Tighter measures for medical device safety
16 November 2023
Since the day you were born, and in most cases prior, medical devices have been used to support your healthcare. Contact lenses and x-ray machines – even bandages and band aids – make up the tens of thousands of diverse products used to detect, prevent or fix medical issues. It is essential, therefore, that medical devices perform optimally. A new set of reforms is underway across the country to set up more safeguards to ensure they do.
Implantable medical devices – such as joint replacements, breast implants and pacemakers – are devices that are introduced into the body. Many of these require surgery to be implanted and remain in the body after the procedure.
Some of these devices are manufactured in Australia, while others are produced in different parts of the world. Whether made locally or imported, all medical devices must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be supplied and used in Australia.
What if a device is faulty?
Most patients will live with their implanted medical device and never encounter a problem, but there are cases in which a device has caused harm or an unexpected health issue in some patients. When this happens, locating, identifying, and notifying potentially affected patients in a timely way is essential.
In 2010, for example, Poly Implant Prothèse (PIP) silicone breast implants were recalled, and then cancelled from the ARTG, along with many other registers around the world. Manufactured in France, these implants were found to contain unapproved silicone gel prone to rupturing.
Hundreds of thousands of women around the world were fitted with the implants; some remain unaware of the recall. Had a workable register of such devices existed, it would have enabled these patients and their clinicians to be contacted more quickly, sensitively, and directly in order to undertake appropriate corrective actions.
Road to reform
In 2017, a Senate inquiry commenced in Australia into transvaginal mesh implants, used to prevent urinary incontinence and pelvic organ prolapse. The use of these devices caused adverse effects such as chronic pain in women around the world. The inquiry raised a number of concerns, including the absence of an accurate record of how many of these medical devices had been implanted in Australia.
The committee made 13 recommendations in its 2018 report, including the need to improve patient information collected before and after implantation of a medical device, and the need to develop ways to report adverse events.
Based on outcomes from this inquiry and others similar to it, the Australian Government's Therapeutic Goods Administration (TGA), which regulates medical devices and monitors their performance at the national level, devised a suite of Medical Device Reforms.
Under the reforms, the TGA imposes new responsibilities – some of which are mandatory – on healthcare professionals and health services.
Support to enact the reforms in NSW
In NSW, the Clinical Excellence Commission (CEC) is supporting the response to the reforms. It is coordinating the implementation of these reforms across the NSW Health system in partnership with the Ministry of Health, Agency for Clinical Innovation, HealthShare NSW, eHealth NSW, Health Infrastructure, Local Health Districts and Speciality Health Networks, and consumer representatives.
The CEC's Medical Device Governance Program (MDGP) is aligned with the TGA's following three strategies:
- improve how devices get on the market
- strengthen the monitoring and follow-up of devices
- provide accessible information to potential patients, families and carers.
The purpose of the TGA's reforms is to improve patient safety in the use of medical devices. The aim of the CEC’s program, in turn, is to support healthcare professionals in this process by raising awareness of changes to the existing procedures and introduction of new requirements, enabling system changes to reflect the requirements of the reforms, and empowering staff and patients to report concerns with medical devices they use.
Stepping up information all-round
Information is at the heart of the reforms. This means a focus on providing, recording and using information.
Under the reforms, for example, it is now mandatory for health professionals to give patients information on their implantable medical device both before and after the device is implanted, and that this be documented in the patient's medical record.
From 2025, it will be mandatory for healthcare professionals to report medical device adverse events to the TGA. This information will then help NSW Health and the TGA to rapidly identify and respond to any issues.
Global coding standards will also be introduced to improve the way medical devices are identified, tracked and traced. Likewise, the government will produce a database to enable timely access to complete, accurate and consistent information about medical devices in use in Australia.
Learn more about the reforms
The CEC has a dedicated webpage on medical device governance. It will also keep healthcare professionals up-to-date with the latest news, resources and information. Subscribe here.
For further information on medical device governance in NSW, email the CEC on cec-medicaldevicegovernance@health.nsw.gov.au.
Tens of thousands of medical devices are used to support our wellbeing. The universal classification system (Class 1, Class IIA, Class IIB and Class III) places each device into a risk category. Under the reforms, some of these devices will be re-classified and new ones added.