Reporting adverse incidents involving medical devices

The MHRA is delighted to be working with the ASGBI to promote the device-related adverse event reporting and investigation system to Surgeons.

Adverse events can arise from a wide variety of causes including problems with the design or manufacture of the device, inadequate storage or maintenance, inadequate Instructions for Use, incompatible device combinations or failure to provide adequate training.

The reporting of these events is important because each will be assessed and investigated by the MHRA on a priority basis and action taken as appropriate. This may include issuing advice to the Health Service or even recall of the device or of a batch.

Although manufacturers have, by law, to report serious adverse events to us as the regulatory body, it is the voluntary reporting system by healthcare workers that frequently results in the most important changes to a device. For example, last year because of such reporting, there were almost 600 improvements in design and quality systems made, and over 250 changes in Instructions for Use.

The MHRA would like to reassure surgeons that we are not assessing any practice issues and all information will be treated in the strictest confidence with no identifier details divulged outside the Agency except in special circumstances which will always be discussed and agreed first with the surgeon in question.

Thank you for visiting and using the resources of this web site to help improve the safety of surgical practice in the UK, Ireland and elsewhere.

Technology has brought many benefits to surgeons and their patients, both in the equipment that we use and in the devices that can now be introduced into the human body to treat a wide range of surgical and medical conditions.

The manufacture of instruments and devices is strictly regulated, and production standards are very high. However, for some time, we have been concerned that the advance of technology is bringing risks and problems to patients and their surgical teams which are not being fully recognised and recorded.

These risks may arise where equipments, devices and implants are being used outside their design envelopes; with inadequate documentation, training and preparation; or occasionally from unexpected device failure. Only by recognising, reporting, recording, analysing and disseminating the lessons from adverse events arising from mishaps with surgical devices can we reduce risks to patients and implement prompt remedial strategies. I stress that this process is intended to encourage voluntary reporting, along the lines of lessons pioneered in the airline industry, and not to apportion blame.

I am particularly pleased that we have been able to address our concerns through this evolving strategic partnership with the MHRA. I am most grateful to Mr David Rew, Council Member of the ASGBI and Consultant Surgeon to Southampton University Hospitals, and to Dr Susanne Ludgate for their enthusiastic work in developing this joint and pioneering project.

This programme is a work in progress, and we are most grateful to all members of the surgical profession for the prompt and informative contributions and feedback with which you will help improve the safety of our patients.

Working together for patient safety