The regulation of medical devices in the UK has recently made headlines again as further criticisms have been levelled against the current system. Several devices, which were considered safe under the regulatory system, have been subject to litigation and controversy in the past few years. Metal on metal hip replacements, mesh implants, Essure contraceptive devices and Nanostim pacemakers have all caused problems for a number of the patients who have received them but have apparently met the required safety standards to be supplied on the market. The list of defective devices has only grown longer over time yet the regulatory system remains flawed.
While the problems many patients have developed after the implantation of these defective medical devices makes it clear that the side effects and complications of medical implants can cause just as much harm as those associated with drugs, the process for having a product approved for use remains far less stringent than for a medicine. Lower requirements of testing and assessment can also lead to less information about potential complications being available to those carrying out a procedure and to those undergoing it.
The regulation of medical devices in the UK is overseen by the MHRA, who have the power to suspend or ban the sale of goods which are considered to be unsafe. They are also responsible for monitoring the notified bodies who assess whether a device meets the required standards of safety. The system should ensure that medical devices are safe before they come onto the market in the UK and also monitor any safety concerns which emerge after they come into use. The number of recent implant scandals would however indicate that this is not always happening in practice.
In terms of a medical device being approved for supply and use in the UK, there is concern that it is too easy for manufacturers to obtain the necessary CE certification from a notified body. Manufacturers have a choice of notified bodies and can approach several of them to “shop around” and identify the body with whom they believe they will have the best chance of obtaining market approval, before making an application. While the standards which have to be met should be uniform across the notified bodies the exact processes and questions which will have to be satisfied will vary, giving the manufacturers options.
In the event that a product has been approved, used and then problems start to emerge, further issues with the regulatory system can be identified. The MHRA relies on reports and other intelligence to identify problematic devices. Adverse incident reports can be made by medical professionals or members of the public through the yellow card system. However, for a report to be made both knowledge and action are required. If a patient or doctor is not adequately informed about the device and associated complications, or if a doctor is failing to investigate the device as a cause of symptoms, then a report will not be made. This can lead to devices being considered safe and effective even when they are causing injury. For instance, when a woman’s incontinence or prolapse is improved following surgery with a mesh device the procedure is considered a success. If symptoms such as severe pain or recurrent infection are not acknowledged and reported, then the extent of the problems with the devices will not be recorded and the device will continue to be considered safe for use.
These are just some examples of areas where the current regulatory system for medical devices has the potential to be lacking. The current system is not robust enough to prevent unsafe medical devices coming into use and is slow to react when problems emerge. Overall, there is a need for more stringent testing, greater transparency and an increased flow of accurate information between those involved in the regulatory process and also to those who may end up living with the consequences of a defective device.
Innovation is needed in the medical field to improve on available treatments as technology and knowledge advance. However, with new products come new risks, including those which are wholly unacceptable and render a device unfit for use. There must be sufficient regulation to ensure that patients do not pay the price for technological and medical advancements while manufacturers reap the profits. In this respect the current regulatory system is failing.
Blog by Amy Haughton, Solicitor