Mandatory reporting of adverse reactions needed, Senate recommends


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.

The Senate committee heard from clinicians and medical colleges who said there was a need for a national register of medical devices to build on the success of individual registers such as National Joint Replacement Registry.

“It’s likely that other implantables in the future will be subject to question and concern, and I call on the government to establish a national implantables register,” said Professor Stephen Robson, President of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

“Many Australians have or will have different implants—joints, mesh, other implants – and, rather than having multiple different registries, there should be a single, appropriately funded and independently run national register of implantables.

“It could be funded by the manufacturers of implants and it should be integral to the ehealth records system in Australia. The next phase of implants in Australia will be genetic implants, and it’s imperative that a national register is embedded in health care in this country before that phase arrives,” he added.

The move was also supported in principle by TGA deputy secretary John Skerritt, who said that without a national register, Australia would end up with a fragmented system of 30 or 40 separate device registers using different datasets and reporting systems and with high individual costs.

The committee agreed and gave the government a deadline of November 2018 report on implementation of previous recommendations from its Review of Medicines and Medical Devices Regulation for a registry for all high-risk implantable devices.

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