Medical/Biomedical/ Infectious Waste Management OBJECTIVES At completion of this chapter, the student should: • Be familiar with the hazards associated with the traditional “red bag wastes,” methods to minimize the hazards, and current criteria for man- aging the wastes. • Be familiar with the traditional sanitarian approach to biomedical waste management and the impacts of the AIDS epidemic and the 1988 beach washups on the Atlantic seaboard. • Understand the regulatory approach of the Subtitle J regulations (40 CFR 259) and the use of the tracking form. • Be familiar with regulatory developments and trends which are reordering options for management of medical/biomedical/infectious wastes. INTRODUCTION For many years, health care workers, hospital administrators, military sanitarians, and other health-related professionals have understood the necessity to protect them- selves, their employees/members, and the public from exposure to wastes that might be reservoirs of disease-transmitting organisms. Local ordinances, state and military regulations, and guidelines issued by federal agencies and professional organizations developed around a few simple practices and vice versa. These practices generally included “red-bagging” the solid wastes 1 and isolating them in cool storage, followed by incineration or sterilization and landfilling. The 1976 enactment of the Resource Conservation and Recovery Act (RCRA) included a definition of hazardous waste which continues as a basis for federal regulation of infectious waste management: 1 The practice of disposing of medical wastes in bright red plastic bags, which distinguish the contents as being distinct from other wastes. 12 L1533_frame_C12 Page 309 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC (5) The term “hazardous waste” means a solid waste or combination of solid wastes, which because of its quantity, concentration, or physical, chemical or infectious char- acteristics may — (A) cause, or significantly contribute to an increase in mortality or an increase in serious irreversible, or incapacitating reversible, illness; or (B) pose a substantial present or potential hazard to human health or the environment when improperly treated, stored, transported, or disposed of, or otherwise managed (42 USC 6903). In 1978, the EPA published proposed regulations for hazardous waste manage- ment, which included several classifications of infectious waste. However, the agency did not make a convincing case for the supposed health hazards posed by these wastes and did not include them in the final hazardous waste regulations. By 1982, the EPA had not promulgated regulations specific to the management of infectious wastes; state and local regulations ranged from nonexistent to overly complex and conflicting; and the agency was under pressure to provide guidance. The agency published the Draft Manual for Infectious Waste Management and, in 1986, published the final version — EPA Guide to Infectious Waste Management. We will borrow heavily from the 1986 Guide in this chapter. This quiet evolution ended with the nation’s growing alarm toward the Acquired Immunodeficiency Syndrome (AIDS) epidemic. Truths, half-truths, and blatant untruths regarding modes of transmission of the Human Immunodeficiency Virus (HIV) caused near panic among some health care workers, in particular, and among the public, in general. Suddenly, landfills began refusing hospital wastes, health care workers began red-bagging “ everything ,” small medical waste incinerators were overwhelmed, and management of infectious waste became a major problem. 2,3 In May 1988, a garbage slick nearly 1 mi long, surfaced along the Ocean County shore of New Jersey. Needles, syringes, and empty prescription bottles with New York addresses washed up on the shore; 6 weeks later, 10 mi of Long Island beaches closed when medical wastes washed ashore. Throughout the summer of 1988, beaches from Maine to the Gulf of Mexico, along the Great Lakes, and elsewhere experienced washups of medical wastes (Office of Technology Assessment 1988, p. 1). In a similarly disturbing incident, children were found playing with vials of blood they had found in a dumpster (Ostler 1998). Public and congressional outrage over the closure of beaches and perceived health threats brought about enactment in November 1988 of RCRA Subtitle J, the hastily conceived Medical Waste Tracking Act (MWTA). The EPA rushed the imple- menting regulations into place in March 1989, reflecting Congress’ hope that their 2 This trend abated after some time, but the damage was done. The alarmed reaction among health care workers resulted in large amounts of plastic and paper items being committed to destruction in small incinerators at a time when hospital and municipal waste incineration was generating concern because of emissions of dioxins and furans. The plastics and chlorine-bleached paper were significant sources of these emissions. 3 In the U.S., the amount (of hospital waste) generated daily is estimated to be between 5 and 7 kg per patient per day, while in Italy, reported amounts are beween 3 and 5 kgs per patient per day (Giroletti and Lodola 1994, p. 161). L1533_frame_C12 Page 310 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC impact would prevent beach washups during the summer of 1989 (adapted from Jenkins 1990, p. 55). The EPA promulgated Subtitle J regulations which were patterned after the RCRA Subtitle C regulations and codified at 40 CFR 259. The regulations included the following elements: •“Medical Waste” Definition: Medical waste is any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals in related research, biologicals production, or testing. • Medical Waste Generator Requirements: Generators were defined as pro- ducers of more than 50 lb of regulated medical waste monthly, managed by shipping off-site. Generators were required to separate, package, label, mark, and track waste according to the regulation. • Medical Waste Transporter Requirements: Transporters submitted a one- time notification to EPA headquarters, which then issued a medical waste identification number. The ID number was to be used on all tracking forms and reports. Transporters were also required to follow rules regarding transport vehicles; ensure that wastes were properly packaged, labeled, and marked; and comply with rules for tracking, record keeping, and reporting of waste shipments. • Medical Waste Treatment, Destruction, and Disposal Facility Require- ments: These facilities included incinerators, landfills, and treatment oper- ations that grind, steam sterilize, or treat wastes with disinfectants, heat, or radiation. These practices were prescribed, defined, and implemented in similarity to the 1986 Guide. Subtitle J instructed EPA to develop a 2-year demonstration program to track medical waste in the participating states and to report back to Congress upon com- pletion of the program. Connecticut, New Jersey, New York, and Rhode Island, as well as Puerto Rico, opted to participate. The EPA rendered interim reports in May and December 1990. The latter, EPA 530-SW-90-087B, offers no conclusions regard- ing effectiveness of the program, and the EPA has published no further evaluation. The program was completed in 1991, and Congress has shown little enthusiasm for an expanded or continued program. The focus for medical waste management regu- latory programs has thus reverted to state and local governments. Available guidance includes the 1986 EPA Guide and the more recent “white paper” published by the Journal of the Air and Waste Management Association , which will also be quoted herein ( see also: Reinhardt and Gordon 1991; Drum and Bulley 1994; Turnberg 1996). MWTA and the 40 CFR 259 Regulations were widely recognized as having minimal effect on the beach washup of medical waste. It was an effort to “do something” about the burgeoning problem of medical waste management and to gather data on the effectiveness of a tracking system patterned somewhat after the “cradle-to-grave” management system for hazardous wastes. L1533_frame_C12 Page 311 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC D EFINITION AND C HARACTERIZATION OF M EDICAL W ASTE Disagreement exists between governments, agencies, and practitioners regarding the meanings of the terms “infectious waste” and “medical waste.” To avoid unproduc- tively dwelling upon this confusion, we briefly point out the terms used and some indication of their usage. We then adopt a convention for use in this text. Infectious Waste In the 1986 guidance document, the EPA defines infectious waste as waste capable of producing an infectious disease. This definition requires a consideration of certain factors necessary for induction of disease. These factors include • Presence of a pathogen of sufficient virulence • Dose • Portal of entry • Resistance of host Thus, for a waste to be infectious, it must contain pathogens with sufficient virulence and quantity so that exposure to the waste by a susceptible host could result in an infectious disease. The EPA further recommends categories of waste be designated as infectious waste, as summarized in Table 12.1. In addition, the EPA has identified an optional infectious waste category which consists of miscellaneous contaminated wastes. The suggestion is that a qualified person or committee should decide whether or not to handle these wastes as “infec- tious” in specific situations. The optional categories and examples are listed in Table 12.2. The terminology problem is further complicated by the fact that the terms infectious, pathological, biomedical, biohazardous, toxic, and medically hazardous have all been used to describe infectious waste. Medical Waste Medical wastes include all infectious waste, hazardous (including low-level radio- active wastes) wastes, and any other wastes that are generated from all types of health care institutions, including hospitals, clinics, doctor (including dental and veterinary) offices, and medical laboratories (Office of Technology Assessment 1988, p. 3). The terminology confusion is worsened by the EPA’s definition of “medical waste” in 40 CFR 259.10 as any solid waste that is generated in the diagnosis, treatment, or immunization of human beings or animals in related research, biolog- icals production, or testing. In the Subpart J regulations, the EPA also defined Regulated Medical Wastes as a subset of all medical wastes and included seven distinct categories: • Cultures and stocks of infectious agents • Human pathological wastes (e.g., tissues, body parts) • Human blood and blood products L1533_frame_C12 Page 312 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC TABLE 12.1 Categories of Infectious Wastes Waste Category Examples a Isolation wastes Wastes generated by hospitalized patients who are isolated to protect others from communicable diseases Cultures and stocks of infectious agents Specimens from medical and pathology agents and associated biologicals laboratories Cultures and stocks of infectious agents from clinical, research, and industrial laboratories; disposable culture dishes and devices used to transfer, inoculate, and mix cultures Waste from production of biologicals Discarded live and attenuated vaccines Human blood and blood products Waste blood, serum, plasma, and blood products Pathological waste Tissues, organs, body parts, blood, and body fluids removed during surgery, autopsy, and biopsy Contaminated sharps b Contaminated hypodermic needles, syringes, scalpel blades, Pasteur pipettes, and broken glass Contaminated animal carcasses, body parts, and bedding c Contaminated animal carcasses, body parts, or bedding of animals that were intentionally exposed to pathogens a These materials are examples of wastes covered by each category. The categories are not limited to these materials. ( Source: EPA 530-SW-86-014.) b Note: Unused sharps that have been improperly managed or discarded should be managed as if contaminated. Both used and unused sharps present the same potential for puncture injuries; testing of improperly disposed sharps to determine the presence of infectious agents is impractical; unused sharps present the same aesthetic degradation of the environment as do used sharps. ( See: Reinhardt and Gordon 1991, pp. 37–38.) c The descriptor “contaminated” may be superfluous — many landfill authorities do not accept such parts whether exposed/contaminated or not. TABLE 12.2 Miscellaneous Contaminated Wastes Miscellaneous Contaminated Wastes Examples Wastes from surgery and autopsy Soiled dressings, sponges, drapes, lavage tubes, drainage sets, underpads, and surgical gloves Miscellaneous laboratory wastes Specimen containers, slides and cover slips, disposable gloves, lab coats, and aprons Dialysis unit wastes Tubing, filters, disposable sheets, towels, gloves, aprons, and lab coats Contaminated equipment Equipment used in patient care, medical laboratories, research, and in the production and testing of certain pharmaceuticals Source: EPA 530-SW-86-014. L1533_frame_C12 Page 313 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC • Sharps (e.g., hypodermic needles and syringes used in animal or patient care) • Certain animal wastes • Certain isolation wastes (e.g., wastes from patients with highly commu- nicable diseases) • Unused sharps (e.g., suture needles, scalpel blades, hypodermic needles) The similarities between “infectious wastes” as listed in the 1986 Guide and “regulated medical wastes” as listed in 40 CFR 259.10 are obvious. The relevance of the “regulated medical waste” definition is doubtful unless the Subpart J program is resurrected. 4 In hope of some consistency, we will confine the discussion in this chapter to “infectious wastes” except where referenced material makes use of an alternate ( see also : Office of Technology Assessment 1988, Chapter 1; EPA 1990, 625-7-90-009, Section 2). I NFECTIOUS W ASTE M ANAGEMENT The objectives of an effective infectious waste management program should be to provide protection to human health and the environment from hazards posed by the waste. Proper management ensures that infectious waste is handled in accordance with established procedures from the time of generation through treatment of the waste (to render it noninfectious and unrecognizable) and its ultimate disposal. An infectious waste management system should be documented in a plan 5 and should include the following elements: • Designation/identification of infectious waste • Segregation • Packaging • Labeling • Storage • Transport and handling • Treatment techniques • Disposal of treated waste • Contingency planning • Staff training ( See also : Reinhardt and Gordon 1991, pp. 13ff; Turnberg 1996, pp. 120–126; Ostler 1998, Chapter 9.) Designation of Infectious Waste The infectious waste plan should specify which wastes are to be managed as infec- tious waste. The six categories of Table 12.1 should be included if applicable. A 4 Or the state or locality in which the question arises has medical waste regulations in effect. 5 Managers or practitioners preparing an Infectious Waste Management Plan (IWMP) should consider combining the IWMP with the Exposure Control Plan required by the Bloodborne Pathogens Standard, if appropriate ( see: Appendix A to this chapter). L1533_frame_C12 Page 314 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC responsible official or committee should determine which, if any, of the optional categories of Table 12.2 are to be included. Segregation of Infectious Waste The 1986 Guide recommends: • Segregation of infectious waste at the point of origin • Segregation of infectious waste with multiple hazards as necessary for management and treatment • Use of distinctive, clearly marked containers or plastic bags for infectious wastes • Use of the universal biological hazard symbol on infectious waste con- tainers, as appropriate (Figure 12.1) Also, segregation of infectious wastes assures that the added costs of special handling will not be applied to noninfectious waste. Packaging of Infectious Waste Infectious waste should be packaged in order to protect waste handlers and the public from possible injury and disease that may result from exposure to the waste. Accord- ingly, the 1986 Guide recommends: • Selection of packaging materials that are appropriate for the type of waste handled • Plastic bags for many types of solid or semisolid infectious waste FIGURE 12.1 The universal biohazard symbol. L1533_frame_C12 Page 315 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC • Puncture-resistant containers for sharps • Bottles, flasks, or tanks for liquids • Use of packaging that maintains its integrity during storage and transport • Closing the top of each bag by folding or tying as appropriate for the treatment or transport • Placement of liquid wastes in capped or tightly stoppered bottles or flasks • No compaction of infectious waste or packaged infectious waste before treatment Shippers of infectious waste are also subject to Department of Transportation reg- ulations for packaging, marking, and labeling of “infectious substances” and “reg- ulated medical waste” if shipped by commercial carriers. 6 Figure 12.2 shows a red bag containing infectious waste being placed uncom- pacted in a rigid container for shipment. Figure 12.3 illustrates an infectious waste receptacle in a clinic. Figure 12.4 shows a sharps receptacle receiving a syringe and needle. Figure 12.5 illustrates transfer of sharps for transport. Figure 12.6 demon- strates handling of red-bagged wastes in rigid containers. Storage of Infectious Waste Storage temperature and duration are important considerations. Warmer temperatures cause higher rates of microbial growth and putrefaction, resulting in odor problems. The 1986 Guide recommends: FIGURE 12.2 Red-bagged waste being placed in a rigid container for shipment. 6 See: 49 CFR 172.101 Hazardous Materials Table entries “Infectious Substances” and “Regulated Medical Waste;” 172.203 for proper shipping name; 172.432 and Appendix G to Part 173 for labels; 173.134 for definitions; 173.196 and 173.197 for packaging. L1533_frame_C12 Page 316 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC FIGURE 12.3 An infectious waste receptacle in a clinic. FIGURE 12.4 Sharps receptacle receiving a syringe. L1533_frame_C12 Page 317 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC FIGURE 12.5 Transfer of sharps for transport. FIGURE 12.6 Handling red-bagged wastes in rigid containers. L1533_frame_C12 Page 318 Tuesday, May 1, 2001 12:46 PM © 2001 by CRC Press LLC [...]... infectious waste Training also serves to reinforce waste management policies and procedures that are detailed in the infectious waste management plan (EPA 530-SW-8 6-0 14, Chapter 3; see also: EPA 530-SW-8 6-0 14, Chapters 4 and 5; Office of Technology Assessment 1988, Chapter 3; EPA 62 5-7 -9 0/009, Section 2; Boecher et al 1989; Keene 1989; Reinhardt and Gordon 1991, Chapter 16; Drum and Bulley 1994; Garvin 1995,... Disposal, White Paper, Medical Waste Committee (WT-3), Air & Waste Management Association, Journal of Air & Waste Management Association, October, pp 1176ff Garvin, Michael L 1995 Infectious Waste Management: A Practical Guide CRC Press, Boca Raton, FL Giroletti, E and L Lodola 1994 “Medical Waste Treatment,” in Technologies for Environmental Cleanup: Toxic and Hazardous Waste Management, A Avogadro and... Fact Sheet No OSHA 9 2-4 6, Washington, D.C U.S Environmental Protection Agency 1986 EPA Guide for Infectious Waste Management, Office of Solid Waste and Emergency Response, Washington, D.C., EPA 530-SW-8 6-0 14 U.S Environmental Protection Agency 1990 Guides to Pollution Prevention: Selected Hospital Waste Streams, Center for Environmental Research Information, Cincinnati, OH, EPA 62 5-7 -9 0-0 09 U.S Environmental... Waste Management: Public Pressure Versus Sound Medicine.” Hazardous Materials Control, September-October, pp 29ff Ostler, Neal K 1998 “Medical Waste Management, ” Chapter 9, in Waste Management Concepts, Neal K Ostler and John T Nielsen, Eds., Prentice-Hall, Upper Saddle River, NJ Reinhardt, Peter A and Judith G Gordon 1991 Infectious Medical Waste Management Lewis Publishers, Chelsea, MI Stericycle, Inc... 1996, Chapter 10) 8 Again, the present number of operating infectious waste incinerators in the U.S is greatly reduced from this number 9 Required by most local codes and state regulations © 2001 by CRC Press LLC L1533_frame_C12 Page 324 Tuesday, May 1, 2001 12: 46 PM FIGURE 12. 9 Cross-section of an incinerator for infectious waste © 2001 by CRC Press LLC L1533_frame_C12 Page 325 Tuesday, May 1, 2001 12: 46... sterilization [adapted from Reinhardt and Gordon (1991, Chapter 6)] Figure 12. 8 illustrates a commercial autoclave for sterilization of infectious wastes Larger autoclaves are © 2001 by CRC Press LLC L1533_frame_C12 Page 321 Tuesday, May 1, 2001 12: 46 PM TABLE 12. 3 Recommended Techniques for Treatment of Infectious Waste Category of Infectious Waste Isolation wastes Cultures and stocks of infectious agents... post-exposure evaluation and follow-up, and labels and signs © 2001 by CRC Press LLC L1533_frame_C12 Page 334 Tuesday, May 1, 2001 12: 46 PM REFERENCES Boecher, Frederick W., David C Guzewich, and Michael H Diem 1989 “Infectious Waste Management at Army Health Care Facilities, Past and Present,” Hazardous Materials Control, November-December, pp 73ff Drum, Donald A and Mike Bulley 1994 Medical Waste. .. L1533_frame_C12 Page 327 Tuesday, May 1, 2001 12: 46 PM FIGURE 12. 12 Microwave disinfection unit (SANITEC®, Inc., 23 Fairfield Place, West Caldwell, NJ 07006 With permission.) later abandoned gamma radiation for another technology (Turnberg 1996, Chapter 10; see also: Wilson 1992, § III) Disposal of Treated Waste Infectious waste that has been effectively treated is no longer biologically hazardous, and... North Keither Drive, Lake Forest, IL 60045 Turnberg, Wayne L 1996 Biohazardous Waste Risk Assessment, Policy, and Management John Wiley & Sons, NY U.S Congress, Office of Technology Assessment 1988 Issues in Medical Waste Management — Background Paper, Superintendent of Documents, U.S Government Printing Office, Washington, D.C., OTA-BP-O-49 U.S Department of Labor, Occupational Health and Safety Administration... most medical waste is generated, 60% of the waste classified as infectious had been managed by on-site incineration The on-site option provides many advantages, including sterilization of pathogenic wastes and volume reductions of 90 to 95% prior to ultimate disposal Most modern medical waste incinerators operate on “controlled-air” using two chambers The primary chamber, into which the waste is fed, . biohazardous, toxic, and medically hazardous have all been used to describe infectious waste. Medical Waste Medical wastes include all infectious waste, hazardous (including low-level radio- active. from other wastes. 12 L1533_frame_C12 Page 309 Tuesday, May 1, 2001 12: 46 PM © 2001 by CRC Press LLC (5) The term hazardous waste means a solid waste or combination of solid wastes, which. products L1533_frame_C12 Page 312 Tuesday, May 1, 2001 12: 46 PM © 2001 by CRC Press LLC TABLE 12. 1 Categories of Infectious Wastes Waste Category Examples a Isolation wastes Wastes generated