Insulin administration: delivery device safety

To protect the safety of healthcare professionals administering insulin, safety-engineered devices with built-in mechanisms to protect from sharps injury are mandatory under the EU Directive on Sharps Safety. These devices fall into two main categories: active devices that must be manually activated by healthcare professionals (HCPs) and passive devices with an automatic safety mechanism that is activated after use. MindMetre Research was recently made aware of anecdotal evidence of insulin misdosage or non-delivery with the use of passive injection devices. As a result, we decided to carry out an enquiry into these phenomena in NHS Trusts in England and Wales, under the terms of the United Kingdom’s Freedom of Information (FOI) Act

Background

The EU Directive on Sharps Safety is mandatory legislation that was adopted in 2010 and transposed into national law by all members by 2013.1 As one of its measures for protecting workers, the legislation stipulates: “eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment, providing medical devices incorporating safety-engineered protection mechanisms”. The risk assessment is described as a determination of exposure, covering “all situations where there is injury, blood or other potentially infectious material”. Critically, the Directive does not provide any advice on the type of device to be used.