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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 116
Loaner Instrumentation
[Reprinted from Communiqué: January/February 2011]

Most Central Sterile Supply Departments (CSSDs) routinely process loaner instrumentation. Technology changes rapidly and, as the cost of instrumentation increases, hospitals frequently elect to borrow rather than purchase instruments and sets. Vendors that supply the instruments generally do not charge for their use because the facility purchases the required products, such as spine and joint implants, and passes the charges on to the patients for whom they were obtained. Traditionally, loaner instruments were primarily used for orthopedic procedures; however, they are increasingly used in surgeries involving the cardiac, urinary, and almost every other bodily system. With the ever-evolving complexity of modern surgical instrumentation it is increasingly important that CSSD managers implement a comprehensive program to process and monitor loaner instruments.

Objective 1: Discuss the importance of preplanning for loaner instrumentation

Whenever possible, the receipt of loaner instrumentation should be planned in advance. A CSSD representative should be designated to routinely review future surgery schedules and identify those requiring loaner instruments. In some larger hospitals this individual also orders the necessary instrumentation. If the facility uses many loaners, the schedule review process should occur at least several days in advance. This will allow for staffing adjustments to accommodate the extra work or, at least, to plan for heavier workloads on the days the instrumentation is received, used and returned. Without preplanning for heavy “loaner” days, time may not be available for other routine work if CSSD employees are focused on processing the loaner instrumentation.

Preplanning also allows the facility to contact the vendor if new instrumentation is being ordered for which CSSD staff will require special in-servicing. As well, discussions about sterilization methods and times may also be needed. Inadequate planning for loaner instrumentation, especially that which incorporates new technology, can cause a case delay or cancellation and significant frustration for Operating Room (OR) and CSSD staff.

Some neurological items may require processing techniques not commonly used in the United States. For example, higher sterilizer temperatures, extended sterilization times, and harsher cleaning chemicals are frequently recommended when processing these items. Advance knowledge of these requirements can help avoid surgical schedule delays, and the physician can be notified in advance of potential problems and product changes, if any, that must be made.

Be sure to plan the delivery schedule to allow sufficient time to properly process the instrumentation because loaner trays must be cleaned, assembled and sterilized, and a biological indicator must be incubated and read prior to use. Receipt of the loaner items 24 to 48 hours prior to use, depending on the volume of trays and the standard work load expected, should allow for processing and any unexpected problems, such as a wet load or a positive biological indicator.

Objective 2: Review procedures to receive loaner instrumentation

Loaner instrumentation may be transported to the facility in several different ways. The best method is personal delivery by the vendor’s representative. He/she knows the instrumentation and processing procedures, and can answer many questions posed by CSSD personnel and OR personnel (including physicians). Other shipping methods include:

• Next-day delivery carriers (for sets shipped from out of state)
• Common courier or public taxi services
• A private courier service provided by staff trained in delivery protocols by the instrument vendor.

A careful inventory of each set should be done as soon as the sets are received in the CSSD. This should be done by a trained CSSD employee and the vendor representative working with a detailed and itemized set listing. Each instrument should be verified as present and intact. Any defective or missing items should be noted at this time.

Failure to perform this inventory check can seriously hinder the surgical procedure if damaged or missing instruments are not identified prior to opening for use during the procedure. Loaner instrument replacements are not immediately available, and problems with sets can cause the procedure to be cancelled at the last minute. CSSD employees must immediately notify the OR manager about damaged or missing instruments. Failure to inventory the sets when they are received may also result in the facility paying for lost or damaged instruments that were never received. Assuring that the itemized count sheet reflects the contents of the set allows CSSD technicians to properly assemble the trays after decontamination.

Cleaning and sterilization instructions should be provided in writing. They should then be reviewed, and clarified with the vendor (either in person or by telephone) at this time to ensure complete understanding of processing requirements. Each set should be labeled to identify the exact set, the physician, and the date and time of surgery to enable all necessary trays to be delivered to the correct location on schedule. Arrangements can also be made with the vendor or courier service for return (pick-up) of the loaner sets after the surgical procedure.

Objective 3: Explain procedures to clean, sterilize and distribute sterile loaner instrumentation

All instrumentation should be completely cleaned and decontaminated after receipt. Loaner instruments should never be considered clean when received because their handling prior to receipt is unknown. For example, sets may have been transported in a pickup truck, family van /car, or even via public transportation. Trays may have been placed on the floor or ground, or may not have been properly cleaned after their last use.

Each tray should be carefully inspected and cleaned following the manufacturer’s instructions. Instruments that can be disassembled should be taken apart for cleaning and should be inspected for dried-on debris. Lumens must be cleaned using the appropriate-sized brush. Recommendations for the use of chemicals and dilution and soak times should be carefully and consistently followed because the use of shortcuts will place CSSD and surgical staff and patients at risk.

When placing trays in washer decontaminators, ensure that the lids are removed and that each layer of instruments is separated from the container; this helps ensure that each level of the tray can be cleaned. Some instruments, including robotics, may require special cleaning equipment. If it is not available, the manual processing time is likely to be long, and processing procedures will probably be complex, but they should be carefully followed. Instruments should never be processed using a cart washer without a cycle specific to cleaning the instrumentation. Ensure that the tray identification placed with the sets remains with them throughout this process. Always remember that improper cleaning will impede the sterilization process, so time and care is needed to ensure that each instrument is properly cleaned.

After cleaning, each instrument should be carefully inspected for cleanliness. Reassemble instruments as necessary and confirm they are functioning properly. Follow the manufacturer’s instructions because some instruments may require difficult and multi-step processes for correct reassembly. Ensure that the loaner instruments are placed in the proper container and in the proper graphic slot, if applicable. Do not modify the basic tray set-up because the manufacturer will have validated the sterilization process according to the original tray configuration. Note: Changing it will not allow for faster sterilization times because the facility will have to verify the new tray configuration.

All containers should be dry prior to sterilization and be sure to retain identification information with each tray. Load the sterilizer carefully without overloading the chamber. It is easy to forget the need for adequate space between each tray, and the technicians must be mindful of the total metal mass going into the chamber when sterilization processing volumes increase. Loading may require a few additional minutes, and additional loads may need to be run, but the chances of successful sterilization and no wet sets are greatly increased when these protocols are followed. Rushing this process may require instrumentation to be reprocessed because of wet trays or unacceptable response of internal chemical integrators. Remember that OR personnel cannot flash sterilize these trays due to the complexity of instrumentation and the size of the trays.

A biological indicator should be run in each load in case an item in the set is used as an implant. Ensure the sterilization parameters recommended by the manufacturer are appropriately set and monitored. When the cycle is completed, sterilization parameters should be carefully verified, and the instruments should be allowed to cool. Biological indicators should be incubated as soon as possible, and the results should be carefully documented. Trays containing implants should not be released prior to the final reading of the biological indicator. Depending on the type of sterilization method used, this could be 24 hours after completion of the sterilization cycle.

Loaner instruments should be staged for delivery after they have been properly cooled. CSSD personnel should carefully check each set to ensure the wrap, locks and external indicators are in the proper condition before the sets are delivered. Sets should be placed in the delivery cart while being careful to keep each case separated by patient/surgeon or procedure. Carts should be labeled with the same information as the sets to allow for fast identification. Arrangements should be made with OR personnel to ensure the items are delivered on time and to the appropriate room or other receipt area. Note: Some facilities place loaner trays on a wire storage rack, and the vendor then sorts, stages and delivers them.

Opened trays should be delivered to the decontamination area as soon as the case is completed. As with all used instruments, gross blood and debris should be removed in the OR by the surgical team at the sterile field. Instruments should be kept moist utilizing enzymes, surfactants or a damp towel while in transit to the CSSD department.

Instruments should be processed following the same manufacturer’s instructions that were used when the loaner instruments were received. Instruments that can be dissembled should be disassembled. Each instrument should be carefully checked to ensure gross soil has been removed prior to mechanical cleaning. Orthopedic instruments should be checked for bone and cement fragments that may have been imbedded. If neurological, spinal or ophthalmic instruments have been exposed or potentially exposed to a prion disease, special processing procedures must be followed.

Objective 4: Summarize protocols to return loaner instrumentation

Cleaned trays should be checked for cleanliness and functionality and to ensure that all instruments are present before they are returned. If trays are being returned by a public delivery service, all trays should be accounted for and verified with the delivery service. This method of return usually does not permit an itemized check but, rather, only a count of the number of trays.

Pick-up by the vendor’s representative is the return system of choice. Each cleaned tray can then be carefully checked to ensure that all items are intact and available. Note: Trays returned unopened from the OR should have the wrap removed or locks broken before they leave the CSSD department.

In Conclusion

Loaner instrumentation processes can be very time consuming and cumbersome for CSSD personnel. Multi-disciplinary policies and procedures should be developed to ensure a process that meets the needs of the patient, OR, CSSD and vendor personnel. Planning to ensure sufficient time to properly process, deliver and retrieve loaner instruments is essential. Careful attention is also required to assure adequate inservice training and the availability of the proper equipment to process these complex sets.

References:

International Association of Healthcare Central Service Materiel Management. Central Service Technical Manual. Seventh Edition. Chicago, IL. IAHCSMM. 2007. See Chapter 12.

ANSI/AAMI ST79:2010. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. See sections 5,6,7,8, and 10.

CRCST 116 QUIZ