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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).
Reprocessed medical devices are usually cheaper than the new medical devices. Hospitals and other end users are able to save a huge sum due to the medical device reprocessing. Other key advantages of medical device reprocessing are reduction in hospital waste which leads to clean environment, and less diseases and infections.
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).
Medical device reprocessing market finds its application in cardiology, gastroenterology, urology and gynecology, arthroscopy and orthopedic surgery, general surgery and anesthesia. Cardiology was the largest application area of medical device reprocessing in 2016, due to the high prevalence of cardiovascular diseases and wide range of approved devices by the USFDA. Additionally, medical device reprocessing offers several advantages to the healthcare providers and patients by reducing the treatment cost of cardiovascular disease.
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.
The risk of surgical site infections, and stringent regulations for medical device reprocessing practices act as major barriers for the growth of the global medical device reprocessing market. The medical devices when used for treatment and surgeries get soiled and infected with microorganisms. The soiled and infected medical devices can increase the risk of infections; therefore, the medical devices are reprocessed at regular time interval. However, inadequate cleaning may lead to retention of biological debris, tissue, and blood in some reprocessed medical devices. The debris may cause the microorganism to survive even after the reprocessing which may lead to the spread of harmful diseases and infections.
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.
Opportunities and Trends
The increasing healthcare expenditure in the emerging economies are creating ample growth opportunities for the global medical device reprocessing market. Healthcare is undergoing rapid changes in the emerging economies due to rising government expenditure, increasing number of hospitals, increase in surgeries, and increasing healthcare awareness. Healthcare awareness has increased in emerging economies due to advancement in reprocessing technologies and government funding. Thus, people tends to opt for surgeries and treatment for the diagnosed diseases.
In emerging economies such as India, China, Brazil, and Mexico, government is increasingly spending on the healthcare. The healthcare expenditure is increasing across the globe with increasing prevalence of diseases and rising government and non-government initiatives. According to the WHO, the increase in total healthcare expenditure is leading to the improvement in healthcare infrastructure. The emerging economies are untapped and suitable market for expanding the medical device reprocessing market.
Geographically, North America was the largest market for medical device reprocessing in 2016, followed by Europe. The North American medical device reprocessing market is primarily driven by the presence of the key established players, USFDA approval for the reprocessing of many medical devices, high expenditure on healthcare, and prevalence of many chronic diseases.
The key players in the global market are receiving regulatory clearance for various advanced reprocessing technologies which is expected to strengthen their position in the global medical device reprocessing market. In February 2017, Teleflex Incorporated (TFX), a global provider of medical technologies, received 510(k) clearances for the U.S. launch of TrapLiner catheter. The TrapLiner catheter was developed by Vascular Solutions, Inc., which was acquired by Teleflex Incorporated (TFX) on February 17, 2017. The TrapLiner Catheter can be used as an alternative method to the trapping technique to exchange an existing over-the-wire catheter while maintaining guidewire position. The technique of guidewire trapping for catheter exchange is most commonly performed in complex interventional procedures. The device is offered in three different sizes: 6, 7, and 8 Fr.
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.