Preliminary

June 1, 2000

The Medical Waste Dilemma:
Guidelines for On-Site Equipment Selection

By Patricia A. Kimball, PhD

RegulatedMedical Waste (RMW) must be transported as a hazardous material according to theDepartment of Transportation (DOT). Although the DOT requirements for interstate andintrastate transportation of RMW have been in effect for well over a year, compliance ispoor. These Federal regulations preempt local and state regulations where these rulesmight be inconsistant with the DOT requirements. The DOT requires that the generatoradhere to specific labeling requirements of bags and containers; packaging that must meetcertain standards to ensure integrity, manifesting, and recordkeeping requirements; andHazMat training of certain staff members. Further, cultures or stocks of infectioussubstances must comply with more stringent requirements for packaging; specifically,cultures and stocks must be transported in containers that meet "Packaging GroupII" standards. If you are not certain the containers that are used for off-siteshipment meet these standards, ask your transporter for a document certifying compliancewith the standards as well as instructions on proper packaging of the infectioussubstances. Remember, you will be held accountable if the packaging does not measure up tothe standards.

After Stericycle's purchase of BFI's medical waste collection and treatment operationslast year, generators around the country were left with few choices for off-sitetransportation of RMW, raising concern among many healthcare workers. In the meantime, theclock is ticking away on the implementation of EPA's medical waste incinerator rules, andmost hospital incinerators will be shut down rather than perform an expensive retrofit oftheir equipment. However, an expensive upgrade is just the beginning of the costsassociated with operation of an incinerator. To continue operating an incinerator incompliance with the new rules, hospitals are required to submit waste management plans,conduct an initial performance test, conduct annual performance tests and inspections,install and maintain continuous emission monitors for certain parameters, comply withreporting and recordkeeping requirements, and comply with operator qualification andtraining requirements. Estimated costs associated with compliance vary but, without adoubt, few hospitals will be able to justify the capital as well as the added cost ofcompliance.

Given thedifficulties encountered in compliance with DOT regulations for off-site shipment of RMW,coupled with the industry consolidation and closure of most medical waste incinerators,many hospitals are seeking options for medical waste treatment and disposal. On-sitetreatment of medical waste using a non-incineration technology (alternative technology)alleviates the burden of DOT compliance and allows a hospital to control its own destiny.In addition, on-site treatment is becoming a cost-effective alternative and manymanufacturers have simplified and automated their systems so that processing is relativelyeffortless.

Preliminary

Perform a preliminary assessment and determine the issues that are important to thefacility. Develop a list of selection criteria and rank in order of importance. As anexample, the list could include cost, automation, flexibility of the equipment, ease ofoperation, redundancy, reliability, efficacy, and safety. This process will provide anobjective approach to the selection process.

Waste Generation History. It is imperative that you know how much medical wasteis currently generated by the facility and make some assumptions on future increases involume. Determine in advance how many hours per day and how many days per week you want tooperate the equipment for staffing purposes. Work in conjunction with the vendor to selectthe processing capacity that meets the facility's needs.

Develop a Budget. How much is the hospital willing to spend on the treatmentsystem and installation? Determination of this budget up front will save a lot of time andwill help with the selection process. Capital constraints have limited some hospitals frominstalling systems in the past, even though a rapid return on investment could bedemonstrated. Consequently, some equipment vendors have addressed the capital issuethrough creative financing and no capital option programs.

Select a Location. If the facility is like most, very little space has beendedicated to the "working end" of the hospital. Develop a general sense of apreferred location at the facility considering utility locations, storage requirements,and the logistics of moving waste before and after treatment. Most companies haveprofessional staff that will perform the necessary site analysis and provide the hospitalwith engineered installation plans.

Landfill and Local Regulatory Issues. Talk to the company that transports yoursolid waste to the landfill and determine if they have any specific requirements fortreated medical waste that should be considered. The solid waste company may even be ableto assist with the selection process as they may have experience with some of thetechnologies under consideration. Find out if there are any state or local rules thatwould affect the technology selection. Some states have specific requirements for treatedsharps, for example, that would need to be addressed by the equipment vendor.

Selection of a Technology

Medical waste treatment technologies can be broadly defined as thermal (wet or dryheat, microwaving, and infrared among others), chemical (chlorine or chlorine derivatives,ozone, enzymes), irradiation (UV, Cobalt 60), or other (specific to small volumes of aparticular category). The resulting end product varies widely from one technology toanother.

Disinfection vs. Sterilization. Disinfection is generally defined as a level ofmicrobial inactivation while sterilization is commonly defined as the complete eliminationor destruction of all forms of microbial life, including highly resistant bacterialspores. Autoclaves, for example, are typically capable of sterilizing medical waste whilemost alternative technologies achieve disinfection as the end product. Currently, nofederal efficacy standards exist for medical waste treatment; however, some states havedeveloped rigorous standards. Therefore, carefully consider this distinction inperformance criteria before narrowing the selection to a particular technology.

Shredding. Mechanical grinding devices are sometimes introduced prior totreatment, during treatment, and/or at the end of the treatment process. A few facilitiesinsist on shredding the medical waste either as a matter of preference or because theyfalsely believe that their liability will somehow be limited. Some technologies, however,depend upon shredding as an integral part of the treatment process, i.e., thosesystems that shred prior to treatment and during treatment. Shredders are typically a highmaintenance item due to unavoidable volumes of trapped metals in the medical waste stream,such as high-quality stainless steel found in orthopedic blades, drills, reamers, andprosthetic devices. Glass is also inherent in the medical waste and over time, glass wearsthe cutting surfaces of the shredder blades. Therefore, if the facility intends to shredwaste either pre- or post-treatment, anticipate that a rigorous maintenance schedule withassociated costs would be required. Shredding the waste simply to render the wasteunrecognizable makes the task more arduous and more expensive than necessary, and a costbenefit analysis should be conducted prior to making that decision. Also, consider thepotential downtime when/if the shredder(s) is out of commission with those technologiesthat depend upon shredding.

Risk Management. When weighing the features of the various technologies,consider potential worker exposure issues that have been raised, particularly involvingmanipulation of untreated medical waste. You should examine whether you feel youremployees are sufficiently protected from airborne release of contaminants in the medicalwaste during any shredding process. Also review potential exposure issues involved whileperforming maintenance on the shredders used to grind untreated waste.

Choices

After performing the steps listed above, you have probably narrowed the choices intechnology options and should now review specific information of the manufacturers andtechnology offered.

Company History. Some companies have been successful in installing hundreds ofunits while others have sold only a handful. Therefore, ask the vendor for a list of itsinstallations as an indication of its acceptance and success in the industry.Manufacturers of medical waste treatment systems come and go, so you want to be assuredthat the manufacturer selected will be around in the future for continued support of theequipment. Insist on a visit to the manufacturing plant and interview the managementstaff. This visit will provide you with a sense of the company's financial security andtheir commitment to the business.

Support. You should expect that the manufacturer have sufficient professionalstaff to assist with equipment siting and in receiving appropriate approvals forconstruction and installation. Some equipment vendors offer complete turnkey systems,alleviating the hospital from any burden of permitting and construction. Ongoing supportafter the sale is crucial.

Equipment Operation and Specification. Determine the system's ease of operation.The whole purpose of installing an on-site system will be defeated if the system is toocomplex to operate. Determine if the system is capable of automated loading and unloading.Assess the other "bells and whistles" that will make on-site treatment a simpleprocedure, such as electronic recordkeeping of processing time/temperature. What are thegeneral space requirements, and finally, what is the capital cost of the system?

Reliability of Equipment Service Network. Demand that the manufacturer definethe reliability of the equipment through service history of similar units. If there is abreakdown, who will service the equipment, and how much time will be required before aservice technician arrives to diagnose and repair the problem? Some equipment is evencapable of self-diagnosis and electronic monitoring by the factory.

Site Visit. Most important of all, before making a final selection, go see asimilar system in operation. The manufacturer should be willing to provide references andschedule a site visit for you. Make certain that the system will be operating when youarrive, and carefully scrutinize the equipment asking poignant questions of the operators,not just the management staff. Ask whether odor is an issue and inquire about ease ofoperation, maintenance and downtime, and ease of loading and unloading. And finally, ifthe facility had to do it all again, would they buy this system?

Optional Services. Some manufacturers now offer a complete turnkey system aswell as contracted services to operate the equipment, removing any hurdles and obstaclesfor on-site treatment. If considering such a program, determine if the company possessesthe type of expertise required to satisfy the demands of a service-oriented company.

Purchasing an on-site system is not as complex as one might think. Doing somepreliminary assessment and following a guideline and some simple rules will greatly assistwith the selection process. Evaluation of the technology and features of the equipment andcareful analysis of the equipment vendor should make the choices obvious.

Patricia A. Kimball, PhD, is the Vice President of Development for San-I-Pak (Tracy,Calif).

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