Broadly speaking, a medical device is considered to be any article that is not a medicine, and that is used for the diagnosis, prevention, monitoring, treatment or alleviation of a health condition.
In Australia, all devices, whether they be a highly technical piece of medical equipment imported from overseas, a supermarket-bought Band-Aid, or software that assists in the diagnosis of a condition, must comply with the Therapeutic Goods Act 1989 – the legislation that regulates medical devices.
Broadly speaking, the legislation is built on a foundation of patient safety and product quality, with the aim of mitigating the potential of causing unnecessary harm to the end user or patient.
The legislation requires that medical devices comply with the Essential Principles around design and construction, the development of solutions that are state-of-the-art and best practice, and that the benefits of the device outweigh the risks.
The primary motivation behind these Principles is safety and performance, ensuring the device offers a proven benefit, and protecting the public.
The Therapeutic Goods Administration (TGA) is responsible for ensuring regulations are adhered to in Australia and is comprised of experts from various disciplines such as medicine, engineering, microbiology, materials, science and others. These experts review the evidence provided and determine whether companies have done enough to satisfy regulatory requirements, and whether a device can be approved for intended use.
While the TGA enforces the regulatory requirements, the onus is at all times on the manufacturer to design products that are safe, high quality, and perform as intended. They also have to provide the evidence proving a device meets the required obligations, that it is safe, effective, and does what it claims to do.
It’s also important to note that the intended use of a device, what the product is for, is determined by the manufacturer. They then need to provide evidence proving that the product has the clinical benefit that they claim.
One of the most misunderstood aspects of med-tech regulation and the TGA is the manner in which medical devices are assessed, and evidence is provided.
Even though all medical devices are required to comply with the essential principles, devices are not all assessed in the same way and each don’t require the same level of evidence.
Instead, there are four levels of classification, with greater scrutiny and evidence required for devices that have the potential to cause a greater level of harm if they’re not designed, manufactured and/or used correctly.
For example, a wound dressing that doesn’t meet required sterilisation standards presents a lower level of potential risk to patients than a surgical implant that has been manufactured incorrectly.
That’s not to say that a lower-risk device isn’t scrutinised, but rather that the level of evidence required to meet the regulations isn’t the same.
This is vital in ensuring devices are as cost-effective as possible. If a Band-Aid was required to undergo the same level of testing as an implant, for example, the extra costs this would generate would need to be passed on to the end user, and likely render the product unaffordable.
Medical devices are intended to make our lives better, whether by improving health outcomes, preventing disease or improving quality of life.
However, if they’re not designed and manufactured correctly or used in their intended way, medical devices can cause harm, injury or even death.
While there is a level of shared responsibility from the designers and manufacturers of these devices, the regulations exist to provide a non-negotiable risk and safety benchmark that is intended to protect the public.
It’s true that the current system is not perfect, and flaws do exist, however the regulatory framework is important in creating a strong safety net to keep patients safe.