Medical Devices: Medical Devices include any instrument apparatus, appliance, material or other article intended to be used for human beings for the purpose of diagnosis, prevention, monitoring etc. In this section, you also find the distinction of medical devices from in vitro medical devices, medicinal and advanced therapy medicinal products.
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Reprocessing: Controlled Reprocessing occurs under validated procedures, complies to the highest safety and quality standards and within a certified quality management system. In this context, reprocessing includes the cleaning, disinfection and sterilisation of a used medical device. In this section you also find the distinction of reprocessing from other terms such as refurbishing, recycling, remarketing etc.
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Market & Industries: Because the reprocessing industry is a relatively young sector, market data for this specialised area is not readily available. The reprocessing industry is a sub-sector of the medical devices sector and as such directly dependent on the manufacturers’ decision on whether to label a device as single-use or multiple-use.
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Technologies: Reprocessing services are provided by third-party reprocessors. Reprocessing involves a series of steps, each of which is thoroughly documented. Reprocessing works as a closed cycle or loop.
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Regulation: Reprocessing is not regulated at European Union level. At national level, some Member States do regulate reprocessing, some do not. These countries can be roughly grouped into three categories.
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Research: Recent research has shown that controlled, validated reprocessing of “single-use” devices does not create any additional risk to patient or user safety. Furthermore, if hospitals are prohibited from using professional reprocessing services, they are often forced to choose between illegal (and dangerous) reprocessing, or cutting costs from other areas of healthcare.
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