Recently the TGA has received adverse event reports that have involved incorrect devices being used or implanted into patients. One event saw a prototype orthopaedic instrument clearly marked "not for clinical use", used on a patient. Another event saw breast implant sizing devices implanted into a patient instead of the actual breast implants.
The TGA would like to remind health professionals that when implanting medical devices into patients they should always ensure that:
- the use-by date on the device has not expired;
- the device is intended for clinical use/implantation and is not a prototype or sizing/guide device; and
- the device is included on the Australian Register of Therapeutic Goods (ARTG) (unless a special exemption has been granted).
Current use-by dates
Health professionals should always check the use-by date of a medical device before use and ensure that it is still current.
Use-by dates are provided on applicable medical devices for a valid reason. Manufacturers test and validate devices extensively to determine the period for which the device can be safely used. This lifespan takes many factors into account, but the most critical are that:
- the device will function in its intended manner, and its components will not degrade to a point that will affect performance or safety
- if the device is sterile, the manufacturer can ensure sterility up until the use-by date expires
- the device is safe for both the patient and the implanting surgeon.
Correct devices for implantation
When any medical device is being prepared for implantation into a patient, healthcare professionals should ensure that the device:
- is intended for implantation
- has the correct model number and intended orientation (left/right)
- is the right size
- is the permanent implant and not a temporary sizer or guide device.
Registered medical devices
All therapeutic goods must be included on the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully supplied in Australia, unless the TGA has granted a special exemption.
If the TGA becomes aware that therapeutic goods are potentially being supplied illegally, the TGA will investigate and take appropriate action.
Therapeutic products purchased from overseas or via the Internet that are not regulated by the TGA may not meet the same standards of safety, quality and efficacy required for products that are included on the ARTG. In recognition that there are circumstances where patients need access to therapeutic goods that are not on the ARTG, special exemptions are available by making applications to the TGA for one of the programs listed below:
- the special access scheme (SAS)
- authorised prescribers
- the personal import scheme
- the clinical trials exemption scheme.
Reporting adverse events
Health professionals and consumers are encouraged to report any problems associated with a medical device to the TGA via the Reporting problems link on the TGA Internet site. All information received contributes to the TGA investigation of potential safety issues.
Reports are investigated under the Medical device incident reporting and investigation scheme (IRIS).