MedAccred audit criteria expands to include x-ray sterilisation

MedAccred, a accreditation program for the medical device industry, has expanded; the audit scope now includes x-ray sterilisation, in addition to the existing ethylene oxide (EO), gamma and e-beam modalities.

Since its inception 10 years ago, MedAccred's audit scope for radiation sterilisation had been limited to gamma and e-beam processes. However, recognising the growing importance of x-ray sterilisation, the sterilisation task group, in collaboration with MedAccred leadership, prioritised the expansion of the audit criteria to accommodate suppliers currently offering or planning to offer x-ray sterilisation services.

The decision to broaden the audit scope was made through a voting process within the MedAccred sterilisation task group, where members expressed their support during routine meetings. The updated audit criteria were published recently and are accessible to subscribers and suppliers participating in the MedAccred program.

Michael Sadowski, lead scientist, sterility asurance global quality of Baxter said: “MedAccred is aware of the ongoing challenges with the supply constraints for traditional medical device sterilisation modalities (i.e., EO, gamma, and e-beam). In order to support the industry in this evolving area, we have proactively developed an audit framework that is now available for use for x-ray sterilisation facilities that support development and routine sterilisation applications.” John Williams, senior director, Microbiology-Sterilisation at Medtronic and Larry Nicholas, CEO of Steri-Tek agree with MedAccred’s ability to see industry challenges and provide support.

The journey towards this expansion began in early 2023, with a primary focus on the execution and completion of the FDA-MDIC Pilot. Following the completion of the pilot, attention shifted to finalising the addition of x-ray sterilisation to the audit criteria. Two working sessions held in July 2023 were instrumental in shaping the content of the updated criteria.

X-ray sterilisation is gaining recognition as a viable alternative to gamma and a complement to e-beam processes. With similar penetration capabilities to gamma, x-ray sterilisation offers the advantage of processing using containers such as carriers, totes, or full pallets. Additionally, both x-ray and e-beam sterilisation require an electron accelerator, running on electricity, making them compatible in facilities.

This update is crucial for industry stakeholders as it allows suppliers of x-ray sterilisation processes to obtain accreditation. Subscribers can now have confidence that these processes are thoroughly audited to confirm compliance with ISO 11137-1 and ASTM E61 practices.

Addressing industry challenges related to Ethylene Oxide Gas (EO), x-ray sterilisation provides an alternative method, adding capacity and diversifying options for medical device sterilisation. While there are legal concerns and sensitivities associated with EO, the new criteria for x-ray sterilisation aim to contribute to a more robust and flexible industry landscape.

Looking ahead, the MedAccred sterilisation task group is actively considering the development of audit criteria for sterilisation-related testing.