Saturday, April 14, 2012

HSA and the regulation of medical devices - an exercise in agenda setting?

The theories of agenda setting are well known, I believe, to all mass comms graduates as well as journalists. Although the formal theories were only formulated about 40 years ago, ideas that the media can influence public opinion have been recognized since the early part of the 20th century.

The recent brouhaha about the regulation of medical devices by the HSA can perhaps be seen in the context of agenda setting. That the media plays an important role in agenda setting is beyond doubt. How the agenda is set however depends on who plays the media. To the media savvy, the media becomes a collaborator in the shaping of public opinion. A media-savvy politician therefore gets a pretty smooth road.

Where HSA failed has been in not recognizing how important the management of public expectations was in the implementation of complex and public-sentiment sensitive policies such as the regulation of medical devices. By defaulting on this, it has willy-nilly allowed the media to set the agenda in a direction contrary to public policy. So, not only has the media been allowed to tell us what issues are important, but it is being allowed to tell us what opinion we should form  about the issue. Note the teaser on the front page of the Straits Times today - "Patients should worry about vanishing medical devices". Really? Vanishing medical devices?

Poor HSA CEO John Lim is in the hot seat now. It seems like it is the fashion nowadays to run down the CEOs! I am waiting for the day when someone flashes an old D&D picture of him on a sedan chair carried by half maked women! But it should be recognized that the move towards regulating medical devices had not been developed overnight, but has been on the stove for about a decade. During this decade, the policy has been deliberated and refined under the guidance of 2 Ministers of Health and 2 Board Chairmen. I guess the second team has been quite unlucky to be on watch when this policy was finally ready to be implemented. But seeing how the SMRT issue developed, it seems highly unlikely even this team will get any credit for the mess. So, sadly, it looks like CEO John Lim will be the one catching the ball.


Anonymous said...

The HSA has itself to blame for the negative publicity; in my view, it had been quite sloppy in implementing the regulatory changes.

The senior management should have taken stock of the large backlog of applications submitted before May 2010 (568) and 4,000 in 2nd half, 2011 as well as 450 just in the first few months of 2012. This should have alerted it to recognize its inability to cope with the implementation of the regulatory changes. It should also have stayed close to the ground and listened to the concerns raised (e.g. from docs and distributors/suppliers) sooner and made changes to the implementation, at least in the shorter term, to reduce delays while it tries to beef up its team to clear the applications.

Btw, the same CEO talked about the regulatory changes since 2007, so there has been almost 5 years lead time for the HSA to put its act together.

Anonymous said...

It is an irony that in the us, eu and Australia the public are pushing for tighter medical device regulations but in Singapore the converse is happening.
It is true that access to good devices has to be prompt but verification has to be performed and the hands of the regulators should not be tied.
We do not need a Lehman brothers style medical device issue to erupt. I would expect industry to always be unhappy about regulations but I doubt all doctors are anti regulations

gigamole said...

Quite clearly this process had been mismanaged over the last decade. These regulations could have been phased in in stages. Staffing could have been better planned for and allocated to clear the backlog.

On the other hand, distributors and suppliers should also not act dumb, as if these sprang up overnight. They knew it was coming and should have planned for it.

It is both an irony and tragedy, especially if these regulations fail to be implemented properly. It is really in no ones interest to keep the status quo where all kinds of thingys can get stuck into the body without first being evaluated for quality and safety.

Consider how unsafe patients would be if drug use was not subject to regulatory oversight.

Methinks Salma Khalik is being a tad irresponsible in fanning the fires here.