Best Practices for the Safe Use of Glutaraldehyde in ...

1 Practices for the Safe Use of Glutaraldehyde in Health CareOSHA 3258-08N 2006 Employers are responsible for providing a safe andhealthful workplace for their employees. osha srole is to assure the safety and health of America semployees by setting and enforcing standards;providing training, outreach and education; estab-lishing partnerships; and encouraging continualimprovement in workplace safety and health. This handbook provides a general overview of aparticular topic related to osha standards. It doesnot alter or determine compliance responsibilities inOSHA standards or the Occupational Safety andHealth Act of 1970. Because interpretations and en-forcement policy may change over time, you shouldconsult current osha administrative interpretationsand decisions by the Occupational Safety and HealthReview Commission and the Courts for additionalguidance on osha compliance publication is in the public domain and may bereproduced, fully or partially, without credit is requested but not information is available to sensory impairedindividuals upon request.

2 Voice phone: (202) 693-1999; teletypewriter (TTY) number: (877) Department of LaborOccupational Safety and Health AdministrationOSHA 3258-08N2006 Best Practices for the Safe Use ofGlutaraldehyde in Health Care2 ContentsIntroduction .. 4 Summary of Health Effects .. 4 Occupational Exposure Limits for Glutaraldehyde .. 6 Glutaraldehyde USE AS A HIGH-LEVEL DISINFECTANT .. 6 Engineering Controls .. 10 Alternatives to Glutaraldehyde for High-Level Disinfection .. 17 Glutaraldehyde USE AS A TISSUE FIXATIVE .. 18 Glutaraldehyde USE IN X-RAY PROCESSING .. 20 GENERAL RECOMMENDATIONS APPLICABLE TO ALL USES OF Glutaraldehyde IN HEALTH CARE .. 23 Additional Resources .. 32 osha Assistance .. 38 osha Regional Offices .. 43 This best Practices booklet is not a standard or regulation, and it creates no new legal obligations. The document is advisory innature, informational in content, and is intended to assistemployers in providing a safe and healthful workplace.

3 TheOccupational Safety and Health Act(OSH Act) requires employersto comply with hazard-specific safety and health standards. Inaddition, pursuant to Section 5(a)(1), the General Duty Clause ofthe Act, employers must provide their employees with a workplacefree from recognized hazards likely to cause death or seriousphysical harm. Employers can be cited for violating the GeneralDuty Clause if there is a recognized hazard and they do not takereasonable steps to prevent or abate the hazard. However, failureto implement these recommendations is not, in itself, a violation ofthe General Duty Clause. Citations can only be based on standards,regulations, and the General Duty Clause. osha standards that mayapply in exposure scenarios similar tothose described in this publication include Hazard Communication(29 CFR ) and Personal Protective Equipment, GeneralRequirements (29 CFR ); Eye and Face Protection (29 CFR ); Respiratory Protection (29 CFR ); andHazardous Waste Operations and Emergency Response (29 (q)).

4 Scenarios where these osha standards may apply areidentified in the text of this of any company or product is for informationalpurposes only and does not constitute an endorsement by document describes best Practices for the safe use of glu-taraldehyde in health care facilities. Glutaraldehyde is used widelyas a cold sterilant to disinfect a variety of heat-sensitiveinstruments, such as endoscopes, bronchoscopes, and dialysisequipment (NIOSH, 2001). In addition, health care employeesmay be exposed to Glutaraldehyde in its uses as a hardener in x-raydeveloping and as a tissue fixative in histology and pathology labs. Glutaraldehyde s properties as a chemical sterilant were initiallyrecognized in the early 1960s as the health care industry searchedfor a safer alternative to formaldehyde, which is regulated by OSHAas a carcinogen (29 CFR ). In the years since its introduc-tion as a disinfectant/sterilant, Glutaraldehyde has been linked witha variety of health effects ranging from mild to severe includingasthma, breathing difficulties, respiratory irritation, and skin rashes(Pryor, 1984; Crandall, 1987).

5 The purpose of this document is to provide information that canbe used by health care employers and employees to understandand control exposures to Glutaraldehyde . This document describesengineering controls, work Practices , and facility design considera-tions that will help reduce employee exposure to document also includes recommendations for personalprotective equipment, employee training, exposure monitoring,disposal Practices , and spill and cleanup procedures. The use ofalternatives to Glutaraldehyde is also addressed. Note: The term health care facilities is intended to encompassthe broad range of health care facility types and sizes, includinghospitals, clinics, freestanding surgical centers, physician offices,and dental clinics, as well as nursing homes and other residentialhealth care of Health Effects The most serious adverse health effect documented amongemployees exposed to Glutaraldehyde vapor is occupational4asthma, a chronic condition characterized by bronchial hyperre-sponsiveness.

6 Reactions can be either immediate or delayed, witha latent period ranging from a few weeks to several years fromthe onset of exposure. Human studies on the effects of glu-taraldehyde exposure consist of many case reports in thepublished literature, some identified by both American and Britishhealth surveillance systems, and symptom surveys of Americanhealth care employees, all of which document an associationbetween exposure to Glutaraldehyde and the development ofasthma. (Gannon et al., 1995; Rosenman et al., 1997; Keynes et al.,1996; Di Stefano et al., 1999). In addition, a few cross-sectional studies also show that anincreased prevalence of irritant symptoms, including itching of theeyes with increased lacrimation (tearing), and rhinitis, is reportedby health care employees who are exposed to short-term (15-minute) concentrations well below parts-per-million (ppm) inair, predominantly in the range of about to ppm(Norback, 1988; Pisaniello et al.)

7 , 1995). In addition to causing respiratory effects, Glutaraldehyde acts asa contact allergen, giving rise to contact dermatitis, usually on thehands but occasionally on the face. Skin sensitization from contactwith Glutaraldehyde has been documented in endoscopy nurses,dental assistants, x-ray technicians, hospital maintenance andcleaning staff, and funeral service employees (Marzulli andMaibach, 1974; Fowler, 1989; Nethercott et al., 1988; Maibach andPrystowsky, 1977; Nethercott and Holness, 1988; Ballantyne andBerman, 1984; Waters et al., 2003). Individuals who have becomesensitized to Glutaraldehyde can develop dermatitis aftercontacting solutions containing as little as percent glutaralde-hyde. In contrast, simple skin irritation typically occurs oncontact with solutions containing more than 2 percent glutaralde-hyde (HSE, 1997). In one study of health care employees who haddeveloped allergic contact dermatitis from Glutaraldehyde , tenemployees who were followed for six months after initial diagnosiscontinued to have persistent hand eczema, although five of theseemployees had left their jobs because of this health problem(Nethercott et al.

8 , 1988).5 Occupational Exposure Limitsfor GlutaraldehydeThe Federal Occupational Safety and Health Administration( osha ) does not have a Permissible Exposure Limit for glutaralde-hyde. The National Institute for Occupational Safety and Health(NIOSH) established a Recommended Exposure Limit (REL) of in 1989 ( ). Otherorganizations that have occupational exposure limits include theAmerican Conference of Governmental Industrial Hygienists (ACGIH),which currently recommends a Threshold Limit Value (TLV) of in air, measured as a ceiling concentration, and the UnitedKingdom Health and Safety Executive which also has establisheda ppm Workplace Exposure Limit (WEL) averaged over both 8hours and 15 occupational exposure limits discussed above were currentat the time this document was published. However, it is essentialthat health care personnel keep informed of current Federal, state,and local regulations applicable to Glutaraldehyde , as well as withprofessional USE ASA HIGH-LEVEL DISINFECTANTP rimary Sources of Glutaraldehyde ExposureGlutaraldehyde-based agents are used to disinfect medicalequipment that cannot be subjected to steam sterilization, specifi-cally heat-sensitive, lensed devices typically requiring high-leveldisinfection between patient uses (ANSI/AAMI, 1996).

9 Glutaraldehyde -based products may be used in a variety oflocations within a facility, such as surgery, endoscopy, andrespiratory therapy. Trade names of Glutaraldehyde -basedproducts include, but are not limited to, Cidex , Sonacide ,Sporicidin , Hospex , and Omnicide (NIOSH, 2001).6 Definitions:Sterilant: Physical or chemical agent(s) or process whichcompletely eliminates or destroys all forms of life, : An agent that destroys pathogens by physical orchemical means. Disinfection processes do not ensure the samemargin of safety associated with sterilization processes and canvary in their extent of microorganism elimination. This variationleads to subcategories, the first of which is high-level Disinfection: A process utilizing a sterilant under lessthan sterilizing conditions. The process kills all forms of microbiallife except for large numbers of bacterial activities range from simple soaking of smallinstruments to automated processing of complex lensed instru-ments, such as endoscopes.

10 Exposure to Glutaraldehyde as a high-level disinfectant occurs primarily during the following activities: activating and pouring Glutaraldehyde solution into or out of acleaning container system ( , soaking basin in manual disin-fecting operations and reservoir in automated processors); opening the cleaning container system to immerse instrumentsto be disinfected; agitating Glutaraldehyde solution; handling of soaked instruments; removing instruments from the container system; rinsing the channels of instruments containing residual glu-taraldehyde solution; flushing out instrument parts with a syringe; drying instrument interiors with compressed air; disposing of spent Glutaraldehyde solutions to the sanitarysewer; performing maintenance procedures, such as filter or hosechanges on automated processors that have not been pre-rinsedwith of health care employee exposure to glutaralde-hyde vapor during high-level disinfection have been reported to7range from none detected to ppm or greater (Naidu et al.)