MHRA warning over unsterile surgical devices


Regulator issues warning after ConMed finds fault in sterile packaging

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a safety warning after it was discovered that equipment designed to be used in electrosurgery could be unsterile.

The alert comes after ConMed Corporation announced it was recalling disposable active electrodes and accessories amid fears of a risk of intra-operative infection from a breach in the sterile packaging. The problem, the company warns, cannot always be seen, especially if the electrode does not protrude through the packaging.

ConMed is currently recalling all affected devices, the product numbers of which are included in a Field Safety Notice .

The warning states: “We have received some complaints whereby the device has broken through the seal of the sterile pouch. ConMed has confirmed that there have been instances where the pouch seal was compromised on the affected products.”

It adds that in no instance has there been illness or injury as a result of the problem, with those affected devices discovered before use.

To read the full warning, click here.

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To see which devices are involved, click here.