Reprocessing of medical devices as a concept is not one coined recently. It has always remained a significant part of the medical device lifecycle in developed and emerging economies alike. Reprocessing of medical devices refers to the method of testing, disinfecting, cleaning, sterilizing, remanufacturing, packaging, and then labelling used or expired but undamaged medical devices, the process being intended to make them patient-ready and at a much lower cost than new devices.
The demand for reprocessed medical devices has significantly increased over the last few years. However, the practice in developing nations is solely aimed at reducing supply costs incurred by hospitals, which often compromises patients’ safety. Several research publications on the medical devices market indicate that until a decade back, medical device reprocessing was mostly performed within the hospital setting by hospital staffs. Not many of them take a note of the proper guidelines and regulations before performing the method. To curb such incidences, the FDA has introduced reprocessing guidelines, which has also positively impacted the market for reprocessed medical devices around the world. The promulgation of FDA guidelines on medical device reprocessing has encouraged many third party vendors to venture into the industry and hospitals have also become more likely to outsource medical device reprocessing to qualified third party service providers.
Browse Market Research Report of Reprocessed Medical Devices Market: http://www.transparencymarketresearch.com/reprocessed-medical-devices.html
Reprocessing Instructions Laid Down by the FDA
To ensure that medical device reprocessing does not compromise patients’ safety, the FDA has formulated six instructions. The instructions laid down by the FDA include:
1. FDA mandates labelling of reprocessed medical devices to address all six criteria it laid down for clear reprocessing. This is intended to help users understand and correctly comply with the reprocessing instructions.
2. The instructions for reprocessing medical devices recommend users to thoroughly clean the device. Cleaning, therefore, is the very first step that should be described in the labelling as part of the processing instruction.
3. The reprocessing instructions included in the labelling should also indicate the appropriate microbicidal process to be followed for the device. This criterion also requires the instructions to be consistent with the prevailing infection control principles.
4. Players venturing into the market must ensure that reprocessing instructions are technically feasible and include only medical accessories or devices that are legally marketed.
Browse Market Research Press Release of Reprocessed Medical Devices Market: http://www.transparencymarketresearch.com/pressrelease/reprocessed-medical-devices.htm
5. The reprocessing instructions included in the packaging must be comprehensive. The users should precisely understand how to perform the complete process safely and effectively.
6. Reprocessing instructions should be mentioned in an understandable, clear, and legible manner. Every step must to be followed for reprocessing must be mentioned in a sequential order.
Reprocessed medical devices are available at a much reduced cost, which helps hospitals and healthcare organizations address the issue of medical wastage in conjunction with the increasing adoption of these devices. The Association of Medical Device Reprocessors (AMDR) says that a typical hospital can save US$500,000 to US$2 million every year by using reprocessed medical devices. This is a primary factor boosting the rapid development of the global reprocessed medical devices market.
According to Transparency Market Research, the global reprocessed medical devices market, which stood at US$0.78 billion in 2013, is expected to reach US$2.58 billion by 2020. If the figures hold true, the global reprocessed medical devices market will exhibit a healthy 19.3% CAGR during the period.
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