single_use_laryngoscope_bladeTHE manufacturers of a medical device implicated in the death of a hospital patient have not been issued with a warning.

An official United Kingdom government medical safety alert was distributed over the death of the patient, who acquired an infection from a laryngoscope handle that had not been decontaminated properly.

The list of bodies, individuals and other interested parties who were contacted in the aftermath of the scandal included health authorities, other bodies, hospital managers and health care professionals.

Yet the companies that make of the reusable laryngoscope handle – which will have provided technical support to the hospital concerned over its correct use – have not received this information.

This could be viewed as being strange, given that the successful use of medical devices relies on medics and clinicians fully understanding the manufacturers’ instructions.

In turn, the companies need to be aware of any shortcomings in the real-world performance of the device or of any misunderstandings as to its correct use.

The Medicines and Healthcare Products Regulatory Agency received a report of an inquest that found the patient died after a laryngoscope handle had not been decontaminated appropriately between each patient use. (MDA/2011/096).

The case referred to all reusable laryngoscope handles – all models and all manufacturers.

The MHRA recommended updating procedures to ensure that reusable laryngoscope handles are decontaminated appropriately between each patient use, in accordance with the manufacturers’ instructions.

It also urged “healthcare professionals using these devices and staff responsible” to be aware of the Association of Anaesthetists of Great Britain and Ireland (AAGBI) guidelines, Infection Control in Anaesthesia 2, 2008.

The MDA was sent to:

  • NHS trusts in England
  • Care Quality Commission
  • HSC trusts in Northern Ireland
  • NHS boards in Scotland
  • Local authorities in Scotland
  • NHS boards and trusts in Wales
  • Primary care trusts in England

Onward distribution was suggested for “relevant employees”.

However, what if the misuse of the device resulted from a misunderstanding of the manufacturers’ instructions or from the possibility that they were unclear?

Isn’t that good enough reason alone to merit communication with the makers’ And wouldn’t those companies welcome such feedback, which could help avoid a repeat scenario elsewhere, at a different time or involving a different device?

While this suggestion may not have much truck with the medical device industry or health bodies, it would surely have some traction with members of the public, who, as a general rule, are not aware of the processes, protocols, expertise and personnel that relate to the use of medical devices in clinical settings.

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