Safety warning over the use of lancing devices in nursing and care homes

The Medicines and Healthcare products Regulatory Agency (MHRA) is issuing a renewed safety warning over the use of lancing devices in nursing homes and care homes after reports from the Health Protection Agency (HPA) of transmission of infection.

The inappropriate use of certain lancing devices by healthcare workers to take blood samples from diabetic residents in nursing homes and care homes has been implicated in the transmission of Hepatitis B between residents. This has resulted in acute infections and deaths.

The MHRA has issued two Medical Device Alerts relating to the use of lancing devices in 2004 and 2005 (MDA/2004/044 – Lancing devices for obtaining blood samples and MDA/2005/063 Lancing devices ? including Roche Accu-Chek Softclix, SoftclixII Softclix Plus and Multiclix devices). The Alerts clearly indicate that healthcare and care workers taking blood samples from multiple patients should check that the lancing device that they are using is intended for multiple patient use.

The MHRA continues to receive reports of hepatitis B outbreaks where the use of the wrong type of lancing device has been implicated in the transmission of the virus and a further Medical Device Alert (MDA/2006/066 – Lancing devices used in nursing homes and care homes) has been issued today to reinforce the earlier advice.

Careworkers or healthcare professionals taking blood glucose samples in any multi-patient environment, including nursing homes and care homes, must only use:

disposable single-use lancing devices for each resident or patient (these are used once and then the entire lancing device is discarded), or
a non-disposable lancing device, but this must be one which is intended to be used to take blood samples from multiple patients, used with disposable single-use lancets.


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