Reprocessed Medical Devices – Low on Cost, High on Quality
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.
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
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 segment is expected to retain its dominance over the forecast period, owing to reduction in product prize, increasing pressure to reduce expenditure of healthcare among hospital authorities, and increasing focus on protection of environment by reducing 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.
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.
Reprocessed medical devices are single-use medical devices, which are recycled by disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization and various other steps to make a used medical devices back in service again. All reprocessed devices are originally labeled as single- use medical devices and need to meet the requirements of the U.S. Food and Drug Administration such as, cleaning, sterility and functionality prior to use. Research publication related to medical devices market suggested that firstly medical devices reprocessing was mostly performed by hospital staffs within hospital setting without any proper guidelines. However, with the introduction of FDA reprocessing guidelines published in year 2015 by the U.S. department of Health and Services which provides recommendations for the formulation and scientific validation of reprocessing instructions for reusable medical devices, medical reprocessing was adopted all over the globe. Now mostly hospital outsource the single-used medical devices to get reprocessed by third party. Whereas, continuously increase in amount of medical waste and lack of proper disposal mechanism brings reprocessed medical devices into the market. And hence the reprocessed medical devices annually, around 95% are recycled rather than dumping it into landfills.
Furthermore, reprocessed medical devices are available in less cost than its original price thus reprocessed medical devices are cost effective with same efficacy as the new product with no threat to patient.
Rise in incidence of cardiovascular disease due to increase in the prevalence of high blood pressure and diabetes worldwide is expected to favor the demand for reprocessed medical devices around the globe. As cardiovascular devices such as blood pressure cuffs, cardiac stabilization and positioning devices, catheters or general surgery devices can be reprocessed.
In year 2015, according to World Health Organization (W.H.O) estimated that around 17.7 million people died due to cardiovascular disease worldwide. Furthermore, the majority of deaths are occurred in emerging economies due to high prevalence rate and lack of healthcare services in rural areas.
Also, due to rising demand for minimally invasive treatment laparoscopy is the other factor leading to growth of reprocessed medical devices market in developed as well as developing regions. Where laparoscopic devices such as endoscopic trocars, components and harmonic scalpels.
According to Centers for Disease Control and Prevention in year 2015 number of adults diagnosed by ulcers in the U.S. that was 6.1% of adult diagnosed with ulcers.
The report segments the global reprocessed medical devices market on basis of technique and geography. On the basis of technique, the market is categorized into laparoscopic devices, gastroenterology, general surgery, orthopedic devices and cardiovascular devices. Among these, the cardiovascular devices segment dominate the reprocessed devices market throughout the forecast period. On the basis of geography, the market is divided into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Among all regions, North America contributes major market share supported by increased incidence rate of cardiovascular disease and growing inclination of the population towards minimally invasive procedures.
Key features of the study:
“*” marked represents similar segmentation in other categories in the respective section.
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