San-i-pak - Articles & Issues

Regulated Medical Waste (RMW) must be transported as a Hazardous Material, according to the Department of Transportation (DOT). Although the DOT requirements for interstate and intrastate transportation of RMW have been in effect for well over a year, compliance is very poor. These Federal regulations preempt local and state regulations (remove preemption in parenthesis) where these rules might be inconsistent with the DOT requirements. The DOT requires that the generator adhere to specific labeling requirements of bags and containers, packaging that must meet certain standards to insure integrity, manifesting and recordkeeping requirements, and HazMat training of certain staff members. Further, cultures or stocks of infectious substances (remove parenthesis) must comply with more stringent requirements for packaging; specifically cultures and stocks must be transported in containers that meet “Packaging Group II” standards. If you are not certain if the containers you use for off-site shipment meet these standards, ask your transporter for a document certifying compliance with the standards as well as instructions on proper packaging of the infectious substances. Remember, you will be held accountable if the packaging does not measure up to the standards.

After Stericycle’s purchase of BFI’s medical waste collection and treatment operations last year, generators around the country were left with few choices for off site transportation of RMW, raising concern among many. In the meantime, the clock is ticking away on the implementation of EPA’s medical waste incinerator rules and most hospital incinerators will be shut down rather than perform a very expensive retrofit of their equipment. However, an expensive upgrade is just the beginning of the costs associated with operation of an incinerator. For continued operation of an incinerator in compliance 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 with reporting and recordkeeping requirements and comply with operator qualification and training requirements. Estimated costs associated with compliance vary but, without a doubt, few hospitals will be able to justify the capital as well as the added cost of compliance.

Given the difficulties 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-site treatment 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 many manufacturers have simplified and automated their systems so that processing is relatively effortless.

PRELIMINARY: Perform a preliminary assessment and determine the issues that are important to your facility. Develop a list of selection criteria and rank in order of importance. As an example, your list could include cost, automation, flexibility of the equipment, ease of operation, redundancy, reliability, efficacy, and safety. This process will provide an objective approach to the selection process.

1. Waste Generation History: It is imperative that you know how much medical waste is currently generated by your facility and make some assumptions on future increases in volume. Determine in advance how many hours per day and how many days per week you want to operate the equipment for staffing purposes. Work in conjunction with the vendor to then select the processing capacity that meets your needs.

2. Develop a Budget: How much is the hospital willing to spend on the treatment system and installation? Determination of this up front will save a lot of time in the long run and will help with the selection process. Capital constraints have limited some hospitals from installing systems in the past, even though a rapid return on investment could be demonstrated. Consequently, some equipment vendors have addressed the capital issue through creative financing and no capital option programs.

3. Select a Location: If your facility is like most, very little space has been dedicated to the “working end” of the hospital. Develop a general sense of a preferred location at your facility considering utility locations, storage requirements, and the logistics of moving waste before and after treatment. Most companies have professional staff that will then perform the necessary site analysis and provide the hospital with engineered installation plans.

4. Landfill and Local Regulatory Issues: Talk to the company that transports your solid waste to the landfill and determine if they have any specific requirements for treated medical waste that should be considered. The solid waste company may even be able to assist with the selection process, as they may have experience with some of the technologies under consideration. Find out if there are any state or local rules that would affect the technology selection. Some states have specific requirements for treated sharps, 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 dry heat, microwaving, and infrared among others), Chemical (chlorine, or chlorine derivatives, ozone, enzymes), Irradiation (UV, Cobalt 60) or Other (specific to small volumes of a particular category). The resulting end product varies widely from one technology to another.

1. Disinfection vs. Sterilization: Disinfection is generally defined as a level of microbial inactivation while sterilization is commonly defined as the complete elimination or destruction of all forms of microbial life, including highly resistant bacterial spores. Autoclaves for example, are typically capable of sterilization of medical waste while most alternative technologies achieve disinfection as the end product. Currently there are no federal efficacy standards for medical waste treatment, however some states have developed rigorous standards. Therefore you should carefully consider this distinction in performance criteria before narrowing the selection to a particular technology.

2. Shredding: Mechanical grinding devices are sometimes introduced prior to treatment, during treatment and/or at the end of the treatment process. A few facilities insist on shredding the medical waste either as a matter of preference or because they falsely believe that their liability will somehow be limited. There are some technologies however, that are dependent upon shredding as an integral part of the treatment process; i.e., those systems that shred prior to treatment and during treatment. Shredders are typically a high maintenance item due to unavoidable volumes of trapped metals in the medical waste stream such as high quality stainless found in orthopedic blades, drills, reamers and prosthetic devices. Glass is also inherent in the medical waste and will, over time, wear the cutting surfaces of the shredder blades. Therefore, if your facility intends to shred waste either pre or post treatment, you should anticipate that a rigorous maintenance schedule with associated costs would be required. Shredding the waste simply to render the waste unrecognizable makes the task more arduous and more expensive than necessary and a cost benefit analysis should be conducted prior to making that decision. Also consider the potential downtime when/if the shredder(s) is out of commission with those technologies that are dependent upon shredding.

3. Risk Management: When weighing the features of the various technologies, you should also consider potential worker exposure issues that have been raised, particularly involving manipulation of untreated medical waste. You should examine whether you feel your employees are sufficiently protected from airborne release of contaminants in the medical waste during any shredding process. Also review potential exposure issues involved while performing maintenance on the shredders used to grind untreated waste.

SELECTION OF A COMPANY: After performing the steps listed above, you have probably narrowed the choices in technology options and should now review specific information of the manufacturers and technology offered.

1. Company History: Some companies have been successful in installing hundreds of units while others have sold only a handful. Therefore, you should ask the vendor for a list of its installations as an indication of its acceptance and success in the industry. Through the years, we have seen many manufacturers of medical waste treatment systems come and go. You want to be assured that the manufacturer you select will be around in the future for continued support of the equipment. You should also insist on a visit to the manufacturing plant and interview the management staff. This will provide you with a sense of financial security of the company and their commitment to the business.

2. Support: You should expect that the manufacturer have sufficient professional staff to assist with siting of the equipment, and in receiving appropriate approvals for construction and installation. Some equipment vendors even offer complete turnkey systems alleviating the hospital from any burden of permitting and construction. In addition, support after the sale is crucial.

3. Equipment Operation and Specification: Determine the ease of operation of the system. The whole purpose of installing an on-site system will be defeated if the system is too complex. Determine if the system is capable of automated loading and unloading. Assess the other “bells and whistles” that will make on site treatment a simple procedure such as electronic recordkeeping of processing time/temperature. What are the general space requirements and finally, what is the capital cost of the system?

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

5. Site Visit: Most important of all, before making a final selection, go see a similar system in operation. The manufacturer should be proud of its installations and should be gladly willing to provide references and schedule a site visit for you. Make sure that the system will be operating when you arrive and carefully scrutinize the equipment and ask poignant questions of the operators, not just the management staff of the hospital. Ask whether odor is an issue, ease of operation, maintenance and downtime, ease of loading and unloading. And finally, if they had to do it all again, would they buy this system?

6. Optional Services: Some manufacturers have gone so far as to now offer a complete turnkey system as well as contracted services to operate the equipment, removing any hurdles and obstacles for on-site treatment. If you are considering such a program, determine if the company possesses the type of expertise required to satisfy the demands of a service-oriented company.

Purchase of an on-site system is not as complex as one might think. Doing some preliminary assessment, following a guideline and some simple rules will greatly assist with the selection process. Evaluation of the technology and features of the equipment and finally, careful analysis of the equipment vendor should make the choices obvious.

References:
Hazardous Materials Regulations (HMR), 49 CFR Parts 171-180

HMR 200; 62 Federal Register 1208; January 8, 1997, amended at 62 Federal Register 49560, September 22, 1997.

49 U.S.C. 5101 et seq.

Environmental Protection Agency; 40 CFR Part 60; 62 Federal Register 48348, September 15, 1997.

Technical Assistance Manual: State Regulatory Oversight of Medical Waste Treatment Technologies; April 1994.