Sterilization equipment. Photo courtesy of Mark Duro
ICT spoke with Mark Duro, CRCST, FCS, chairperson of the IAHCSMM Orthopedic Council and manager of central sterile processing at New England Baptist Hospital, regarding capital equipment and instrument purchasing in the sterile processing department.
Q: Why are the very personnel who process the instruments/trays not necessarily included in facilitys decision-making about equipment purchases? How can they change that?
A: I think in most cases it is simply just not thought of to include CSSD in the decisions making process. It has never been that way in the past so why consider it now? Its important now to ensure CSSD is made aware of any potential purchases. The first thing we need when a product is even considered for evaluation is the manufacturers' instructions for use (IFU). We cant evaluate an item if we dont know how to process it. I know of a facility that made a purchase of new arthroscopy cameras without consulting or involving the CSSD come to find out that they did not have the low temperature sterilization technology available to process the cameras. The facility needed to purchase a low temperature sterilizer to accommodate the processing needs.
In an effort to make this happen having the operating room, materials management and CSSD is key a simple conversation with materials management to ensure when evaluation is going to take place or before a purchase is considered that the IFU be obtained and passed off to CSSD to be looked at to ensure we can comply with the instructions. Also our vendors can help. If a vendor does have a new product they would like to show a surgeon making them aware that we need the IFU ahead of evaluation is helpful. Once a vendor knows we need this they will be aware that it may make the procurement of their product go smoother.
Q: What are some of the critical details that the SPD/CSSD can provide when it comes to making smart purchasing decisions?
A: In some cases facilities may look at extended cycles. When comparing devices, if comparing two similar devices simply choosing one that does not have an extended cycle can be a positive in the decision making. We want to simplify our processes and if we have to add an addition cycle into the ones we already have it creates delay(as we have to change settings and create programs) and the potential for error.
Q: What are some suggestions for determining need, related to capacity, inventory, etc.?
A: CSSD is key in the involvement for determining inventory. CSSD can provide how quickly and efficiently an item can be turned over. We cant assume we can move an item quickly through our decontamination process. It is not as simple as taking the used instrument set and simply putting it into a washer. Some devices require many steps including flushing, brushing, disassembly and sonic. Some IFUs have you repeat the process numerous times. We could receive an item at specific time and it may not see the washer disinfector for up to 20 to 40 minutes.. if all the correct steps have been followed.
I had a brief conversation with Chuck Hughes regarding this at IAHCSMM based off some points he made at the AORN Sterile Processing/Materials Management Specialty Assembly. We were discussing benchmarking and Chuck had a great point that we can say our average turn time in decontamination may be 15 minutes -- but there are devices out there that cannot be done so quickly due to the numerous steps involved. He also mentioned this in his presentation at the FDA summit when he discussed numerous processing steps involved. So it is important for CSSD to be involved. Our turnover time will dictate how many devices we need to purchase and if the item is a major cost it could affect scheduling if additional units cannot be purchased.
Capacity is another issue. The design of trays and cassettes vary in size and shape and not all are made to DIN size specs. We may not have the correct washer manifold rack to accommodate specific items and potentially may have to look at alternative manifold racks. Also if we are purchasing a system how is that going to affect our processing capacity if we containerize these sets(if we can) it will also bog down our capacity and create potential extra steps.
Q: Why must facilities get an idea of the manufacturers IFU before purchase and how much of an impact do IFUs have on departments ability to meet these reprocessing requirements?
A: Getting The IFU is the first and foremost important item of things to do when purchasing new equipment. This will determine if we have the ability to process the item. Some facilities may not have what is needed to clean the item like specific enzymes, detergents, lubricants, cleaning brushes and equipment (sonics, sonic irrigators etc.). Also we must have the IFU for all items we are processing, we need to make sure it is up to date and accurate.
Q: What are some best practices for adding new instrumentation/sets/trays to existing inventory?
A: In a nutshell some things to think about:
IFU needs to be obtained
CSSD involvement to ensure the device can be processed
All items need to be verified and checked to packing slip to ensure items are accounted for and correct
Ensure no items have been damaged
Contact vendor if issues arise
Vendor needs to provide in-servicing (OR and CSSD)
IFU should be available during in-service to clarify any questions or help with interpretation
Discuss problematic or complex instruments that may not be covered in the IFU
Record in-service.(upload to tracking system if possible)
Ensure proper packaging is used (not all items can be containerized)
New product testing should take place. (upload results to tracking if possible)
Upload IFU into tracking(or file)
Upload product testing into tracking
Build recipe or count sheet and upload into tracking(or file)
Program sterilization parameters based off of IFU into tracking system into set(this will ensure it get processed according to IFU).
Program storage location into tracking
Q: Loaner instrumentation can be a nightmare what are some suggestions for dealing with unexpected challenges?
A: I think one of the best ways to dodge some unexpected challenges with Loaner instrumentation is to ensure you have a solid loaner Policy. IAHCSMM Updated its Position Paper and Loaner instrument Policy template. The template is a great way to incorporate all the items you might be missing in your current loaner policy. The intent is to extract what you need or use it as a guide for building a new one. You can find the template here: http://www.iahcsmm.org/CurrentIssues/Loaner_Instrumentation_Position_Paper_Sample_Policy.html
Also, the unexpected with loaners is always an issue. Sometimes situations and emergencies are out of our control but with a policy in place we can better handle our loaner issues. Another way to help control some of the loaners that do not arrive according to your hospitals policy is to publish your loaner policy that can be viewed in your vendor management system so they are aware of the policy to ensure they are compliant with the policy.