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Device design: addressing issues

The issue of regulation for new techniques and technologies went under the spotlight at a seminar, hosted by the Royal College ofSurgeons. SUZANNE CALLANDER reports on the concerns voiced by surgeons and doctors regarding the approvals process for medical devices.

Challenging the industry views expressed at an Ethics and Patient Safety seminar, hosted by the Royal College of Surgeons, which focused on the introduction of new device technology (Published in the February issue of The Clinical Services Journal – p17), Peter Wilmshurst, consultant cardiologist at the Royal Shrewsbury Hospital and senior lecturer in Medicine at the University of Keele, took the opportunity to put forward his personal experiences regarding the regulation issues surrounding medical devices. He said: “Ideally, assessment of any

treatment should be sufficiently rapid to ensure that good treatments get to patients quickly. However, there should also be sufficient checks in place to ensure that less effective or unsafe treatments do not make it to market. There also needs to be adequate post-marketing vigilance to detect problems. “For the patient, it is important that

assessments of treatments are comparable, whether it be a coronary stent or a drug. They both need to be tested. However, regulators will view an intracoronary stent, or any other medical device, as a device like any other, and this can be a problem.” There are a number of classes of

medical devices – for low risk devices (Class 1) manufacturers are able to self- declare conformity, affix a CE mark and register the product with a competent authority. For medium risk devices (Class 2) such as X-ray equipment, monitoring equipment and ultrasound; and high-risk implantable devices (Class 3) such as stents and prosthetic valves and joints, a conformity assessment procedure needs to be undertaken. Comparing the procedures for drugs

MARCH 2012

Charnley pioneered the metal on polyethylene hip replacement in the 1960s– a good example of a disruptive innovation.

and devices, Dr Wilmshurst explained that for drugs the European Medicines Agency (EMA) has a committee that looks at products for human use and grants European authorisation for marketing of the drug. Authorisation will require proof of safety and efficacy and new drugs require randomised controlled trials. If you want to bring out a generic version of an existing drug you need to demonstrate that it is chemically and biologically equivalent. The EMA also publishes the reasons that the drugs were approved and has a role in post-marketing surveillance. “The situation is different for devices

in the EU with each state having its own competent authority,” said Dr Wilmshurst. “The decision about whether to grant a CE mark is made by one of around 76 Notified Bodies, many of whom are private companies. It is necessary to satisfy requirements on safety and performance, but performance is defined

by the manufacturer, and a device does not even have to demonstrate any clinical benefit. It only needs to be able to do what the manufacturer says it can do.” He went on to comment about a device that he is aware of, which only has a 50% success rate, but this did not stop the product coming to market. “It is not necessary to

demonstrate equivalence with similar devices. Also, if the manufacturer suggests that the device is similar to an existing device it may only require a literature review to gain a license. “There are obvious problems

with this system,” said Dr Wilmshurst. “There are

discrepancies between the notified bodies. Further, the notified bodies are not working for patients or the EU. Their clients are the device manufacturers, and the reason for granting a CE mark is not published – it remains commercially confidential. Such secrecy contrasts with the published rationales for approval by the EMA for drugs or indeed, the Food & Drug Administration (FDA) in the USA for both drugs and devices.” Dr Wilmshurst went on to discuss the

issues of potential conflicts of interest in clinical trials set up to support licensing applications. “Clinicians are in a good position to identify a gap in the market for a device and then go on to design a solution and become involved in research in which they may have a financial interest. This can lead to a clear conflict of interest.” There are other areas where conflicts

of interest can occur. He said: “When surgeons use a device for the first time


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