Saturday, April 7, 2012

Regulation of medical devices? What shocking news?

Woke up this morning to the shocking news of HSA's intention to regulate medical devices. More correctly,  the shocking news of the doctors' responses to the impending regulations. What crap!

Regulation of medical devices have lagged far behind that for pharmaceuticals, and regulations have been long overdue. While pharmaceuticals require extensive testing for safety and efficacy, medical devices have escaped such scrutiny. As a result many poor quality products have been inflicted on unsuspecting patients. These range from breast implants, stents, artificial joints and various other prostheses. (Consumer Reports reviews this problem with reference to a report from the Institute of Medicine. 4 types of devices were singled out - surgical meshes, lap-bands, hip implants and cardiac devices.)

Recently, the French Company making the Poly Implant Prosthese (PIP) gel breast implants were hit by a major scandal when it was discovered that they had been using industrial grade silicone instead of medical grade ones, leading to the company going into liquidation. Of greater concern than the financial woes of the company was the exposure of unsuspecting women to the increased risk of ruptures of the poor quality implants.

Will the new regulations slow down the utilization of medical devices? Without doubt. But this slow down is necessary until manufacturers and doctors get used to dealing with public expectations of quality. Currently device failure rates are not even being monitored so no one has any idea of of how many faulty devices breakdown or fail.

HSA's regulations are both timely and essential for the protection of consumer safety, and we should welcome them. On the other hand, our doctors' hysterical lamentations that these regulations will only increase their practice inefficiencies and reduce the quality of medical care are misplaced, and sound totally self-serving.


Anonymous said...

1st question: Why does HSA still have to conduct investigations over devices already approved by FDA for use? It not only takes time, costs money plus I can't see what real value HSA will add by conducting tests on these devices in view of its limited resources as well compared to the FDA.

I believe doctors in Singapore already follow closely FDA approval before using devices where the regulation is silent in Singapore. A good case is the example you mentioned - the PIP implant. Because they were not approved by FDA, plastic surgeons in Singapore did not use them on patients and Singapore is spared.

My view is that FDA approved devices should not be aubject to additional investigation.

2hd question: Would HSA be responsible for picking up costs of reversionary procedures etc when the devices they approve for use turn out to be harmful to patients? If not, it may provides a false sense of security to patients (and docs as well) to have HSA put its seal oif approval on devices.

gigamole said...

Can't really speak for the HSA but my impression is that available regulatory approaches for medical devices globally are far from mature and consistent. The FDA apparently hasn't really gotten their act together (see latest post:;postID=7477287132459447823) where this is concerned, so it doesn't make sense to follow them too blindly. And even if you want HSA to accept the leadership of the FDA, some local filter of these decisions is necessary. And after approval some sort of tracking of the safety/efficacy issues will be necessary, just as pharmaceuticals need to be monitored.

For the 2nd question, this is really no different from regulation of pharmaceuticals. The regulatory processes are to protect the medical consumers, but the liability is always on the manufacturers.

IMHO doctors are wrong in targeting HSA. Rather they should ask manufacturers to provide better evidence on safety/efficacy and good manufacturing. If these exist, I imagine approvals should be a cinch.

As a potential patient-consumer, this would be what I expect.

Anonymous said...

The ST has left out (as usual) the part where even sterile cotton balls and condoms, wheel chairs and walking sticks fall under the category of "medical devices". Depending on the item, there are additional charges (starting from $6k till sky), leading to real problems sourcing some low cost items locally as suppliers find it unprofitable to register these "medical devices". Then, even it was economically viable, approvals take a long time and are not a cinch. This is because the list of "medical devices" is literally exhaustive and the head count at HSA has not been vamped up to cope with compulsory registration.

gigamole said...

I suspect inevitably there will quite a bit of delays due to the different players trying to navigate through this new reality. But there will be a new status quo. Hopefully it won't take too long getting there. But eventually I think it will be better for all concerned.

Critical question the patient-consumer needs answers for is how to ensure quality of the products being used on them, sometimes in very invasive ways. Can we just rely on the sales brochures provided by the sales reps?

Anonymous said...

When even condoms are Class C medical devices, the "system" is getting ridiculous.

gigamole said...

:) Funny!

But it may not be so funny if he should pick up HIV because of a leaky condom manufactured in Ah Huat's backyard rubber/plastics factory in Johore Bahru.:)