Calls for a medical devices registry to reduce risk of patient harm

Published: 05 Feb 2020

UK health leaders have joined forces to call for the creation of a national medical devices registry to record details of implants and devices in patients.

The Healthcare Quality Improvement Partnership has today published a new report, Proposal for a Medical Devices Registry which makes 33 recommendations in support of the development and implementation of a national implantable medical devices registry.

The report was produced following a think tank debate in Summer 2019 attended by patient representatives, royal colleges, major healthcare organisations and agencies, regulators, and representatives of the English, Welsh and Scottish governments.

Professor Danny Keenan, HQIP Medical Director, said:

“The use of medical devices and implants has significantly improved the lives of millions of people across the UK and both the NHS and the independent sector help hundreds of thousands of patients each year. But the current lack of a national database or register means that the health community can only be reactive when patient safety is compromised by unsafe medical devices.

“If implemented, the recommendations we’ve published today would help to identify emerging problems or complications and reduce the risk of any further patient harm.”

The report highlights a number of significant patient safety and quality issues including:

  • future implications given the multitude of implants used in everyday practice and the need to act swiftly when safety issues are identified
  • concern that implants are not being tracked and monitored by one responsible body and no one has immediate and ready access to data to alert relevant bodies and more importantly, the patient population, to defective devices or poor outcomes. This is particularly important for newly released devices
  • a number of reported national incidents relating to medical devices
  • the need for early consideration about how to improve the safety and governance of implantable medical devices
  • the ability to carry out research into the efficacy of different devices using “real-life” data.

In addition, there was universal consensus among participants that patient and clinical involvement should be integral elements in establishing a new registry.

The Medical Devices Think Tank which took place in Summer 2019 was attended by representatives of:

  • Academy of Medical Royal Colleges
  • Healthcare Quality Improvement Partnership (HQIP)
  • GIRFT (Getting It Right First Time)
  • Medicines & Healthcare Products Regulatory Agency (MHRA)
  • National Voices
  • NICE
  • NHS Digital
  • NHS England and NHS Improvement
  • NHSX
  • Private Healthcare Information Network (PHIN)
  • Royal College of Surgeons (England and Scotland)
  • Scottish government
  • Welsh government.

A full report and a short version are available.