Medical device industry calls for My Health Record to include medical device data
The Medical Technology Association of Australia (MTAA) today broadly welcomed the recommendations from the Senate inquiry into transvaginal mesh implants.
As the Government considers the Committee’s recommendations, MTAA will continue to be an active participant in this process to ensure the best outcome for patients.
Ian Burgess, Chief Executive Officer of the Medical Technology Association of Australia said:
“MTAA is committed to working with the Government to progress relevant recommendations as determined by the Government.
On behalf of MTAA, I acknowledge the women who shared their deeply personal stories during the Senate Committee process.
The medical device industry’s fundamental purpose is to provide patients better health outcomes.
Over many months, the Committee heard from patients, clinicians, manufacturers, regulators and other experts to better understand the complexity of pelvic organ prolapse and stress urinary incontinence and the range of available treatment options.
MTAA and our members have been active participants in this process having provided submissions to the inquiry and appearing before the Committee at its public hearings.
MTAA notes that while the Committee recommends the Government consider a registry for all high-risk implantable devices, the report acknowledges the evidence of the Department of Health and MTAA that funding of registries should recognise they provide benefits to a range of stakeholders including hospitals and patients.
Registries can be invaluable but they are complex and expensive. We need to ensure that when we set up a registry we’re very clear around what data is being collected and the extent of that data.
Further, in terms of the cost of registries, we need to ensure all those that benefit pay for it - including regulators, healthcare professionals, insurers, hospitals and policy makers.
The development of My Health Record will provide a tremendous opportunity to improve data collection across the whole health system and across the patient journey, not just specific to a particular silo of the health system.
We believe that the Government should prioritise consideration of the inclusion of medical device data in the My Health Record.
The Committee’s report also notes that adverse event reporting is mandatory for device sponsors and MTAA supports the Committee’s recommendations to enhance reporting by medical practitioners and patients.
The Committee also recommends the Department of Health work with MTAA and the Medical Board to review systems in place to support consistent, high ethical standards.
The report notes the evidence of MTAA and member companies that no financial or other incentives have been provided to medical practitioners to use or promote transvaginal mesh implants, and that members of MTAA are bound by a Code of Practice that sets high standards for ethical interactions with healthcare providers.
Should the Government accept this recommendation, we look forward to working with the Department. A key reform would be the implementation of a harmonised industry code of practice which all device manufacturers and suppliers are required to adhere to by law or regulation. The MTAA Code of Practice would be an appropriate basis for such a harmonised code.”