This page contains a Flash digital edition of a book.
ETHICS


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


THE CLINICAL SERVICES JOURNAL 25


Page 1  |  Page 2  |  Page 3  |  Page 4  |  Page 5  |  Page 6  |  Page 7  |  Page 8  |  Page 9  |  Page 10  |  Page 11  |  Page 12  |  Page 13  |  Page 14  |  Page 15  |  Page 16  |  Page 17  |  Page 18  |  Page 19  |  Page 20  |  Page 21  |  Page 22  |  Page 23  |  Page 24  |  Page 25  |  Page 26  |  Page 27  |  Page 28  |  Page 29  |  Page 30  |  Page 31  |  Page 32  |  Page 33  |  Page 34  |  Page 35  |  Page 36  |  Page 37  |  Page 38  |  Page 39  |  Page 40  |  Page 41  |  Page 42  |  Page 43  |  Page 44  |  Page 45  |  Page 46  |  Page 47  |  Page 48  |  Page 49  |  Page 50  |  Page 51  |  Page 52  |  Page 53  |  Page 54  |  Page 55  |  Page 56  |  Page 57  |  Page 58  |  Page 59  |  Page 60