Regulatory Focus™ > News Articles > Study: Medical Device Safety Could Be Improved With Help of Software

Study: Medical Device Safety Could Be Improved With Help of Software

Posted 09 March 2012 | By

A new study published in the American Health Association's journal Circulation: Cardiovascular Quality and Outcomes says that commercially available software could discover problems with medical devices well before traditional adverse event tracking systems are able to, reports Fierce Health IT.

The study looked at 2710 implantable cardioverter-defribrillator leads, of which 107 failed during the study. Software used by the study was able to successfully alert the authors to problems with the leads more than a year before the products would have been recalled.

"An active automated safety surveillance system could have identified this implantable cardiovascular device problem substantially sooner than was achieved through existing postmarket surveillance methods," wrote the authors of the study. "Such a tool, when applied to clinical registries and remote monitoring databases, may limit the exposure of large populations to underperforming and potentially hazardous cardiovascular devices."

Because the majority of medical products on the market rely on voluntary adverse event reporting, detecting signals of sustained malfunctions can be particularly difficult, which can delay necessary recalls.

Read more:

Fierce Health IT - Study: Software can detect underperforming implantable devices earlier

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