The novel Regulation 2020/1207 specifies rules for the implementation of Article 17 (3) of Regulation (EU) 2017/745, where local law has allowed reprocessing of single-use devices. The regulation will be equally helpful where EU member has directed not to apply the rules concerning manufacturers’ obligations laid down in (EU) 2017/745 Regulation on health institutions in perspective to the use of reprocessed single-use devices.
2020/1207 Regulation also provides rules where a Member State has opted to apply Article 17(3) of Regulation (EU) 2017/745 also with reference to single-use devices that are reprocessed by an external Re-processor.
Important Terms & Definitions Related to Reprocessing of Single Use Devices
For the purposes of this Regulation, the following definitions shall apply:
‘Reprocessor’ is defined in EU 2020/1207 as “the health institution and the external reprocessor reprocessing single-use devices.”
‘External Reprocessor’ is defined in EU2020/1207 as “the entity reprocessing single-use devices at the request of a health institution.”
‘Reprocessing Cycle’ is defined in EU 2020/1207 as “a cycle that includes all reprocessing steps applied to a single-use device to ensure that the safety and performance of the reprocessed device is equivalent to that of the original device.”
Insight Analysis into the Regulation
Common Specifications for Re-processing Single Use Devices
Regulation (EU) 2017/745 allows reprocessed single-use devices only where it is endorsed by local law. For single-use devices that are reprocessed and utilized within a health institution, Regulation (EU) 2017/745 permits Member States not to implement all rules relating to manufacturers’ obligations laid down in that Regulation. One of the terminologies; used for such reprocessing specification is that it is performed in relation to the common specifications (CS).
Minimum Requirements for Staff, Premises and Equipment
Common specifications should include Risk management procedures which take into account quality of reprocessing activities, in which those need to cater the minimum requirements for staff, equipment and premises.
Analysis of Characteristics of Single-use Devices
Some single-use medical devices are not adequate for reprocessing. CS related to risk management should incorporate the examination of the characteristics of single-use devices in view of design assembly, making material, component properties and intended application, so as to evaluate the appropriateness of such single-use devices for reprocessing. It is essential to define the individualities of single-use devices to be taken into consideration within risk management procedures, as to ascertain the exclusion of those single-use medical devices that cannot be safely processed again due to their specific hazard potential or particular technical features.
Risk management should take into consideration the risks concerning composition of material, microbiological contamination, leachable substance, endotoxins, prions and contagious spongiform encephalopathy agents, reactions related to pyrogenic, allergic, and toxic behaviors. This is done so as to evaluate whether single-use device is appropriate for reprocessing.
The technical individualities and geometrical dimensions of the products should also be taken into account when evaluating appropriateness of single-use medical devices for reprocessing.
Based on these instances, examples of single-use devices that could be reflected inappropriate for reprocessing include the following:
- Medical Devices emitting radiation
- Medical Devices utilized for administering cytostatic or radio-pharmaceutical medicines
- Medical Devices having medicinal substances
- Medical Devices for application in invasive procedures on the central nervous system
- Medical Devices that carries a risk of transmission of spongiform encephalopathies
- Implantable medical devices
- Medical Devices for which serious incidents have occurred after reprocessing (the cause of the incident is related to the reprocessing, or is relevant to it in any way)
- Medical devices with batteries which cannot be altered or having a risk of malfunctioning after reprocessing
- Medical devices with internal data storage important for the use of the device and which cannot be modified or offers a risk of malfunctioning after reprocessing
- Medical devices with cutting or scraping blades
- Device drills or components wearing off that are no longer appropriate after the first usage and cannot be modified or sharpened before the subsequent medical procedure
Procedure of Risk Management to include Reprocessing Cycle
To ascertain the safety and performance of the reprocessed single-use medical device, common specification (CS) related to risk management should incorporate the procedure by which the reprocessing cycle is developed. In actual, the reprocessing cycle should be founded on the physiognomies of the single-use medical device and the outcomes of a technical assessment. To confirm that the performance and safety of the reprocessed single-use device persists correspondent to the native single-use medical device, it is vital to identify a maximum number of reprocessing cycles which can be implemented to the reprocessed single-use medical device given that the performance and safety persist equal to the new single-use device.
General Safety & Performance Requirements in EU 2017/745
The common safety and performance requirements provided in Regulation (EU) 2017/745 will be applicable to reprocessed single-use medical devices. Health organizations, together, when suitable, with the external reprocessors, are responsible for the safety and performance of the reprocessed device. The health institutions and external reprocessors should then have a quality management system confirming that the appropriate requirements are complied with. The quality management system should encompass all components and features of the organization concerning the reprocessing. In specific, the quality management system should exhibit that the appropriate processes for the reprocessing of single-use devices have been implemented and that all situations for a safe, healthy and effective reuse of the reprocessed device have been fulfilled. The quality management systems of a health institution and the external reprocessor working on its behalf should be well-matched, so as to confirm permanence of the reprocessing quality.
System for Incident Reporting with the use of Reprocessed Sign-use Devices
Each health institution utilizing single-use devices reprocessed by the health institution or by an external reprocessor (at the demand of that health institution) should have an incident reporting system in place so as to ensure the safety and performance of reprocessed single-use devices. The system will also allow them to gather information on incidents coming in connection with such medical devices and should report dangerous incidents to the competent authorities (CAs). The manufacturer and, when appropriate, the external reprocessor should also be informed of such occurrences.
Traceability & Reprocessing Cycles
The external re-processors and health institutions should have a system so as to confirm traceability of the reprocessed single-use device, particularly as regards to the reprocessing cycles accompanied on a single-use medical device, and the ultimate lifecycle and final disposal of the reprocessed single-use device.
Consultancy Support for Health Institutions & External Reprocessors for Reprocessing
As the Medical Device Coordination Group has been consulted in this regulation and the measures offered in this Regulation; well matches with the opinion of the Committee on Medical Devices, therefore it is important for all healthcare institutions and external re-processor to adapt their management system for compliance.
We have tried to explain the regulation in very easy terms to our readers, but we acknowledge that implementing these requirements can be challenging. Therefore TS Q & E can help all health care institutions and external re-processor to adapt their systems so as to fulfill the requirements of Common specification and the new regulation.