Even as discussions continue in Singapore between the HSA and medical practitioners, this problem has been brewing in the US of A as well.
Recently, St Jude's Medical, Inc in St Paul, Minneapolis, USA has been involved in a spat with authors of a report entitled "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads" in the Heart Rhythm Journal. St Jude's Medical, Inc are the manufacturers of the Riata electrodes. Concurrently, they have stopped selling two of the electrodes. Electrodes which had been 'approved' by the FDA, ..... apparently.
Truth is the FDA's way of regulating of medical devices is not exactly exemplary. A report from the Institute of Medicine has pointed out major deficiencies in the way the FDA deals with medical devices and have recommended a major overhaul of the regulatory process for medical devices. This will come as no comfort to those in Singapore who advocate blind acceptance of what the FDA pronounces as acceptable.
Globally, the experience in regulating medical devices has lagged far behind the regulation of pharmaceuticals. Is it necessary? Absolutely. But the question of how needs a lot more discussions and harmonizing. This is a rapidly growing problem that badly requires some regulatory solutions. To do nothing will be irresponsible. We need the HSA to be vigilant, and to keep their eyes on developments not only in the US but in other countries such as Britain, Australia, Canada, Japan as well as the European Community.
So to those who are targeting the HSA as villains in this regulatory necessity, think again. They would do better to redirect their angst towards those who are making money out of peddling inferior and/or unsafe devices.
5 years ago