The use of non-FDA approved Stents in Malaysia

This letter was sent to the Sun in response to their article on the usage of non-FDA approved stents in Malaysia.

I am told that there is widespread use of non-FDA approved coronary stents, especially drug-eluting stents, in Malaysia. I think that the main reason is cost.

Obviously, the Ministry of Health is very concerned, concerned enough to cause them to attempt an introduction of the "Medical Devices Act". Let me begin by complimenting the Ministry of Health for beginning the process of registering all medical devices. At the moment (until the Medical Devices Act 2008 is passed and gazetted), such registration is voluntary. We certainly hope that by 2008, all stents will be registered, subject to an approval mechanism based on clinical trial data before they can be used. Let us begin to have our own "FDA".

I, for one, am not keen to push American standards here. We need our own standards. Until such time when our own standards are ready, it is reasonable to follow the American FDA standards. The Euro CE mark, has proven too lax and easy to obtain.

Coronary stents are wiremesh slotted tubes, implanted into the human coronary arteries, to treat heart artery narrowings. There are two main types, the standard "bare metal stent" and the latest "drug-coated stents". It is important to note that these stents once implanted in the human heart artery are there permanently and cannot be easily removed, so safety is of paramount concern. What more when these drug-coated stents, made of metal or metallic alloy, have a mixture of polymer coating with toxic drug effusing from them, at a finely timed rate.

These special drug-coated stents are very complicated to manufacture. With so many compounds coated on the stents, safety is a very big issue. Not only safety in the 6 months to 1 year after implantation, but safety for the remainder of the patient’s life. We want devices that are safe, in the short, medium and long term, effective with good large clinical trial data, with post-market surveillance by the manufacturing company for the long term as sometimes these devices do not show their ill-effects immediately. Even the FDA approved drug-coated stents are still wrestling with the issue of long term safety, what more the non-FDA approved stents by small company with limited resources to do proper trials and long term followup?

I am very surprised that some of my colleagues are implanting non-FDA approved stents based on cost, and urgency. What about patient safety and efficacy (effectiveness), in this age of evidence based medicine? I would like to remind my colleagues who are using non-FDA approved stents that under urgent medical indications and even for patients who have budget constraints, there is always the choice of the good old "bare metal stents", which are still very good stents. In fact, I understand that at ministry of health hospitals, bare metal stents are still very popular.

Better a safe bare metal stent, than an unsafe non-FDA approved drug-eluting stent, however much the medical urgency. As always, doctors should be guided by the important dictum, "if you can do no good, as least do no harm". Safety, for medical devices is a must, more important then cost or urgency.