Medical device reprocessing is the process of cleaning, disinfecting, remanufacturing and testing, packaging, labelling, and sterilizing of already used medical devices. Medical devices reprocessing facilitates in reusing medical devices and treating multiple patients. Medical devices get contaminated with the repeated use on the patient; therefore, these are reprocessed to avoid the risk of infection. Inadequate reprocessing can also result into tissue irritation, health care associated infections, and threat to the patient safety. Global medical device reprocessing market is expected to grow significantly during the forecasted period (2017 – 2023).
The global medical device reprocessing market is highly regulated by the regulators such as U.S. Food and Drug Administration (USFDA), European Medicines Agency (EMA), China Food and Drug Administration (CFDA) and Japan Pharmaceutical Manufacturers Association (JPMA).
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The various devices reprocessed by the players in the medical device reprocessing market are catheters, laparoscopy instruments, biopsy instruments, endoscopy instruments, cables, columns, curves and cutters, and other reprocessed medical devices. The catheter held largest share in the market in 2016 due to the increasing utilization of reprocessed electrophysiology, diagnostic, and cardiology catheters.
Global medical device reprocessing market is expected to grow significantly during the forecast period. The major factors driving growth of the global medical device reprocessing market are low prices of reprocessed medical devices, and pressure to reduce volume of regulated medical waste. The cost of reprocessed medical devices significantly lower than new medical devices, which is increasing the adoption of reprocessed medical devices among its end users. The lower cost of the instrument also decreases the cost of the treatment which makes the treatment of different chronic diseases affordable for patients.
Moreover, the players in the global market has to adhere stringent regulatory guidelines such as guidelines for labeling of the devices, guidelines for the design and safety of the devices, and submission of 510(k) form to validate reprocessing instructions and methods by manufacturers. This delays the usage and sale of such devices and hence hampers the growth of the global medical device reprocessing devices. Commercial reprocessing of already used medical devices are performed under the stringent regulatory guidelines of the FDA in the U.S.
Some of the other key players in the global medical device reprocessing market are Stryker Corporation, Vanguard AG, Medtronic plc, Pioneer Medical Devices AG, HYGIA Health Services, Inc., SureTek Medical, Centurion Medical Products Corporation, Vascular Solutions, Inc., SteriPro Canada, Inc., and Johnson & Johnson.
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