INSTRUMENT ISSUES IN

Scientific research and technological progress are constantly changing the face of medicine. As the pace of these changes continues to increase, the pressure on healthcare workers to keep up has never been greater. As new medical and surgical instruments come into play, the sterile processing department (SPD) must correctly prepare these tools for use while ensuring that they are safe for use on patients.

As some of the newer instrument sets become increasingly heavy, sterilization practices can be impacted. Many of the instrument and medical device manufacturers are requiring extended cycle times, says Linda Clement, BSM, CRCST, consulting services manager for the Sterile Processing Division of STERIS Corporation. As a sterilizer manufacturer, we recommend minimum sterilization times based on what we test for, and those times are almost in the minority now. There are so many different recommendations from device manufacturers our SterilTek division has compiled a database of processing instructions for about 1,200 medical devices. Among these, there are 142 different sterilization parameters for prevacuum wrapped cycles alone! Its very difficult for technicians and managers to get a handle on that and make sure that theyre properly sterilizing these devices.

It also brings up concerns about the monitoring product and the packaging materials; are they able to withstand these extended cycles as well? Clement continues. If you have other items in a load that dont require those times, does it affect them? This is a really hot topic and these instructions arent always readily available. Sometimes you really have to work with the device manufacturers to get the information you need.

Certainly there is a lot of controversy about tray weights; they seem to be getting heavier and heavier, and that makes it difficult for everyone in the sterilization field, says Laurie Clark, product technical manager, Kimberly-Clark Health Care. Our packaging has to stand up to heavier trays, the sterilizers have to sterilize heavier trays, the people doing the processing have to lift heavier trays, so its a big issue.

Clement points out that sterilizer manufacturers typically test their machines with sets weighing 16 to 17 pounds, but actual sets used in healthcare facilities may now be much heavier. Some of these sets are weighing in excess of 25 pounds, so that makes processing these sets a real challenge, she says. From our standpoint, you need to do your own internal verification testing to make sure that youre still achieving sterility within these sets. There are many challenges out there as technology improves and there are so many more medical devices and configurations of instrument sets. Especially with the aging population and the high number of total joint replacement procedures that are done now.

While the internal verification process is vital for every SPD, Clement notes that it can be overlooked. Many SPD professionals arent even aware that they need to be doing this type of testing, she says. AAMI (the Association for the Advancement of Medical Instrumentation) spells out how to do it pretty clearly, but there are a lot of departments that dont even have current AAMI standards. In my job I do assessments of sterile processing departments, so I try to provide that kind of education when Im there. I think its just a matter of awareness.

Clement adds that the verification process is not always an easy thing to do. You actually have to sacrifice an instrument set; the verification requires putting monitoring devices inside the tray, and then at the end of the cycle, taking out the biological and chemical indicators and incubating the biologicals. If a specialty set comes into the department the morning or the night before a case and you need to have it ready, youre not going to know the results of the verification testing prior to using the set, so that gets a little tricky.

According to AAMI, all steam sterilizers should be tested using biological indicators (BIs) upon installation and routinely thereafter to ensure their effectiveness in sterilizing medical and surgical items.¹ The AAMI standard also specifies that all steam sterilizers should be tested using BIs after relocation, sterilizer malfunctions, major repairs, and sterilization process failures. When any variable of a sterilization process is outside of its acceptable limits, a sterilization cycle always should be regarded as unsatisfactory, regardless of the results obtained from BIs. BIs provide evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores.

AAMI explains that a BI test pack should consist of 16 clean, preconditioned, reusable huck or absorbent surgical towels that are in good condition, each approximately 16 inches by 26 inches.² Each towel is folded lengthwise into thirds and then folded widthwise in the middle, and then the towels are placed one on top of another, with folds opposite each other, to form a stack that is approximately 9 inches wide, 9 inches long, and 6 inches high.

One or more BIs are placed between the eighth and ninth towels in the approximate center of the pack. If chemical indicators are used, they should be placed adjacent to the BI(s). AAMI also notes that a wrapper should not be used for the test pack. Commercially available disposable test packs should only be used if they are backed by scientific experiments. Manufacturers of disposable test packs should provide written information giving instructions for the use, storage, handling, and testing of their products.

Clark mentions that loaner instruments constitute another prominent issue in the industry. Do they get there in time, and is everything in there? Sometimes it can be a challenge to get processing instructions from the device manufacturers, she says. It can be a delicate balancing act to make sure that items are ordered from the company thats providing them in time for the hospital to correctly process and sterilize the set and have it available when its needed. Sometimes procedures get added and cancelled at the last minute, and when you talk about trying to get loaner instrumentation in, thats obviously a more complicated process than if youve got it yourself. The issue is that some of these sets are very expensive and some hospitals cant afford to purchase them, or many of them.

The need to manage loaner instrumentation and implants has been addressed by the American Society for Healthcare Central Service Professionals (ASHCSP) and the International Association of Central Service Materiel Management (IAHCSMM). The associations adopted the following positions:³

• A partnership must be developed between the vendor, central service, and operating room. This partnership must be built on mutual trust and collaboration. Healthcare facilities should provide vendors with information regarding time requirements for pre-procedure and post-procedure processing, and these time requirements should be adhered to by the vendors. Vendors should be able to provide specific instructions for any flash sterilization that may be required. Central service should keep a record of each set that is used, including time in and out, and other processing specifics 

• There should be policies and procedures, created in collaboration with vendors and/ or other healthcare facilities, to address the systematic management of loaner instrumentation and implants from acquisition to disposition. These policies and procedures should include ordering, transport in, check in, pre-procedure processing, charging (if applicable), post-procedure processing, check out, and transport out 

• The designated staff responsible for the management of loaner instruments and implants must be trained and knowledgeable of all aspects of this process The issue of adequate education and training in the SPD is always a concern as well. We certainly understand that education is probably the first thing that is cut from a budget because its usually not seen as value-added in a hospital,

Clement says. We know that it does have value and what the repercussions of not having education are, however. We as a corporation have taken some initiative to provide education programs directly to our customers. We have one-hour presentations that we can do at lunch times or at in-services, either in the OR, sterile processing departments, GI lab, or wherever it may be. We also have one-day seminars for both sterile processing and endoscopy, which are two separate presentations. We did about 28 of those last year; were taking them out regionally so we can conduct education programs in several cities throughout the country and provide an opportunity for people who want a more convenient and economical way to get education. For everything that we provide, we make sure that nursing and sterile processing continuing education units are available as well. We also have many different things available on our Web site we have reference booklets, study guides, published self-study articles, and an educational self-paced video series. Our study guides are free of charge, and these are things people can do at their own pace on their own time.

Clark notes that her company provides many educational opportunities as well, covering various sterile processing issues. We have educational modules at Kimberly-Clark that we publish called ESPs (excellence in sterile processing). Those are available through our Knowledge Network. Customers can go online and request that a representative come in and give them that educational module.

Clement and Clark will be at ASHCSPs 2006 Annual Conference & Exhibition to talk about these and other hot topics in the industry, along with representatives from AAMI and the FDA.

Automatic Washers

Stephen Kovach, director of education, Healthmark Industries, emphasizes the importance of understanding medical automated washers and verifying their performance. Just like with sterilizers or any other process youre using, you do need to verify that its working properly, he says. Im a former CS manager, and when I started 25 years ago, people just thought, Put the item in the machine and it comes out clean. Theres actually a lot more to it than that.

In terms of validating automated washers, Kovach explains that until 1999, there werent many commercial products available for users. The medical automated washer companies have to provide a way to show that their equipment is cleaning properly, and a lot of it is done in-house, but there are easy ways for the user to make sure the washer is working. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) states that all medical equipment must be maintained, tested, and inspected. Joint Commission doesnt tell you with what, how, or how often, but they say it must be done. Users have to look at their own processes and find out what they need to do. AAMI guidelines say that there should be a quality system that calls for the decontamination processing parameters to be monitored and documented. Again they dont specify how to do this, how frequently to do it, or with what, but they say you should be doing this and then leave it up to the user. There are many tools for this.

Kovach cites seven critical factors for the automated washer, and adds that how these factors interact with each other is important. The factors are:

• Instrument design what is the instrument youre going to clean? Is it cannulated? Does it have to be taken apart?

• Soil what type of soil will be seen on these instruments? A product must be used that is targeted to that soil 

• Water quality from pH to water hardness. The label claims on the detergents will state that concentration depends on pH and water hardness 

• Temperature the temperature changes at different stages of cleaning 

• Chemical activity what is being used; an enzyme, a neutral pH, or an alkaline detergent?

• Mechanical action are the spray arms working? For example, the arms have holes for the water to come out of; what if two of them are blocked? This could compromise the functionality and efficiency of the washer 

• The human factor training and loading are two of the components. The equipment may be working correctly, but if the instruments are loaded improperly, they will not get exposed to the cleaning solution 

If you have a quality process, youll do a lot better, Kovach contends. Another example your detergent generally comes in barrels or containers. Every day youre using detergent, and one of the biggest failures is the pump dispenser [on the washer]. If you just draw a line every day on your container to see how much is used, and if that line doesnt move the next day or doesnt move as much as its supposed to, you know you have an issue with the amount of concentration going in. Its that simple -- putting a line on a container. Cleaning the screens every shift is also vital; not every day, but every shift. These things are part of the process in decontam they need to be done every time.

There are many potential errors that can occur during the loading process, Kovach explains. For example, sending a tray through while its in a container with the lid still on and the instruments inside. Even though there are some holes, the instruments are not going to be exposed. The other one is instrument companies recommend that items with box locks be opened. Some people leave the box-lock instruments closed and lay them on top of each other. How is the cleaning solution going to get exposed in those areas if they are closed?

For the decontamination process, Kovach suggests that facilities should have written competencies that staff members review each year. They should be able to demonstrate that they know how to clean items manually, load the automated washer, and use the sonic, for example. Regardless of how old the equipment is, you should have the manufacturer come in and conduct an in-service on how the equipment works, yearly at a minimum. People forget, and if you have new people they are taught by someone else. Have that company come and do that, and if you have multiple shifts, have them come in during more than one shift; they need to be there when your staff is there. Have them back every year. There could be upgrades to the machine and its always good to get that third party in and reinforce your policies on what needs to be done and how to use the equipment the right way, and what better way than from the manufacturer?

Kovach acknowledges that the increasing complexity of instruments and sets presents challenges on the decontamination side of things as well as the sterilization side. AAMI has a document that basically says the manufacturers have to supply information to the end user on how to clean and sterilize the item.⁴ The information is there; people just have to request it. One instrument manufacturer might say you can only sonic this item, or you have to use a certain type of manual detergent in a certain pH range. People need to be aware of that. The manufacturer will tell you if disassembly is required or not, which is also very important. With the new instruments, you need to make sure you get the correct information on cleaning and sterilization from the manufacturer.

The sheer volume of instrument-specific information may be difficult to organize and access for some departments. Kovach notes that instrument tracking systems may be useful in this respect. You can track your instruments, but some systems also have all the decontamination instructions as well as pictures. There are programs out there that can help you. As you move more toward computer-based information, you can enter competencies, you can have instructions on how to take the instrument apart, how it should be cleaned, and how it should be reassembled for sterilization. It all ties in, and it makes it easier. All the information for the instrument can be loaded into the computer and accessed at any time. Its a very practical way to do it. This costs money, of course, but I have a saying: Quality doesnt cost it pays. If you put the quality in, it will pay off in the long run, and thats why I believe in a quality improvement process for everything, especially for the medical automated washer.

In addition to AAMI and JCAHO guidelines, Kovach points to a new ASTM document as well.⁵ This was peer reviewed, and its a guide for blood cleaning efficacy of detergents and washer/ disinfectors. This guide is based on a standard test soil correlating to coagulated blood, and the guide strictly deals with cleaning. It tells you how this test can be used to make sure an automated washer is working correctly. People need to look at what theyre doing and how they can better do their jobs, and this helps them do that. When something fails, does the product help you solve the problem? This is very important, and it takes work. If you havent been testing and verifying and you think somethings been working and now its not, it takes time to solve that.

The market is dynamic, and this area is dynamic; its going to keep moving and advancing, and people need to be aware of the latest scientific information and back what they do with good research and information, Kovach continues. Just buying something because its cheaper doesnt necessarily save you anything. If you want to get the best product, you really have to do your homework, and thats something I think has changed in the past 15 years or so. Technology has advanced so much and there are so many new products; people really need to look at that.

He stresses the importance of industry conferences and meetings in this respect. Going to the meetings and listening to the speakers is important, but probably the most important thing that takes place is the networking that happens outside of the presentations. The valuable information that is exchanged at these meetings is probably the reason everyone should be able to get to them somehow. Whether national or local, I feel people really need to get out and go to them. All the meetings are important.

Kovach will be at ASHCSPs 2006 Annual Conference & Exhibition to share more information on automatic washers and the decontamination process. 

References:

1. ANSI/AAMI ST46:2002. Steam sterilization and sterility assurance in health care facilities.

2. Ibid.

3. ASHCSP/IAHCSMM position paper on loaner instrumentation. http://www.ashcsp.org/ashcsp/news/Joint%20paper%20on%20loaner%20instruments.pdf   

4. AAMI TIR12:2004. Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers.

5. ASTM D7225-06. Standard Guide for Blood Cleaning Efficiency of Detergents and Washer- Disinfectors.