NO GO FOR OZONE

Those who fail to do so face le­gal ac­tion, says min­is­ter

New Straits Times - - Front Page - RE­PORTS BY ALIZA SHAH AND HASHINI KAVISHTRI KAN­NAN

A FEW months after an in-depth se­ries of ex­posés by the ‘New Straits Times’ on the dan­gers of ‘ozone ther­apy’, the Health Min­istry yes­ter­day an­nounced a blan­ket ban on the com­mer­cial use of ozone ma­chines from July 1. The ba­sis of the ban: there is no sci­en­tific ev­i­dence to sup­port the ben­e­fits ex­tolled by pro­po­nents of the ther­apy, and the health risks in­volved are unimag­in­able.

THE 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.

Datuk Seri Dr S. Subra­ma­niam

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