NHS England publishes report on patient safety

November 2023

A recent report by the NHS England National Patient Safety team assessed the delivery of insulin with passive safety pen needles prompted by a Type 1 diabetes patient's incident of developing diabetic ketoacidosis (DKA).  Over a three-year review, between 2019-2022, a theme of incident reports describing observation of pooled insulin during the administration, with associated actions taken such as additional blood glucose monitoring to maintain patient safety. Some reports noted unexpected presentations of high blood glucose values and unforeseen presentations of DKAs. These reports speculate that the use of passive safety pen needles may have resulted in the outcome, due to pooled insulin not being noticed at the time. 

The mechanism of delivery using a passive safety needle requires consistent pressure to be applied on contact with the skin and throughout delivery of the medication. If pressure is reduced the safety mechanism deploys and contact with the patient is lost, meaning any undelivered medication will sit either in the device or on the patient’s skin. Early activation of the safety mechanism on passive devices, blocks the insulin from being administered to the patient and is largely caused by a lack of training in how the device must be used. 
Alternative safety needles for insulin pens that have an active safety mechanism are also now available. The design of active safety pen needles use a technique for insulin delivery similar to conventional pen needles. Reliance is on the user to manually activate the safety device to protect the user and promote safe management of sharps. 

Unifine® SafeControl® is an active safety pen needle designed to give healthcare professionals (HCPs) confidence in delivering a full medication dose to the patient, whilst also providing protection from needlestick injuries (NSIs). In a clinical study* in 2020, 98% of respondents agreed they were in control of the dose delivery using the SafeControl active safety pen needle. It features an active safety mechanism, which engages through a manual push tab that gives the HCP total control, and the covering the needle at both ends after the injection has been administered to protect from NSIs from both ends of the needle. The device is designed to provide a balance of safety and control during the injection process, supporting those who offer lifesaving care the peace of mind they deserve whilst ensuring dose accuracy for their patients.    
Both passive and active safety needles for insulin pens are available, and education and training for administration is required. Where there is limited ability to provide education and training for insulin delivery or a heavy reliance on a temporary or transient workforce, the decision to use an active safety device may be considered to be less of a risk in terms of accurate and assured delivery of insulin¹. There remains a need for optimal balance across all factors in the choice of the best possible drug delivery device in terms of safety, ease of use, simplicity of operation and dosage accuracy. 

Request a copy of the report here

*Owen Mumford, Project Tarvos, USA, Data on file, 2020; 2. Data on File, 2022 L.; 3. Data on file 2022 CC.; 4. Data on file 2023 JB