Safety recommendation
HSIB recommends that the Medicines and Healthcare products Regulatory Agency [Head of Metabolic Disorders and Renal Systems] reviews and acts on the available evidence to regulate for the use of pressure infusion bags that allow fluid labels to be read when inflated.
Response:
We agree that it is good clinical practice to allow visibility of fluid bag contents whilst inserted in a pressure cuff. We will seek agreement from the manufacturers of pressure cuffs registered with the MHRA to the possible reduction of risk associated with a transparent window showing the fluid bag label (ACTION).
In addition, we will consider whether this issue meets the criteria of a national safety communication such as a Device Safety Information (DSI) to inform healthcare professionals of the importance of using transparent pressure cuffs (ACTION).
Response received on 7 November 2022.