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By Pat Tydell, RN, MSN, MPH, and Jack Donaldson, RN, CNOR,CSPDM
One of the most crucial issues facing hospitals and other medical facilitiestoday is protecting against disease transmission. Healthcare workers are oftenexposed to hepatitis B virus (HBV), human immunodeficiency virus (HIV), andother dangerous bloodborne pathogens on a daily basis. Through the institutionof safe work practices and engineering controls, healthcare workers' exposurecan be significantly reduced.
OSHA guidelines are clearly in support of standard precautions to treat bloodand other body fluids as if they were infectious for HBV, HIV, and otherbloodborne pathogens. The collection and disposal of biohazardous liquid canpose a significant risk, bringing an untold occupational challenge to hospitalstaff. From pathologic body sites, the microbial content of suction load may behigh and contain significant pathogens.1 Bacterial content ofabscesses can include Clostridium, Bacteroides, and Straphylococcus.The respiratory tract can contain Streptococcus, Pseudomonas, Klebsiella,Serratia, and a variety of gram negative organisms. The female genito-urinarytract can contain polymicrobial flora similar to that of the intestinal tractplus Herpes virus.1 When healthcare workers come in contact withthese biohazardous fluids, reducing their exposure by minimizing splashing,spraying, and splattering is critical.
One source of biohazardous fluids that healthcare workers come in contactwith on a daily basis is from suction canisters. The use of reusable anddisposable suction canisters in the healthcare community and medical industry iswidespread. The use of surgical and medical suctioning occurs in several areasthroughout the hospital. These areas include the emergency room, intensive careunits, oral surgery and obstetric departments and, most frequently, in thesurgical department. The use of suction canisters can include general patientcare areas as well.
Standard precautions is an infection control system that assumes that everydirect contact with blood and body fluids is a potentially infectious exposure.This system is based on the premise that not all patients with bloodborneinfections have been diagnosed, and therefore, precautions must be applied.2
There are additional basic principles that should be followed for safehandling of suction canisters to minimize the risk to healthcare workers.Disposable units should be discarded when full or when removed from a patient.Although many hospitals (approximately 80%) have switched to disposable suctioncollection units, glass and metal units are still used. Some institutions haveconverted partially and have both systems in use.1 As with thesuction canister itself, so too should the connectors and associated tubing bedisposable. Use of disposables reduces the handling of the contaminatedequipment by healthcare workers.
Care needs to be taken when removing the collection canister from the patientcare areas. Liquid contaminated waste needs to be carried out in a sealedimpervious container. Neither should the container be transported unless sealedto prevent spillage or contamination of others en route to its final disposalsite. Once the protectively enclosed collector unit has reached a disposal area,its contents should be disposed of according to policy. The disposal shouldoccur in a non-patient care area to avoid the contaminated aerosols generated bythe suctioning process. The personnel doing this should be gowned, gloved andmasked to protect against aerosolized contaminants, spillage, and splattering.
If the canister is reusable, additional care needs to be taken in order toplace the equipment back in service. Also, a clean unit should always beavailable for back-up.
An engineering control system that helps reduce exposure to body fluids isliquid medical waste solidification products. Liquid medical wastesolidification products have been used in the healthcare and medical industryfor over 12 years. Healthcare workers have benefited from the protection theseproducts provide including the elimination of spilling, splashing andaerosolization. However, until recently, none of the solidification technologiesdemonstrated the level of efficacy required by most states in order to convertthe infectious waste to a non-infectious state and ultimately be disposed of inthe white bag waste stream.
Unfortunately, there were solidifiers that received approval in some stateagencies based on limited efficacy studies for landfill disposal. However, theywere later determined to be ineffective treatment technologies and ultimatelylost their approvals.
The disposal of medical waste is regulated on an individual state basis.Accordingly, not all the states have the same efficacy requirements. It isimportant to note, however, if a technology is approved by a certain state as anAlternate Medical Waste Treatment Technology. It has to be registered with theUnited States Environmental Protection Agency before it can be marked and soldin that state.3
Conversely, just because a solidification product obtains an US EPAregistration, it does not mean it automatically becomes a countrywide-approvedAlternate Treatment Technology. The product must still demonstrate the efficacyrequired within the state it plans to sell in.
If this process sounds confusing--you're right. However, in order to assistmanufacturers through this process several state agencies formed a committeecalled State and Territorial Association on Alternate Treatment Technologies(STATT)4. This committee developed a guidance document for evaluatingAlternate Technologies that have been registered with the US EPA as a chemicaltreatment product. In addition, Underwriters Laboratories Inc. (UL) hasinitiated the development of a standard. UL, through the Accredited OrganizationMethod of American National Standards Institute (ANSI) is seeking recognition ofthis standard as an American National Standard.
The scope of the standard is as follows. The standard is intended todetermine whether individual equipment or systems provide for microbialinactivation and reduction of the risk of injury to persons and damage toproperty related to their use.
a. Hazardous waste identified or listed in 40 CFR Part 261.
b. Radioactive waste defined and regulated by the Nuclear Regulatory Commission.
c. Domestic sewage materials identified in 40 CFR 261.4(a)(1).
A product that contains features, characteristics, components, materials orsystems new or different from those covered by the requirements in thisstandard, and that involves a risk of fire, electric shock, or injury to personsshall be evaluated using the appropriate additional component and end-productrequirements to determine that the level of safety, as originally anticipated bythe intent of this standard, is maintained.
A product whose features, characteristics, components, materials, or systemsconflict with specific requirements or provisions of this standard. Whereconsidered appropriate, revisions of requirements shall be proposed and adoptedin conformance with the methods employed for development, revision andimplementation of this standard.
OBF Technologies' mission was to develop a product that would demonstrate therequired efficacy as set forth by STATT and meet the proposal standards forUnderwriters Laboratories, while keeping in balance with the environment.
In 1997, OBF Technologies developed the first protocol for a Sanitation/Solidification product to be approved by the US EPA and subsequently receivedofficial registration from the US EPA March 7, 1997. EPA registration number59839-1.
A widely used cold sterilant--known for demonstrating the high-level ofefficacy (sterilization) when challenged by the most virulent organism--isglutaraldehyde. After several years of research and development, the companyconverted liquid glutaraldehyde into a patented dry crystal. This process allowsthe liquid glutaraldehyde to become encapsulated within a prilled silica crystaland is only released when it comes into contact with the liquid waste inside thesuction canister. This technology allows the end user to benefit from the high-level of efficacy demonstrated by the dry glutaraldehyde crystal whileminimizing the risk commonly associated with liquid glutaraldehyde. By combiningthe dry glutaraldehyde crystal with a fast and encapsulating group of acrylicpolymers, the company developed new technology called PremiCide.
PremiCide is a suction canister sanitation and solidification system thatallows for transport, storage, and disposal of sanitized medical waste.
The efficacy demonstrated by PremiCide includes a 410 log reduction of the Bacillussubtilis spore and 610 log Mycobacterium Phlei in 100% whole bloodserum. In addition, it inactivates non-sporulating gram positive bacteria,fungi, non-sporulating gram positive bacteria, and crystals.
It is manufactured in single-use (unidose) sizes to sanitize all suctioncanister volumes. A patented closed delivery system called PremiGuard bringsadded safety to the treatment, handling, and disposal of liquid laboratory,human and animal waste.
The closed delivery system allows the treatment of infectious liquids tooccur within the sealed collection canister, eliminating unnecessary chemicalspills and potentially hazardous aerosolization and splashing of the infectiouscollected waste fluids. The cap was designed to fit most suction canister lidsand can be used with or without suction.
To ensure the safety associated with the use of this solidification andtreatment product, the company conducted several environmental studies andpersonal safety studies concluding that when used according to directions ofuse, the product does not qualify as a hazardous waste and the occupationalexposure level to the dry glutaraldehyde is below recognized exposure limits. Inaddition, a LD 50 Acute Dermal Toxicity Study demonstrated an undetectable levelof toxicity according to the procedure listed in the TSCR guidelines, 40 CFRPart 798.
Pat Tydell, RN, MSN, MPH, is the Risk Manager at North Chicago VeteransAdministration Medical Center (VAMC) in North Chicago, Ill.
Jack Donaldson is the Nurse Manager of Sterile Processing at SutterMedical Center in Sacramento, Calif.
1 Neblett, Thomas R. Ph.D. "Characteristics of Medical and Surgical Suction Systems. The Microbiology and Nosocomial Hazards of Collection Vessels." Published monograph of research conducted at Biosan Laboratories, Inc. 10657 Galaxie Ave. Ferndale, Mich. 48220.
2 Goodman, Terri, RN, MA, Ph.D. "Control of Infections Related to Bloodborne Pathogens." Infection Control Today. June, 2000.
3 Ng, Rebecca, BS, REHS. "Medical Waste Disposal Training and Audits." Infection Control Today. November, 1999.
4 Underwriters Laboratories, Inc. "Standard for Safety for Alternative Technologies for the Disposal of Medical Waste- UL2334." www.UL.COM/epn/medwaste.htm.
5 OBF Industries, Inc. www.enviro-safe.com
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