On loan: The challenges associated with loaner instrumentation

OR Today Magazine | Cover Story | November 2012

Loaner instrumentation is becoming more and more prevalent in health care facilities today. This is due to a number of different factors, including the need for facilities to increase efficiency and the growing complexity of modern surgical and orthopedic instruments.

Given this, the management of loaner instrumentation and implants has become a hot-button issue among health care professionals. It’s particularly relevant to Central Sterile Supply Department (CSSD) personnel who are responsible for processing, storing and issuing reusable medical instruments. “Loaner instrumentation management is usually one of the top concerns when I go in to do a sterile processing audit,” says Rose Seavey, MBA, BS, RN, CNOR, CRCST, CSPDT, the president and CEO of Seavey Healthcare Consulting, LLC.

What is “loaner instrumentation”?

Loaner instrumentation often consists of multiple trays and many types of instruments and/or implants, Seavey explains. “Some of these items are very complicated or sophisticated devices that are new to the facility. The concern is usually built around the enormous amount of trays CSSD receives and the lack of time they are given to reprocess these trays properly.” Some CSSD personnel are also concerned about receiving loaner instrumentation without thorough manufacturer’s instructions for use (IFUs) for processing, care and handling of the instruments.

Seavey, who is the former Director of the Sterile Processing Department at the Children’s Hospital of Denver, recently worked with the International Association of Healthcare Central Service Materiel Management’s (IAHCSMM) Orthopedic Council in the creation of a Loaner Instrumentation Sample Policy & Procedure and a Position Paper on the Management of Loaner Instrumentation. These were created to help CSSDs meet the challenges of managing loaner instrumentation and implants.

Mark Duro, CRCST, FCS, an IAHCSMM Approved Instructor and the manager of the Central Sterile Processing Department at New England Baptist Hospital, worked closely with Seavey and other members of IAHSCMM’s Orthopedic Council in drafting the sample policy and procedure template. “This first-of-its-kind policy template reflects subject matter associated with loaners, as well as minimal regulatory guidelines, and provides recommendations for creating loaner instrumentation policies and procedures,” says Duro.

Beyond efficiency and technology, Duro lists a number of other reasons for the growing prevalence of loaner instrumentation in hospitals today:
• Insufficient inventory
• Clinical trials
• Patient-specific needs
• Lack of storage space at hospitals
• Multiple cases
• Items/set are missing

“Poor management of loaner instruments and implants can result in disruption to the function of the operating room and CSSD, and poor communication between facilities and vendors can lead to a failed patient outcome,” says Duro. “There is a lot of information that the CSSD staff needs to receive in order to make sure they are able to process instruments and implants correctly.”

Poor loaner instrument and implant management, including last-minute arrivals and the failure to obtain manufacturers’ IFUs, can result in a host of problems for CSSD and OR personnel:
• A lack of processing time, which
can lead to inadequate processing.
• Insufficient processing staff and capacity being available.
• Inability to ensure that implants can be properly monitored.
• Lack of training for staff on how to process sets and work with complex medical devices.
• Unclear labeling and set identification.
• Inability to ensure that all loaned instruments and implants are accounted for.
All of this, Seavey says, can eventually lead to compromises in patient health and safety. “CSSDs need to verify that they can follow the exact IFUs from the manufacturers on how instruments get processed, and then follow these IFUs and not take shortcuts.”

A formalized loaner instrumentation program

Both Seavey and Duro stress that the key to effective management of loaner instrumentation and implants is implementing a formalized loaner instrumentation program that includes specific policies and puts established controls in place to effectively manage borrowed instruments and implants. “Facilities should place an emphasis on developing a standardized, concrete system of loaner management,” says Seavey.

In its Position Paper, IAHCSMM states that “healthcare facilities that borrow surgical instruments should have a welldeveloped loaner program and written policy that establishes standardized receipt and use of all loaner instrumentation. This policy should be established with input from CSSD, OR and various departments such as, Infection Prevention and Control (IPC) Administration, Materials Management, Risk Management (RM), and surgeons.”

Specifically, the IAHCSMM Loaner Instrumentation Sample Policy & Procedure recommends that a loaner instrumentation program include the following:
• Requestingloanerinstrumentation or implant(s).
• Time requirements for pre-procedure and post-procedure processing and in-servicing, as needed.
• Acquisition of loaner items, including a detailed inventory list (preferably with pictures).
• Obtaining FDA-cleared manufacturers’ written instructions for instrument care, cleaning, assembly and sterilization.
• Cleaning, decontaminating and sterilizing borrowed instrumentation by the receiving facility.
• Transporting processed loaner instrumentation to the point of use.
• Post-procedure decontamination, processing and inventory.
• Returning instrumentation to the industry representative.
• Maintaining records of the transactions.

It’s important to note that IAHCSMM is not a standards-making group, so its recommendations are not standards, but rather guidance. “The IAHCSMM Sample Policy & Procedure should be considered a template to provide guidance and help facilities develop their own loaner instrument-related policies and procedures,” says Duro.

In addition, the Association of periOperative Registered Nurses (AORN) has published Recommended Practices on sterilization that recommend that every healthcare organization have a formalized program in place for loaner instruments. According to AORN Director of Evidence-Based Perioperative Practice Lisa Spruce, RN, DNP, ACNS, ACNP, ANP, CNOR, Recommendation XIV in Sterilization outlines the specific steps that should be included in such a program.
“There should be a systematic process set up in advance that details the steps in loaner instrumentation, and central sterile processing personnel should know these steps and be well aware that the manufacturer’s written instructions should be followed,” says Spruce. “Manufacturers’ instructions should always be followed to assure that the instruments are being cleaned and sterilized properly.

“It is the responsibility of the healthcare facility to assure that loaned instruments are sterilized before patient use,” she adds. “Failure to do so could result in the transmission of infectious agents to patients.”

Out in the field

Eva McCullock, RN, BSN, CNOR, the operating room clinical educator at Durham Regional Hospital in Durham, N.C., says that her facility receives loaner instruments without thorough manufacturer’s IFUs no more than five times per month. “When we are notified that a loaner tray will be coming in for a case, we let the vendor know that they must provide cleaning/sterilization parameters for the items.”

All vendor loaner trays must be signed in with a staff member from CSR to verify the quantity and completeness of the tray, McCullock explains. “At this time, the CSR staff member is also to ensure that we have the appropriate parameters for the item.” When loaner trays do arrive without manufacturer’s IFUs, McCullock says they contact the vendor to request that the information be sent to the CSR manager. “We ensure that the vendor understands that the tray will not be processed without the parameters being provided.”

Durham Regional does not accept any sterile trays from other facilities, McCullock adds. “Everything gets opened and sent through our own decontamination/sterilization process.”

Sharon Greene-Golden, MHA, CRCST, FCS, the manager of sterile processing at Bon Secours Mary Immaculate Hospital/ DePaul Medical Center in Hampton Roads, Va., says that her facilities have a standard policy that governs the receipt of instruments. “Our policy states that any instruments being brought into the hospital must be signed in and checked by a vendor in the presence of a SPD for cleanliness. The instrument must then be cleaned in our sterile processing decontamination area and processed by the staff at this facility.”

However, Greene-Golden says that loaner instrumentation at her facility is typically received without IFUs. “We have started requesting that vendors bring in the IFUs with the instruments, or e-mail us the information. The IFUs provide the necessary guidelines for the cleaning, processing and handling of the instruments, so we must have them on hand before instruments can be processed.”