The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Ethyl chloride spray should not be used in association with medical devices containing a common plastic.
The TGA has been made aware of a chemical incompatibility between a common plastic used in some medical devices, acrylonitrile butadiene styrene (ABS), and ethyl chloride, a topical anaesthetic spray.
ABS is a thermoplastic polymer that is widely used in cannulae and tubing.
Ethyl chloride spray (also known as chloroethane or monochloroethane) is a skin refrigerant intended for topical application and acts as a mild topical anaesthetic through its chilling effect.
The TGA received advice that a white deposit was observed on the surface of an amnioscope (device used to examine the foetus and the fluid sac around it) after it came in contact with ethyl chloride spray during an operation overseas. The deposit was also noted on the patient. ABS is widely used in similar medical devices.
The white deposit seen in the overseas operation was not sampled and tested and therefore its exact composition is not clear. However, chemical compatibility charts describe the effect of ethyl chloride on ABS plastic as "SEVERE" and for this reason direct contact between the two should be avoided. Given the nature of amnioscopy and cannulation, it is possible that devices made of ABS and ethyl chloride are used together very frequently. Direct contact between the two is likely to affect the safety or performance of the device.
Health professionals and facilities are advised to avoid using ethyl chloride spray in conjunction with medical devices containing ABS.
Appropriate warnings should be noted in the Instructions for Use for both products.
The TGA has not received any adverse event reports of this nature in Australia.
Reporting problems
Consumers and health professionals are encouraged to report problems with medical devices. Your report will contribute to the TGA's monitoring of these products. For more information, see the TGA Incident Reporting and Investigation Scheme (IRIS) or contact the TGA's Devices Post Market Monitoring Section on 1800 809 361.
What to report? Please report adverse events, as well as near misses
The TGA encourages the reporting of any suspected adverse event or potential adverse event relating to a medical device. Adverse events can involve actual harm to a patient or caregiver, or a near miss that may have resulted in harm.
Some issues relating to medical devices that may lead to adverse events and prompt you to report include:
- mechanical or material failure
- design issues
- labelling, packaging or manufacturing deficiencies
- software deficiencies
- device interactions
- user/systemic errors.
Suspected adverse events or near misses can be reported directly to the TGA:
- online at Report a problem
- by emailing iris@tga.gov.au
- by mail to IRIS, TGA, PO Box 100, Woden ACT 2606
- by fax to 02 6203 1713.
For more information about reporting, visit www.tga.gov.au or contact the TGA's Medical Devices Branch on 1800 809 361.
Disclaimer
The Medical Devices Safety Update (MDSU) is aimed at health professionals and is intended to provide practical information on medical device safety, including emerging safety issues. The information in the MDSU is necessarily general and is not intended to be a substitute for a health professional's judgment in each case, taking into account the individual circumstances of their patients. Reasonable care has been taken to ensure that the information is accurate and complete at the time of publication. The Therapeutic Goods Administration gives no warranty that the information in this document is accurate or complete, and does not accept liability for any injury, loss or damage whatsoever, due to negligence or otherwise, arising from the use of or reliance on the information provided in this document.
© Commonwealth of Australia 2020
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For correspondence or further information about Medical Devices Safety Update, contact the TGA's Medical Devices Branch at iris@tga.gov.au or 1800 809 361.