Monday, May 23, 2011


There is a strong move in Europe, calling for tougher regulations in medical devices. The May 14th issue of the British Medical Journal carried a series of articles on medical device regulations and approvals. They had editorials and commentaries on how regulatory authorities carry our device checks and clinical evidence, and how the process of approval is carried out.
At the same time, the European Cardiac Society, has submitted a consensus report to the European Council of Ministers and the European Parliament, calling for more consultation and a more active role for clinicians in device approvals.
Suffice to say that the at the moment, the European standards lags far behind the American standards. In the field that I know well, the stents and interventional cardiac devices, CE marks are obtain so easily, based only on the fact that there are studies ( sometimes relative small studies ) show that the devices are safe ( not necessarily good, or proven good ). They left it to the individual practitioner to use his discretion, too use or not to use. Sometimes, even this discretion is taken away, when healthcare facility owners, stock certain devices that are CE mark approved, are cheap and ask the practitioners in that institution to use them. In the end, the patient suffers. We must base our approval of devices, in the case of stents, these are permanent implants, on good clinical trial evidence of safety and efficacy.
There is not enough doctor and patients interest in the devices, what they are for, and how they are approved. As long as along the way, the vendor brings some papers, saying that there is CE mark, it is cheap, hospitals and even physicians are tempted to use them, as a lower cost of device may translate to a better profit margin, maybe a cheaper price for procedure, thereby with heaving marketing, claim that they can offer treatment at lower cost. By the time the device fails, it may be months or years down the road, and they cannot be blamed anymore.
I know this well, in the issue of stents and even drug eluting stents ( DES ). Every so often, I get to see ( for a second opinion ), patients who had "generic", me too, DES implanted where the efficacy is unproven The studies on those copy cat stents, involve 80-90 patients, over short period of time ( maybe 12-18 months ), they get CE mark, and bingo, it is touted as, as good as the proven stents. Of course, these "me too" generic stents cost almost half that of proven stents. I tell my patients, it is too good to be true. Cheap things no good, good things no cheap.
What the Europeans, and ourselves as well, is very concerned also, is the "too close" working relationship between the investigating physicians and the industry making the devices. Big name physicians, and in our circle we know who they are, always get involved in talking about, and launching new stents that they have fathered through regulatory authorities, using their "big name". Of course they are handsomely paid. It is well known in our circles that at this meeting, Dr A will teach and tout this DES as the best, and 6 months later, at another interventional meeting, he will teach and tout that the rival is the best. Of course he gets very rich.
I suppose, at the end of the day, like everything else in medicine, doctors and patients must keep abreast with the latest technologies, and also get more involved with the regulatory approval process. Patients must also read more widely and keep abreast. With the internet ( the world is flat ), we have access to a whole wealth of information that 20 years ago, we do not have. As I always tell my patients, what ever I say and discussed with you, you can always double check with "", and read for yourself. We must empower the patient more, so that they are not easily taken in by shylocks.
Back home, it is even worse. We have been hearing of a "Medical Devices Act" for the last 10 years. We are still waiting. At the moment, registration of medical devices are voluntary. At the last count, there are more then 20 DES being used in the country. In USA, there are only 4 FDA approved DES. There are some DES being used whose manufacturing companies, I do not even know. The only thing is, they are cheap, and some physicians use them, so that they are "more affordable". But the total hospital discharge bills is the same as the FDA approved DES. Even if we have a medical devices act, I doubt that we can give our patients the best, based on medical evidence. We will probably end up like where European standards are at the moment. I suppose, it is still a small step forward. Even the FDA standards are not the best, but it is the best that we have. The FDA approval panels are also not beyond reproach.
Anyway, we all hope one day that our patients and our physicians will be better informed on medical devices and take a greater interest in what is being implanted into their body. The devices must be proven safe and effective, with good short term and long term medical evidence.

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