Sterility concerns about Becton-Dickinson equipment

The Association of Anaesthetists and the Royal College of Anaesthetists are aware of the publication yesterday by Becton-Dickinson (BD) of a Field Safety Notice that raises concerns about the sterility processes employed for some of their equipment used for volumetric pumps, syringe pumps and gravity infusion sets.

The notice details the equipment that may present a risk to patients. Although the notice advises that users ‘quarantine and destroy’ the relevant equipment, this recommendation should be tempered by the advice given in a National Patient Safety Alert issued yesterday by the Medicines and Healthcare products Regulatory Agency and supported by the NHS in England and the devolved administrations.

The Association and the College offer their members the following advice:

• read the Field Safety Notice and National Patient Safety Alert carefully
• identify the BD equipment that may be affected
• identify alternative equipment if possible and ascertain whether stocks are sufficient. There is likely to be supply disruption for this BD equipment for four weeks from the publication of the National Patient Safety Alert
• given the low risk of contamination (while the risk is unquantifiable, it is very small) and the potential for risks associated with a change in drug/fluid delivery or infusion equipment, it may be safer for some patients to continue to be treated with existing BD equipment, for example when urgent surgery is required and no suitable, alternative device is available. This decision is for clinicians to take on an individual patient basis after an assessment and documentation of risk, and with close infection surveillance during and after use
• NHSE leaders have indicated that Trusts employing clinicians who take responsible decisions in these circumstances will receive appropriate support if adverse incidents occur as a result
• NHSE leaders acknowledge that the disruption to supplies of BD equipment may impact on the restart of planned elective surgery
• Based on current evidence, there is no need for a review of patients previously treated with these devices.