Growing up, I became quite the horror movie buff. I recall Lon Chaney as the Wolfman, roaming the moors in search of his next victim, and Bela Lugosi’s Count Dracula who would strike fear in the hearts of Transylvanians – and moviegoers alike. And who can forget Boris Karloff and his menacing character Frankenstein who, with bolts in his head and his rigid arms outstretched, would lumber through the countryside like some sort of maniacal monster?
While each of these movies and the characters portrayed in them were unique, they all had one thing in common: the shrill, piercing scream from a beautiful actress, followed by a fight scene with her love interest, the leading man. Typically, the man would be knocked out or otherwise incapacitated, as his love was whisked away by the monster. In the end, though, the “bad guys” lost the fight – thanks to garlic necklaces, wooden stakes, fire and a silver bullet. If only it were that simple.
As I’ve grown into adulthood, I’ve discovered another “monster” of sorts that evokes fear, madness and, in some cases, shrieks and hand-wringing from central sterile supply department (CSSD) professionals across the United States. This monster’s name? Loaner Instrumentation.
Having traveled across the country consulting and speaking, I am truly amazed at the visceral reactions I get from the mere mention of loaner instrumentation. The CSSD professionals with whom I’ve spoken have raised a number of questions and concerns about managing the loaner process – from receipt and decontamination to preparation, sterilization, storage and, ultimately, the loaner tray’s return to the vendor.
At my previous facility, St. David’s Medical Center in Austin, Texas, our department processed nearly 22,000 loaner trays in 2009 alone. As one might imagine, this had a significant impact on our day-to-day operations. As challenging as our own situation was, we certainly weren’t alone. CSSD professionals are routinely challenged with backlogs of instrumentation due to equipment capacity and productivity constraints. These individuals often find that their washers and sterilizers are inadequate in their ability to handle the additional instrumentation, and, beyond that, existing staff cannot keep up with the burgeoning workload caused by loaner trays.
Although loaner instrumentation is, indeed, a significant challenge, the good news is – if managed effectively through policies and procedures, planning, collaboration and hard work – the daunting function can transition from horror story to action adventure.
The Ins and Outs of Loaner Receipt
The first loaner-related challenge comes as the sets arrive at the facility. Make no mistake, it’s this very step that can make or break a CSSD’s loaner instrumentation success.
Collaboration with operating room staff (including surgeons) and sales representatives is at the heart of any good loaner instrumentation program. It’s important that CSSD professionals understand that when these sets enter the facility, that facility is then accepting responsibility for those instruments.
When I speak at seminars, I always ask the question, “When do loaner instruments arrive at your facility?” The answers I hear typically run the gamut of “One hour before a procedure,” “The day of surgery,” “The night before the surgery,” or “Twenty-four to 48 hours prior to a scheduled procedure.” It may come as a surprise to some CSSD professionals, but the correct answer is a minimum of 24 hours and, preferably, 48 hours prior to a scheduled procedure. This is where working with your vendor is imperative. Often, your vendors do not have adequate inventories to provide this amount of service. This presents many problems and challenges; therefore, achieving appropriate inventory levels must be a priority.
As loaner trays enter the facility, they should always be checked in by a CSSD staff member. This inspection should verify that the items are correct and that the correct number of items is present. Missing or inappropriate items should be documented at this time. If there is any question of missing instruments, the CSSD staff members may use a digital camera to visually document the instruments received. The delivery person should log these sets into the facility. A sample log might include arrival date, delivery person name, surgeon name, patient name, surgery date, company name and number of sets, and procedure date and time.
Once all loaner trays have been logged in properly, they can then move on the decontamination process.
Decontamination Due Diligence
As CSSD professionals are aware, decontamination is the single most important step in the sterilization process. If an instrument is not clean, it cannot be sterilized. Because of this step’s critical importance, never trust the decontamination or sterilization process to another facility. All items coming in from the street should be treated accordingly and taken through the entire decontamination and sterilization process in-house.
Manufacturers’ written cleaning instructions must always be followed according to AAMI ST79. Also, with the new Joint Commission standards released in June 2009, surveyors will be verifying that facilities are indeed following manufacturers’ written recommendations. Following decontamination and disinfection, loaner instruments can then move to the inspection and assembly area.
An Eye on Inspection and Assembly
When beginning the inspection and assembly process, CSSD professionals are striving for three things: cleanliness, completeness and functionality. This is the second area where a collaborative effort will pay great dividends. Working closely with the vendor, CSSD staff can have set recipe/count sheets for these sets. In-servicing will also help staff understand how and what each tray/instrument is used. If missing or damaged instruments are discovered during inspection and assembly, staff should contact the appropriate person for resolution at that time. After proper assembly, the instruments are then ready for sterilization.
Promoting Sterilization Quality
After loaner instrumentation has been properly decontaminated, inspected and assembled, it must then be sterilized according to the manufacturer’s written instructions. It is important to note that many loaner instrument sets (vendor trays) require extended exposure to steam sterilization. Always consult manufacturer recommendations before sterilizing any loaner instrumentation. It is the vendor’s responsibility to provide cleaning, decontamination and sterilization instructions to the facility prior to their use of the loaner instrumentation.
It’s also important to recognize that inadequate time from receipt to sterilization can result in increased flash sterilization rates. CSSD managers must ensure that departmental policies and procedures are developed and implemented regarding sterilization parameters that will be used in their facility. This is especially true of flash sterilization, which has come under scrutiny from the Joint Commission. The use of flash sterilization should be kept to a minimum and used in an appropriate, controlled manner. Flash sterilization should be used only when there is insufficient time to process by the preferred wrapped or container method (AORN 2007 675); Insufficient instrument inventory is no longer an acceptable reason for flash sterilization, and implantable devices should not be flash-sterilized (Garner and Favero, 1985; CDC, 2003a, 2003b). All flash sterilization cycles must be monitored, with instrumentation tracked to the appropriate patient.
Challenges of Extended Cycles
With the majority of loaner instrument trays requiring extended exposure to steam sterilization, CSSD professionals have witnessed firsthand how extended cycles have become a detriment to efficiency and sterility assurance.
Extended cycles can backlog washers and sterilizers, which poses a problem for those CSSDs that lack the equipment to handle the additional instrumentation. Devices that are validated for use in normal sterilization cycles may be damaged in extended cycles, so CSSD staff must contact each manufacturer to verify proper sterilization cycle parameters. The barrier characteristics of the sterile packaging may also become compromised in extended cycles, so staff should contact the device manufacturers to verify their validation for extended cycles.
Finally, self-contained biological indicators may not be appropriate for extended cycles. ISO standard 12161 for biological indicators states, “User should not over process the culture medium, as extended sterilization may induce changes that can affect its growth-promoting properties. The ability of culturing medium to promote the growth of low numbers of microorganisms should be demonstrated.”
CSSD professionals should inquire about the testing that the SCBI manufacturer has performed.
Good Policies and Procedures is Imperative
CSSDs must have detailed policies and procedures to ensure that they are providing a clean, sterile and safe product for patients. Loaner instrumentation policies and procedures should address ordering, transport, check-in/receipt, processing, appropriate charging/billing, post-procedure processing, check-out and transport from the facility. Each of these items must be detailed and provide clear guidelines for staff and vendors.
IAHCSMM Orthopedic Council Aids Process
Responding to the needs of its membership, the International Association of Healthcare Central Service Materiel Management (IAHCSMM) has created the Orthopedic Council to help offer real solutions for CSSD professionals around the world. The Council began through the vision and leadership of IAHCSMM past-president Don Gordon, and now has representation from industry and CSSD professionals from various locations, including the U.S., Canada, England and Australia.
Since its inception, the Council has strived for ways to resolve some of the many issues that CSSD departments face every day. As the committee moves forward, it is developing collaborative partnerships with the Association of periOperative Registered Nurses (AORN) and the Orthopedic Surgical Manufacturers Association. The Council will develop standard policies and procedures, work with manufacturers to reduce the number of extended sterilization cycles, look for appropriate container solutions, and become a general resource for its membership.
Under the leadership of Mark Duro, CSSD manager at New England Baptist Hospital, the Council will continue to grow and become an increasingly valuable asset to CSSD professionals around the world.
Loaner instrumentation poses a number of unique complications and challenges that must be carefully addressed by each healthcare facility. The only way that the nightmares associated with loaner instrumentations will end is through the development of a team of stakeholders to assess and address this process, and the development and implementation of meaningful policies and procedures that create a win-win solution for all parties involved.
Above all, it’s essential that all parties involved recognize that behind each and every loaner tray is a patient – a person who, lying under the drapes on a surgical table, is counting on others to do the right thing and not jeopardize their health and safety. It’s our job to be their advocate!
Bob Marrs serves as director of consulting services and field operations for Aesculap.
Association for the Advancement of Medical Instrumentation ST79:2006. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.
International Association of Healthcare Central Service Materiel Management. Infection Prevention and Control. In: Central Service Technical Manual. Lind N, and J. Ninemeier J, eds. 7th edition, page 100. 2007.