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Healthcare professionals such as doctors, nurses and pharmacists are, almost without exception, dedicated to helping patients and ensuring patient safety. Unfortunately, on rare occasions the medicines and medical devices that healthcare staff use may not work as well as expected, or may not be used as intended by the manufacturer.
That’s why the Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England are working together to develop an integrated reporting route for healthcare professionals. The aim of this will be to improve the quantity and quality of incident reporting for medication errors and the full range of medical devices used in hospitals including defibrillators, infusion pumps, hip and knee implants, pacemakers, hospital beds, and operating tables.
This joint work is in response to a number of strategic drivers including the implementation of the recommendations made by Sir Robert Francis QC and Professor Don Berwick on patient safety, and a review by Earl Howe into the MHRA’s handling of the PIP breast implant fraud. It also takes into account the revised definition of adverse drug reaction to include medication errors in the EU Directive on Pharmacovigilance. These reports recommended taking steps to maximise the quality and quantity of adverse incident reports from healthcare organisations and the need to enhance the ability to learn from these adverse events.
Currently, there are two national reporting systems for incidents involving medication errors and medical devices – one is operated by the MHRA and the other, the National Reporting and Learning System (NRLS), is operated by NHS England.
The NRLS collects reports from healthcare professionals about patient safety incidents, which could have or did lead to harm for one or more patients receiving NHS care. NRLS patient safety reports include many types of incidents such as falls, diagnosis and surgery. These tend to be reports about system and use errors from a human factors perspective rather than problems with individual products.
The MHRA currently collects reports from healthcare professionals, manufacturers and the public about safety and performance issues specifically related to medicines, vaccines and medical devices. Reports for medicines and vaccines include all side-effects through the MHRA’s Yellow Card Scheme, but reports about serious and unexpected side-effects are particularly valuable as they can have a major influence upon the Agency’s assessment of the performance of the medicines and whether regulatory action is appropriate to protect patients. In the same way for medical devices, adverse incident reports help MHRA to monitor the safety and performance of medical devices in use in all healthcare settings.
Better patient care
While adverse incident reporting is not the only method of assessing the safety and performance of medicines and medical devices, it is a good indicator of how specific medicines and medical devices are performing in real patient situations. After considerable engagement with healthcare commissioners and providers MHRA and NHS England jointly issued two patient safety alerts to healthcare providers.
These officially started a process to improve the quality of reporting for both medication errors and medical device incidents within the National Reporting and Learning system.
Through these alerts healthcare commissioners and large healthcare provider organisations (in the NHS and independent sector) are being asked to improve clinical governance arrangements for reporting and learning from medication errors and medical device incidents. They have been asked to identify board directors, multidisciplinary committees and safety officers who will have the responsibility to oversee and support incident reporting and learning in these important areas.
The appointed medical device safety officers and medication safety officers will be specifically supported by new national networks. A key aim is to eliminate duplicate adverse reporting data entry by healthcare professionals, as is currently the case in the present NRLS and MHRA reporting systems. The networks will also improve communication and feedback on reported safety issues, and enable safer practice to be discussed and shared through webinars, online forums, conferences and workshops.
Smaller healthcare provider organisations should continue to report medication and device incidents, take action to improve medication and device safety locally and work with the safety officers.
Making data available
The new integrated reporting route will improve the quality of reporting medication and medical device incidents and ensure specific details such as model numbers and the manufacturers of specific medical devices are available. Currently, these details can at times be missing in some adverse incident reports but the new safety officers will be asked to ensure that the MHRA and NRLS receive the information they need.
The overall implementation of this work is being closely monitored by NHS England and MHRA, who, based on earlier engagement with stakeholders believe that this is a good step forward for both organisations as it shows commitment to developing new ways to help improve patient safety through reporting, learning and the sharing of best practice.
New technology is also being developed by the MHRA to help our surveillance of medical devices. We are working with a number of NHS trusts to pilot a new tracking system for high-risk medical devices such as hip implants and heart valves. The system will incorporate unique device identifier bar codes into patient electronic records. This information (suitably anonymised) will then be analysed by the Clinical Practice Research Datalink (CPRD) – a secure e-health research service – and will enable the MHRA to better assess the performance of high-risk medical devices and to trace patients in the event of a device recall or safety alert.
This project is one of a number that MHRA has established to strengthen the implementation of existing controls; to meet the requirements of future EU medical device regulations and to help MHRA ensure that medical devices used to treat, diagnose and monitor health conditions are as safe as they can be.