HEALTHCARE GUIDANCE
There are more than 500,000 medical devices used in healthcare settings every day and they transform the lives of many millions of people every year. Mark Grumbridge of the Medicines and Healthcare products Regulatory Agency, discusses the importance of reporting incidents Mark Gumbridge, Senior Clinical Advisor at MHRA
The vast majority of medical devices used in healthcare settings perform well, but, occasionally things do go wrong. When they do it is important it is reported to us so we can investigate with our clinical and technical experts, as well as the manufacturer, and, where necessary, take action to prevent it from happening again. Within this, healthcare professionals play a vital role to make sure equipment is working reliably, safely and effectively in delivering vital, sometimes life-saving care to patients. SOME FACTS The Medical and Healthcare products Regulatory Agency (MHRA) received more than 13,500 adverse incident reports last year, up from 8,500 in 2009 and on a steadily rising curve. Almost 7,000 of these reports came from manufacturers and slightly fewer than 3,000 came from the NHS. A rise in reports does not necessarily mean there are more incidents. It is more likely that reporting is getting better. It is also important to note
Scheme. Many people think this is only for medicines but the Yellow Card Scheme now supports the reporting of all suspected problems or incidents with all healthcare products, not just suspected side effects to medicines. It is simple to use and all reports are investigated by specialists at the MHRA. It is important such incidents are reported, no matter how small you may think it is. It can help to identify emerging trends which can help us, or the manufacturer of a device, to issue updated advice on the use of a device or, in extreme circumstances, to remove the device from use. Many of the reports we get do not mean a complete failure of a device but nevertheless, we are interested to receive these as they can provide valuable information which we can feed back to the manufacturer or the specific user group. A manufacturer’s response may be to look at design changes to improve their device. These changes might make it more difficult for the device to be inappropriately used or feed into changes to the instructions for use or training support packages which are developed to support introduction of devices to new users. The information we receive may also feed information to professional bodies (such as the medical Royal colleges) so they can consider if there are any changes to education and training programmes needed, in order to reduce the risk of avoidable adverse incidents in the future. Adverse incident reporting is a vital part of supporting continuous improvement in the way devices are used and so contribute directly to the development of medicine.
Written by Mark Grumbridge, Senior Clinical Advisor, MHRA
Issuing guidance to healthcare professionals
Medical Devices
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that when an incident is reported to us, it does not necessarily mean the device was at fault. Yet, it is still important that adverse incidents are reported to us. The numbers coming from NHS sources, however, has actually been declining in recent years and this has been a matter of considerable concern. So much so we have been working with NHS England on a major project to re-establish both the responsibilities and connections with the system to reverse this trend. To protect patients there are a number of methods we use to continually monitor the safety of medical devices. YELLOW CARD SCHEME One of the important ways anyone can report a problem with a medical device to the MHRA is through our Yellow Card
MEDICAL DEVICE SAFETY OFFICERS We’re working with NHS England to make adverse incident reporting easier and to improve the management of medical device incidents in the health service, through the appointment of Medical Device Safety Officers with specified roles. They will be invited to attend monthly medical device webinars covering significant events and identified safety themes, and examples of learning and best practice from across healthcare sectors. In March 2014, MHRA published a joint E
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