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 [原创][分享]Healthcare Waste Management - STAATT III会议纪要 |
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healthaegis
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作者：healthaegis 在 海归商务 发贴, 来自【海归网】 http://www.haiguinet.com
State and Territorial Association on Alternate Treatment Technologies
(STAATT or STA2T2) III Meeting Summary
STAATT III guidance conference was hold during December 5-7, 2005 in Orlando, Florida. This meeting was sponsored by Department of Health, State of Florida. Many State and Federal agency officials, independent consultants and representatives from United Kingdom attended this 3-day meeting. The first two days were focused on several technical and regulatory issues. The last day meeting was a discussion among administrative officials, independent consultants and equipment vendors.
During the first two days, attendees presented and discussed the following topics:
DAY ONE
TYPES OF TESTS
It’s recommended that efficacy protocol obtain prior approval from the regulatory agency from which approval is being sought. Initial efficacy testing is required with biological indicators for all alternative treatment technologies and autoclaves. Validation testing to validate the operation of the system by the operator and the system should be conducted for all autoclaves and treatment technologies. Challenge testing or QC can be conducted through either parametric monitoring or through the use of biological indicators provided that parametric monitors have been validated through efficacy testing and as determined through discussions between regulators and vendors.
WORST CASE TESTING SCENARIOS FOR HEAT AND CHEMICAL TREATMENTS
There was consensus for proceeding with a 4 log10 reduction of bacillus spores and a 6 log10 reduction of Mycobacterium. Consensus was not reached on the subject of Prion-contaminated and bioterrorism-generated waste. The same worst case scenarios should be in place for chemical and heat treatment technologies.
Are there other biological indicators that should be used? Bacillus atroaphaeus is more resistant to dry heat, while Geobacillus stearothermophilus is more resistant to wet heat. However, even a dry heat treatment, in the presence of a moist waste, becomes wet heat.
A 95% confidence that the equipment meets a 4 log10 reduction throughout the treatment compartment of the unit was discussed. This gets to the fact that microbiological methods are subject to some interpretation, and it also accounts for that random failure that you encounter. In other words, what does that outlier mean in perspective to the larger assessment? If you get a 3.8 log10 reduction, then you may still pass. But if you get two results at 2.5 log10 reduction, then you could fail, based on the number and severity of failures.
BIOLOGICAL INDICATORS
Responses to key questions:
• The number and type of indicators from STAATT II should be carried forth to STAATT III. There were additional comments regarding materials generated through such incidents as bioterrorism and whether a 4 log10 reduction of bacterial spores would be considered safe.
• There were no reported incidents of treatment systems that could effectively inactivate bacterial spores and mycobacteria but not lesser vegetative microorganism, such as fungi and viruses.
• There were no reports of signicant variation between the Bacillus strophaeus and Geobacillus stearothermophilus species.
• Suction canisters should meet the same challenge as other medical waste technologies (i.e., 6 log10 reduction of mycobacteria and 4 log10 reduction of bacillus spores).
• Use AOAC species in STAATT III for chemical treatment.
Exceptions to the 6 Log/4 Log test criteria were discussed for plasma arc and pyrolysis technologies. Both are high heat technologies without direct exposure of the waste to a flame (which sets it apart from incineration according to US EPA regulations). Plasma arc reduces waste to molten slag, while pyrolysis breaks down waste at high heat in the absence of oxygen.
No sample can be recovered from plasma arc treatment, and coupled with the high temperatures that climb into the thousands of degrees, it was concluded that plasma arc units could be excepted from efficacy testing. A definition for what comprises a plasma arc treatment will be discussed with vendors, including typical flame and torch temperatures. Because of the lower temperature and reports of potential sample recovery from pyrolysis technologies, it was concluded that no similar exception be made for pyrolysis.
TEST LOAD COMPOSITION
Waste composition that typify actual waste to be processed should be relative to, among other things, the type of technology being considered and the type of waste the facility treats. The exception is that waste types provide a commonly encountered rigorous challenge to the treatment process. There were studies reported on waste composition in the USA and Asia, but there was little correlation between the findings of the two studies.
Which leads to the question: how can regulators establish test load compositions when there is so much variability in the waste stream? Opinions differ from regulator to regulator on what a typical load should be, and perhaps they should not be responsible for determining the composition of a standard load. If the site is expected to know what types of waste they will process, they may never be able to give actual numbers, especially if they are a commercial or central processing center.
In the United Kingdom, they have assessed waste and identified items that will be difficult to treat. Other approaches include specifying and organic content, including actual waste and particle size. In subsequent meetings, we hope to achieve a standard load, but for now, determining a test load remains a collaborative effort between the vendor and regulator. A revision to STAATT II 3.2, paragraph 3, will add a remark about suction canisters to the list of examples, signifying them as a unique challenge.
APPROPRIATE BACTERIAL CONTROL
Since the last STAATT meeting, experience has demonstrated that not all spores are created equally by different manufacturers. You can request the same strain from two commercial manufacturers, but your results may differ. This difference is now attributed to different D-values for the sample.
D-value is defined as the time at which 90% or a 1 log reduction in the concentration of viable organisms occurs. It is an indication of relative resistance. Organisms of the same species can have their D-values altered to either make them less or more resistant to a particular treatment process. Some manufacturers of spore strips can provide the customer with D-values for their products.
A range of D-values are established by the United States Pharmacopoeia (USP) for systems using steam, dry heat and Ethylene Oxide that process medical instruments. Commercial spore manufacturers must comply with USP and FDA regulations on the labeling of spores products and their D-values. It is the consensus that D-values be considered as a factor in the selection of bacterial spores and further consideration will be given to this topic.
However, there are not good resources for D-values for chemical treatments. In absence of D-values for chemical treatment, to account for the variability between sample stocks, it was proposed during initial efficacy testing to use random samples from as many as three suppliers, using three batched from each. Multiple strips/suspensions could be used as part of a single run. While additional purchase and enumeration costs, it was determined that the group did not have enough information to reach a conclusion on thermal D-values, or an alternative to thermal D-values.
AUTOCLAVES
Autoclaves during the time of STAATT I and II were not considered “emerging” or “alternative” technologies. The consensus of the group now is to include and equipment that treats medical waste including autoclaves to be medical waste treatment technologies unless otherwise specifically excluded from this guidance.
Parameters for autoclaves have changed little over 100 years, since the days of Louis Pasteur. Commonly used parameters are 121C and 16 psig for 40 minutes. Autoclaves are effective in treating the majority of components of the medical waste stream.
Since autoclaves were not initially included as alternative medical waste treatment technologies, they were not initially included in STAATT’s I or II. However, new studies have reported the sensitivity of autoclaves in the presence of items typically found in the medical waste stream such as suction canisters and Tyvek suits. In one study, solidified suction canister waste was not effectively treated at typical temperature and pressure parameters, nor was this waste treated at an elevated temperature and pressure over the same length of time. For the rolled Tyvek suits, samples processed at 130C passed, but samples processed at 125C did not.
Additionally, if an autoclave will be used for the treatment of suction canisters, animal carcasses, or other thermally resistant materials, then that is acceptable, but they must meet the criteria of an alternate treatment system, meeting more stringent parameters.
Consideration was given to revisiting the operational parameters of autoclaves, and there is consensus to do so. However, no details have yet been provided on what those provisions should be. Operational parameters will continue to be determined by the vendor and regulator. The device should not be operated at parameters below those established by the vendor’s efficacy testing.
DAY TWO
EFFICACY FIELD TESTING – UNITED KINGDOM
A study was carried out in the UK assessing different types of technologies, each equipped differently to process waste. Those that operated most efficiently involved the rupturing of containers holding large liquid volumes, such as chest drains and suction canisters. Rigid containers that did not rupture and integrate their liquid volume into the waste load resulted in inconsistent or unsuccessful treatment of the liquid volume. Officials in the UK are working to assist industry to meet existing standards.
EFFICACY FIELD TESTING – CALIFORNIA
Based on surveys in California, 1.6% of suction canisters are solidified and sent to a landfill. An overwhelming 82.7% are treated in autoclaves.
As part of a study to determine if suction canister were adequately treated by autoclaves, a variety of suction canisters, solidifiers, and autoclaves were evaluated to determine if they meet the regulations of the California Medical Waste Management Act, those being 250F for 30 minutes, demonstrated by a 4 Log10 reduction of Geobacillus spores. Samples were prepared by stapling glassine envelopes to tongue depressors, which were positioned in the center of a solidified suction canister load. Thermonocouples were also positioned to take readings at the center of the mass before the canister was sealed. Among the results: 1) 8 of 20 suction canisters at off-site treatment facility tested positive; 2) 24 of 25 samples (96%) did not achieve the necessary temperature to inactivate spores; and 3) for samples tested in five different autoclaves, 15 of 16 samples failed to kill the spores.
As part of a parallel study, two different cart-loaded autoclaves were challenged in similar manner using tongue depressors and suction canisters, but the loads ere distributed near the bottom, in the middle, and near the top of the cart. When subjected to a normal autoclave cycle, the samples failed to achieve acceptable temperatures, with the samples at the bottom of the cart proving the most difficult to treat. Log10 reduction ranged from 1.6 to 3.5 for Bacillus stearothermophilus and/or Bacillus astrophaeus spores.
As a result, new measures were taken in the state of California to segregate suction canisters for incineration disposal, or to use canisters that were non-autoclavable (i.e., subject to melting or rupturing), in which case the liquid waste was distributed throughout the load. Recommendations for further exploration involved modifying the configuration of the waste load, as well as examining the thermodynamics of the test cycle as opposed to the effected of steam penetration.
FIFRA
Key points presented regarding the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA):
• If a technology is an instrument or contrivance that inactivates microorganisms on medical waste, then the technology is considered a device and FIFRA registration is not required;
• If the technology employs a chemical or substance that inactivates microorganisms on the medical waste, then the chemical in the technology is considered a pesticide and FIFRA registration is required;
• A pesticide device is not required to be registered under FIFRA;
• However, that same device is regulated under FIFRA.
It is against the law for anyone to sell or distribute chemical pesticide without EPA labeling. To obtain FIFRA registration, test data can come from the state, provided that the state is a STAATT participating state.
Additionally, the US EPA’s Antimicrobials Division is considering expanding its technical requirements for antimicrobial efficacy. For suction canisters, the consensus challenge remains a 4 Log10 inactivation of bacterial spores and a 6 Log10 inactivation of mycobacteria, with new specifying a 100% organic (whole blood) load. The group is also considering specifying a 95% confidence level.
UNTREATED CONTROLS
If you inoculate a waste load with 108 cfu/g of spores, without the addition of an inactivating agent, you may recover 104 cfu/g, and upon treatment of the wste inoculated at 108 cfu/g of spores, you may recover 102 cfu/g. This would amount to a 2 Log10 reduction of spores. It was the consensus that the control, or the amount of microorganisms that cannot be recovered upon inoculation, should continue to be factored into enumeration.
PARAMETRIC MONITORING
Consensus was stated here and reiterated later that challenge testing and QC can be conducted through either parametric monitoring or through the use of biological indicators provided that parametric monitors have been validated through efficacy testing and are revalidated at regular intervals as determined through discussions between regulators and vendors. Information regarding parametric records should be recorded as a permanent record.
BIOLOGICAL AEROSOLS AND CHEMICAL EFFLUENT
There was consensus for recommendations for regulators to consider in their approval process in relation to environmental issues:
• Aerobiology studies of areas adjacent to the treatment equipment/system;
• Biological and chemical testing of the liquid discharges from the equipment/system;
• Balance of air handling through the technology and/or within the area where the equipment is located;
• QC of environmental factors and equipment use to minimize potential negative environmental impacts from using the treatment equipment;
• Negative pressure within the system;
• Fixed portal radiation monitors;
• Application of HEPA and charcoal filters.
TEST LABORATORY
Should selection of laboratories conducting and form of testing be left to manufacturers?
Consensus: the laboratory conducting any form of efficacy testing for medical waste treatment equipment is independent of that vendor of the treatment system. After that, reviewing information provided by the lab, including data and protocols, becomes the responsibility of the regulator.
Consensus: the lab is responsible for a chain of custody involving the preparation of the sample, the collection of the sample, and the generation of data as result of the test.
Recommendation: as a means of minimizing delay and potential rejection of data that does not meet the needs of the regulator, lab and consultants need to inform regulators of their intended test protocols and expected results. This can help ensure that the lab will generate the right data, as opposed to possible retesting for avoidable reasons.
BIODEFENSE
This is one of three presentations covering emerging issues to the medical waste treatment industry.
Biodefense and plans for the disposal of bioterrorism waste are being linked to equipment that can destroy pathogens. Since 2001, there have been at least 23 reported cases of anthrax exposures.
Alternative treatment technologies, in the context of STAATT discussions, are intended for the treatment of medical waste. While some equipment may be able to decontaminate large amounts of building contamination residue (BCR), other equipment is limited by a number of factors, including penetration issues and the configuration of certain systems. It was explained that authorities responsible for bioterrorism response in some areas feel that they may have an outlet for disposal of BCR using alternative treatment equipment for medical waste, without enough understanding of the limitations of the technologies. No recommendations were made, except for the possibility for future discussion.
TREATMENT OF CHEMOTHERAPEUTICS AND PHARMACEUTICALS
This is the second of the three presentations covering the emerging issues to the medical waste treatment industry.
Chemotherapeutics and pharmaceuticals are commonly found in health care facilities. While chemotherapy waste in significant enough amounts is regulated by the EPA through the RCRA, there is not a similar regulatory body or regulation that cover pharmaceuticals entering the waste steam. These substances are appearing wastewater, and there are concerns as to whether drug waste should be a concern when present in the solid waste stream. Some states already limit or ban the commingling of drug with medical waste.
While some high heat technologies can be expected to deactivate pharmaceuticals, the group did not make any recommendations for the use of alternative treatment technologies for the disposal of pharmaceuticals. Additional data would be welcome covering the environmental ramifications of pharmaceuticals in the medical waste stream.
PRIONS
This is the third of three presentations covering the emerging issues to the medical waste treatment industry.
While more difficult to destroy and an issue of heighten public perception, reported incidents of prion infections in the USA amount to a roughly one in a million possibility of ever becoming infected with a prion disease.
There are no recommendations (currently) for the consideration of prions in the STAATT III guidance document.
DAY THREE
There were approximately 40 vendor representatives participated the last day meeting. They were representing about 30 equipment manufacturers. The group presented the consensus and discussion result from the previous two-day meeting. Vendor representatives challenged some consensus and expressed their concerns. The most commonly discussed topics were types of tests (efficacy testing, validation test, challenge test or QC), biological indicators, autoclaves, parametric monitoring.
The final STAATT III report is expected to be due in the mid June, 2006.
作者：healthaegis 在 海归商务 发贴, 来自【海归网】 http://www.haiguinet.com
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 [原创][分享]Healthcare Waste Management - STAATT III会议纪要 -- healthaegis - (19077 Byte) 2006-3-21 周二, 21:56 (974 reads)
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