Safety and Quality Updates: February 2023

16 February 2023

New this month: Latest safety alerts; Medsafe guidelines update; Cookgas laryngeal masks recall; Fentanyl and suxamethonium ampoules packaging similarity; Paracetamol packets size reduction; WebAIRS

New Safety Alerts

See all safety alerts

webAIRS article: Anaesthetic near misses

WebAIRS has recently received a report of a near-miss incident involving a medication. An epidural top-up box was incorrectly re-stocked so that there was a high risk of an ampoule of 0.5% bupivacaine 20ml being given to a patient instead of 2% lignocaine 20ml prior to a caesarean section.

The drug was drawn up, but the error detected when the medications were re-checked before administration. The nurse unit manager was notified so that all the other epidural top-up boxes could be re-checked. While there was potential for patient harm, on this occasion it was fortunately avoided.

Reporting of near-miss anaesthetic incidents is just as important as reporting incidents where there is harm to a patient, as the sharing of near-miss experiences helps to prevent similar future errors and improve patient safety.

Join webAIRS to report any near misses or harm to patients.

For further information please contact

Medsafe Guidelines update

Medsafe has revised its guidelines on the regulation of therapeutic products within New Zealand. These guidelines cover the regulations of therapeutic products, medicines, and medical equipment.

The full list of these revised guidelines can be viewed on the Medsafe website.

Product Recall: Cookgas Laryngeal Masks

Obex Medical has issued a recall for its Cookgas Laryngeal Masks. Labelling in the instructions for use and the text printed on the side indicate an orogastric tube size discrepancy.

Full information can be found via the Medsafe website.

Paracetamol package size reduction

The TGA has published an interim decision to reduce the maximum package sizes for various paracetamol products.

This decision was made in response to an independent report commissioned by the TGA which found hundreds of Australian hospitalized and around 50 deceased each year due to paracetamol overdoses.

This interim decision is open to public consultation until 3 March 2023 when a final decision will be made.
More information can be found on the TGA website here.

Internal notice: Fentanyl and Suxamethonium ampoules packaging similarity

The NSW Government has released a safety notice warning of the risk of mistaking fentanyl and suxamethonium ampoules from one sponsor due to similar packaging and design.

Near-miss incidents have been reported in South Australia and New South Wales. The safety notice includes recommendations to reduce the risk and consequences of ampoule error. It is advised that opioid reversal agents be made available in areas where these ampoules are used.

The supplier of these products is working on better packaging to resolve the issue.

Last updated 15:55 16.02.2023