The Compliance and Enforcement Group (COEN), an EU body focused on the sphere of information exchange between market surveillance authorities and coordination of enforcement activities, has issued a checklist dedicated to the instructions for use (IFU) for reusable and re-sterilizable medical devices. 

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Regulatory Background 

According to the document, a special IFU Working Group has been formed by the COEN to investigate the most important issues related to the instructions for use of re-sterilizable medical devices. The document also refers to the international harmonized standard ISO 17664 (Sterilization of medical devices – Information to be provided by the manufacturer for the processing of re-sterilizable medical devices). The COEN acknowledges the importance of the safety-related information for the medical device manufacturers and other parties involved in operations with re-sterilizable medical devices. Thus, the present document constitutes additional guidance intended to provide ancillary information regarding the key safety and performance aspects, besides the aforementioned international standard. 

It is also important to mention that the end-users and industry representatives are allowed to provide their feedback and suggestions regarding the present checklist and possible ways to improve it. 

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Instructions For Use: Key Points

First of all, the COEN outlines the most important issues taking place nowadays. In particular, the COEN is deeply concerned with the fact that numerous re-sterilizable medical devices are currently being supplied and distributed without the Instructions For Use. According to the research made by the COEN, this appears due to the following reasons:

  1. Invasive surgical instruments, which are re-sterilizable medical devices, are being classified as Class I medical devices under the risk-based classification. Due to the fact that conformity assessment for such devices is not required, medical device manufacturers do not include Instructions For Use in the scope of documents and materials accompanying the device when being distributed and provided to the end-users. 
  2. There is a special exclusion allowing the manufacturers to avoid the obligation to supply the device with IFU – “if they can be used safely without any such instructions.” This exclusion could be applied in the case of Class IIa medical devices. According to the position of the COEN, the medical device manufacturers are actually applying for such an exclusion much more often than it is reasonably justified due to the nature of the device and its features.   

The COEN also mentions that in some cases the reprocessing of medical devices could be complicated due to their geometrical or physical properties. It is stated that compliance of the particular device in question with the applicable requirements could be demonstrated through the compliance assessment based on the standard ISO 17664. At the same time, the manufacturers are quite rarely providing the appropriate self-declaration.

IFU Checklist 

According to the guidance, the IFU checklist attached as the annex thereto is intended to assist the competent authorities with the key points of attention to be considered when assessing the re-sterilizable medical device. Despite the fact that the checklist is based on the requirements of the aforementioned standard, it contains only certain key points, but not the whole picture, and thus, should be deemed admissible only for a brief assessment. At the same time, the checklist describes the simplest approach to be applied when assessing the re-sterilizable medical device. However, the COEN emphasizes that the present checklist could not be used instead of the ISO 17664 standard. By creating this guidance document, the COEN also intends to increase and expand the awareness of all the parties involved in the operations with the re-sterilizable medical devices regarding the most important aspects related to the safety and suitability of the intended purpose of such devices. 

Each item included in the checklist could be assigned with one of the following values:

  • Yes,
  • Not completely fulfilled, 
  • Not fulfilled,
  • Not applicable. 

It is also important to mention that each time using the last value, Not applicable, it is necessary to provide a detailed justification for such a decision. 

According to the position of the COEN, the completion of the checklist will provide the party performing it with the relevant and relatively accurate information regarding the compliance of the device subject to review with the applicable requirements, and also regarding the information that is missing. The information obtained as the result of such a simplified conformity assessment could be used by the parties when acting within the scope of their responsibilities. 

However, the COEN explicitly states that irrespectively of anything indicated hereabove, the re-sterilizable medical device manufacturers should still refer to the ISO 17664 standard when demonstrating complaint with the applicable safety and performance requirements.

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Validation Assessment Checklist

Another important aspect covered by the present guidance is a validation procedure to be performed by the medical device manufacturer in order to demonstrate compliance with the applicable essential requirements. 

Each time conducting re-sterilization of medical devices it is important to ensure the effectiveness of reprocessing since in certain cases it could be quite difficult due to the technical matters. Thus, the COEN states that the reprocessing procedure should be duly validated. 

The document also provides a definition of validation, set forth in the standard ISO 14937, which defines validation as a “documented procedure for obtaining, recording and interpreting the results required to establish that a process will consistently yield product complying with predetermined specifications.” It is also important to mention that the whole checklist «Assessment of the Validation» is actually based on the requirements set forth in the aforementioned standard ISO 14937 (Sterilization of health care products – General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices). The COEN mentions that the significant part of the data necessary to assess compliance with the aforementioned standard could be obtained only from the validation. 

Another important point is that the conformity assessment is usually performed by the competent authorities, while medical device manufacturers and other industry representatives have limited access to the information regarding the procedure itself and on the criteria used. By making the checklist publicly available, the COEN intends to increase awareness of the medical device manufacturers in order to assist them in maintaining compliance with the applicable safety requirements. The manufacturer shall also consider the information contained in the checklist when preparing technical files and other documents. 

In the same way, as for the previous checklist, the COEN mentions that the present checklist on the assessment of the validation does not cover the entire scope of aspects to be assessed. The document only highlights key points related to the validation procedure, while end-users and procurement personnel should make their decisions based on the assessment in accordance with the applicable international standard – ISO 14937. 

Summarizing the information provided here above, the two checklists developed by the COEN are dedicated to the most important aspects related to the reusable and re-sterilizable medical devices, including the applicable safety requirements and the way the validation should be performed. The documents are not exhaustive and thus could be used only as an additional source of information, but still could be useful for medical device manufacturers and other parties involved since they describe the most important criteria that would be considered by the competent authorities.

EUA eligibility criteria checklist

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Sources:

https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_checklists-iso-17664-14937_en.pdf


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