Author: J. Vincent Sanchez, CRCST | Client Manager

Loaner instrumentation is one of the most challenging aspects of sterile processing. The instruments keep getting more complicated; they arrive in huge batches, often without enough time for reprocessing—and all of this makes it hard to ensure patient safety and proper processing.

Today, we consider some of the common challenges that come with loaner instrumentation, as well as how a modern tracking system can help ensure that loaners are processed properly and only safe, sterile instrumentation is used.

Loaners: Why Do We Need Them?

It should come as no surprise that healthcare facilities routinely borrow instrumentation from vendors. There are a few key reasons for this: [1]

  • Cost: Instrumentation, especially complete sets of neurologic and orthopedic instruments, is often extremely expensive. Some facilities may lack the funds to purchase the instrumentation, or they may not do the procedures that require those instruments frequently enough to justify spending that kind of money.
  • State-of-the-art: As instrument technology develops, surgeons may request access to the latest instrumentation—which the facility may not have unless they request a loaner.
  • Too much demand: Even if a facility purchases one or more instrumentation sets, its caseload may outpace the SPU’s ability to keep up, requiring that loaners be used to fill the gap.

For these reasons, loaner instrumentation won’t be going away anytime soon—and neither will the following challenges.

Arriving on Time

Timely arrival of loaners into Sterile Processing is crucial. The Association for Advancement of Medical Instrumentation (AAMI) recommends that facilities assume every item delivered from the outside is contaminated—so every piece of loaner instrumentation needs to arrive with enough time to complete a full sterility assurance cycle.[3] Regardless of where the loaner items came from and whether or not they were sterilized at the previous facility, the receiving facility must properly decontaminate, assemble, and sterilize the loaner items.

AORN suggest an arrival time of 48 hours prior to the case start time to ensure adequate time not just for preparation and processing, but also to account for any special circumstances or problems, such as special cycle parameters or damaged instruments.[5]

A surgical instrument tracking solution can help enforce arrival time policies by requiring vendor representatives to identify themselves and their trays upon arrival and automatically placing a timestamp on the transaction. This data can then be pulled from the system by management to hold vendors accountable.

Critical Cleanliness

Before instrumentation can be sterilized or used on a patient, it must be clean—but as minimally invasive surgery becomes more common and instrumentation becomes more complex, cleaning instrumentation gets harder.[7] This is particularly true for orthopedic instrumentation, which is often composed of multiple, interlocking pieces which may move once assembled. Some tools can retain pathogens (such as the culprit behind staph infections) even after sterilization because of the way they’re put together, so it’s critical to follow the manufacturer’s instructions—which should include any special reprocessing instructions.[8,9]

A surgical instrument tracking solution can help by providing an interface into instructions for use (IFU) solutions such as OneSOURCE, enabling staff to access IFU documentation on demand.[10]

Accurate Allocation

Loaners often take immediate precedence over other items in the reprocessing cycle,[11] and vendors can bring more sets than are necessary for just-in-case contingencies or evaluations, unnecessarily increasing the workload for the SPU. Any experienced sterile processing technician can attest to the frustration of processing 30 loaner trays for a total hip replacement, only to see 20 go unused. Not only does this waste time and energy, but it also wastes resources, in terms of sterilization tools and equipment and also in terms of the actual borrowed instrumentation.

A surgical instrument tracking solution can help by interfacing with the OR’s surgical scheduling system, enabling technicians to make sure that the only loaners delivered and processed are for scheduled cases. LoanerLink, developed by Censis, goes even further by automating the ordering and check-in process for loaner instrumentation, helping ensure that only surgeon-requested loaner items are delivered, processed, and utilized.[13]

Sterility

Ironically or not, sterility presents the greatest challenge to the Sterile Processing Department when it comes to loaner instrumentation. IFUs should be kept available to staff, because loaner instrumentation sometimes requires special sterilization cycles. Here are a few variables that can impact sterilization processes:

  • Exposure times: Normal surgical instrumentation may only require four minutes of exposure, but loaner sets might require longer exposure times.[14] You might need to separate loaner instrumentation from regular sets and run additional sterilizer loads.
  • Weight of sets: If instrument sets are overweight, they could compromise sterility. Because of this, AAMI recommends a maximum loaner set weight of 25 pounds, including the sterile packaging.[15]
  • Implants: Implantable pieces further complicate sterilization processes—and are of particular concern with orthopedic and spine instruments. A single orthopedic small fragment set may have more than 300 implantable screws and plates, all of which must be thoroughly checked for cleanliness and damage, and properly monitored with a biological indicator to ensure sterility and patient safety.[16] They may also require special handling or processing as outlined in the manufacturer IFUs.
  • Complexity: Complex instruments must be disassembled before sterilization, and failing to do so may prevent them from being properly cleaned (as noted earlier) as well as prevent proper sterilization after assembly

A surgical instrument tracking solution can help by providing access to manufacturers’ IFUs, prompting technicians with reminders and instructions for specific instruments or sets, and ensuring that loaner sets are processed according to the correct parameters and, if necessary, with a biological indicator.

Loaner instrumentation is a sterile processing reality that must be handled properly in order to ensure that patients receive quality care and optimal surgical outcomes. It’s critical that facilities develop policies and procedures that address each of these challenges.

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References
[1]Rose Seavey, RN, BS, MBA, CNOR, ACSP, “Reducing the Risks Associated With Loaner Instrumentation and Implants,”AORN Journal 92, no. 3 (September 2010): 322-323.
[3]ANSI/AAMI ST79:2017 A Comprehensive Guide to Steam Sterilization (Arlington, VA: AAMI, 2017), 30.
5Gloria G. Huter-Kunish, RN, CNOR, CSPDT, “Processing Loaner Instruments in an Ambulatory Surgery Center,” AORN Journal 89, no. 5 (May 2009): 863.
[7]Dayane De Melo Costa et al, “Reprocessing safety issues associated with complex-design orthopaedic loaned surgical instruments and implants,”Injury 49, (2018): 2006.
[8]De Melo Costa et al, p. 2010
[9]Seavey, p. 328
[10]See https://www.onesourcedocs.com/ifu.htm
[11]Seavey, p. 324
[13]See https://www.censis.com/loanerlink/
[15]AAMI, p. 31, 50
[16]Seavey, p. 328
15
AAMI, p. 31, 50
16
Seavey, p. 328

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