IME Report Finds Deaths And Injuries Caused By Faulty Medical Equipment

Thousands Of Patients Have Been Victims Of Faulty Devices

25.07.2014

The Institution of Mechanical Engineers’ (IME) has claimed faulty medical equipment in use within the NHS is to blame for hundreds of deaths and thousands of injuries.

Its study found that 13,642 incidents were reported to regulators involving medical devices that were not working correctly. In 309 of these incidents, the fault led to the death of a patient, while around 5,000 others suffered serious harm.

A tenth of the incidents reported related to an orthopaedic implant such as a hip replacement, while other machinery was found to be leaking, cracked, smoking, or had caught fire in more than one in ten cases. Three per cent of reports made to the regulator referenced faulty scanning equipment or radiotherapy machinery.

A third of the reported problems resulted in an investigation by the manufacturer of the device in question, but fewer than 10 per cent of incidents prompted an inquiry from the regulator.

The IME also stated that faulty or missing medical equipment means that thousands of operations are cancelled every year. Engineers at the Institution have called for the NHS to take urgent action to improve equipment quality, particularly as the role of technology within patient care is growing all the time.

Dr Patrick Finlay, lead author of the report and Chairman of the IME Biomedical Engineering Association said: “Government and the NHS need to take urgent action to prioritise the role engineers play in hospitals and trusts. Technology is leading to huge advances in healthcare, but this technology is dependent on the work of biomedical engineers who are inadequately recognised and in short supply in most hospitals.”

He added that the people who design, manufacture and maintain the equipment used in healthcare must be heard if the technological benefits of the latest medical equipment are to reach patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) has urged that all incidents of faulty medical machinery be reported correctly, as they are reviewed and analysed for learning and can lead to vital safety information being distributed to medical professionals.

Expert Opinion
It is unclear if the rise in reports of faulty medical devices is down to improved reporting standards or a drop in device quality. However, it is clear that failings highlighted by the IME study need to be resolved quickly by the NHS, medical professionals and the manufacturers of medical equipment.

“We have acted for a number of patients who have suffered as a result of problems with medical equipment and machinery in hospitals. Patient care should always be the top priority and it is vital the devices being used to treat them meet the highest possible standards. The NHS should seek to work more closely with the regulator not only in improving the accuracy of the reporting of faulty medical equipment but in considering how such faulty equipment not only affects the lives of patients but the day to day running of the NHS and what will no doubt be a consequential impact on other patients.

“Increasing the prominence of biomedical engineers within the NHS and other medical facilities is a positive step, as they have the skills and experience to help reduce the frequency of deaths and serious harm caused by malfunctioning machinery.

“It is vital that the IME’s findings are reviewed by the regulator to see if further steps can be taken to ensure only safe devices make it to market and into use within the NHS and other healthcare services.”
Kevin Timms, Solicitor