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Medical device pharmacovigilance is complicated. Alongside clinical safety, there are technology risks, from cybersecurity threats to outdated software, that can put patients at risk.

In this two-part episode, Omar Aimer, President of ISoP and former co-lead of the Medical Device Safety Special Interest Group, discusses the challenges with medical device safety monitoring and what needs to change to keep patients safe.

Tune in to find out:

• How reporting for medical devices differs from medicines and vaccines
• How AI may be used for predictive safety monitoring
• Why regulatory and data harmonisation remains the key to improving medical device safety

Want to know more?

Listen to the first part of the interview here.

If you would like to learn more about the status and suggestions for future improvements in medical device safety monitoring, Omar has recently published a paper on the topic in the journal Drug Safety, as well as an article for Uppsala Reports.

Much like any other market, AI/ML are fast infiltrating the medical device field, and may require tailored frameworks for effective safety monitoring, as discussed by Babic et al. in their Nature paper.

Founded in 2018, ISoP’s Medical Device Safety Special Interest Group works to develop “best practices and policy in the field of medical device performance monitoring and safety surveillance”.

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About UMC
Read more about Uppsala Monitoring Centre and how we promote safer use of medicines and vaccines for everyone everywhere.