It was found that all ozone machines run by beauty parlours were not registered under the Ministry of Health (MOH), although under the Medical Device Act 2012, they are required to do so. The ozone machines are also bound by regulations similar to those governing the use of haemodialysis equipment.
Many beauty parlours which offer ozone therapy are advertising that the therapy can address hundreds of health issues, including chronic illnesses, despite the Medicines (Advertisement and Sale) 1956 (Revised 1983) Act, that prohibits them from making claims about 20 chronic illnesses, including kidney and heart ailments, diabetes, asthma, drug addiction, erectile dysfunction and cancer.
Under the law, no one operating ozone machines are allowed to claim that they are beneficial to health. By doing so, the offence is punishable by a maximum fine of RM200,000 or three years' jail, or both.
MOH warns public against ozone therapyHealth Deputy Minister Datuk Seri Dr. Hilmi Yahaya warned the public against going for ozone therapy as it uses O3 gas and upon entering the blood stream, will form bubbles which will travel to the individual's brain or heart and can be deadly.
The Malaysian Medical Device Authority (MDA)'s CEO, Zamane Abdul Rahman, said that the by mid-2017, the agency will ensure that those employing or operating medical machines with the slightest suggestion of health benefits, will be resitered.
"The MDA strives to ensure that medical devices in the country are of high quality, effective and safe in order to protect public health and safety," he added.
The office has however banned the import of ozone therapy machines and that the Customs Department had been notified of the ban. It has also found that many beauty parlours were bringing in ozone machines manufacture by suspicious sources from China, Taiwan and South Korea.
Collaboration between PSD and MPD to tighten regulationsThe MDA will be collaborating with teams from the MOH's Pharmaceutical Services (PSD) and Medical Practice (MPD) divisions. The PSD enforcers will be cracking down on many ozone therapy centres, which were also found to offer other treatments such as illegal beauty injections, as well as using medicine that only doctors can prescribe. A PSD spokesman also said that they are looking to amend the Sales of Drug Act 1952 as well.
"The amendment will see the penalty amount being increased from the current maximum of RM25,000 to RM100,000 and the law will also provide a minimum penalty of no less than RM5,000. This is to ensure that the act serves its intended purpose of being a deterrent," the spokesman added.
The team from MPD will be investigating doctors that collaborate with beauty parlour to perform intravenous procedures.
The law currently makes ozone therapy illegal as heparin, a blood thinner, which is a prescription drug, is administered before the procedure. Doctors are not allowed to participate in the process. The Malaysian Medical Council (MMC) and MOH had also previously warned doctors against being involved in any illegal "alternative" treatment.
Health risks of ozone therapyUniversiti Kebangsaan Malaysia Medical Centre's environmental health physician and toxicologist Associate Professor Dr. Mohd Hasni Ja'afar said that ozone gas is an oxidative germicide that interferes with the body's immune system and cellular DNA. It is commonly used to disinfect hospital wards.
Health risks include a steep drop in blood pressure, infections, hypothermia and air embolism, all fatal causes. Ozone is currently used to treat certain types of joint pain, skin and limb problems, but as a blood-cleansing therapy, it must never be attempted, he added.
"There is no clinical evidence to support claims of health benefits as being promoted... what is clear is the risks that come with it," he said. MIMS
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