Connected devices lead Medsafe to rethink safety alerts

NEWS  - eHealthNews editor Rebecca McBeth

The rapid rise of connected medical devices such as continuous glucose monitors and smartphone apps that control insulin pumps is leading New Zealand's medicines regulator to rethink how patients get critical safety alerts and recall notices.

Chris James, group manager at Medsafe, said at the MTANZ conference on June 30 that while digital connectivity opens new channels for reaching patients to notify them of safety issues or recalls, it also creates significant gaps that regulators and importers or manufacturers need to address.

The devices increasingly allow companies to contact patients directly through apps or through the device itself, which can assist with recalls but also introduces new uncertainties.

"How many people will get an alert and just push it without looking, how many people will just ignore an alert, how many people are not using an app when they should?" he asked.

James said the stakes are high as devices like continuous glucose monitors, which can feed data directly into insulin pumps, carry serious risks if a safety issue is not addressed. 

"With some of these devices, if you have issues, they can be very serious very quickly, so it is about trying to make sure we are getting out to every single patient who may be impacted."

Medsafe's medical device team is just three people responsible for all post-market regulation of medical devices in New Zealand. James said they rely heavily on the companies importing or manufacturing devices to communicate quickly and accurately when issues arise.

James told attendees that recall letters must be approved by Medsafe before being distributed and the regulator also expects a report back. 

He said this is becoming increasingly important as direct patient contact through apps and devices becomes more common, raising questions about how many patients were successfully reached and whether there is any ongoing risk.

Image: Chris James, group manager at Medsafe, speaking at the MTANZ conference

If you would like to provide feedback on this news story, please contact the editor Rebecca McBeth.

You’ve read this article for free, but good journalism takes time and resource to produce. Please consider supporting eHealthNews by becoming a member of HiNZ, for just $17 a month.

Read more Digital Patient news

Return to eHealthNews.nz home page