Reducing the Risks Associated With Loaner Instrumentation and Implants
Article Outline
- Abstract
- Reasons for Borrowing
- Key Challenges
- Policy Development
- Protocols and Procedures
- Specific Processing Concerns
- Summary
- Examination. Continuing Education Program
- Learner Evaluation. Continuing Education Program
- References
- Biography
- Copyright
Abstract
Surgical facilities borrow specialty surgical instrumentation and implants from vendors and other facilities to provide needed inventory to perform scheduled procedures without the burden of purchasing these items. Borrowing has many advantages, including reduced costs and the ability to expand services offered, but borrowed items must be handled and processed in a consistent way to ensure safe patient care. Instruments and implants must be received in time to be properly reprocessed by the borrowing facility. Lack of planning on the part of a hospital or vendor, lack of communication, lack of appropriate policies to guide the processing of items, increasingly complex instrumentation, and increasing workloads are factors that can contribute to lapses in processing requirements and, ultimately, risk to patients and staff members. Improving communication and policies and procedures can improve the quality and safety of loaner instrumentation and implant use.
Key words: loaner instrumentation, loaner implants, instrument safety, instrument processing, sterilization, sterile processing department
Today's health care facilities routinely borrow specialty surgical instrumentation and implants (ie, loaner items), a practice that increasingly concerns many perioperative professionals because it presents potential risks to patients and staff members. Perioperative professionals who loan or borrow surgical items must consistently manage the process to ensure safe patient care. The ability to borrow devices to care for patients has benefits; however, health care facilities have an ethical responsibility to ensure that these devices are free of contamination and are appropriately processed at the time of use.1 In addition, national initiatives to reduce health care-associated infections (HAIs), including surgical site infections (SSIs), require that health care professionals provide safe instruments and implants for patients.
Reasons for Borrowing
There are a variety of reasons why borrowing instruments from vendors or neighboring health care facilities is on the rise.
Key Challenges
Many challenges are associated with the management of loaner instrumentation. In some facilities, dealing with loaner items is a daily struggle that can have a profound effect on the department personnel's productivity.
Lack of Planning and Communication
Scheduling, planning, and communication between the surgeons, OR and SPD staff members, and vendors regarding the need for loaner items may be inadequate to allow for efficient and effective processing of the devices in a timely manner. In some cases, the vendor may have only one or two sets of specific instruments available to loan. If those sets are in use when requested, then the vendor may not be able to deliver the devices the day before the procedure at the borrowing facility is scheduled. This can be as frustrating to the vendor as it is to facility personnel who requested the instruments.
Insufficient Reprocessing Time
On receipt, “All loaner instruments should be considered contaminated and delivered directly to the decontamination area for processing.”2(p469) Providing safe instruments and implants necessitates that all loaner items be delivered to the health care facility with sufficient time so that they can be properly reprocessed by the borrowing facility.3 Unfortunately, vendors frequently deliver loaner items to the health care facility just before the scheduled procedure (Figure 1); thus, loaner items may arrive at the user facility with insufficient time for them to be appropriately cleaned, inspected, inventoried, wrapped, sterilized, cooled, documented, and tracked to the patient according to published standards and recommended practices. This can result in staff members rushing to process the instrument trays, which often leads to missed steps or errors in reprocessing. If items are not properly cleaned, then they cannot be adequately sterilized; this puts patients at risk. Inadequate decontamination processes also place the health care worker at risk. Personnel may be tempted to cut corners by flash sterilizing devices in a misguided attempt to meet department needs. “Flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process.”2(p461)

Figure 1.
Example of a borrowed set of instruments arriving in need of inspection, decontamination, and sterilization.
Additional Workload
For the most part, loaner items consist of multiple instrument trays (Figure 2). Borrowing instrument sets for several procedures can dramatically increase the workload of already busy SPD personnel. When loaner items arrive, more often than not, the loaner items become the priority in the decontamination, packaging, and sterilization areas. Because of the volume of loaner items, personnel may have to put aside other departmental duties to process the loaner items correctly. Sterile-processing personnel also must take the time to acquire or complete necessary documentation (eg, inventory sheets, manufacturer reprocessing instructions) when instrument trays do not arrive with these items.

Figure 2.
Receiving multiple sets with instruments that may require different types of processing can result in an increased workload for employees.
Complex Instrumentation
Advancing surgical technology often makes borrowed surgical instruments complex to process and use. The instrumentation may be unfamiliar to SPD personnel and, thus, necessitate following detailed reprocessing instructions. Complex devices often require difficult, multistep cleaning, disassembling, and packaging, as well as extended sterilization and drying times.
Heavy Loads
Specialty trays (eg, orthopedic trays) tend to be heavy; thus, SPD personnel may need to separate or reconfigure the containers or packaging (Figure 3). The complexity, heavy metal mass, and required containment devices may necessitate sterilization parameters beyond the normal cycle times. Repackaging may be required to make tray weight more manageable.
Monitoring
Sterilization monitoring is crucial. If trays contain implants, they must be monitored with a biological indicator (BI) and not released for use until the result of the BI is available.2 If the trays are new to the facility (eg, borrowed from a new source), testing and verification of sterilization also should be performed.
Inspection and Inventory
Personnel should visually inspect each instrument or device in the loaner trays and inventory the tray for completeness. Loaner items, however, are frequently delivered without instructions, inventory lists, or a complete description or picture of the devices. Without a completed inventory list, it is difficult to determine whether the set was complete when delivered. If the set is not inventoried before the procedure begins, then missing or damaged items can become a concern during the procedure. If personnel do not return all borrowed items to the vendor or other health care facility, then the borrowing organization may be charged for the missing items.
Policy Development
In an effort to reduce the risks associated with loaner items (eg, SSIs, HAIs) health care facility personnel should develop a standardized, thorough system for handling loaner instruments, implants, and equipment. A successful loaner management system begins with a well-written multidisciplinary policy. The policy should be intradepartmental and developed in concert with all stakeholders (eg, surgeons; personnel from the OR and SPD; personnel from the infection prevention and control, risk management, quality, safety, and purchasing departments).
The procedures delineated in the policy should include
In addition to itemizing specific responsibilities and procedure steps, the policy should address how department personnel will handle policy enforcement and what controls are in place for monitoring policy adherence. The increasing volume and mounting concerns with borrowed items has been the driving force behind the creation of many professional recommendations and guidelines.
ASHCSP and IAHCSMM Guidelines
In 1995, the American Society of Healthcare Central Service Professionals (ASHCSP) and the International Association of Healthcare Central Service Materiel Management (IAHCSMM) published a joint position paper on effectively managing loaner instrumentation and implants. These organizations revised the position paper in 2004 to reflect current reprocessing recommendations and to give better guidance on the management of loaner devices.4 This updated position paper is a useful guideline for health care personnel in establishing policies and procedures on management of loaner instrumentation and surgical implants and can be accessed at http://www.ashcsp.org/pdfs/ASHCSP-IAHCSMMLoanerPaper.pdf. The IAHCSMM also provides a loaner instrumentation guideline in The Central Services Technician Manual.5 The chapter on complex surgical instruments identifies the basic protocols important at each step in the management of loaner items.
AORN Recommended Practices
AORN directly addresses loaner instrumentation in two current recommended practices. “Recommended practices for cleaning and care of surgical instruments and powered equipment” states, “Borrowed or consigned (ie, loaner) instruments should be examined, cleaned, and sterilized by the receiving health care organization before use, according to manufacturers' written instructions.”3(p422) “Recommended practices for sterilization in the perioperative practice setting” states, “A formalized program between health care organizations and health care industry representatives should be established for the receipt and use of loaner instrumentation.”2(p468)
AAMI Recommendations
The Steam Sterilization Hospital Practices Working Group of the Association for the Advancement of Medical Instrumentation (AAMI) developed the recommendation titled Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities.6 This recommendation was approved and accepted by the American National Standards Institute (ANSI) and is known as ANSI/AAMI ST79:2006, A1:2008 and A1:2009. Sterilization professionals refer to this document as AAMI ST79. The purpose of AAMI ST79 is to give guidance in the steam sterilization of products in health care facilities as well as the maintenance of the sterility of processed items until they are used.6
Section 5.2.1 of AAMI ST79 discusses the need for policies and procedures relating to the receipt of purchased or loaner items:
When loaner items are delivered to the receiving area, personnel should document that, according to the packing slip, the correct number of packages has been received. Under no circumstances should the packages be opened. The packaged items, along with any instructions for use, should be delivered to the Central Service processing/decontamination area as soon as possible.6(p36)
Section 10.9 of AAMI ST79 addresses the need for periodic product testing of processed items:Quality assurance testing of routinely processed items representing a product family should be performed on an ongoing basis. A program should be established to periodically test routinely sterilized products. Before newly purchased or loaner sets are placed into routine use, they should be evaluated to determine if the existing product testing is applicable to these sets. If the existing product testing is applicable, then the sterilization cycle used for the applicable product family should be used for the new or loaner set. If the existing product testing is not applicable to these sets, then product testing should be performed before they are placed into routine use.6(p110)
Step-by-step instructions for product testing within facilities can be found in AAMI ST79 sections 10.9 and 10.10.Protocols and Procedures
After the development team members have created the policy, they should share it with all involved parties, including surgeons, vendors, and personnel in neighboring facilities. Communicating facility expectations clearly beforehand will help participants understand their roles and how to comply with the policy. To ensure compliance, involved department staff members must create methods to monitor the process and to report and act on failures. Partnerships built on mutual trust and collaboration between personnel in the OR and SPD, surgeons, and vendors must be developed as part of the management plan for loaner items.
Perioperative Personnel
“The safety of patients undergoing operative or other invasive procedures is the primary responsibility of the perioperative registered nurse.”7(p1) Perioperative professionals must ensure that surgical items are free of contamination at the time of use to minimize patient risks of developing SSIs. Perioperative nurses, therefore, should be well versed in the facility's policies and procedures regarding the management of borrowed or consigned instruments and implants. A key component of communication is informing SPD personnel about loaner instrumentation needs as soon as possible. When personnel make arrangements to borrow instruments, they should notify SPD personnel about any specific processing required, including but not limited to:
Vendors
Vendors should be informed of the time requirements for pre- and postprocedure processing. Loaner items should arrive in sufficient time to be completely reprocessed by the receiving facility. Many facilities require borrowed items to arrive 24 to 48 hours before the scheduled procedure. Vendors should be expected to
SPD Personnel
Knowing what items will be coming in will allow the SPD personnel to efficiently plan for handling these devices. In most cases, SPD personnel are responsible for reprocessing and managing loaner items; accordingly, these personnel should be educated and knowledgeable in all aspects of the loaner procedures and practices.4
Loaner instrumentation can arrive at health care facilities in a variety of ways. Many of the transport methods are uncontrolled environments in which the integrity of the package may or may not have been protected during handling and transportation. If items arrive at the facility already wrapped or packaged, they should be opened and reprocessed according to the manufacturer's written recommendations.3
When evaluating loaner sets, SPD personnel should consider specific characteristics such as design configuration, number of components, materials of construction, size, need for disassembly, surface finish or texture, and the presence of lumens and/or mated surfaces to see if these characteristics fit an existing product family. Sterile-processing department personnel should have available and consult reprocessing instructions provided in writing by the manufacturer. If the loaner set characteristics do not match an existing product family, then the organization should establish a new product family with the loaner set as the master of that family product. Medical device manufacturers can be consulted to assist with the identification of the product family and master product considerations.6(p110)
Sterile processing personnel are responsible for monitoring the cleaning and sterilization process, as well as documenting those processes. All items should be traceable to the patient for whom they were used.2, 6 After the surgical or invasive procedure is completed, the borrowed instruments should be disassembled, cleaned, and decontaminated. Staff members should verify that all loaner instruments are accounted for and are in good working condition. Any discrepancies should be reported and documented.4 The SPD personnel should return the borrowed instruments to the person designated as responsible for returning them to the vendor or supplier. Personnel should document the date, time, and signature of processing individual, and these records should be maintained by the borrowing facility.4
Specific Processing Concerns
Many instruments require specific handling and can be damaged by improper cleaning and processing. Other concerns include the weight of the instrument sets, the processing of implants, and the use of flash sterilization.
Manufacturers' Instructions
The ANSI/AAMI ST79 recommends that devices be labeled and that the labels identify “specific methods of cleaning and sterilization that have been validated by the manufacturer.”6(p43) They also recommend that these instructions be kept on file and be available for review and updating. Personnel should contact the manufacturer regarding items without specific label instructions so that the manufacturer can provide a recommended method of cleaning and processing.6(p43)
Complex instruments sets often require extended exposure times. Instead of the typical sterilization exposure times of four minutes at 270° F (132° C) in a prevacuum cycle, some sets are only validated for longer sterilization exposure times, such as five, eight, 10, 18, or 20 minutes. If a shorter than recommended exposure time is used, then the items may not be sterile. These extended exposure times are necessary for both terminal and flash sterilization.
Instrument Set Weights
Instrument sets that are excessively heavy may compromise sterilization and drying time, and may cause injuries to health care workers who must handle them. For this reason, both AORN and AAMI recommend the total weight of instrument sets should not exceed 25 lb, including the contents, containment method(s), and packaging.6, 8 Loaner trays weighing in excess of 25 lb should be reconfigured or reorganized to decrease the weight of each tray to 25 lb or less.
Implants
Implants present another set of concerns because they “are foreign bodies and they increase the risk of surgical site infection.”2(p463) Every sterilizer load that contains an implant must be monitored with a BI inside of a process challenge device (ie, a test pack), along with a Class 5 chemical integrating indicator. Implants should not be released until the results of the BI have been confirmed to be negative for microbial growth.2, 6 If an implant must be released before the results of the BI are known, then this medical exception should be documented. An example of the AAMI ST79 implant log is given in Figure 4, and an example of an exception form published in AAMI ST79 Annex L is given in Figure 5.6
To address growing industry concerns related to loaner items, the International Association of Healthcare Central Service Materiel Management has developed a dedicated multidisciplinary committee called the Orthopedic Council. The council membership includes participants from AORN, the Association for the Advancement of Medical Instrumentation, the Association for Professionals in Infection Control and Epidemiology, the Orthopedic Surgical Manufacturer's Association, and an orthopedic surgeon, and is chaired by a member of the International Association of Healthcare Central Service Materiel Management.1, 2 The Orthopedic Council's goals include:
Facilities can benefit from this work by having a standard policy to follow and an avenue to address issues and concerns related to loaner instrumentation.

Figure 4.
Example of documentation required for premature release of implants based on the Association for the Advancement of Medical Instrumentation's Annex L Implantable Load Record.
It is vital that documentation of all methods of sterilization be fully traceable to the patient for whom the implants are used. To track the implants to the patient, documentation of the cycle information and monitoring results should be maintained by the facility (ie, the SPD or OR, depending on who sterilized the implant) in an electronic or manual log.2, 6 The implant log and exception form show how to properly record exceptions to the normal sterilization process and provide the institution with the ability to track implants and instruments.
Flash Sterilization
Arranging for the loaner items to arrive at least the day before the scheduled procedure will decrease the need to rush the decontamination process and the need for flash sterilization. A proper decontamination removes bioburden and prepares items for sterilization. When personnel are rushed or improperly trained, failures in this process occur, and these “Failures in instrument cleaning have resulted in transmission of infections.”2(469) If items must be sterilized by the flash method, then they should receive the same decontamination processes as items that receive terminal sterilization, and the device manufacturer's written instructions for cycle type, exposure times, and temperature should be followed.2, 6 Flash sterilization “should not be used for implantable devices except in cases of emergency when no other option is available.”2(p463) If personnel must flash sterilize an implant, then they should run a rapid action BI with a Class 5 chemical indicator with the load. Perioperative personnel should quarantine the implant on a sterile back table in the OR and not use it until the results of the rapid-action BI are known.2
Summary
The use and management of loaner instrumentation is a growing concern for many health care professionals. Loaner instrumentation and implant use enables health care facilities to provide adequate services to patients and reduce costs; however, it also represents risks to health care personnel and patients if these instruments and implants are not properly handled and processed by vendors, hospitals, and SPD and perioperative personnel. Addressing the tracking, processing, and sterilization concerns of loaner implants and instruments by developing an intradepartmental policy and monitoring that policy for compliance is instrumental in decreasing the risks of HAIs and SSIs and promoting optimal patient outcomes.
Examination. Continuing Education Program
Reducing the Risks Associated With Loaner Instrumentation and Implants
PURPOSE/GOAL
To educate perioperative nurses about processing and use of loaner instrumentation and implants.
OBJECTIVES
The Examination and Learner Evaluation are printed here for your convenience. To receive continuing education credit, you must complete the Examination and Learner Evaluation online at http://www.aorn.org/CE.
QuestionsThe behavioral objectives and examination for this program were prepared by Helen Starbuck Pashley, RN, MA, CNOR, clinical editor, with consultation from Susan Bakewell, RN, MS, BC, director, Center for Perioperative Education. Ms Pashley and Ms Bakewell have no declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
Learner Evaluation. Continuing Education Program
Reducing the Risks Associated With Loaner Instrumentation and Implants
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References
- . Loaner instrumentation: keeping patient safety first!. Managing Infection Control. 2007;7(4):78–92
- Recommended practices for sterilization in the perioperative practice setting. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2010;p. 457–480
- Recommended practices for cleaning and care of surgical instruments and powered equipment. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2010;p. 421–445
- . http://www.ashcsp.org/pdfs/ASHCSP-IAHCSMMLoanerPaper.pdfAccessed April 22, 2010
- Complex surgical instruments. In: Central Service Technician Manual. 7th ed.. Chicago, IL: International Association of Healthcare Central Service Materiel Management; 2007;p. 197–235
- . Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. In: Arlington, VA: Association for the Advancement of Medical Instrumentation; 2009;
- . http://www.aorn.org/PracticeResources/AORNPositionStatements/Position_PatientSafety/Accessed April 22, 2010
- Recommended practices for selection and use of packaging systems for sterilization. In: Perioperative Standards and Recommended Practices. Denver, CO: AORN, Inc; 2010;p. 447–456
Rose Seavey, RN, BS, MBA, CNOR, ACSP, is the president/CEO of Seavey Healthcare Consulting, Inc, and a former director of the sterile processing department at The Children's Hospital, Denver, CO. As the president/CEO of Seavey Healthcare Consulting, a consultant for Getinge, USA; 3M Healthcare; Ultra Clean, Inc; Steris Corporation; Symmetry Medical; Medline; Key Surgical; and the Millennium Surgical Corporation, and a stockholder in Ultra Clean Systems, Inc, Ms Seavey has declared affiliations that could be perceived as posing potential conflicts of interest in the publication of this article.
- 1 Williamson J. New committee aims to ease orthopedic set concerns. Healthcare Purch News. 2009;33(10):33-35.
- 2 Informing and Industry: IAHCSMM expands member offerings, targets orthopedic set challenges. OR Today. 2009;9(10):14-15.
- 3 International Association of Healthcare Central Service Materiel Management. Complex surgical instruments. In: Central Service Technician Manual. 7th ed. Chicago, IL: International Association of Healthcare Central Service Materiel Management; 2007:197-235.
indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article, reviewing the purpose/goal and objectives, and completing the online Examination and Learner Evaluation at http://www.aorn.org/CE. The contact hours for this article expire September 30, 2013.
PII: S0001-2092(10)00663-0
doi:10.1016/j.aorn.2009.12.032
© 2010 AORN, Inc. Published by Elsevier Inc. All rights reserved.


