Following the entry of the (EU) Regulation 2017/745 (MDR), in addition to the changes of economic operators and the new requirements for post-market surveillance and introduction of unique device identifier, the requirements for reprocessing medical device have also changed to a large extent. So what is the definition of reprocessing? The EU MDR defines reprocessing as a process carried out on a used device in order to allow its safe reuse including cleaning, disinfection, sterilisation and related procedures, particularly packing, transport and storage, as well as testing and restoring the technical and functional safety of the used device. It should be noted that European definition of reprocessing refers to a procedure performed on the used devices, e.g., the first or one-off reprocessing e.g. non-sterile implants i.e., preparation for the first use is excluded from the definition.
1. Reusable medical devices vs. single use medical devices
The EU definition of reprocessing only refers to a process carried out on the used devices. However, the used devices may be the reusable devices or single-use devices.
- Reusable medical devices, e.g. surgical instruments are intended by their manufacturers to be reused. Therefore, their reuse is taken into account in the development process of the medical devices and has particular implications for the selection of raw materials and design of the device.
- the manufacturers of reusable medical devices should also provide clearly reprocessing information on the device’s instruction for use (IFU).
- These reprocessing information include cleaning, disinfection, packaging and/ or sterilization method, and the number of reuses.
Unlike reusable medical devices, single-use devices are intended by their original manufacturers to be used on one individual during a single procedure. This definition implies that
- the single-use devices are not developed and designed to withstand a reprocessing procedure;
- and the original device manufacturers do not provide any instruction or validated process to allow a safe reprocessing of the devices;
- however, the manufacturers may provide information on the characteristics or technical factors known to them that could pose a risk if the devices were to be reuse.
2. Risks and hazards associated with reprocessing
Regardless of whether they are the reusable or single use medical devices, cleaning, disinfection and/or sterilization are required before the device can be reused. Because reprocessing has been considered in the design of the reusable devices, the choice of raw materials and geometry of the devices may withstand well the heat and chemical detergents during cleaning and disinfection. However, such consideration was not taken into account at the design of single use devices. Therefore, certain hazards and risks, e.g., remaining contaminants, the chemical residues and performance changes, are directly associated with the reprocessing of single use medical devices, according to the opinion of Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR).
3. New regulatory requirements under MDR for single use devices
The EU legal framework distinguishes reprocessing reusable devices from single-use devices when establishing the requirements for the reprocessing under EU MDR. The Regulation does not explicitly use the term “reprocessing”, but refers to “the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and the validated method of re-sterilization.
The requirements for proper reprocessing are specified in laws, standards and recommendations. Suitable methods must be used for reprocessing, which generally comprises cleaning, disinfection, functional inspection, packing, sterilisation, transport and storage. These methods must be validated in accordance with the state of technology and science, and their efficacy must be demonstrated and be transparently and reproducibly guaranteed within the framework of an appropriate quality management system.
Since single use devices are intended by the manufacturer to be used only one time, and the particular risks related to their safe reuse and performance, Article 17, EU MDR provides greater clarity for reprocessing service providers and healthcare institution regarding their responsibility and requirements for reprocessing of single use devices .
Reprocessing service provider are now subject to monitoring by national competent authorities in the European countries where reprocessing single use devices is permitted. To date, most EU and EEA countries forbid reprocessing and reusing of single use devices within their territories. It is also forbidden to use or distribute single use devices that have been reprocessed abroad. However, unused single-use products that are supplied in non-sterile condition but intended for sterile use must be reprocessed in accordance with the manufacturer’s instructions before use. The EU countries currently authorizing reprocessing single use devices are Belgium, Croatia, Germany, Ireland, The Netherlands and Sweden. Even in these countries that permits reprocessing of single use devices, a stricter national provisions apply.