Medical devices require 'drastic change' in rules

The Royal College of Surgeons has said that drastic changes to the rules around medical devices are needed to better protect patients.

BBC Panorama has been investigating the medical devices industry and found implants being put into people after failing in trials, some involving baboons or after tests only on pigs and dead bodies. Speaking before the BBC Panorama viewing, the Royal College of Surgeons said it was important that a register of every device in every patient is set up so doctors know if new innovations are causing harm.

The Medicines and Healthcare products Regulatory Agency said the regulatory system for medical devices had been in place for 25 years and medical technology had ‘improved and transformed countless lives’, with the government stating that the MHRA had a ‘robust process’ in place to support the regulation of new medical devices.

Derek Alderson, President of the Royal College of Surgeons, 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.”