It says it’s ergonomic – but is it really? How can you tell?

As I sat eating my breakfast and reading the papers on the weekend, I was fascinated to see the continued tradition of the good old-fashioned ‘snake oil’ salesman is still alive and well.

The paper contained articles interviewing people pushing anything from herbs claiming to cure the terminally ill, to wristbands that improve an athlete’s performance – as well as their gravitational balance! These ‘cure what ails ya’ products attempt to promote the belief that these out-there claims are entirely reasonable.

When you’re buying products, particularly for the workplace, you’re very likely to see claims about the benefits of the use of that product. So, what claims are manufacturers/distributors actually allowed to make?

Though the Therapeutic Goods Administration (TGA) has been in existence for over 25 years, there still seems to be little understanding amongst the wider health and safety community about the Commonwealth Therapeutic Goods Act (which is administered by the TGA).

Recommending or providing a product while suggesting it will have a positive therapeutic effect on someone can be seen under the TGA as having provided someone with a medical device (whether the product was paid for or not!)

Consider the following example:

‘This footrest will alleviate the pain you are experiencing in your knees…’

Before you say ‘footrest…pfft…as if that is a medical device’, consider the TGA definition:

Medical devices: are used on humans, have therapeutic benefits, general have a physical or mechanical effects on the body or are used to measure or monitor the functions of the body.

There are some product exclusions, however the definitions of a medical device is intentionally designed to cover almost anything where a therapeutic claim is made. The intent of the Act is to ensure that medical devices (in this example, the footrest), do exactly what is claimed. The TGA says the person making this claim becomes the defacto ‘manufacturer of a medical device’ and therefore has a legal obligation to comply with the ‘14 Essential Principles’ regarding the design, sale and manufacture (among other things) relating to the medical device.

So…how does this relate to people who are not health professionals or recommending these products? As a buyer, you need to be aware of what can be legally claimed about a product. In order to comply with the TGA requirements, a manufacturer/distributor may make claims about:

• The specifications/details of the product (ie colour, dimensions, features (for example, if it’s height adjustable);
• What the intention of the product is;
• How it may be used.

The manufacturer/distributor may NOT make any claims about therapeutic benefits the product may or may not have, unless they have established evidence. Simply put, don’t buy into claims about therapeutic benefits of any product, unless they are proven to be true.

If you would like more information about the TGA, click here.

This blog post is by one of our engineers, Bill Contoyannis. Bill is a biomedical and forensic engineer who has spent the last 25 years investigating medical device incidents and failures. He has lectured extensively on issues surrounding patient safety, avoiding device failures and the regulatory and legal frameworks in which these occur.