What exactly is a ‘Malaysian’ standard?
| Dr Kamal Amzan is concerned about where the country is heading, and whether the correct diagnoses and treatment will be able to save us all. He believes that politics is both an art and a weapon, which can be deadly in the wrong hands.Follow him on Twitter at @drkamalamzan. |
MAY 25 — The Health Ministry wants to register bandages, syringes and stethoscopes.
Health Minister Datuk Seri Liow Tiong Lai said in The Star (May 22, 2012) that this was to protect consumers from low-quality products that could pose health risks.
“We are setting a Malaysian standard and once the new regulation is implemented, many of the low-quality products, including those from China, will not be allowed to be used here,” said the health minister.
There is a new Medical Device Authority set to begin its function next month.
First of all, what is the “Malaysian” standard for syringes, bandages, and condoms? What are the criteria you use to determine such “high” standards? The breaking point? The legibility of measurement markers? Whether they leak, or were contaminated during production?
Or will you just adapt the many international standards that are available nowadays for medical devices and products, and label them “Malaysian”?
Secondly, most manufacturers have stringent quality control, certified by the many internationally accepted standards like ISO 13485 for medical devices and ISO 7886-4:2006 for single use hypodermic syringes, male condoms ISO 23409:2011, and a host of other agencies like the European Committee for Standardisation, the American Society for Testing and Materials etc. These international agencies ensure the minimum standards are maintained by the manufacturers.
Instead of asking the manufacturers, distributors, importers to register all medical products, doesn’t it make more sense to only allow those that have met international standards into the country? After all, that was the intention of setting up such an agency wasn’t it?
Syringes and bandages are non-reusable. We use them once and then they are disposed off — whether they are used in the clinic, hospital ward or operating theatre. The only place we re-use them is when we feed babies medicine or during procedures needing irrigation where we fill the syringe repeatedly with saline.
So when you say good quality syringes, how long do you intend them to last for? Apart from what I mentioned earlier the other group that share syringes are the addicts. If anything, I believe that syringes should break after the first use to prevent recycling.
Registering stethoscopes? Whatever for? The one that I have with me is currently eight years old and is working fine. They come with a warranty anyway.
Do we use syringes, bandages, and wear condoms differently from the rest of the world, necessitating new standards of our own? I hope this will not be a trend because not too long ago, we did the same when we used our own system to rank the universities, citing major differences between international and local universities.
We are supposed to be more globalised, not localised.
Thirdly and most importantly, will it increase the manufacturing cost? As we know whenever a government agency is involved in such an exercise there are contracts for the printing of stickers, certificates and “kursus” to attend. Someone will have to bear the cost, and I truly hope it won’t be the taxpayers.
And last but not least, which company will be awarded the contract to print the certificates, stickers or any other mode of certification, and at what cost?
The Ministry of Health would be better off channelling funds needed for this exercise to rural hospitals instead. Get more beds and ventilators there as well as ambulances and paramedics to provide the necessary pre-hospital care.
Focus on developing excellent, affordable healthcare for Malaysians. That could perhaps be known as the “Malaysian” standard, envied by everyone else worldwide. Leave the certifications and standardizations to the globally accepted international agencies, please.
Your resources are needed elsewhere.
* The views expressed here are the personal opinion of the columnist.
