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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.
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.
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 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 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.
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 Patient Safety Alert with NHS England which required the NHS and large independent healthcare organisations to identify medical device safety officers (MDSOs) to champion reporting of and learning from adverse incidents with medical devices.
There are currently 296 medical device safety officers around the United Kingdom and they act as a point of contact between MHRA and NHS England. To support the MDSOs there are monthly online exercises (webexes) with MHRA and NHS England. To further this relationship, we held a national conference in early 2015 to facilitate dialogue between MDSOs and the centre and support progress in the promotion of medical devices safety and increase reporting.
Monitoring and maintaining
To assist with the ongoing monitoring of the safety of medical devices we set up the Devices Expert Advisory Committee (DEAC). This was formed following an independent review on MHRA access to clinical advice and engagement with the clinical community. This new committee replaced the Committee on the Safety of Devices.
The DEAC is responsible for providing independent, expert strategic advice to the agency in support of its role to ensure that medical devices are acceptably safe and are used effectively. Membership of the committee is made up of clinicians from various specialties such as anaesthesia, cardiology as well as internal experts. It will also support the agency in developing and maintaining collaborative relationships with clinical professional bodies. Patient safety is our top priority and we have robust safety monitoring systems in place. Where incidents do occur, we take swift and robust action to protect patients.
Since 2013 we have been working with the Department of Health to improve procurement processes in the NHS with the aim of freeing up money and resources in support of frontline care.
In order to do this, the NHS will soon adopt GS1 standards for products (including medicines and medical devices), patient identification (using bar coded patient wristbands) and locations in order to improve purchasing efficiency, control of supply chains within hospitals and patient safety.
GS1 standards are also one of the main systems being adopted worldwide for Unique Device Identification (UDI) and in support of the eProcurement programme MHRA has started to use UDIs based on GS1 standards in healthcare recalls. Barcodes based on the GS1 standards can be read at any point in the healthcare supply chain so that a product subject to a safety alert can be quickly located and recalled.
When combining the unique identification of patients with the unique identification of healthcare products, it means that every procedure, product, or implant for every patient can be directly attributed to them and recorded on their electronic record, giving complete end-to-end traceability all the way from manufacturers to patients.
Patients can have peace of mind knowing their implants are immediately identifiable and connected to their personal records. Additionally healthcare professionals can identify quickly which patients are affected, should a safety concern arise with a particular device.
New regulations for medical devices are currently under negotiation in Europe. These will supersede existing medical device directives and will require UDI for all devices sold in Europe with phased implementation beginning in the next few years. With early implementation of GS1 standards, the NHS in England will be ahead of the curve.
Earlier this year, MHRA informed the health services about a medical product recall using GS1 Unique Device Identifiers. This was a significant milestone for the healthcare industry and set the scene for how important patient safety information like recalls will be communicated to patients and healthcare professionals alike in the future.
Patient Group Consultative Forum
The MHRA Patient Group Consultative Forum (PGCF) is open to people with an interest in medicines and medical devices and patient groups who can find out the views of their members and feed these views into the Forum. We hold up to four meetings per year in London, with additional opportunities to participate in dialogue through electronic means such as surveys and webinars. This initiative supports the agency’s commitment to the principles of patient and public engagement and involvement.
The PGCF is expanding and currently has more than 70 individual members representing between them a wide range of different medical conditions, charitable organisations and patient and carer networks. Some of the conditions represented by members of the Forum are: heart disease; asthma; diabetes; cancer; and muscular dystrophy. Member organisations include: Action Against Medical Accidents; Bladder and Bowel Foundation; Diabetes UK; Cancer Research UK; British Heart Foundation; British Kidney Patient Association; Independent Cancer Patients’ Voice; and Asthma UK.