Doctors should be mandated to report all adverse reactions to medical devices and implants, a Senate committee has recommended after investigating the widespread underreporting of problems with transvaginal mesh implants.
In a report released on 28 March, the Senate Standing Committee on Community Affairs also recommended that a single national register be set up to cover all implantable devices.
The inquiry, which was set up in February 2017, found there were numerous problems with reporting and recording of adverse events for medical implants, and the TGA had limited powers and budget to operate an effective system of post-market surveillance of adverse events.
After hearing from patients, consumer groups and medical organisations, the inquiry concluded that action was needed to improve adverse event reports for medical devices and implants. It noted that currently there is only a mandatory requirement for the marketers of medical devices to report adverse events, and companies rely on voluntary reports from doctors for most data.
The inquiry also found there is significant under-reporting of adverse events because patients are unaware they can report adverse events or have difficulty reporting them because they don’t know who to report to.
The TGA does not have scope within its budget to promote the reporting of adverse events via public information campaigns, and instead relies on media releases and discussions with medical groups to encourage reporting. It also has no power to mandate reporting of adverse events, the report notes.
The committee therefore recommended that Commonwealth and state governments consult with the Medical Board of Australia to review the current system of reporting adverse events to the TGA and implement mandatory reporting of adverse events by medical practitioners.
It also called for the TGA to be given more resources and support to improve awareness of the reporting system; and to examine options to simplify the adverse event reporting process.