Figures released by the Medicines and Healthcare Products Regulatory Agency (MHRA) have revealed there were almost 16,000 cases of faulty medical equipment linked to 309 fatalities and 5,000 serious injuries reported to it in 2013.
The report also highlighted a rise in the number of cases of medical equipment not working properly over the past decade to around 100,000 which can be associated with over 2,000 deaths and 22,000 injuries over the same period. And according to the MHRA, these numbers may be an under estimation and it believes the true figures could be around five times as high.
One reason for this is the way incidents are reported as the organisation states only around 10 -20 percent of patients actually reported them, as was the case in the PIP breast implants scandal of recent years. This would place incident levels at somewhere around half a million in the last ten years, including 11,500 deaths and 110,000 serious injuries. The MHRA is now working with NHS England to stop under reporting to get a true handle on the figures involved.
Cases such as the failure of a pump fitted to 12,000 patients to help with blood pressure leading to at least one death, and another where a faulty battery was fitted to a life-saving pump used by the Ambulance Service are among the thousands of statistics spoken of in the report. In the second case, a man was rushed to hospital for emergency cardiac surgery when the pump ceased working and there were no spare batteries on board. He died a day later in hospital.
According to the MHRA, these occurrences are nothing new but there is no way of knowing whether all incidents – or how serious those reported are – are thanks in part to an EU law concerned with confidentiality meaning manufacturers or individual NHS trusts cannot be named in the report.
However, as part of its research, the organisation can release names and products where there are widespread safety concerns regarding the failure of a medical device or devices. It revealed there were 49 of these incidents, known as a medical device alert, in 2014 including an infant warmer with a potential risk of serious injury and a wheelchair so badly designed it could tip backwards with a patient in it. There were also faults identified with a number of defibrillators, automatic drug-dispensing pumps, breathing ventilators and software for CT scans.
The MHRA also advised it requested 1,129 improvements to be made by manufacturers on new medical equipment coming to market, and said manufacturers stopped making 143 products because of the MHRA’s insistence on changes or for commercial reasons in the past year.
Part of the problem, it said, is that medical devices and equipment are often released and tested on patients to identify faults and areas for improvements with manufacturers only having to test their products for “quality, safety and that they work.”
If you have suffered negligence as a result of equipment failure, and would like some help and advice, we can help. Visit our dedicated website www.medicalnegligence-solicitors.com or call us on 0800 999 1875. You can also request a call-back at a time convenient for you here.