Ministry orders humidifier-sterilizer recall

Animal testing links six products to inflammation of lungs


The Ministry of Health and Welfare on Friday ordered a recall of six models of humidifier-sterilizer on suspicions they can cause life-threatening pneumonitis.
The government will designate all humidifier-sterilizers as quasi-drugs subject to monitoring and regulation. Currently, humidifier-sterilizers are classified as industrial products and are exempt from health regulations.

The six brands to be recalled are Oxi Ssakssak, Cefu, Wiselect, Homeplus PB, Ato Organic and Gaseupgi Clean Up. They all use polyhexamethylene guanidine phosphate or Oligo 2-(2-ethoxy) ethoxyethyl guanidinium chloride. 

The recall came alongside the ministry’s announcement of lab testing of humidifier sterilizers.

Researchers observed mice that inhaled vapor from humidifiers using each product for over a month. “Their lungs were found to have been inflamed, and idiopathic symptoms were detected. The same progress may have occurred among the pneumonitis patients who were exposed to sterilizer-humidifiers,” said Dr. Jang Se-jin of Asan Medical Center, who took control of the research.
The chemicals are contained in wet wipes, shampoo and other commodities, too, but the authorities believe that direct inhalation is the only route by which they damage the lungs. Other products containing the materials are safe, they said.

Humidifier sterilizers were first introduced in 1997. While other countries use sterilizers for cleaning, Korea is believed to be the only country where the agent is mixed with water and vaporized in the air for a long period of time. Small particles are believed to have been carried in to the lungs and gotten stuck, damaging the organs.

“Some of the victims have used the sterilizers for up to 10 hours a day. Long-term exposure to the substances must have caused many deaths,” a ministry official said.

The government decided to issue the recall order and tighten its monitoring on the sterilizers. “Since they were classified as industrial products, prior authorization was unnecessary before the manufacturing stage. But we will reclassify them as quasi-drugs to establish the legal basis to put them under tight control,” Jeon Byung-yool, chief of the Korea Centers for Disease Control and Prevention, said.

The manufacturers will have to make monthly reports on the recall progress to the Korea Food and Drug Administration.

According to the health authorities, there are about 13 distributors selling humidifier-sterilizers manufactured by three companies. They produce about 600,000 units a year and the market is worth around 2 billion won ($1.8 million). Industry insiders said it was likely that the three manufacturers would cease production.

The government acknowledged a possible link between the sterilizers and lung damage in August when six deaths, including two pregnant women in Asan Medical Center, were reported.

A group representing about 1,000 people who say they have family members who have been made sick by the sterilizers claimed Friday that the actual number of deaths could reach 28. They also urged the government to seek compensation from the manufacturers for the victims and their families.

“A lung transplant costs around 100 million won. Intensive care unit expenses is about 3.5 million won every month. Even so, people die,” said Lim Jong-chan, who lost his daughter and whose wife is unconscious in an intensive care unit after contracting pneumonitis.

By Bae Ji-sook (baejisook@heraldcorp.com)