The selection and insertion of vascular grafts in haemodialysis patients

The MHRA agrees that the risk of selecting and inserting an incorrect device i.e., arteriovenous grafts can be mitigated by ensuring that medical device manufacturers consider the impact of Human factors, i.e., context of use and usability guidelines when designing packaging. Before a device is granted a UK Conformity Assessed (UKCA) mark and supplied on the GB market, an ‘Approved Body’ will have completed an assessment to ensure it conforms with the current regulations. The MHRA regularly audits Approved Bodies once they are designated. Technical files are sampled as part of surveillance audits to help ensure that correct evidence has been provided by the manufacturer and assessed appropriately.

Following your report, we will engage with the designated and applicant Approved Bodies to ensure that they are aware of this recommendation and modify our processes to ensure that when auditing Approved Bodies, their consideration of the context of use and usability guidelines when assessing adherence to packaging standards in conformity assessments is reviewed. This will be followed up at regular surveillance audits conducted by the MHRA to ensure that Approved Bodies are correctly monitoring manufacturers.

Actions planned to deliver safety recommendation:

1. Provide a copy of the HSSIB report to designated and applicant Approved Bodies ahead of the next UK Approved Body (UKAB) operational meeting along with a covering letter from MHRA. To add onto the agenda to provide a ‘verbal update’ during the meeting itself. By: To be confirmed – next meeting date has not been set, expected December 2023/January 2024. Resources in place: UKAB Operational meetings are standing meetings that occur approximately once per quarter. Additional comments: Meeting has both designated and applicant Approved Bodies (AB).
2. Surveillance strategy for each designated AB to be updated to note that where relevant, client files reviewed must show that the consideration to the usability of devices has been reviewed, by end of November 2023. Additional comments: Documentation to be amended to include this as a standing item the audit team should cover. This is reviewed by the lead auditor ahead of each surveillance audit. Client files reviewed on a sampling basis and these audits are conducted annually.
3. Update the AB team’s Standard Operating Procedure (SOP) to reflect the processes implemented based of this recommendation, by end of Quarter 4 2023. Resources in place: Will need to consider timing of change to SOP to align with review of existing SOPs. Additional comments: AB team would have to review the changes before the document is finalised.

Response received on 13 November 2023.