-use medical device reprocessing. The biggest advantage is that hospitals can reduce the cost associated with medical device to 50%, which becomes a crucial factor when dealing with expensive devices such as catheter and cardiac ablation devices. At present, 250 medical devices are already being processed with 10% of medical devices eligible for single-use medical device reprocessing. In terms of environmental protection, hospitals are able to reduce the medical waste to an estimated 50% by the use of single-use medical device reprocessing. Medical waste treatment not only puts enormous cost pressure on hospitals, but in countries such as U.S., China and Japan, it has become a full-fledged industry. For instance, Ascent, a subsidiary of Stryker Corporation, was able to eliminate 1,684 tons of medical waste from landfills during 2007, with the help of reprocessing. The market penetration for single-use medical device processing is poised to increase in small and mid-sized hospitals due to environmental sustainability and immense cost savings related to reprocessing.
North America is estimated to be the growth pocket for single-use medical device reprocessing market
U.S. has the biggest healthcare system in the world with government spending an estimated 30% of annual budget on healthcare. U.S. is also home to large-sized hospitals such as Cleveland Clinic, Mount Sinai Hospital, Beth Israel Deaconess Medical Centre and Johns Hopkins Hospital. These hospitals are subject to meeting sustainability goals and contain costs at the back of recession. For instance, in 2007, 45% of U.S. hospitals entered into an agreement with third-party processing companies and this number increased to 70% in 2008 due to severe economic crisis. Single-use medical device reprocessing is subject to FDA and required third-party processing companies to maintain quality standards in accordance with the original equipment. FDA formulated stringent regulation to create standardization and avoid infections related to the reuse of single-use devices. FDA has set up a grievance mechanism for reporting of adverse events related to use of single-use device which in turn reinforces accountability.
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In regions such as Asia Pacific, Europe and South America, there is a lack of regulatory standards is a restraining factor for the growth of single-use medical device reprocessing market. European Union has not mandated guidelines regarding the reprocessing. Individual countries such as Spain, England and France are not in favor of reprocessing. With respect to Asia Pacific, the reuse of single-use medical devices is prevalent with no set of regulations. In countries such as India, Japan and South Korea, there are no government regulations pertaining to single-use medical device reprocessing.
Single-use medical device reprocessing market is in nascent stage with few players dominating the market
The key players in the single-use medical device reprocessing market are Stryker Corporation, Medline ReNewal, Centurion Medical Products Corporation, Midwest Reprocessing Center, SterilMed Inc., Vanguard AG and Hygia Health Services Inc, among others. These players have successfully demonstrated the impact of single-use medical device reprocessing on cost savings and environmental protection. These companies will benefit in a large manner as the regulatory scenario becomes established in Europe and Asia Pacific.