PUTRAJAYATHE Health Ministry has issued a blanket ban on the commercial use of “ozone therapy” machines in the country.
Business premises, including scores of beauty parlours, offering ozone therapy and those promising that the therapy would address ailments, have until July 1 to shut down operations.
Health Minister Datuk Seri Dr S. Subramaniam made it clear yesterday that those who failed to do so would face legal action.
He has set July 1 as the deadline for them to shut down their illicit business.
His order came a few months after the New Straits Times published a series on the mushrooming number of businesses taking advantage of a loophole in regulation that had allowed them to put ozone machines at the core of their business model.
The NST had reported that these unregulated and unmonitored beauty parlours running ozone therapy packages had little, if at all, safeguards in place to protect large segments of the society, who were lured by promises of health benefits by the operators.
In the series, NST also took to task scores of celebrities for endorsing the illicit treatment.
However, many of them who initially claimed ignorance, later retracted their endorsement.
The NST Special Probes team had initiated a project earlier this year with the National Pharmaceutical Regulatory Agency (NPRA) to expose the blatant and irresponsible use of ozone therapy machines by many beauty parlours in the country.
The project led the team to many such parlours, which not only had untrained individuals hooking the machine onto their customers, but were infusing the treatment with banned, poisonous substances.
The Medical Device Authority (MDA) chief executive officer Zamane Abdul Rahman had, in response to the series, told the NST that there was technically no way out for these operators.
He said this was because the use of ozone devices was governed under the MDA Act, which would be enforced by the middle of this year.
Under the law, Zamane said, to register the devices, owners
must be able to provide medical and clinical proof on how exactly their devices functioned, how they benefit the users, and the safety aspects.
Dr Subramaniam, in announcing the ban, yesterday said: “The Health Technology Assessment carried out by the Malaysian Health Technology Assessment Section (MaHTAS) revealed that there was no scientific evidence to support therapeutic benefits from the therapy.
“In fact, it exposes users to the risks of bleeding as a result from the usage of heparin (blood thinning medicine), embolism (occlusion of blood vessels from air bubbles) and infection from unsterile instruments and permanent disability resulting from impairment of organs, such as kidneys.”
He said the decision to ban the practice was made after taking into consideration the risk of severe medical complications that it could lead to.
He said it had come to his knowledge that the practice had led to complications, and even death.
He reminded operators this: “All forms of ozone therapy, which involves usage of ozone machines, injection into people’s veins and running blood through the machines, falls under the ambit of medical treatment.”
He also underlined Section 2 and 5 of the MDA Act 2012, which says ozone therapy machine is a medical device that must be registered and licenced.
“Anybody who fails to comply or contravenes the above requirements can face legal action and is liable to a fine not exceeding RM200,000 or imprisonment for a term not exceeding three years, or both,” he said, adding that so far, the ministry had not received any application or registration for such machines in the country.
The use of injection needles and injection syringes for intravenous heparin is regulated under Medical (Instruments) (Exemption) Regulation 1986, where the instruments can only be used by registered medical practitioners or registered medical assistants, he said.
Legal action can be taken against unregistered or unlicenced facilities providing ozone therapy if there was evidence that there was usage of injection needles and syringes at the facility, he said.
Dr Subramaniam said the collaboration between enforcement agencies under the ministry would be further strengthened to ensure that the safety and wellbeing of the public was continuously improved and upheld.