보건복지부 영문홈페이지

Order for withdrawal of six humidifier disinfectant products from the market issued

 

- The animal inhalation test confirmed the biopsy result showing the same symptoms of the lung disease found in the patients earlier in summer, of which causes were not identified then

- It is strongly recommended that all the humidifier disinfectant products that will be later tested be stopped being used

- All the humidifier disinfectant products will be designated as “quasi-drug item.”

 

Ministry of Health and Welfare (Minister Rim, Chae Min) and Korea Centers for Disease Control and Prevention(Director Jeon, Byung Yul) announced that six humidifier disinfectant products of which toxicity was confirmed based upon the epidemiological investigation, the animal inhalation test result and expert reviews will be ordered to be withdrawn from the market and a related procedure will be implemented.

 

As a result of the animal test, 6 products in total; two products of which toxicity was confirmed (A and B); three other products that contain the same substance*(C,D and F); one product that has a similar substance*(F), will be collected back from the market.

* A substance investigation was conducted by Korea Food and Drug Administration

 

< Six products subject to the withdrawal order >

․PHMG : polyhexamethylene guanidine

․PGH : Oligo(2-(2-ethoxy)ethoxyethyl guanidinium chloride

 

The animal inhalation test was conducted by Korea Institute of Toxicology (researcher: Toxicity Inhalation Test Research Center Director Lee, Gyu Hong) affiliated with Korea Research Institute of Chemical Technology. One month after the test began (27 Oct.), the first autopsy was executed and it found that two out of the four testing groups (Group A was exposed to Oxy Ssakssak and Group B was exposed to Cefu) displayed abnormal biopsy results.   

 

One group (Group B, exposed to Cefu) exhibited signs and symptoms; inflammation around bronchiole, falling away of epithelial cells inside bronchiole and pulmonary fibrosis, which clearly coincide with the clinical features observed in the affected human body. In another group (Group A, exposed to Oxy Ssakssak), inflammation was observed around bronchiole. Also, both groups displayed an apparent increase of breathing rates and respiratory distress.

 

The other one group didn’t show any changes but at the end of next month when three month will have passed after the test began, the second autopsy will be carried out to verify the final result.

 

Experts confirmed the test result above at a consultation meeting held on 10^th and reviewed related measures to be taken.

 

Ministry of Health and Welfare informed representatives of the six manufactures that the concerned products are subject to the withdrawal order in accordance with the Basic Laws on Product Safety in the afternoon of 11 Nov. and it will check with Korea Food and Drug Administration for implementation of the related procedure.

 

The concerned manufacturers will be required to report withdrawal progress status and results to local offices of Food and Drug Administration in their districts on a regular basis. 

 

Information on the products subject to the withdrawal order and the concerned manufactures will be disclosed on a product safety portal system (http://www.safetykorea.kr) through Ministry of Knowledge Economy, Korean Agency for Technology and Standards from 15 Nov. and sales of the subject products will be blocked by registering them on the harmful product blocking system of Korea Chamber of Commerce and Industry.     

 

If any of the subject products are found being sold at a small retailer, delaying the withdrawal, it can be reported to the concerned manufacturers of which contact information is disclosed or to local community healthcare centers.

 

Ministry of Health and Welfare will designate all the humidifier disinfectant products as quasi-drug items sometime in Dec. and the remaining products besides the six products whose withdrawal has been ordered will also be animal-tested.

 

It is once again strongly recommended that people stop using not only the subject humidifier disinfectant products but also the remaining ones still sold in the market.

 

Additional cases will be studied through related academic associations and KCDC website and local community healthcare centers will open to receiving reports on lung damage cases suspected of being caused by humidifier disinfectants.