Figure 1: Classifications


The Bloodborne Pathogens Standard and Disinfection

By Tom Bach

Hepatits B Virus (HBV) and Human Immunodeficiency Virus (HIV) are two significantbloodborne pathogens that are of concern to healthcare staff when using a hospitaldisinfectant to clean up a blood or other potentially infectious material (OPIM) spillaccording to the OSHA Bloodborne Pathogens Standard (29CFR 1910.1030) or when evaluatingan appropriate liquid chemical germicide (LCG) to high-level disinfect heat-sensitivemedical devices.

This OSHA Standard, originally published in the Federal Register on December 6, 1991,with an effective date of March 6, 1992, is designed to protect employees from contractinga bloodborne disease during the performance of their normal job duties. Due to the broaddefinitions within the standard, by design, workers that may come in contact with thesebody fluids may include police officers, first-aid responders, dental personnel,laboratory technicians, funeral directors, nurses, and GI personnel. This list is by nomeans all-inclusive. This Federal Standard1 covers numerous compliance subjectsincluding, but not limited to, the following:

  • Definition of the standard

  • Definitions of the numerous terms used within the standard

  • Requirements of a written Exposure Control Plan

  • Exposure determination

  • Initial and annual follow-up training requirements

  • HBV vaccination

  • Engineering controls, i.e., sharps containers

  • Definition of occupational exposure

  • Housekeeping and decontamination requirements

  • Record keeping requirements

Although issued more than eight years ago, this standard continues to involve numerousman-hours by many business entities to maintain proper compliance with a standard whosegoal is the protection of employees from contracting HBV or HIV via the normal performanceof their job.

To keep the standard current, OSHA has revised the Compliance Directive (November 5,1999) to the original standard that includes some key revisions. These revisions includethe following:

  • Annual review of the employer's Exposure Control Plan--allows for improvements to protect employees by using safer medical devices.

  • Engineering Controls and Work Practices--stresses the use of effective controls to include safer devices, improved work practices, and more efficient personal protective equipment.

  • Multi-Employer Worksites--focuses on healthcare employment agencies.

  • HBV Vaccinations--adds the latest CDC guidelines on vaccinations, post-exposure evaluation, and follow-up.

  • Training--stresses effective training, including "interactive" training rather than static review of films or videos.

Occupational exposure can result from any number of sources including human,environmental surfaces, medical devices, and related equipment. Human-to-human exposure isreduced through a common sense approach to Universal Precautions.2 AlthoughBody Substance Isolation is noted within the standard, most professionals follow UniversalPrecautions including gloves, gowns, and face protection.

Universal Precautions mandate personal protection against disease based on the premisethat all human body fluids and all patients are assumed to be contaminated.

Engineering controls include appropriately placed sharps containers, biohazardidentification, segregation, and handling. Additional controls include isolation areaventilation requirements, regulated waste containers, handwashing facilities, andappropriate gloves, gowns, and face protection. Again, this list is not all-inclusive, andthe only means of understanding this comprehensive standard is to take the necessary timeto read it thoroughly. Housekeeping applies to any person who is cleaning up a blood orOPIM spill and the procedures required to ensure that a surface to be cleaned anddecontaminated is essentially free of infectious contaminants. Whether cleaning ERsurfaces or decontaminating a flexible endoscope, the principal of rendering the surfacefree of organic soil and related infectious organisms is the same.

Within a large hospital, the list of employees that must be covered under the standardcan be enormous. With the exception of training requirements specific to any onedepartment, the general training and offering of the HBV vaccine is the same. It is thespecific handling of medical devices, equipment, linens, etc., that can result invariations to the written Exposure Control Plans that must be prepared.

A copy of the complete standard can be obtained by contacting the local OSHA office.The listings can be found in any phone book under the US Government heading, Department ofLabor.

Because of the threat of HBV and HIV transmission in blood, healthcare professionalsare looking for information and guidance regarding the proper treatment of instruments andsurfaces to ensure that these pathogens and others are inactivated.

Currently, there are no readily available practical methods for testing a disinfectantagainst HBV since this organism cannot be grown in a typical lab culture. No methodscurrently exist for evaluation of a disinfectant against HCV. HIV is considered to be veryfragile outside the human body and is relatively easy to inactivate by cleaning anddisinfecting. The only approved method that exists to evaluate a disinfectant against HBVinvolves the use of live primates and puts these animals at risk for contractinghepatitis. The US Environmental Protection Agency (EPA) is currently evaluating methodsthat will use surrogate viruses, closely related to human HBV for predicting the efficacyof disinfectant products against this virus. These methods will be used to generateacceptable claims and will ultimately require validation to maintain these claims.

Although data have not yet been generated, based on practical scientific knowledge andthe epidemiology of microorganisms, one can deduct that based upon a product's efficacyagainst higher organisms, as evident by the Spaulding Classification 3 (Figure 1),that it will effectively inactivate both HBV and HCV. This rationale is predicated uponefficacy data against Mycobacterium tuberculosis. Dr. Earle Spaulding of TempleUniversity (Philadelphia, Pa), originally presented the Spaulding classification to themedical community in a 1939 paper on the disinfection of surgical instruments in achemical solution. Due to his extensive study of disinfection and sterilization of medicalinstruments, Spaulding further refined his classification of appropriate treatment ofmedical devices based upon how a device is used. Chemical disinfection was classified aslow level, high level, and sterilization based upon whether a device contacted intactskin, mucous membranes, or was introduced into the sterile cavity of the body.

According to scientific knowledge of a microorganism's resistance to disinfection,there is a hierarchy of susceptibility to the cidal effects of disinfectants. Adisinfectant's strength must match the decontamination requirements of a medical device,depending on its contact with external or internal (sterile) parts of the body or forsurfaces exposed to blood or OPIM under the OSHA Standard. This is the rationale for theSpaulding classification. Figure 2 represents the descending order of the susceptibilityof various microorganisms to disinfection as associated with the Spaulding classification.It is important to note that HBV falls under low-level disinfection while TB falls underintermediate-level disinfection.

After much industry and end-user debate and confusion, OSHA provided clarification thatnarrowed the scope of products claiming HBV efficacy to cleaning surfaces known to becontaminated only with HBV and/or HIV (for example, as in a research setting).4According to OSHA recommendations, "when bloodborne pathogens other than HBV or HIVare of concern, OSHA continues to require the use of EPA-registered tuberculocidaldisinfectants." This letter of clarification relates to surface disinfection only anddoes not apply to cleaning and reprocessing medical devices.

Although this OSHA clarification addresses the use of disinfectants on environmentalsurfaces, the principal of a product's germicidal strength based on its ability to kill TBapplies to both disinfectants regulated by EPA and liquid chemical germicides regulated bythe FDA. Reprocessing a medical device involves both meticulous cleaning and high-leveldisinfection of many small intricate surfaces both internal and external. It is thecombination of meticulous cleaning, rinsing, and drying followed by high-leveldisinfection that renders the device safe for reuse.5 Isn't it the goal of theInfection Control Practitioner as well as the GI Nurse, Reprocessing Technician, andEnvironmental Services Technician to ensure that the "surfaces" that theemployees, patients, and visitors contact are appropriately cleaned and decontaminated?

Tom Bach is the Technical Service Manager for Reckitt Benckiser Professional,Reckitt Benckiser North America (Wayne, NJ). The company is the manufacturer of the LysolIC and Professional Lysol Brands of Infection Control Products and programs that supportclean and healthy environments.

1. Federal Register. Vol. 56, No. 235. Friday December 6, 1991, Part 1910.1030.(Amended).
2. Occupational Safety and Health Administration. Occupational exposure to bloodborne pathogens: final rule. Federal Register. 1991; 56:64003-182.
3. Alvarado CJ. Revisiting the Spaulding classification scheme. In: Chemical Germicides in Healthcare. William A. Rutala ed. Washington, DC: APIC; 1994:203-208.
4. McCull R. Occupational Safety & Health Administration. Health Compliance Assistance Office: Interpretation and Compliance Letters. The OSHA policy on the use of disinfectants that are registered with the EPA as being effective against HBV and HCV. September 24, 1996.
5. Society of Gastroenterology Nurses and Associates, Inc. Endoscope Cleaning and High-Level Disinfection, Self-Study Module. SGNA Practice Committee; 1996.

Figure 1: Classifications

Body Contact
Disinfection Requirements
FDA Device Class
intact skin
low level
mucous membranes
high level
sterile body cavity

For a complete list of references click here

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