Applying AAMI Standards to Real-World SPDs

October 1, 2005

Applying AAMI Standards to Real-World SPDs

By Jennifer Schraag

ICT takes a roundtable approach in examining the challengesand ensuing implications of applying AAMI standards in todaysproduction-driven SPDs.

The Association for the Advancement ofMedical Instrumentation (AAMI) has been at the forefront of developing standardsfor proper sterilization procedures for more than three decades, but just howwell are AAMIs standards addressing real-world sterile processing departments(SPDs), and are these standards truly practical and doable? We asked someindustry experts their opinion on the topic.

In my opinion, Id say were doing an excellent job asfar as producing documents that are becoming our American national standards forend users to follow, says Chuck Hughes, general manager/educator with SPSMedical Supply Corp. Hughes currently serves on 10 AAMI sterilization workinggroup committees. I think they are very practical and thats reinforced bythe end users that are involved with the AAMI standards and contributeaggressively to the documentation.

Speaking of being involved, Linda Clement, BSM, CRST,consulting service manager of STERIS Corp., says AAMI would benefit highly frommore such participation. I think the AAMI committee members who work on theuser documents do a great job focusing on the real world challenges insterile processing. Although I think the working groups could greatly benefitfrom more user participation actual SPD managers, technicians, etc. There isa small number of users who work in healthcare institutions and consistentlyattend and participate in the meetings, she states.

Hughes says another issue involving the standards and itsensuing compliance has to do with getting the word out. Were doing ahorrible job getting that information out to users, he says. Not everyonecan attend a conference or a seminar. How are we going to be able to reach thosepeople who work in the trenches? Those people who come to work everyday and aregood hardworking individuals, but cannot leave their facility for this kind ofinformation. That really is going to continue to be a challenge over the nextyears in our industry.

Do you notice any particular areas of widespread noncomplianceof the AAMI standards? Are there any you feel may have a higher compliance ratethan others?

In consulting with SPD and operating room (OR) AAMIstandards, I have observed the physical environment in SPD areas and flashsterilization in the OR. In the SPD space is rarely adequate. Temperature and humidity levels are frequently outsideacceptable ranges, ventilation and airflow are not within recommended practiceguidelines, and workflow is often inefficient. These issues are primarily aresult of poor department design and lack of awareness by facility management ofthe types of services provided by the department and the volume of items theyprocess. Flash sterilization in the OR is over used and improperly monitoredwith biological and chemical indicators. In addition, record-keeping has often been poor ornon-existent. However, in the past few years I have seen much improvement incompliance with the use of personal protective equipment (PPE) and sterilizationmonitoring and recordkeeping in SPDs.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

Quite a few. Its rare for a facility to receive anextremely high grade from us in terms of full compliance. Generally what we findis that the supervisor that is in charge of the department may be thinking thatcertain aspects are being followed within the department, when in fact peopleare people and they tend to take shortcuts. So, sometimes there is a difference between shifts or therecertainly can be a difference between facilities.

Chuck Hughes, general manager/educator, SPS Medical Supply Corp. and AAMI committee member

Interms of compliance and how well the users are going to comply with AAMI reallydepends on education and how well they know the standards and whether thestandards make sense in the real world.

Marcia Frieze, CEO, Case Medicaland AAMI committee member

Do SPDs commonly have the proper materials to uphold the AAMIstandards or are financial constraints inhibiting absolute compliance?

Many SPDs do not have current copies of AAMI standards orother valuable educational or reference materials in their departments. In addition, SPDs, although extremely important to a hospital,are still often overlooked when it comes to requests for equipment, materials,or human resources. They offer critical support to the largest revenue producingdepartment in the hospital the OR. However, they usually are not high on thepriority list when it comes to allocating financial resources. Without adequatefinancial support, compliance can be prohibitive.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

I think they have the resources, its just a matter ofknowledge and discipline. Once the information is there, its a matter ofdiscipline on whether or not that information is adhered to. Id say ingeneral we do a poor job. Theres a long way to go. Many hospitals, were delighted to see their adherence, butthere are healthcare facilities that are out there that seem to not be payingattention as well.

Chuck Hughes, generalmanager/educator, SPS Medical Supply Corp. and AAMI committee member

EverywhereI have worked, and particularly at St. Josephs, the materials for complianceare readily available. In my previous experience there have been some facilitiesthat lack the appropriate supervisory personnel to adequately maintain absolutecompliance among all staff members which is why we have a supervisor availablefor all shifts and relief lead technicians for those times when we [thesupervisors] are not available.

David John Martin Jr., CRCST,sterile processing evening shift supervisor, St Josephs Hospital and MedicalCenter

Are facilities keeping up with revisions ofthe standards? Do you find this to be another possible financial constraint?

No. Of the hospitals I have consulted with over the pastfew years, some have never heard of AAMI, others have outdated standards, andfew have current standards available in their departments. I think this issue isa combination of lack of awareness and information, and a lack of financialresources.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

Its a combination of things. Theyre not budgeting forthe purchase of these materials and somehow, somewhere, theyre using a fewhundred dollars as an excuse not to purchase them. I still feel it is simplythey do not have the information and that this information is not something thatis completely understood. We do an awful lot of seminars on the AAMI standards and whatwere trying to do is to clarify them or help them to interpret their meaning.One of the things that AAMI complains about is the fact that the informationdoesnt get out there, people arent ordering them, but at the same time Ithink there is a better marketing job that needs to be done, and letting peopleknow there are standards for their specific area. Right now were in themiddle of a major update for sterilization. Customers tend to get somewhat stalled. They dont knowwhether to purchase the current standards or to wait six months to a year topurchase the new standards. That is a bit problematic for the industry.

Chuck Hughes, generalmanager/educator, SPS Medical Supply Corp. and AAMI committee member

Whatarea(s) may be the most challenging of the standards for SPDs to maintain andcontrol compliance?

The most challenging area is processing loaner orthopedictotal joint replacement instruments and other complex medical devices. Theorthopedic instrument sets are extremely heavy and are difficult to dry. Thesesets dont always arrive in the SPD in a timely way to provide adequateprocessing time, which can pressure SPD staff members to cut corners duringprocessing. They also have difficulty acquiring sterilization validationdocumentation from the manufacturer. As surgical technology continues to evolve,more and more complex medical devices are being manufactured and some of thesedevices are extremely difficult to clean or verify their cleanliness.

Additional challenges to standards compliance are:

  • Instructions for processing these types of devices can bedifficult to acquire from the manufacturer.

  • Representatives from the SPD are rarely included in thepurchase planning process to evaluate processing needs and to ensure thatavailable processes and sterilization technologies are available to processthese devices.

  • Thorough product/device trials are not always conductedprior to purchasing a new device.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

I think hospitals are probably doing a good job ofinforming what the policies and procedures are, but they seem to not have theresources to police them or to inspect they are indeed not being done properly. Of course, insome cases, it is very challenging. To quote a good friend of mine, Weretrying to educate a parade. SPDs have the burden of not necessarily having astable workforce, so youre always getting new people and trying to teach themproper policies and procedures to inform them and then inspect that theyveactually followed those procedures it is an ongoing challenge.

Chuck Hughes, general manager/ educator, SPS Medical SupplyCorp. and AAMI committee member

Whatspecific steps can managers take to ensure AAMI compliance?

Managers should ensure that they have a copy of the mostcurrent AAMI standards in their department and review them routinely. For new managers with little or no sterile processingexperience, national CS professional organizations and their local chapteraffiliates can provide valuable educational materials and certification programsto assist in acquiring basic and ongoing knowledge of sterile processingpractices. Vendors also provide a wide variety of educational offerings fromeducational videos, self-paced study guides, clinical support, consultingservices, and regional seminars to support best practices and standardscompliance.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

Get out of their office. Manage by wandering around.Sometimes its good to get out and stir the pot and look over peoplesshoulders and ask them questions. Nothing in my opinion takes the place ofmanagement by wandering around and jumping in and doing hands-on with the staffand observing first hand. As managers and supervisors, we inform but are weinspecting? The old expression, seeing is believing, still applies in thisenvironment.

Chuck Hughes, general manager/educator, SPS Medical SupplyCorp. and AAMI committee member

Be involved!Schedule time to work with the staff regularly. Our management team recognizesthe strengths and the areas for improvement in all of our staff members and ourprocesses. We use mistakes made as opportunities for growth and awareness, notfor punishment. It is amazing to see the difference this makes in productivityand in the staff making their own decision to do the right thing. If you are ona level playing field, and you remove the fear, you will have more opencommunication with your staff and they will be much more comfortable sharing thetruth of what is going on in your department. We have found that celebratinghonesty, not punishing it, provides us with more effective avenues for educatingour staff. If there is ever a time that blatant disregard for compliance isfound or an employee is found to be negligent, the individual is put on acomprehensive development plan of action. Adequate supervisory staff is alwaysessential.

David John Martin Jr., CRCST,sterile processing evening shift supervisor, St Josephs Hospital and MedicalCenter

What measures can regularly be taken ineducating staff on the standards?

AAMI standards review should be incorporated into routinedepartment educational programs. In doing this, all staff members receive consistent andcurrent information regarding standards and this can also be used as a good toolfor department self-assessment of current work practices.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

Have routine educational programs. The more compliantfacilities that I visit actually make time on a weekly basis to in-service.Inservices on a monthly, or even on a weekly, basis should not be limited tojust product inservices, but should include specific standards and servicing. Thats something thats not been readilyavailable.

Chuck Hughes, general manager/educator, SPS Medical SupplyCorp. and AAMI committee member

What can be done toensure all staff is abiding by PPE standards?

Ive seen tremendous improvement in staff compliance withwearing PPE. The most common issue is the availability of appropriate, qualityPPE in decontamination areas. The PPE purchasing decision-making process shouldnot only be cost. PPE must be adequate to ensure the safety of staff membersperforming decontamination activities. I think focusing on educating staffmembers on the importance of PPE in the workplace and the OSHA standardsregarding standard precautions has also increased safety awareness andcompliance among SPD personnel.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

I used to hear from supervisors I just cant get Maryto do it right. OSHA changed that its a violation of federal law ifhealthcare facilities personnel in high risk areas do not provide proper PPE andensure that it is used properly. I think today, the enforcement of proper use of PPE is clearlythere. Chuck Hughes, general manager/educator, SPS Medical SupplyCorp. and AAMI committee member First, educate!Then monitor compliance regularly and re-educate if necessary. Last, ifnoncompliance is an issue for an individual employee they need to be disciplinedusing a comprehensive development plan that outlines what the questionablebehavior is, what the appropriate performance/behavior expectation is, and anopportunity for the employee to determine the best plan of action for themselvesto attain the desired behavior/performance objective. People succeed much moreoften when they get to make their own decisions as to how to best accomplish abehavior/ performance goal.

David John Martin Jr., CRCST,sterile processing evening shift supervisor, St Josephs Hospital and MedicalCenter

How can managers ensure their staff isntcutting corners when the lengthy processes required by the standards go againstthe requirement of staff to be highly productive?

This can be a tall order for SPD managers who workdiligently to comply with standards and recommended practices on a daily basis. Developing a good working relationship with their hospitalinfection control practitioner (ICP) is a good place to begin. ICPs can beinvaluable allies and champions for the SPD when it comes to fighting thesetypes of battles with the many internal customers that SPDs have, such as the ORstaff, who also struggle with a busy surgery schedule, unreasonable roomturnover expectations, demanding surgeons, and insufficient inventories ofsurgical instruments.

Linda Clement, BSM, CRST,consulting service manager, STERIS Corp.

We have increased our dry time from the 20 minute standardto 40 minutes to accommodate the density of the larger consignment trays. We runa rapid readout biological monitor with every steam load to ensure theperformance of each sterilizing cycle and thus assuring the sterility of eachload sterilized. Recommended practice is once a week and with each load ofimplants. We use the STERIS sterilant to decontaminate our fiber optics andheat/pressure sensitive items. The standard suggested is the use of a high-leveldisinfectant.

David John Martin Jr., CRCST,sterile processing evening shift supervisor, St Josephs Hospital and MedicalCenter

Are there any other common concerns relatedto compliance with AAMI standards in SPDs?

Its been in the AAMI standards for quite some time andwill continue to be in the standards that SPD personnel be certified both atthe staff and management level and its unfortunate that a lot of theindustry is waiting for the states to pass it as a law. I really believe theanswer is to simply make that a policy or requirement in each institution andnot wait for big brother to look over your shoulder and tell you to do the rightthing.

Chuck Hughes, generalmanager/educator, SPS Medical Supply Corp. and AAMI committee member

Ourindustry is faced with more challenges than it ever had, like heavy sets,devices with lumens, power equipment, and robotic devices. The mission of AAMIwas to focus on the science of sterilization and of setting standards forsterilizing these newer complex and challenging devices. If we dont addressthe challenge of sterilization and decontamination at AAMI, the healthcarecommunity will not have guidance and realistic standards to follow. I think the beauty of AAMI is that it brings manufacturers andusers together, and people from the scientific community. We may disagree andcome with different perspectives, but in the end there is consensus and everyonecomes to a decision that is in the best interest of the patient.

Marcia Frieze, CEO, Case Medicaland AAMI committee member