RCS statement on medical device regulation

BBC One's Panorama will air a programme on medical device regulation  tonight, which is part of a larger international investigation, called the Implant Files, carried out by the International Consortium of Investigative Journalists (ICIJ). UK partners for the investigation have included the BBC, The BMJ and The Guardian. Professor Derek Alderson, President of the Royal College of Surgeons, will appear on the Panorama programme tonight, calling for drastic regulatory changes for medical devices.

In a statement, Professor Alderson said:

“We extend our sympathies to all patients that have experienced pain or complications following the use of a medical implant. Medical devices are manufactured and used to high standards in the UK. Nevertheless, there have been sufficient number of incidents to underline the need for drastic regulatory changes that the RCS has long called for.
 
“In contrast to drugs, many surgical innovations are introduced without clinical trial data or centrally held evidence. This is a risk to patient safety and public confidence.
 
“The RCS believes that all new surgical procedures and devices should be registered, with related data collected in the appropriate national audits, before they are routinely offered to patients. All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.  This requires Government funding and support, and potentially national guidelines on the introduction of new procedures and technologies.
 
“Where feasible, there should be clinical trials, although that can be difficult for some procedures. Surgical trials, many of which the RCS supports, play a critical role in improving patient care - and testing the safety and efficacy of new innovations and devices.  
 
“Our Commission on the Future of Surgery, which is due to report its findings later this year, will make specific recommendations on all of these points.
 
“It is imperative that when adverse incidents do occur they are reported by staff and thoroughly investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).”

Notes to editors

The Royal College of Surgeons of England is a professional membership organisation and registered charity, which exists to advance surgical standards and improve patient care.

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