Don’t Drown in Wave of Device Adverse Events in EU

Device-related adverse events are increasing in the EU, with the most recent numbers showing a 13 percent rise in the UK to 10,280 in 2010.

When another 752 incidents are included in periodic summary reports, the total climbs to 11,032 — 66 percent greater than a decade ago, according to the Medicines and Healthcare Regulatory products Agency (MHRA).

Meanwhile, U.S. devicemakers are feeling the heat from FDA enforcement actions for AE reporting failures. The agency recently warned Johnson & Johnson subsidiary Animas for repeated failure to report adverse events with its insulin pumps.

Animas failed on at least three occasions to report events within the required 30 days.
Two of the events were reported late but the third, in which an insulin pump may have contributed to diabetic ketoacidosis, was never reported.

It’s a tough time for adverse event reporting in the EU and U.S. and devicemakers need Medical Device Adverse Event Reporting: A Guide to EU and US Premarketing and Postmarket Compliance to avoid finding themselves in a clutch.

Don’t be caught off guard — this book can be a guardian angel when you need a quick reminder or pre- or postmarket compliance. Order yours today.