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Special Article
Evidence integration on health damage for humidifier disinfectant exposure and legal presumption of causation
Mina Ha, Taehyun Park, Jong-Hyun Lee, Younghee Kim, Jungyun Lim, Yong-Wook Baek, Sol Yu, Hyen-Mi Chung, Kyu Hyuck Chung, Hae-Kwan Cheong, Review Committee for the Epidemiological Correlations between Humidifier Disinfectants Exposure and Health Effects
Epidemiol Health. 2023;45:e2023095.   Published online October 24, 2023
DOI: https://doi.org/10.4178/epih.e2023095
  • 1,698 View
  • 118 Download
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
Inhalation exposure to humidifier disinfectants has resulted to various types of health damages in Korea. To determine the epidemiological correlation necessary for presuming the legal causation, we aimed to develop a method to synthesize the entire evidence.
METHODS
Epidemiological and toxicological studies are systematically reviewed. Target health problems are selected by criteria such as frequent complaints of claimants. Relevant epidemiologic studies are reviewed and the risk of bias and confidence level of the total evidence are evaluated. Toxicological literature reviews are conducted on three lines of evidence including hazard information, animal studies, and mechanistic studies, considering the source-to-exposure-to-outcome continuum. The confidence level of the body of evidence is then translated into the toxicological evidence levels for the causality between humidifier disinfectant exposure and health effects. Finally, the levels of epidemiological and toxicological evidence are synthesized.
RESULTS
Under the Special Act revised in 2020, if the history of exposure and the disease occurred/worsened after exposure were approved, and the epidemiological correlation between the exposure and disease was verified, the legal causation is presumed unless the company proves the evidence against it. The epidemiological correlation can be verified through epidemiological investigations, health monitoring, cohort investigations and/or toxicological studies. It is not simply as statistical association as understood in judicial precedents, but a general causation established by the evidence as a whole, i.e., through weight-of-the-evidence approach.
CONCLUSIONS
The weight-of-the-evidence approach differs from the conclusive single study approach and this systematic evidence integration can be used in presumption of causation.
Summary
Korean summary
저자들은 가습기살균제 노출로 인한 건강피해의 법적 인과관계 추정요건인 역학적 상관관계를 확인하기 위한 과정으로서 체계적 문헌고찰과 역학과 독성학의 전체 과학적 근거를 체계적으로 종합하는 방법을 제시하였다. 이것은 법적 증거 방법에서 개별 연구가 가지는 제한점이나 불확실성을 이유로 배척하지 않고, 전체 증거의 부분으로서 종합적으로 접근하는 것을 통해 사실 관계에 도달하는 방법이다. 이 전체증거접근법은 향후 인과관계 추정에서 전범(model)이 될 수 있다.
Key Message
We establish a systematic method for integrating a body of scientific evidence of epidemiology and toxicology to verify the epidemiological correlation, which is essential for presuming legal causation of health damages due to exposure to humidifier disinfectants. In terms of a legal proof, this method does not exclude individual studies due to their limitations or uncertainty but integrates them as part of a body of evidence to arrive at a conclusion that better reflects the truth of the evidence. This weight-of-the-evidence approach can be a model for future causal inference.
Original Article
A comprehensive study of deaths due to exposure to humidifier disinfectant in Korea: focusing on medical records, assessment of exposure to humidifier disinfectants, and causes of death
Yeong Jun Ju, Seungho Lee, Seungsoo Sheen, Dong-Woo Choi, Jong-Han Leem, Soon Young Lee
Epidemiol Health. 2021;43:e2021091.   Published online November 1, 2021
DOI: https://doi.org/10.4178/epih.e2021091
  • 9,264 View
  • 292 Download
  • 4 Web of Science
  • 3 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
We aimed to determine the characteristics of the deceased victims of deaths caused by exposure to humidifier disinfectants, and present the distribution of the victims’ data submitted for damage application, demographic characteristics, imaging findings, characteristics of humidifier disinfectant exposure, and distribution of the causes of death.
METHODS
An integrated database of victims was established using the medical records data of 1,413 victims submitted during the application for death damage caused by exposure to humidifier disinfectants, and the demographic characteristics, medical records, imaging findings, exposure characteristics, and cause of death were examined.
RESULTS
The average numbers of data submissions of each applicant for death damage were 3.0 medical use records. A total of 608 (43.0%) victims had more than one finding of acute, subacute, or chronic interstitial lung diseases. The average daily and cumulative use times of the victims were 14.40 and 24,645.81 hours, respectively, indicating greater exposure in this group than in the survivors. The humidifier disinfectants’ components comprised polyhexamethylene guanidine (72.8%), chloromethylisothiazolinone/methylisothiazolinone (10.5%), other components (15.0%), and oligo-[2-(2-ethoxy)-ethoxyethyl] guanidine chloride (1.5%). The components’ distribution was 67.8% for single-component use, which was higher than that in the survivors (59.8%). The distribution of the causes of death were: respiratory diseases (54.4%), neoplasms (16.8%), and circulatory diseases (6.3%). Other interstitial lung diseases (65.5%) were the most common cause of death among those who died due to respiratory diseases.
CONCLUSIONS
Careful discussions of appropriate remedies should be conducted based on a comprehensive understanding of the characteristics of the deceased victims, considering their specificities and limitations.
Summary
Korean summary
가습기 살균제 사망 피해 신청자 들 중 건강피해를 인정받지 못한 신청자들이 여전히 많이 남아있으며 (약 40%), 피해판정의 복잡성과 다양한 이슈들이 산적해 있어 사망 피해 신청자들의 적정 구제를 위해 종합적인 특성파악을 바탕으로 세심한 관점에서의 검토가 필요하다. 특히, 가습기 살균제 사망 피해 신청자의 특수성과 피해구제의 제한점을 고려하여야 하며, 기계적인 건강피해 판정을 지양하고 사망 피해 신청자 중심의 세밀한 특성 파악을 바탕으로 다양한 전문가집단이 참여하는 종합적인 논의를 통해 적정구제를 이루어 나가야 함을 제안한다.
Key Message
Careful discussions of appropriate remedies should be conducted based on a comprehensive understanding of the characteristics of the deceased victims, considering their specificities and limitations.

Citations

Citations to this article as recorded by  
  • Polyhexamethylene Guanidine Phosphate Enhanced Procoagulant Activity through Oxidative-Stress-Mediated Phosphatidylserine Exposure in Platelets
    Ju Hee Choi, Keunyoung Kim
    Toxics.2024; 12(1): 50.     CrossRef
  • Gene expression related to lung cancer altered by PHMG-p treatment in PBTE cells
    Yoon Hee Park, Sang Hoon Jeong, Hyejin Lee, Cherry Kim, Yoon Jeong Nam, Ja Young Kang, Jin Young Choi, Yu-Seon Lee, Su A. Park, Jaeyoung Kim, Eun-Kee Park, Yong-Wook Baek, Hong Lee, Ju-Han Lee
    Molecular & Cellular Toxicology.2023; 19(1): 205.     CrossRef
  • Health Effects Associated With Humidifier Disinfectant Use: A Systematic Review for Exploration
    Ji-Hun Song, Joonho Ahn, Min Young Park, Jaeyoung Park, Yu Min Lee, Jun-Pyo Myong, Jung-Wan Koo, Jongin Lee
    Journal of Korean Medical Science.2022;[Epub]     CrossRef
Brief Communication
Evaluation report on the causal association between humidifier disinfectants and lung injury
Mina Ha, Soon Young Lee, Seung-sik Hwang, Hyesook Park, Seungsoo Sheen, Hae Kwan Cheong, Bo Youl Choi
Epidemiol Health. 2016;38:e2016037.   Published online August 18, 2016
DOI: https://doi.org/10.4178/epih.e2016037
  • 21,322 View
  • 515 Download
  • 6 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
OBJECTIVES
As of November 2011, the Korean government recalled and banned humidifier disinfectants (HDs) from the market, because four case-control studies and one retrospective epidemiological study proved the association between HDs and lung injury of unknown cause. The report reviewed the causal role of HDs in lung injury based on scientific evidences.
METHODS
A careful examination on the association between the HDs and lung injury was based on the criteria of causality inference by Hill and the US Surgeon General Expert Committee.
RESULTS
We found that all the evidences on the causality fulfilled the criteria (strength of association, consistency, specificity, temporality, biologic gradient, plausibility, coherence, experiment, analogy, consideration of alternative explanations, and cessation of exposure), which proved the unknown cause lung injury reported in 2011 was caused by the HDs. In particular, there was no single reported case of lung injury since the ban in selling HDs in November 2011 as well as before the HDs were sold in markets.
CONCLUSIONS
Although only a few epidemiological studies in Korea have evaluated the association between lung injury and the use of HDs, those studies contributed to proving the strong association between the use of the HDs and lung injury, based on scientific evidence.
Summary
Korean summary
본 논문에서는 Hill의 기준과 US Surgeon General 전문위원회에서 제시하는 기준에 근거하여 가습기살균제와 폐손상과의 인과성을 검토하였다. 검토결과, 11개 조건(관련성의 강도, 일관성, 특이성, 시간적 선후관계, 생물학적 용량-반응 관계, 개연성, 기존 지식과의 일치성, 실험, 유사성, 다른 가능한 해석에 대한 고려 및 노출의 중단) 을 모두 충족함을 확인하므로 써, 2011년 발생한 원인미상 폐손상의 원인이 가습기살균제 노출로 인한 것임을 알 수 있었다. 무엇보다도 가습기살균제 시판 전에는 원인미상 폐손상이 보고된 바가 없었고, 2011년 11월 가습기살균제 판매중지 이후 폐손상이 한 건도 발생하지 않은 것은 원인미상의 폐손상이 가습기살균제로 인한 것임을 강력하게 지지하는 것으로 판단된다.

Citations

Citations to this article as recorded by  
  • New-Onset and Exacerbation of Lung Diseases after Short-Term Exposures to Humidifier Disinfectant during Hospitalization
    Seula Lee, Kyunghee Han, Jeonggyo Yoon, Eun-Kyung Jo, Wonho Yang, Yoon-Hyeong Choi
    Toxics.2022; 10(7): 371.     CrossRef
  • Characterizing Subjects Exposed to Humidifier Disinfectants Using Computed-Tomography-Based Latent Traits: A Deep Learning Approach
    Frank Li, Jiwoong Choi, Xuan Zhang, Prathish K. Rajaraman, Chang-Hyun Lee, Hongseok Ko, Kum-Ju Chae, Eun-Kee Park, Alejandro P. Comellas, Eric A. Hoffman, Ching-Long Lin
    International Journal of Environmental Research and Public Health.2022; 19(19): 11894.     CrossRef
  • Physical analysis reveals distinct responses of human bronchial epithelial cells to guanidine and isothiazolinone biocides
    Tae Yoon Kwon, Jaeseong Jeong, Eunyoung Park, Youngbin Cho, Dongyoung Lim, Ung Hyun Ko, Jennifer H. Shin, Jinhee Choi
    Toxicology and Applied Pharmacology.2021; 424: 115589.     CrossRef
  • Need for individual-based evaluation to determine the association between humidifier disinfectants and health injuries
    Hyeong-Cheol Kim, Hyunil Kim, Eun-Chan Mun, Yesung Lee, Soyoung Park
    Annals of Occupational and Environmental Medicine.2021;[Epub]     CrossRef
  • Strength of Association. Report 1. Graduations of Relative Risk
    А. Котеров, A. Koterov, Л. Ушенкова, L. Ushenkova, Э. Зубенкова, E. Zubenkova, А. Вайнсон, A. Vaynson, М. Калинина, M. Kalinina, А. Бирюков, A. Biryukov
    Medical Radiology and radiation safety.2019; : 5.     CrossRef
  • Causal inference in environmental epidemiology
    Sanghyuk Bae, Hwan-Cheol Kim, Byeongjin Ye, Won-Jun Choi, Young-Seoub Hong, Mina Ha
    Environmental Health and Toxicology.2017; 32: e2017015.     CrossRef
Epidemiologic Investigation
Epidemiologic research on lung damage caused by humidifier disinfectants
Moo-Song Lee, Hwa Jung Kim
Epidemiol Health. 2016;38:e2016031.   Published online July 20, 2016
DOI: https://doi.org/10.4178/epih.e2016031
  • 15,890 View
  • 276 Download
  • 4 Web of Science
  • 4 Crossref
AbstractAbstract AbstractSummary PDFSupplementary Material
Abstract
In April 2011 a tertiary hospital located in Seoul, Korea reported several cases of severe respiratory distress of unknown origin in young adults. To find the route of transmission, causative agent and patient risk factors of the outbreak, an investigation of the epidemic was initiated. A hospital based case-control study was conducted to indicate that humidifier detergent use was the cause of the outbreak. This information led the Ministry of Health and Welfare of Korea issued an order that humidifier detergents should be withdrawn from the market. Here, we describe the major events of planning, execution, and interpretation of the study, and discussions between researchers and public authorities following the decision to perform an epidemiologic study, chronologically.
Summary
Korean summary
본 역학조사는 일개 병원에서 신고한 질병 유행에 대해 다학제적 연구 결과로써, 질병의 임상적 특성과 역학적 원인 파악 후 정책적 대책으로 이어진 사례이다. 향후 가습기 살균제 이외에도 일반국민의 건강에 영향을 미칠 수 있는 다양한 생활환경요인에 관심을 가지고, 필요 시 적극적인 조사와 대응이 필요할 것이다.

Citations

Citations to this article as recorded by  
  • Evaluation of polyhexamethylene guanidine-induced lung injuries by chest CT, pathologic examination, and RNA sequencing in a rat model
    Cherry Kim, Sang Hoon Jeong, Jaeyoung Kim, Ki Yeol Lee, Jaehyung Cha, Chang Hyun Lee, Eun-Kee Park, Ju-Han Lee
    Scientific Reports.2021;[Epub]     CrossRef
  • Comparison of Long Term Follow-up Chest CT Imaging in Adult and Pediatric Patients with Humidifier Disinfectant-related Lung Injury
    Soyeoun Lim, Jong Han Leem, Young-Seoub Hong, Jungwon Kim, Soyoung Park, Joon-Sung Joh, Woon-Jung Kwon, Yangho Kim
    Journal of Korean Medical Science.2020;[Epub]     CrossRef
  • Guanidine-based disinfectants, polyhexamethylene guanidine-phosphate (PHMG-P), polyhexamethylene biguanide (PHMB), and oligo(2-(2-ethoxy)ethoxyethyl guanidinium chloride (PGH) induced epithelial-mesenchymal transition in A549 alveolar epithelial cells
    Yong Joo Park, Mi Ho Jeong, In Jae Bang, Ha Ryong Kim, Kyu Hyuck Chung
    Inhalation Toxicology.2019; 31(4): 161.     CrossRef
  • Development of QSAR Model for Subchronic Inhalation Toxicity Using Random Forest Regression Method
    Jae Hong Shin, Byeong Hun Lee, Sung Kwang Lee
    Bulletin of the Korean Chemical Society.2019; 40(8): 819.     CrossRef

Epidemiol Health : Epidemiology and Health