What happens if compliance is not taken seriously?
When non-compliance with the regulations happens, it is inevitable that a problem or injury may occur. As part of the Australian regulatory framework, there exists incident reporting.
The Medical device incident reporting & investigation scheme (IRIS), is part of the current legislation.
An adverse event is an event that led to:
- a serious injury or serious deterioration to a patient, user or other person, including
– a life-threatening illness or injury
– permanent impairment of a body function
– permanent damage to a body structure
– a condition necessitating medical or surgical intervention
- to prevent permanent impairment of a body function or permanent damage to a body structure.
A ‘near adverse event’ is an event that might have led to a death or serious injury. It may be that due to the timely intervention of a healthcare practitioner a death or serious injury did not occur. For an event to be defined as a near adverse event, it is sufficient that:
- an event associated with the device happened
- if the event occurred again, it might lead to death or serious injury
- testing or examination of the device or the information
- supplied with the device, or scientific literature indicated
- some factor that could lead to a death or serious injury.
Medical device adverse incidents involving actual harm toa patient / caregiver or that could have resulted in harm should be notified to the facility’s Quality / Risk Manager who should coordinate reporting to external organisations, such as the supplier of the device and the TGA. These events should be investigated as quickly as possible.
In cases where it is difficult to judge whether to report or not, then reporting is recommended.
The Therapeutic Goods Administration (TGA) has a very easy to follow online format for reporting an event associated with a Medical Device.
Please note this is different from a product recall that is generally imitated by the manufacturer of a device. Uniform recall procedure for therapeutic goods (URPTG) https://www.tga.gov.au/publication/uniform-recall-procedure-therapeutic-goods-urptg-v20
If a device fails to do what is has been intended to do as per the manufacturer’s instructions for use (IFU) https://www.tga.gov.au/sites/default/files/electronic-instructions-use-eifu.pdf then it is beholden on the user of the device to submit an incident report to the TGA. You may consider this a minor incident such as a bur breaking, a light blowing, a handpiece fracturing a material not setting or any other incident that occurs. It is important to initiate an incident report with the TGA as it allows others to be aware of the reported incident as well as assisting the manufacturer overcome a potential fault with their device.
As the key link in the supply chain within the dental industry, the Dental professional must ensure that however small the incident appears to be it may be monumental if it is occurring in hundreds of different clinics in Australia.
If in doubt report the incident. To understand an overcome a problem with a device only enhances the credibility of an Australian Dental Industry that is at the forefront of medical device excellence.
Dr Roy Hardman (PhD)
Specialist Medical Devices Consultant
Ph 03 9885 5388 Mobile 0419 100 978