AE Reporting by Devicemakers Up Significantly, TGA Says

May 29, 2015

The number of adverse events reported by devicemakers in Australia jumped by more than a thousand in 2014, compared with the previous year, regulators say.

In 2014, companies submitted 3,697 AERs to the Therapeutic Goods Administration, or 85 percent of the total 4,337 device-related reports, according to postmarket vigilance data released May 26. This was significantly more than the 2,456 adverse events devicemakers reported in 2013.

The TGA attributes the spike to greater awareness among device users to report incidents to the manufacturer.

The remainder of the reports — 640 — were filed by doctors, allied health professionals, nurses and consumers. Unlike devicemakers, these groups aren’t required by the TGA to report adverse events.

The number of reports by doctors dropped to 115 in 2014, from 376 the previous year when a major breast implant recall was underway, the TGA notes. Allied health professionals and nurses filed 232 and 167 reports, respectively — up from 158 and 93. Consumers accounted for just 122 reports, down from 178 in 2013 when a total of 3,000 AERs were logged.

View the TGA report at www.fdanews.com/06-01-15-TGApostmarket.pdf. — Elizabeth Orr