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Evaluating Occupational Health Risks Associated with Substitution of High-Level Disinfectants in Hospitals

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Evaluating Occupational Health Risks Associated with Substitution of High-Level Disinfectants in Hospitals EVALUATING OCCUPATIONAL HEALTH RISKS ASSOCIATED WITH SUBSTITUTION OF HIGH-LEVEL DISINFECTANTS IN HOSPITALS by KAREN L. RIDEOUT B.A., Wilfrid Laurier University, 1999 B.Sc. (Hons.), Mount Saint Vincent University, 1999 A THESIS SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE DEGREE OF MASTER OF SCIENCE in THE FACULTY OF GRADUATE STUDIES (School of Occupational and Environmental Hygiene) We accept this thesis as conforming to the required standard THE UNIVERSITY OF BRITISH COLUMBIA April 2003 © Karen L. Rideout, 2003 In Page 1 of 1 In presenting this thesis in partial fulfilment of the requirements for an advanced degree at the University of British Columbia, I agree that the Library shall make it freely available for reference and study. I further agree that permission for extensive copying of this thesis for scholarly purposes may be granted by the head of my department or by his or her representatives. It is understood that copying or publication of this thesis for financial gain shall not be allowed without my written permission. Department The University of British Columbia Vancouver, Canada Printed for Karen Rideout <[email protected]> 4/23/2003 ABSTRACT Glutaraldehyde, a chemical associated with respiratory illness, has been used for high-level disinfection in hospitals for 40 years. Two substitutes have recently been introduced—ortho-phthalaldehyde and a mixture of hydrogen peroxide and peracetic acid—despite limited health effects information about the products. This project used a two-tiered approach to evaluate the risks associated with substitution of high-level disinfectants. It involved predicting the relative toxic effects of all the products and assessing the current practices regarding the use of high-level disinfectants in British Columbia hospitals. Relative potential toxicities were examined based on regulatory data, a review of the published literature, and a qualitative structure-activity relationship analysis. There was no published literature and little regulatory data available for ortho- phthalaldehyde and there is no history of using ortho-phthalaldehyde solutions in any industry. Structure-activity results suggest ortho-phthalaldehyde has dermal and respiratory sensitizing potential. Although little epidemiological data was available for hydrogen peroxide or peracetic acid, structure-activity analysis results suggest little risk of sensitization. Current practices in industry were assessed using a comprehensive survey of current practices and decision processes in all hospitals in British Columbia. Of 95 hospitals, 64 returned surveys; 80% of these used high-level disinfection. Among user hospitals, 49% used glutaraldehyde only and 51% had introduced alternatives. Concern about employee health was the most common reason for substituting but was frequently not considered when choosing specific alternatives. Although occupational health and safety staff were available to 67% of user hospitals, they were involved in the decision process about the use of chemical high-level disinfectants in only 41%. Hospitals that involved occupational health, infection control, or regional staff in high-level disinfectant decisions used glutaraldehyde alternatives less frequently. In most hospitals it was difficult to find any one person knowledgeable about the use of disinfectants at the site. Despite the fact that little is known about the risks to employees from glutaraldehyde alternatives, their use is widespread. The potential risks of all high-level disinfectants are serious; thus, regulators are faced with important risk management decisions not only before introducing new chemicals, but also after they have been introduced into the workplace. TABLE OF CONTENTS Abstract ii Table of Contents iii List of Tables ix List of Figures xii List of Abbreviations xiii Acknowledgements xiv CHAPTER I. Introduction 1 1.1 Chemical Substitution for High-Level Disinfection 1 1.1.1 Project Development 1 1.1.2 Chemical Substitution 1 1.1.3 Chemical High-Level Disinfection 2 1.1.4 Chemicals Used for High-Level Disinfection 3 1.1.4.1 Glutaraldehyde 4 1.1.4.2 Ortho-phthalaldehyde (OPA) 5 1.1.4.3 Peracetic Acid-Hydrogen Peroxide 5 1.2 Strategies to Evaluate the Problem 7 1.2.1 Predicting Toxic Effects 7 1.2.2 Assessing Current Patterns of Use in the Healthcare Industry 8 1.3 Objectives 9 CHAPTER 2. Predicting Toxic Effects 10 2.1 Regulatory Processes 10 2.1.1 Objectives: Regulatory Processes Review 10 2.1.2 Background: Canadian and American Regulatory Processes 10 2.1.2.1 Canada: Therapeutic Products Directorate 10 2.1.2.2 Canada: Pest Management Regulatory Agency 11 2.1.2.3 US: Center for Devices and Radiological Health 13 2.1.2.4 US: Environmental Protection Agency 14 2.1.3 Methods: Obtaining Regulatory Testing Information 15 2.1.3.1 Access to Information in Canada,,,,,,,,, 15 2.1.3.1.1 Access to Information Requests to Health Canada for Cidex OPA® and Compliance™ 15 2.1.3.2 Freedom of Information in the United States 17 2.1.3.2.1 Freedom of Information Act Requests to the Food and Drug Administration for Cidex OPA® 18 2.1.3.2.2 Freedom of Information Requests to the Food and Drug Administration for Compliance™ 19 2.1.3.2.3 Freedom of Information Requests to the Environmental Protection Agency for Cidex OPA® 19 2.1.3.3 Regulatory Information from Manufacturers 20 2.1.3.3.1 Advanced Sterilization Products Data 20 2.1.3.3.2 Metrex Data 21 2.1.4 Results: Regulatory Toxicology Data Obtained 22 2.1.4.1 Cidex OPA® Data 22 2.1.4.1.1 Data from Regulatory Agencies 22 2.1.4.1.2 Data from Manufacturer 23 2.1.4.2 Compliance™ Data 27 2.1.4.2.1 Data from Regulatory Agencies 27 2.1.4.2.2 Data from Manufacturer 29 2.2 Comprehensive Literature Review 30 2.2.1 Literature Review Objectives 30 2.2.2 Literature Review Methods 30 2.2.3 Results of Literature Review 31 2.2.3.1 Glutaraldehyde 31 iv 2.2.3.1.1 Dermal Effects of Glutaraldehyde Exposure 31 2.2.3.1.2 Respiratory Effects of Glutaraldehyde Exposure 32 2.2.3.1.3 Glutaraldehyde Toxicology Studies 34 2.2.3.2 Ortho-phthalaldehyde (OPA) 35 2.2.3.3 Hydrogen Peroxide 36 2.2.3.3.1 Effects of Hydrogen Peroxide Ingestion 36 2.2.3.3.2 Dermal Effects of Hydrogen Peroxide Exposure 36 2.2.3.3.3 Respiratory Effects of Hydrogen Peroxide Exposure.37 2.2.3.4 Peracetic Acid 37 2.2.3.4.1 Dermal Effects of Peracetic Acid Exposure 38 2.2.3.4.2 Respiratory Effects of Peracetic Acid Exposure 38 2.3 Structure-Activity Relationship Analysis (SAR) 40 2.3.1 Use of SAR to Predict Respiratory Sensitization 40 2.3.2 SAR Objectives 42 2.3.3 SAR Methods 42 2.3.3.1 Respiratory Sensitizing Predictors 42 2.3.3.2 Chemical Asthma Hazard Assessment Program: Hazassess..45 2.3.4 Results of SAR Analysis 46 2.3.4.1 Glutaraldehyde 46 2.3.4.2 Ortho-phthalaldehyde (OPA) 47 2.3.4.3 Hydrogen Peroxide 48 2.3.4.4 Peracetic Acid 49 2.3.4.5 SAR Analysis Summary 49 2.4 Discussion of Predicted Toxic Effects 51 2.4.1 Glutaraldehyde Toxicity and Prediction of Respiratory Sensitization... 51 2.4.1.1 Glutaraldehyde Toxicity 51 2.4.1.2 Limitations of Animal Models for Predicting Respiratory Sensitization 54 2.4.2 OPA Toxicity 54 2.4.2.1 Production of OPA Vapour 54 2.4.2.2 OPA Toxicity Data 56 2.4.2.3 Structure-Activity Relationships for OPA 56 v 2.4.2.4 Tier Approach to Predicting Respiratory Sensitization Potential of OPA 58 2.4.3 Peracetic Acid and Hydrogen Peroxide CHAPTER 3. Assessing High-Level Disinfection Practices in the Healthcare Industry 3.1 Current Practices Survey Objectives 3.2 Current Practices Survey Methods 3.2.1 Preliminary Notices 3.2.2 Database Development 3.2.3 Questionnaire Development 3.2.4 Survey Implementation and Follow-up 3.2.5 Data Management and Analysis 3.2.5.1 Hospital Characteristics 3.2.5.2 Exploratory Statistical Analysis 3.3 Current Practices Survey Results 3.3.1 Survey Response and Hospital Characteristics 3.3.2 Chemicals Used for High-Level Disinfection 3.3.3 Relationships Between Hospital Characteristics and Choice of High-Level Disinfection Chemicals 3.3.4 Hospitals Using Only Glutaraldehyde for High-Level Disinfection 3.3.5 Hospitals Using Glutaraldehyde Alternatives 3.3.6 Decision Making for High-Level Disinfection 3.3.6.1 Why: Reasons for Choosing Disinfectants 3.3.6.2 How: Criteria for Choosing Specific Alternatives 3.3.6.3. Who: Decision Makers for High-Level Disinfection 3.3.7 Factors Associated with the Use of Any Alternatives 3.4 Discussion of Current Practices Survey 3.4.1 Discussion of Survey Results 3.4.2 Strengths and Limitations of the Survey Tool CHAPTER 4. Conclusions and Recommendations 98 4.1 Synthesis of Predictive Toxicology and Industry Data 98 4.2 Recommendations for Policy Makers and Hospital Decision Makers.. 100 4.2.1 Health-Based Product Recommendations 100 4.2.2 Recommendations for Decision Makers 100 4.2.3 Recommendations for Policy Makers 102 4.3 Future Work 103 References 105 Appendix I. Correspondence with Health Canada Access to Information Office 116 Appendix II. Correspondence with the Information Commissioner of Canada..137 Appendix III. Correspondence with the United States Food and Drug Administration Regarding Freedom of Information Requests for Cidex OPA® 141 Appendix IV. Toxicity Comparison Tables: Glutaraldehyde (Cidex®) vs. Ortho- phthalaldehyde (Cidex OPA®), Obtained from Freedom of Information Request to the United States Food and Drug Administration 150 Appendix V. Correspondence with the United States Food and Drug Administration Regarding Freedom of Information Request for Compliance™ 153 Appendix VI.
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