Reprocessed or refurbished medical devices are devices that have been previously used and by performing certain validated processes such as disinfection and sterilization, are readied for use again. Reprocessing involves three steps that are point of use processing, thorough cleaning, and disinfection or sterilization. After performing these tasks the device is tested, if necessary remanufacturing is also performed and then packaging and labelling is carried out. These devices usually cost a fraction of the original new device and thus, are widely preferred in cost-sensitive regions such as India and China.
As per the stats of Association of Medical Device Reprocessors (AMDR), around 2 million tons of waste generated by U.S. hospitals each year and millions of waste include functional medical devices which are used only single time and the medical waste is the major source causes to production of carcinogens, therefore the increasing medical waste is harmful for the environment also.
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The rising healthcare cost and the low cost of reprocessed devices are major factors observed behind the market growth, as hospitals try to reduce the expenditure without compromising on quality and performance of medical devices
According to European Association for Medical Device Reprocessing (EAMDR), third-party reprocessing companies market were established in the recent past and the industry is less developed than manufacturers market. Also, based on Robert-Koch-Institute’s (RKI) study and the stats of German reprocessing companies, 15-20% of single-use labelled devices can be reprocessed. These factors collectively are expected to create a highly conducive environment for growth of the reprocessed medical devices market in Europe in the near future.
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Reprocessed medical devices market taxonomy:
Global Market, by Product Type
- Non-invasive Devices
- Orthopedic Devices
- Diagnostic Imaging Devices
- Surgical Devices
- Cardiac Equipment
- Opened but Unused Devices
Global Market, by Geography
- North America
- Latin America
- Middle East
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Cost effectiveness, equivalent performance to the original devices, warranty and availability of sources driving growth of reprocessed medical devices market
As per stats of the United States International Trade Commission (USITC), U.S is the largest market and it accounted more than 35% of the global market in the year 2011. Original equipment manufacturers (OEMs) holds major share in sales of reprocessed medical devices market in the U.S. This is mainly attributed to their robust sales and distribution network. However, some foreign countries account for a significant percentage of their sales. For example, the market in countries such as Italy, India, Brazil, South Korea, Japan, Spain, and Portugal account for 45 percent of GE Healthcare’s sales of reprocessed medical devices. Also, for the U.S., Europe is the major supplier region for reprocessed devices, followed by Canada and Mexico.
Also, the USITC stats indicate that the production of reprocessed devices increased by 12% during 2009-2011. This is mainly attributed to production capacity expansion by a large number of medical device remanufacturers during this period. The 2008-2009 recession was the supportive factor behind this growth, as during this period various patients lost their medical insurance and it affected the reimbursement of devices, which in turn led to uptake of cost-effective devices.
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