Protecting Patients with Medical Device Regulation

The term “medical device” is comprehensive and covers everything from large-scale equipment to consumable products. No matter the size or cost of a product, all medical devices must be held to the same regulatory standards to safeguard patient health and wellbeing. 

While partnering with a professional and experienced supplier of medical equipment in Australia will all but guarantee that your equipment meets regulatory standards, it is still important for all people in the healthcare industry to understand their rights and responsibilities when it comes to medical device regulation. 

What is a medical device?

To better understand these regulations, it’s important we start by confirming what types of products fall under the definition of medical device.

As per the Therapeutic Goods Administration, a medical device is defined as a device that:

●    Is used for humans
●    Are intended to diagnose, prevent, monitor, treat, or alleviate a disease or injury, or modify or monitor anatomy or physiological functions of the body
●    Generally achieve their purpose by a physical, mechanical, or chemical action.

A more detailed definition can be found by consulting the TGA website. 

Within this broad definition there are several classifications that take into account the degree of invasiveness, the duration and location of use, and whether the device requires a source of energy.

●    Class I: Risk — low. Example — bandage.
●    Class I (supplied sterile): Risk — low-medium. Example — hypodermic needle.
●    Class I (incorporating a medical function): Risk — low-medium. Example — medicine cup.
●    Class IIa: Risk — low-medium. Example — contact lenses.
●    Class IIb: Risk — medium-high. Example — blood bag.
●    Class III: Risk — high. Example — major joint replacement.

TGA explained

The TGA, or Therapeutic Goods Administration, is part of the Australian Government Department of Health. In their own words, the Administration aims to “safeguard and enhance the health of the Australian community through effective and timely regulation of therapeutic goods.”

In a practical sense, this means that the TGA monitors all aspects of therapeutic goods development, including pre-market assessment, post-market monitoring and enforcement of standards, and the licensing of Australian manufacturers and verifying overseas manufacturers’ compliance with the same standards as their Australian counterparts.

The TGA has the power to take action if they discover there is a problem with a device or medication. This can include continued monitoring or removing a device completely from the market.

The TGA acknowledges that some medical devices do carry inherent risks. Their role is to apply “scientific and clinical expertise to its decision making to ensure that the benefits of a product outweigh any risks.”

Regulation of therapeutic goods

Generally speaking, therapeutic goods, which include medical devices, must be entered in the Australian Register of Therapeutic Goods (ARTG) before they can be supplied in, imported into, or exported from Australia. There are minimal exceptions to this rule.

The ARTG can be accessed by anyone and contains information including the product name, any active ingredients, classification, sponsor, and manufacturer.

The term sponsor refers to the person or company who makes the initial application to have a product manufactured, imported, or exported. As of October 2019, there were approximately 91,000 products on the ARTG and the number will have only grown since then.

Protecting patients

Too often, we hear of patients suffering complications or side-effects from medical devices. Often these devices have not even been used incorrectly, making the clinician another victim of the situation. The role of the TGA is therefore to protect all people involved in the development, manufacturing, and application of medical devices.

In the words of the TGA:

    “The Australian public should feel confident in the safety and quality of approved medical devices in Australia, with our regulatory requirements for medical devices amongst the most stringent in the world”

The fact that the ARTG is completely accessible online means that you can search for any medical device you are thinking of purchasing to double check that it is approved for sale in Australia. Another way you can be confident about the regulatory status and quality of your equipment is by buying from an experienced, professional supplier.

There are simply so many medical device providers out there, making the process of purchasing equipment potentially overwhelming for healthcare managers. The accessibility of the internet has only increased the number of companies selling supplies online. However, not all of these companies offer the same level of pre and post sales support, including repair and maintenance. Medical equipment requires scheduled maintenance from a trained technician — the last thing you want is to have a broken machine and no one to fix it.

Ultimately, the best way to protect your patients is by partnering with a supplier that understands the rules and regulations that govern the sale of medical equipment in Australia.