Regulation of Medical Devices
Doctors are often castigated for shoddy or compromised research leading to poor quality data which is sometimes biased because funding comes from sources with vested interests in the outcomes of trials. But, did you know that the regulatory authority for medical devices, MHRA (Medicines and Healthcare products Regulatory Agency) and similar bodies throughout Europe, are under no obligation to demonstrate due diligence and care before authorising the use of medical devices in humans? Indeed when pressed for information by researchers (BMJ December 1, 2018) they cite issues of “commercial confidentiality “ and refuse to release details of testing and outcomes before permission is granted for use in patients.
Shockingly, this means that for example, a new heart defibrillator device was sanctioned for use after a trial on only 33 patients. Another device used to correct curvature of the spine had no trials in humans at all but received licence for use, and NICE recommendation, based solely on data collected from experiments in pigs and cadavers.
This lack of properly collected, unbiased, scientific information has been responsible for the medical scandals surrounding the use of mesh in pelvic surgery, poor silicone breast implants and metal on metal hip replacements.
Despite pressure from world respected sources such as the BMJ, academics, patient groups and consumer organisations, moves to bring device regulation under control equal to that of the European Medicines Authority have failed. New medications are subjected to very stringent scrutiny before obtaining a license for use yet medical devices are by and large given a green light on very dubious grounds and moreover without any scrutiny . How can we trust MHRA when they obfuscate? How can we trust similar regulatory authorities throughout Europe when it is clear they are influenced by lobbying from manufacturers, trade associations, notified bodies, other government bodies with political axes to grind and “experts” from industry? Multiple requests for answers to questions posed under freedom of access to information have been turned down in 16 different countries. Meanwhile, injuries and malfunction reports have trebled in the last 10 years.
Along with many colleagues I call for an end to secrecy, publication of injury and malfunction reports, transparency about the methods used by MHRA to judge that a medical device is safe and clear indications if there are conflicts of interest. If it`s good enough for the pharmaceutical industry then it should be good enough for MHRA.