Is medical device regulation failing to ensure patient safety?

For the last decade I have been part of the medical devices industry, most recently as part of a design consultancy firm specialising in medical device innovation. In the last few years our world has been shaken with reports of the failure of medical device implants and the insinuation of industry wide misconduct.  The headline statistics are certainly shocking, in the investigation recently published by the ICIJ (ref. their research suggests that in 2017 nearly 300,000 patients were harmed by medical devices in the US alone. Clearly something is wrong.

However, personally I have never come across anyone in the industry who wishes to cause harm to a patient, in fact it’s completely the opposite. Where I work, it is our company’s primary policy to improve lives through innovation and the stories that have hit the headlines do not to make it clear that most people in the industry are diligently working towards making sure all new devices are safe.

I spend my life around medical devices. These include items as varied as a surgeon’s scalpel, an insulin injection pen or a portable oxygen delivery system. They also include implantable meshes and spinal support systems and complex hospital equipment designed to keep extremely sick people alive.

Each device I work with is the product of many years of design and testing before it is allowed near a patient. During that time, it undergoes substantial testing to ensure that it works according to the design intent, for the conditions it is expected to experience and the intended life both on the shelf and in use. Biocompatibility testing is carried out to ensure that anyone encountering contact with materials does not suffer an adverse reaction and a robust risk management process, including medical professional opinion, underpins all this to attempt to account for foreseeable harms from the use of the product. At every stage in this development process the concern is for the patient and one of the most common questions asked is whether you would be happy for a close relative to use the final product.

If a device does reach a human being for clinical evaluation, and not all do, the use in that person is strictly controlled. The safety profile, as far as possible, needs to be determined and the risks of the use of the device, as well as the benefits, need to be established and controlled as far as possible. In the United Kingdom, this assessment is carried out by the Medicines Healthcare Regulatory Authority (MHRA) and it takes several months for agreement, during which this information is assessed. It is also usual for an independent Research Ethics Committee to confirm the well-being of trial participants and agree to the trial. Once agreement is obtained recruitment may begin and appropriate volunteers may start a trial once they have signed an informed consent form which details the potential risks and benefits of the study. All trial participants may withdraw from a trial at any time without needing to give a reason.

Prior to a device being launched on the open market in Europe and depending on risk classification (the lowest risk devices can be launched after the creation of appropriate technical document with limited oversight), the summary of all the development documentation detailed above, and more is assessed by a Notified Body. These organisations, whilst not part of governmental structure, are designated by their national competent authority (e.g. MHRA) as having passed a strict assessment which confirms that they have the relevant in-house knowledge to question and approve a device for use. Post market surveillance also takes place to ensure that as more information becomes available through use, appropriate changes are made to the design and even withdrawal of product if it is deemed necessary because of a safety risk.

Europe is currently poised to welcome an update to the Directives and Regulations governing the development and assessment of Medical Devices to the market. This is the culmination of nearly a decade of discussions from the European Commission downwards to ensure the safe development of medical devices. The new Medical Device Regulations (MDR) place stricter requirements on the in-patient testing of devices, the post market follow-up (especially with regard to implantable devices) and the re-classification of some devices into higher risk categories. All medical devices, both yet to be conceived and those on the market already, must meet these regulations as manufacturers will no longer be permitted to rely on historical approval.

I am not claiming my world is perfect and the statistics show this. But carefully implemented medical device regulation maintains and promotes high standards of safety and efficacy. I’m proud to say that here at Cambridge Design Partnership the focus is always on the welfare of the patient. I wouldn’t have it any other way.

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Louise Place

Head Of Regulatory Affairs & Quality Assurance Consultant