Sunday, April 08, 2012

Doctors like me are upset about HSA's medical device regulation... why?

Sunday Times 8th April 2012


They have met privately, written to their professional bodies, blogged, and gathered to tell the Health Sciences Authority (HSA) what they think of the tightened regulation of medical devices in force here since the beginning of the year.

The bottom line is that private specialist doctors think it takes too long, costs too much and requires far too much paperwork to get medical devices cleared for use.

Despite meetings with HSA officials, including one with about 50 at Gleneagles Hospital last month, the doctors say their difficulties have not yet been resolved.

Their work has been affected, because some doctors have run out of supplies of some items their patients need.

Read digital version here ( must pay- I think) or buy the Sunday Times.

Dear Friends,

I have blogged about this issue here

Straits Times/Sunday Times health correspondent,Salma Khalik, interviewed me for the above story.

Despite advice to the contrary, I feel that many reporters working in Singapore’s “controlled” environment try to do the “right thing” and airing the doctors’ point of view over the Mainstream media (MSM) will ultimately help our patients. Of course, we know Singapore’s SPH and Mediacorps is a duopoly of mega-proportions and this decision is made on political grounds (as the PAP believes a fully independent media is not conducive to their type of rule -to put it mildly).

If you read the whole article ( sorry- I only have the free and hence incomplete version), the HSA says it is trying to engage the doctors. I am wary of engaging them now as I do not want a “half-measure” solution that only postpones the problem while our SME vendors are dying day by day ( like a death of a thousand cuts).

With my hand on heart, I sincerely feel that wrong policies should be rescinded or at least severely altered. That means in the least,medial devices that have been cleared by USA’s FDA need not need registration and the doctors or vendors bear responsibility when we use them. Period.

Let us get the entrepreneurship amongst the vendors going again… for the sakes of all our patients.


Dr Huang Shoou Chyuan


Anonymous said...

I find it quite strange - isn't the HSA run by doctors as well? At least that's what I notice in the list of Board members and the CEO. It seems to me that doctors (in HSA) who would have undergone similar medical training don't seem to understand their own colleagues' needs in trying to help patients when they sit at the opposite side of the table.

nofearSingapore said...

Hi anon: HSA is a statutary body ( probably under MOH). The executive officers eg CEO are doctors ( but not necessarily so) and allied health personel ( pharmacists). It is governed by a Board of Dirs some of whom are doctors. Chairman is a doc. The executive officers are mainly non-practising docs and often rely on practising docs for advice. Perhaps they sort advice from public hospital docs but the perspective of private sector docs are different. Medicine at the cutting edge changes very quickly in every specialty and to have to wait 6-12 months each time we need something "newish" is not on. We are not talking about devices made in Timbucktoo but devices that had already been thoroughly been evaluated by FDA ( which is a very detail process). Problems: 1.SME's who support med industry will die 2. Cost will rocket 3. We become second rate and fall behind and become less competitive.

Anonymous said...

hsa i think very strong one moh also very strong one. what to do.

like dr lim, being sue and lose.

hope you can win.

hope there can be a prof, prof lim not only in ecomnomics but medicine as well.

Anonymous said...

Thanks for your clarification and glad to read that the guys at the opposite side of the table (HSA) are listening to the concerns raised and will be flexible in the implementation. Hopefully, this will result in win-win for all stakeholders. Right way to go! No point hurting everyone in the process (including patients that they aim to protect) even if the intentions are good.

Anonymous said...

Andy ho's commentary in the straits times has clarified weaknesses in the us FDA 510(k) system, I think as doctors we should be cautious and not assume all 510(k) products are safe to use. For most doctors, we would prefer HSA to continue with pre-market assessment of these devices but what we require is faster access to these products.

Muhammad Amir said...

The bottom line is Medical Device Company that private specialist doctors think it takes too long, costs too much and requires far too much paperwork to get medical devices cleared for use.