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By Marcia Frieze, MS, and Kerrye Allen, RN
Decidingon the right sterilization method for the appropriate surgical device has becomea challenging quest. Increase in minimally invasive surgical procedures and thegrowth of more resistant microbes require greater diligence and team decisionmaking when choosing a new sterilization system, including sealed containers.This decision requires the joint efforts of healthcare managers, sterileprocessing technicians, OR staff, infection control personnel, physicians,materials management, and medical device manufacturers.
Issues of cost, ease of use, and rapid turnovers must be balanced withethical concerns regarding patient care and safety. The need to sterilizeinstrument sets and medical devices rapidly has challenged our concept ofadequate decontamination and sterilization procedures. Third party reprocessinghas brought about questions of single-use devices. Are these items safe formultiple processing? In terms of decontamination and sterilization, the marginof safety needs to be assessed as to which methods can ensure a greater level ofsterility assurance for items particularly challenging to process. Thus, it isthe combined efforts of healthcare professionals and vendors working in concertto determine the appropriate sterilization process used with each sterilizationcontainer, wrap, and instrument set.
There is no question that certain materials, such as high-density polymers,and certain instruments, such as minimally invasive surgical devices, are agreater challenge to clean and sterilize. Furthermore, the barrier properties ofthe wrap/container to contain clean sterile instruments must be evaluated basedon event-related factors.
In the past, sterilization containers and methods, such as ethylene oxide,were exempted from validation testing or reviewed by regulatory agencies withlittle relevant data. In contrast, the latest systems have been subjected tolengthy reviews with endless requests for clarification and testing with therequirement of incremental validation below the half cycle parameters based onthe overkill method, the norm for past sterility assurance and FDA pre-marketclearance.
Thus, it is up to a team of decision makers to review the requirements of thefacility when it comes to deciding on a new sterilization system. This shouldinclude data in relation to process, material and biological compatibility,durability, and adaptability. Given the decline in healthcare reimbursement,there is no question that a tray system, used for various methods ofsterilization and composed of reusable and adaptable components, is anadvantage. As instrument protection is a primary planning consideration fordelicate or costly instrumentation, the team should devise a strategy thatincludes steps for customization of various instrument trays based on needassessment. In doing so, the advantage of standardization and simplification ofinstrument sets in cost savings from repair and replacement, as well as areduction in excess inventory can justify the initial expense of a containersystem.
The team should evaluate current repair and replacement expenses along withthe costs of disposable wrap. All medical devices require wrap or sealedcontainers for the protection of instrument sets from environmental factors. Thetime to wrap, material costs over time, tape, labor and expenses related toreprocessing must be included in the evaluation procedure. A sealed container isvirtually impossible to penetrate or puncture. If the filter is protected by anoffset retention plate, the assurance of safety is enhanced and chance tamperingis further reduced with the use of a tamper-evident seal.
As sterility is a statistical concept; a major goal is to review themanufacturer's instruction manual for proper care and handling as well asprocess information. Request current validation testing information. Has thesterilization container been validated using the newer methods of sterilization?Has the manufacturer undertaken an event-related study? How secure is the seal?How well will the container allow for sterilization of blades and lumens? Howdurable is the product? Is the container dry?
Plastic sterilization containers have a history of problems with wet packsbecause of the accumulation of condensate on the internal and external surfacesof the case after the sterilization process has been completed. As a result,some manufactures have added metal inserts or incorporated metal parts or acomposite material of plastic and metal in the case design.
Moisture has always been considered a breeding ground for bacteria, althoughthe inside of the container should be free of microbes after sterilization. Inaddition, condensate accumulation causes technical and quality assurancequestions for the processing team and a lower expectation of sterilityassurance. As a result of wet packs with flash sterilization, a processedinstrument must be used immediately after this method. In Australia andcountries in Europe, flash sterilization has been banned entirely. Pre-vacuumsteam sterilization is the method of choice for rapid sterilization.
Wet packs are a problem with some metal container systems as well. In thepast, an absorbent towel had been used to absorb moisture and to protectinstrumentation. If the purpose of the towel is to provide protection, examineother options including instrument mats that provide drainage or instrumentbaskets with secure adaptable inserts. If the sterilization container requires atowel because of moisture, check to see if the sterilizer is properlyfunctioning and that parameters for dry time have been met. Some containers aredesigned with a greater ability to conduct heat than others, thus an assessmentof the design of a particular container should be reviewed by the team for thepurpose of determining the probability of wet packs. More importantly, invite arepresentative from the company to meet with the team to answer questions anddemonstrate effectiveness of the tray system in your sterilizer.
Wrap, whether disposable or linen, is inconsistent from hospital to hospital.Some use various layers and brands while others mix cloth and non-wovenpolypropylene disposable wrap. Without wrap standardization, this means yourload is inconsistent. By placing products only in containers and metal trayscompatible with load content and materials, most of the variables arecontrolled. In this way, healthcare facilities will increase the probability ofhaving a sterile set at the OR site.
Healthcare staff from the OR and SPD have recognized the need for sealedcontainers and highly perforated metal trays long before many of the majormedical companies began providing custom trays for instrument sets and implants.Recently, several hospitals have explored ways to place their custom plastictrays in metal trays and containers. In the New York metropolitan area, MercyHospital on Long Island and Englewood Hospital in New Jersey requested aconversion from plastic trays and custom metal wrap cases, provided by severalorthopedic manufacturers, to perforated metal trays and sealed containers. Whywould the hospital spend this extra money to replace a product in some casesprovided with the instrumentation or implant? According to Marge Kulesa, RN,orthopedic nurse clinician, "I believe in the long run it is a cost savingin personnel because it decreases the need for wrapping and the time and costinvolved in the wrapping of the tray. It is so easy to use and there are no ripsin the wrapping. There has been an increase in staff and nursing satisfaction asthe instruments are sterile."
Conversion to a sealed container system must be viewed as a significantadvantage over a wrap tray. First, over time, sealed containers save time anddollars associated with wrapping. Secondly, the healthcare team could avoidreprocessing trays with torn wraps discovered upon inspection or at the lastminute in the OR. Thirdly, orthopedic devices represent the greatest challengefor transport and handling due to the weight/mass. A wrapped case, even one withproduct information, is a challenge to identify properly as to top and bottom.Sharp edges on the tray or case can tear the wrap causing lost time in thesurgical suite and reprocessing delays. This is especially true of plastic casesas they become brittle and break in the corners.
Handling and transporting heavy orthopedic trays create further challenges.Once they are wrapped, heavy cases have no handles. Furthermore, the wrap itselfobscures any written information about the contents. A sealed container hashandles and identification such as engraved or silk-screened labeling. Manyhealthcare facilities have instituted a bar code tracking system, and awell-designed case system provides a location for that. Since most orthopediccases require many containers, a case cart can be used to transport the bulkyorthopedic sets to the OR. Specially designed case carts with bays for sealedcontainers can decrease the need for shelf space and aid in transportingsurgical devices.
"Anunclean item used in surgery is as dangerous as a loaded gun," says BerthaLitzky, PhD, microbiology. Most healthcare workers recognize the importance ofproperly and expeditiously cleaning surgical devices. Not only instrumentationbut also sterilization case systems must be easy to clean. Furthermore,sterilization itself is a risky business, as nocosomial infections remain aserious healthcare concern. There are no absolute rules when it comes tosterility assurance: sterility is a statistical concept. Healthcare workers andmanufacturers need to join together to provide solutions for the sterilizationof medical devices. This team should evaluate the cost savings associated withthe use of sealed containers, such as avoiding the additional expense of linenor disposable material, reprocessing, and labor to wrap trays at their site whenconsidering the cost involved in the purchase of sealed containers. This doesnot include the cost of replacing torn wrap or the repair or replacement expenseof damaged instruments or the loss of time due to inadequate labeling.
Nancy Chobin, RN, clinical educator, has recognized the need to standardizeand simplify instrument sets using a team approach. "Sooner or laterhospitals are going to find out that garbage in, garbage out--the way nurses arecoming in and out. We have all these traveling people. They don't know oursystems. The doctors get frustrated because the nurse doesn't know what hewants, and it sets up a vicious cycle." Our primary concern as healthcareproviders and medical device manufacturers must be the need to deliver properquality care with the greatest margin of safety for the patient rather thanworrying about the cost to our immediate bottom line.
Marcia Frieze, MS, is the CEO of Case Medical, Inc. (Ridgefield, NJ) andKerrye Allen, RN, is the OR and CS Manager at the University of Tennessee, Bowld.