CRCST
Technical Continuing Education (TCE)
SELF-STUDY PLANS

This series of self-study lessons on Central Service topics was developed by the International Association of Healthcare Central Service Materiel Management (IAHCSMM). The lessons are administered by Purdue University’s Continuing Education Division.

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Lesson Plan CRCST 89
Loaner Instrumentation and Implants
[Reprinted from Communiqué: July/August 2006]

Many healthcare facilities increasingly use loaner instrumentation and implants to
supplement their own inventories and purchasing resources. As with many other healthcare alternatives, there are some advantages and disadvantages to this practice that generally apply to most facilities, and there are other issues that are specific to each situation. There is no doubt, however, that problems can arise in any facility that does not have effective policies and procedures in place to manage the tracking and processing of instrumentation loaned by other facilities or physicians, or provided by third-party vendors. This topic is so important that the American Society for Healthcare Central Service Professionals (ASHCSP) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) have developed a position paper on loaner
instrumentation.¹ Many of the guidelines and recommend practices suggested in this position paper are noted in this Self-Study Lesson.

Central Service personnel generally have numerous special concerns about the procedures and the protocols under which loaner instruments and implants are managed and controlled. For example, Central Service personnel must frequently process and issue these items within the very short time periods that may occur between receipt of items and when they must be used. Also, tracking and accountability concerns require special handling practices throughout the facility, including the Central Service areas. This Self-Study Lesson provides basic information about best practices to be evaluated as loaner instrumentation and implant processes are developed and implemented.

Objective 1: Explain the concept of loaner instrumentation and the need for the careful management and control of loaned devices.

For numerous reasons, there are times when healthcare facility personnel may need to borrow instrumentation and surgical implants from a specific vendor, or a neighboring facility, for one-time use. Surgeons may also have personal instruments they wish to use and it may sometimes be necessary, or practical and cost-effective, to consign items from vendors for multiple uses. It is important that procedures be in place to control (track) these items. All affected personnel must know and consistently follow procedures for record-keeping, ordering, transport to and from the facility, before and after procedure processing, charging, and loaner instrumentation checkout. In the absence of effective plans and protocols for all of these details, confusion can arise, equipment can be lost and, most importantly, patients, employees, and the facility itself can be placed at unnecessary risk.

Objective 2: Indicate general advantages and disadvantages to the use of loaner instrumentation.

There are both potential advantages and disadvantages for facilities that use loaner instrumentation.2 For example, when loaner or consigned devices are used, purchase and storage costs are eliminated and, if vendors are used, their staff will assume some responsibility for monitoring instrumentation use. This will not, however, diminish the facility's responsibility for proper device processing. Also, upgrades may be made as technology changes, although vendors typically use instruments until they are no longer needed, and the quality of loaner instruments may not be the highest available. The facility may also be able to reduce their required storage space, unless the instrumentation is provided on consignment, in which case the facility's personnel assume responsibility for on-site storage.

Depending upon the applicable agreement, potential disadvantages include the need for the facility to pay shipping costs. Also, users of loaner instrumentation are not likely to have knowledge of, or control over the item's history, including the facility and patient of last use. Two other significant concerns are the potential that loaner items will not be available when needed, and the possibility that, when the items do arrive at the facility, there will not be adequate time for Central Service personnel to properly decontaminate, process, and sterilize the devices before use.

Objective 3: Discuss administrative procedures to effectively manage loaner instrumentation.

Policies and procedures must be in place to manage, control, and track loaner instrumentation and implants from the time they are received until they are returned to the lender. Staff members who are involved in any aspect of this process must be trained in, knowledgeable about, and consistently follow all process requirements. It is always best for policies and procedures to be developed in collaboration with those who loan the instrumentation. Accountability is an important concern, and the responsibilities of both the lender and staff members in the facility receiving loaner instrumentation must be clearly identified.

Specified facility personnel should be responsible to interact directly with designated vendor staff. Central Service employees must be informed about all specifics of each loaner agreement, including the number of instrument trays—or other items to be received—and, in single-use agreements, identification of the
specific surgical case for which loaned items will be used. The time the instrumentation is needed, the method of transportation, and a definite arrival schedule must also be agreed upon. Note: Because of the need for pre-procedure processing, it is especially critical that those providing loaner instrumentation are aware of, and comply with time requirements for delivery of the instrumentation. If the delivery is late and if the instruments are needed quickly, flash sterilization (a less-desirable alternative that is normally used only for dropped devices or other within-operating-room emergencies) may become necessary. Other problems with loaner devices late arriving include the possibility that thorough inspection and cleaning may not be done adequately at the time of processing, and that some items may become unaccounted-for because the tracking system has been compromised.

Methods for transporting loaner devices to and from the facility are important considerations. Ideally, the instrumentation will be packed in secure and impenetrable containers to help reduce the possibility of contamination and damage during transport. Two alternative shipping methods include courier and personal transport by the vendor's representative.

Loaner instrumentation packaging from the vendor should include a shipping list that identifies the devices shipped (including quantities, if applicable) and a copy of the device manufacturer's written handling and processing instructions. If a vendor's representative personally transports an item, he or she should assist with the instrument inventory and check-in. If a representative of the lender is not available at time of check-in, this should be noted on the shipping list in case problems with inventory count occur at time of instrument return. (For example, a notation, "Not responsible for incorrect inventory upon return," may be written on applicable documentation.)

A method for within-facility tracking of each device is required. Tracking begins by
completing an instrumentation receipt log that includes the date and time of receipt, the signature of the staff member receiving the device, the doctor's name, and the specific trays, items, and/or implants included in the shipment. In some facilities, a "no-charge" purchase order number—which reflects the market value of the loaned instruments—is assigned to each loaner device. The instruments are then tracked in the same manner as those owned by the facility. In some facilities, a manual tracking system is used, and the documentation follows the instruments through the facility. Automated systems can also be used. A common method involves the use of bar codes that enable device locations to be identified by a scanning process. More sophisticated systems scan digital photos into the system to provide visual assistance in tracking and identification.³ It is also important that an accurate inventory and tracking system be used to account for consigned items stored at the facility.

Accountability for loaned instrumentation continues after the surgical procedure is
completed. After devices are disassembled, cleaned, and decontaminated, tracking data must be updated. The personnel responsible for returning the instrumentation must indicate the date, time, and method of return transport. The signature of the staff member processing the return helps confirm that the final steps in the tracking process were completed. Ideally, the loaner instruments will be inventoried, with the vendor's representative present, before the items leave the facility. The method of return transport should be agreed-upon, and a copy of the shipping slip, indicating contents of the return package, should be included.

Entry of applicable information into the facility's loaner history tracking system can help determine the frequency of an item's use and should be done when the item arrives. This procedure can help prevent items being used for purposes for which a contract has not been negotiated or which the Food and Drug Administration (FDA) have not approved.⁴ Accurate information about the frequency and type of loaner instrumentation historically used can also help facility officials negotiate
consignment and purchasing agreements.

Objective 4: Review special concerns when handling loaner instrumentation.
Many Central Service processing concerns are best addressed if loaner instrument sets are delivered in a timely manner. Loaner items should be received at the facility by at least the night before a surgical procedure is scheduled, to help assure that thorough inspection and processing can be done.⁵

The manufacturer's processing instructions for each loaner device must be followed
carefully as the item is cleaned, decontaminated and disinfected, processed and sterilized, and as validation and test procedures are performed.

There are numerous basic policies and procedures for handling loaner instrumentation and devices that should always be followed:

• Because all loaner instrumentation should be considered contaminated when it is received, the designated receiving location for most loaner devices should ideally be the processing and decontamination area within the Central Service Department. In some facilities and for some loaner instruments, however, deliveries are made to the facility's Central Receiving area or operating room. It then becomes necessary to transport items after receipt to the Central Service Department's processing and decontamination area. Staff receiving the items should wear personal protective equipment (PPE), including gown and gloves. Note: Sterile implants packaged by the manufacturer should not be received in the decontaminated area. Instead, receiving tasks should be performed in the clean area of Central Service or in the operating room.

Pre-inspection for damage and cleaning of all items—including those that have been wrapped, but not used by other facilities—is important. If problems are noted, accountability documentation should be updated, the supplier of the loaner instruments should be notified, and operating room staff should be alerted if it may cause a surgical procedure to be delayed.

After inspection, complying with the manufacturer's instructions and applicable
facility protocols for cleaning, decontamination and disinfection, processing, storage, and distribution become very important.

While processing procedures differ between facilities, the following guidelines are useful for any facility:

• Instruments should be removed from the shipping package and inspected as soon as possible after delivery. Applicable devices should be cleaned and inspected.

• The wrapped tray containing the loaner devices should be labeled with the doctor's name, day and time of the surgical procedure, number of trays, name of the vendor providing the instruments, and the tray's contents.

• After sterilization and cooling, the loaner devices can be transported to the operating room. Alternatively, a special location ("loaner shelf") may be used to store the items for later use.

Implantable devices should be quarantined after sterilization until biological monitoring results are known. Note: If the necessary quarantine time must be reduced, the sterilization chart and other monitoring data should be analyzed. Documentation is necessary to note the early release of the item, and applicable operating room personnel—including the surgeon—should be notified.
Loaner devices require processing after use and before return. Post-inspection disassembly, cleaning and decontamination, and terminal sterilization with a flash method, or washer-sterilizer for unwrapped devices, following normal facility protocols, are important procedures. Sterilization is important to help prevent human or cross-contamination by facility personnel as items are prepared for return. This practice will also help protect those who transport the items and the employees in other facilities who will next use the devices.

Conclusion

Adequate time is necessary after loaner instrumentation and devices are received to comply with all of the processes required to best assure patient safety and to maximize efforts to manage and control instrumentation while at the facility. The processing of loaner instrumentation should follow the same basic procedures as those used for facility-owned items. To assure accountability, a written agreement between the facility and the lender should be in place to guide all steps involved in ordering, transporting, receiving, on-site processing and use, and return of these items. Fortunately, available guidelines—including the ASHCSP/IAHCSMM Position Paper on Loaner Instrumentation—address many of the concerns that will arise as facility policies, procedures, and protocols are developed.

Endnotes

1. ASHCSP/IAHCSMM Position Paper on Loaner Instrumentation. To view this
   position statement, go to the IAHCSMM Web site, www.iahcsmm.org, type
   "ASHCSP Position Paper" into the site's search box, and click "Enter."
2. Becki Harter. ICRE07 - 0406: Basic Principles of Processing/Reprocessing, Part III. Processing, Reprocessing, Storage, Distribution and Loaner Instrumentation. Infection Control Education Institute. Retrieved from www.iceinstitute.com/ c_basic_principles3.html on 4/10/06.
3. Borrowing Trouble: Loaner Instrumentation Poses Big Challenges – Viewpoint." Healthcare Purchasing News. November, 2003."
4. See Reference 2.
5. See Reference 3.

Additional References:

AAMI – Association for the Advancement of Medical Instrumentation. Steam sterilization and sterility assurance in healthcare facilities. ANSI/AAM ST46: 2002, Arlington, VA: AAMI 2002, American National Standard.

AORN – Association of periOperative Registered Nurses. Recommended practices for sterilization in perioperative practice settings. August 1999 revision. In: AORN Standards, recommended practices, and guidelines. Denver, CO, AORN, 2003.

ASHCSP – American Society of Healthcare Central Service Professionals. Recommended Practices, Section 6—Sterilization, American Hospital Association, Chicago, IL, 2001.

IAHCSMM – International Association of Healthcare Central Service Materiel Management. Central Service Technical Manual, Sixth Edition, Chapter 8, Equipment Management. IAHCSMM, Chicago, IL. 2003.