The European Commission (EC), a legislative body of the European Union, has adopted a regulation dedicated to the common specifications for the reprocessing of single-use devices.
Regulatory Background
The new Commission Implementing Regulation (EU) 2020/1207 is based on the Medical Devices Regulation 2017/745 (MDR), which repeals the Directives 90/385/EEC and 93/42/EEC.
In particular, the new regulation is actually based on the following points:
- The MDR allows reprocessing of single-use medical devices only in cases when it is explicitly allowed under the applicable national legislation. Moreover, the Member States are allowed to waive the rules set forth under the Regulation when it takes to reprocessing and uses within a healthcare facility, providing that such reprocessing is being performed in accordance with common specifications (CS).
- Common specifications regarding risk management should cover general requirements for personnel engaged in such an activity, facilities, and also for equipment used.
- Certain single-use medical devices should not be subject to reprocessing. Thus, the common specifications should cover the analysis of characteristic allowing to determine whether the particular device could be reprocessed or not. Such determination should be based on the construction, materials of the device, its properties, and application. The regulation contains a list of examples of medical devices that could not be reprocessed, such as radiation-emitting devices, ones used for administering cytostatic or radiopharmaceutical medicines, devices incorporating medical substances (combination products), and other devices. According to the general rule, the approach should be based on the intended purpose of the device and its composition.
- It is necessary to establish the appropriate reprocessing procedures (reprocessing cycle) in order to ensure that the reprocessed device could be used in the same way as the initial single-use medical device. The manufacturer shall also determine a maximum number of reprocessing cycles the device could be subject to.
- The reprocessed medical devices should comply with the safety and performance requirements introduced for the devices of such kind by the MDR. The entities involved in the reprocessing cycle should establish a quality management system covering all the processes in order to ensure the reprocessing quality.
- Each healthcare institution using reprocessed medical devices should establish and maintain an efficient reporting system in order to collect the information related to adverse events and duly report it to the regulating authority. Such a system should also ensure the traceability of medical devices including the number of reprocessing cycles they have passed.
New Regulation on Reprocessing of Single-Use Devices: Key Points
The new regulation should be applied in cases when the Member States decides to apply the provisions set forth by the MDR in the sphere of reprocessing single-use medical devices.
The regulation outlines the main definitions used in the context of reprocessing including, inter alia, the following ones:
- External reprocessor – the entity reprocessing single-use devices at the request of a health institution,
- Reprocessing cycle – a cycle that includes all steps of the reprocessing process applied to a single-use device in order to ensure the equivalence of the safety and performance in comparison to the initial medical device.
The regulation also describes the way the whole reprocessing process should be established and carried out by the entity.
In the case that a healthcare institution engages the third party to carry out reprocessing, it is necessary to enter into the agreement (the regulation utilizes the term “contract”) with such a third party. According to the regulation, the agreement should cover the following aspects:
- Responsibilities of the parties,
- Details regarding the responsibilities of the external reprocessor,
- Requirements for staff engaged,
- Requirements for the Quality management system in the part of compatibility,
- On-site audit(s) as the procedures to be carried out in order to monitor the quality of reprocessing.
Requirements for Reprocessors
The regulation also sets forth the requirements the reprocessor shall meet in order to comply with the appropriate eligibility criteria. These requirements cover such aspects as personnel, equipment, and premises. According to the requirements, the reprocessor shall have a sufficient number of specialists with relevant knowledge and experience, each acting in accordance with defined tasks within the scope of his/her responsibilities. The entity shall also duly designate one or more persons responsible for reprocessing. Such person shall have the appropriate qualification, and also to pass special training on adverse event reporting. It is important to mention that the responsible person shall be permanently available.
In accordance with the requirements for the premises and equipment, the regulation sets forth the rule prescribing that both premises and equipment should be duly adapted for reprocessing purposes due to the type of the device, reprocessing cycle, and the number of steps. All equipment used in reprocessing should be subject to maintenance and calibration necessary to ensure and sustain its correct operations.
Another important requirement relates to the surfaces and their microbiological and physical quality that should be checked on a regular basis.
The types of single-use medical devices the entity will reprocess should be described by the reprocessor in the appropriate technical documentation. If the reprocessor suspends its operations with certain types of medical devices, it shall duly reflect this in technical documentation.
Single-Use Medical Device Reprocessing Suitability Assessment
The regulation also describes the approach to be used when determining the suitability of particular medical devices for reprocessing. Such determination is a mandatory part of the reprocessing process and should be performed as the first step.
In order to make the correct determination, the healthcare institution shall assess the characteristics of the device in the context of safety and performance to identify whether the equivalence to the initial single-use medical device could be achieved.
According to the regulation, the aforementioned assessment should include the following steps:
- CE marking verification,
- Registration status verification (the device in question should be duly registered, and its certificate should be valid),
- Checking available information regarding the restrictions for safety reasons the device was subject to,
- Performing a rigorous analysis of the single-use medical device, its design, composition, and properties.
The healthcare institution may also consult with external reprocessors when it is reasonably necessary to perform the accurate assessment of the single-use medical device subject to reprocessing. Additional information regarding the device could be verified via the European Database on Medical Devices (EUDAMED). When assessing the single-use device itself, the healthcare institution shall analyze all the information regarding the device in question which is publicly available, including the information published by the medical device manufacturer or its authorized representative on their websites.
It is important to mention that the final decision made by the healthcare institution should be based on the written positive opinion issued by the person responsible for reprocessing.
Other important points of the new regulation on reprocessing of single-use medical devices include, inter alia, the following ones:
- The initial intended purpose of the device indicated by the manufacturer should not be changed in the course of reprocessing,
- The reprocessor shall continuously monitor the regulatory status of the initial single-use device,
- The reprocessor shall also monitor any changes to the initial medical device made by its manufacturer and take them into consideration when determining the suitability of the device for the purpose of reprocessing.
Summarizing the information provided here above, the new EC regulation on reprocessing of single-use medical devices describes the way medical devices could be reprocessed and also sets forth the appropriate rules and requirements all parties involved shall follow.
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