Reprocessed medical devices are used to perform certain validated processes such as disinfection and sterilization that cab be further utilized again. Reprocessing involves three steps that are point of use processing, thorough cleaning and disinfection or sterilization. Post application of the three steps the devices are tested and remanufactured after appropriate packaging and labelling. Furthermore, such devices usually cost a significantly less as compared to the new device and thus, are widely preferred in cost-sensitive and emerging economies such as India and ASEAN countries. According to the Association of Medical Device Re-processors (AMDR), around 2 million tons of waste is generated by the U.S. hospitals each year and millions of waste include functional medical devices that are disposable in nature causes huge medical waste, which is the major source of carcinogens and further negatively affects the environment.
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In 2011, as per the United States International Trade Commission (USITC), the U.S is the largest consumer and manufacturer of medical devices and accounts for more than 35.0% of the global market. In the U.S., Original equipment manufacturers (OEMs) holds major share in sales of reprocessed medical devices market. This is mainly attributed to their robust sales and distribution network. Furthermore, as per the USITC some foreign countries such as the U.S., Canada account for a significant percentage of their sales. For instance, according to Remanufacturing Industries Council, the medical device market in countries such as Italy, India, Brazil, South Korea, Japan, Spain, and Portugal is accounted for 45% of GE Healthcare’s sales of reprocessed medical devices in 2011. Also, for the U.S., European countries are the major suppliers for reprocessed devices, followed by Canada and Mexico.
The global reprocessed medical devices market was valued at US$ 1,054.6 million in 2016 and is expected to witness a robust CAGR of 20.4% during the forecast period (2017 – 2025).
Global Reprocessed Medical Devices Market (US$ Mn) by Geography – 2017
Source: Coherent Market Insights
Cost effectiveness, equivalent performance to the original devices, warranty and availability of sources driving growth of reprocessed medical devices market
The USITC statistics 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.
The cardiovascular medical devices is to remain dominate through forecast period. This can attribute to reduce the product prize, high usage and growth in pressure to reduce expenditure of healthcare among hospital authorities and increase focus on protection of environment by reduction of medical waste dumping.
Increased focus on protecting the environment by reducing medical waste being dumped in landfills is significantly contributing to the growth for reprocessed medical devices market
Over 90% of potentially infectious medical waste was incinerated before 1997. In August 1997, the U.S. Environmental Protection Agency (EPA) promulgated regulations creating stringent emission standards for medical waste incinerators due to significant concerns over detrimental air quality affecting human health. EPA’s Office of Air Quality Planning and Standards continues to review and revise the Hospital Medical Infectious Waste Incinerator (HMIWI) standards as required most recently in May of 2013.
The growth in reprocessed medical devices market is also favored by the rise in awareness regarding the adverse environmental effects of dumping medical wastes in landfills. The widespread use of plastics and other non-biodegradable artificial polymers in medical devices is likely to magnify the benefit of this factor to the global reprocessed medical devices market, as the use of biodegradable materials in medical devices has still not been widely incorporated. According to World Health Organization (WHO), every year an estimated 16 billion injections are administered worldwide, but not all of the needles and syringes are properly disposed of afterwards.
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Some major key players in the global reprocessed medical devices market include Stryker Corporation, Johnson & Johnson, Vanguard AG), Medline ReNewal , SteriPro Canada, Inc., Pioneer Medical Devices AG, Vascular Solutions, Inc., HYGIA Health Services, Inc., ReNu Medical, Inc., SureTek Medical, Centurion Medical Products Corporation and Vanguard AG.