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The list for 2023 1. Gaps in recalls for at-home medical devices cause patient confusion and harm. 2. Growing number of defective single-use medical devices puts patients at risk. 3. Inappropriate use of automated dispensing cabinet overrides can result in medication errors. 4. Undetected venous needle dislodgement or access-bloodline separation during hemodialysis can lead to death. 5. Failure to manage cybersecurity risks associated with cloud-based clinical systems can result in care disruptions. 6. Inflatable pressure infusers can deliver fatal air emboli from IV solution bags. 7. Confusion surrounding ventilator cleaning and disinfection requirements can lead to cross-contamination. 8. Common misconceptions about electrosurgery can lead to serious burns. 9. Overuse of cardiac telemetry can lead to clinician cognitive overload and missed critical events. 10. Underreporting device-related issues may risk recurrence. You can download the full report via the link below. ECRI Members can also download the Top 10 Health Technology Hazards for 2023 Solutions Kit on their member page.

Vision for medtech The vision focusses on 3 central objectives: right product right price right place. These concepts centre on delivering the highest quality of care for patients and interact with and balance against each other - often, as focus on one component increases, focus on the others can decrease. Striking the best possible balance between these objectives is difficult, but the aim is to reach an optimal point where all 3 elements are weighted appropriately so the UK medtech sector best supports the UK health and care system in delivering improved health outcomes for patients. Four priority areas Having considered the broader landscape and current activity, the strategy has identified four priority areas: Priority 1: resilience and continuity of supply. Priority 2: innovative and dynamic markets. Priority 3: enabling infrastructure. Priority 4: specific market focusses.

During a cardiac ablation procedure, the catheter irrigation fluid bag emptied and was replaced by staff. While priming the tubing, air was noted in the tube, and the catheter was immediately removed from the patient. The patient experienced a decrease of heart rate and blood pressure requiring a code response. Radiofrequency cardiac ablation requires the use of heparinised irrigation fluid to cool and anticoagulate the ablation site. If the procedure requires more fluid than originally hung, it requires the bag to be replaced. This introduces an opportunity for air to enter the irrigation tubing. Air emboli can then be infused into the patient causing cardiac arrhythmia, myocardial infarction, respiratory symptoms and/or neurologic symptoms, and, potentially, total cardiovascular collapse. Solutions During cardiac ablation procedures, air should be removed from any bags and the pump (or any other pressurized delivery device) tubing primed before being connected to a patient. Do not bypass alarms that detect air in the pump or tubing systems. Do not prime the irrigation line without first disconnecting the tubing set from the patient, even if a stopcock is in use. Review the manufacturer’s instructions for how to change fluid bags to ensure safe operations. Be aware of potential access points for air to enter the system and mitigate the risk.

Ian Lindsley, Secretary of the SHBN, began by welcoming those on the call and talking through the speakers and the presentations. The first presentation was given by Martin McMahon of the Health and Safety Executive on the Post Implementation Review (PIR) of the Sharps Regulations 2013 by the HSE. The PIR will assess post implementation effectiveness of these legislative regulations against the objectives as laid out in the original impact assessment and must be concluded, submitted and agreed by Minister by 10 May 2023. The HSE are currently engaged in the evidence and analysis process to inform the final report to Parliament and asked those on the webinar and others to complete the questionnaire. The next presentation was given by Terry Grimmond, Consultant Microbiologist, and provided attendees with an update on the progress of the new national Blood and Body Fluid Exposures (BBFE), or sharps injuries, survey and database. Attendees were informed of the importance of the creation of a national database for sharps injuries. To date, thirty trusts have responded to the survey which has now been shortened to three key questions in order to encourage further responses. Trusts informed the BBFE working group that workloads are currently incredibly high so it was agreed a shorter survey could increase response rates by taking significantly less time than the original 20+ question survey. The data so far indicates a lower rate of sharps injuries than perhaps expected, especially when compared with the RCN survey published in 2021. Terry called for more trusts to complete the survey and encouraged attendees to reach out with any questions or queries. The third presentation continued with the theme of sharps injuries and healthcare worker safety and was given by Rose Gallagher, Professional Lead Infection Prevention and Control and Leona Cameron, Head of Health, Safety and Wellbeing, Royal College of Nursing. The presentation explained, in terms of sharps injuries, it is not just healthcare staff who are at risk; ancillary staff who work in healthcare environments or handle healthcare waste or equipment are also at risk. The RCN Survey published in 2021, with responses from more than 7,000 members, found that 63% have had a sharps injury in their career. Employers have a legal duty to carry out a suitable and sufficient sharps risk assessment in order to identify and implement adequate control measures to reduce the risk of harm. Controls in practice aim to change the behaviour of workers to reduce exposure to occupational hazards and should be implemented widely. The presentation concluded with a note on sustainability – healthcare is the 5th largest greenhouse gas producer globally and therefore action to reduce its climate warming emissions through procurement, transport, waste management and energy consumption are key. The fourth presentation was given by Lindsay Keeley, Patient Safety & Quality Lead of the Association for Perioperative Practice (AfPP) and covered the topic of theatre safety. The presentation explained the current legislation in place around theatre safety and focussed on risk management and safety in the perioperative environment. The point was made that risk management and patient safety is one of the most fundamental principles of service delivery in healthcare today especially in the operating theatre. There is a minimum benchmark standard of five staff for each operating theatre depending on skill mix, speciality, complexity, and patient care and those staff have a duty to take reasonable care of their own health and safety and that of others who may be affected by their actions. The presentation concluded by setting out the six key elements of effective safety programmes: hazard assessment, training, policies & procedure, accident investigations, measurement and management commitment. Lindsay informed attendees that the AfPP provides evidence-based guidance, standards and recommendations on risk management to enhance perioperative practitioners’ knowledge on safe handling and positioning of patients in the perioperative environment. The final presentation was a case study on surgical smoke and creating a smoke free environment in theatres by Lisa Nealen, from the Queen Elizabeth Foundation Trust, Newcastle. Lisa spoke about her own personal experiences of not only the hazards of surgical smoke but also the health hazards posed by surgical fluid waste and explained why it is so important that we create safer theatre environments for patients and staff. The presentation detailed how to create a smoke free operating theatre and the guidelines which have been adopted which help to deliver a safer working environment.