Monday, April 9, 2012

Regulation of medical devices - a follow up

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.


Anonymous said...

If even a much bigger and experienced outfit like FDA that has been regulating medical devices since eons ago has limitations and weaknesses, I can't imagine how HSA would be able to do a better job, being much smaller and having limited inexperience, since it's only started putting its act together this year. I'm not advocating blindly following FDA, but just being realistic that in the short term, it would at least be more practical to accept FDA or some other equally reputable authorities seal of approval. And, it doesn't preclude HSA from monitoring and evaluating FDA approved devices brought in by the docs themselves or distributors/manufacturers in the meantime. And, certainly when the HSA has gathered enough expertise, experience and sorted out teething problems in regulating devices, it can certainly then require every device, regardless of prior approval by any other authorities to be checked by HSA prior to use. This would at least relieve the immediate short term time delays in approving devices that have adverse impact on the docs who need them urgently. I think we have to strike a balance with regards to regulation and safety vs expediency/fulfilling real needs.

gigamole said...

I suspect there has been a bit of an overreaction about these regulatory changes. I am not so certain that HSA wants to do so much in terms of detailed evaluations of medical devices. I am fairly certain they can't handle it. I suspect what will happen is that they will as in pharmaceuticals, just take a common-sensed risk based approach and do only what needs to be done. Those that have already been evaluated in depth by other regulatory agencies will probably have a easier route through the regulatory process.

On another note, it seems very much that doctors are somehow being recruited by manufacturers and vendors to argue the case against regulation.

Incidentally, Gigamole had already posted about this issue in 2009.
See :

Anonymous said...

Good to read in the news that HSA will be flexible and is taking into account the affected docs's concerns. Nothing beats working towards win-win arrangements for all stakeholders concerned :)

gigamole said...

Yep. Though I do think that HSA didn't do that well in managing this process. Even though the regulations are a necessity, the management of public expectations and those of stakeholders have been rather tidak apa. They had tons of time to do this. Yet they botched up. Consequently they managed to allow the main stream media to set the agenda. Now they are in a mess. You can't implement policies while defending from the back foot.