Warning on medical device rules

The Royal College of Surgeons has warned that rule changes are needed urgently to protect patient welfare. An investigation by 58 media organisations has found that patients have been given unsafe devices, spurring calls for a register of implanted devices, and long-term tracking of patients. According to the BBC:

“BBC Panorama has been investigating the industry with the International Consortium of Investigative Journalists and organisations around the world including The Guardian newspaper and the British Medical Journal.”

The investigation alleges that patients have received devices which actually failed in trials, for example those carried out in animals. A spokesperson for the Department of Health and Social Care said it expected the Medicines and Healthcare Regulatory Authority:

“to follow up any safety concerns swiftly and with patient care in mind.
“We will work with the regulator to see what future changes may be required”
“The need to protect public health, whilst not stifling innovation, must be carefully balanced. The MHRA welcomes innovative medical devices that can bring huge health benefits to people as long as this doesn’t compromise patient safety”

The MHRA said the regulatory system for medical devices had been in place for 25 years and medical technology had “improved and transformed countless lives”.

Sources point towards the CE marking system, designed to ensure safety of devices across Europe, and note that its effectiveness may be subject to companies being willing to follow the rules laid down by specific national regulators. Companies may attempt to achieve CE-marked status in another country if their original application fails. Weaknesses in the evidence presented for obtaining a CE mark are highlighted by the investigation.

MedTech Europe, representing the medical devices industry, said:

“Millions of people have safely benefited from medical devices and can now live healthier, more productive and more independent lives.
“Life is unimaginable today without the hundreds of thousands of medical devices in our hospitals and in our homes.”

Prof Derek Alderson, president of the Royal College of Surgeons, said:

“All implantable devices should be registered and tracked to monitor efficacy and patient safety in the long-term.”

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Published on 27. November 2018 in News, News EU, News UK