Processing Loaner Instruments in an Ambulatory Surgery Center
Article Outline
- Abstract
- Arrival of Loaner Instruments
- Packaging and Sterilization
- Postprocedure Processing
- Conclusion
- Examination
- Answer Sheet
- Learner Evaluation
- References
- Copyright
Abstract
Loaner instruments often do not arrive at receiving facilities in the time frame or the condition that is needed to use them safely. Their cleaning and decontamination status may be unknown. There may be no inventory of what has been loaned or information about processing requirements for the instrument's use. These situations can create problems for both the loaning facility and the receiving facility and must be addressed to reduce costs from damage to or loss of instruments.
The use of documents and checklists to verify the cleaning, decontamination, and sterilization processes used allows ambulatory surgery centers to solve these problems, cut costs, and protect staff members and patients. AORN J 89 (May 2009) 861–866. © AORN, Inc, 2009.
Key words: loaner instruments , instrument processing , instrument cost reduction
Most staff members in hospitals and ambulatory surgery centers (ASCs) have received loaner instruments and equipment that are delivered in less-than-ideal condition. One look can tell the receiving staff member that a trip to decontamination is needed for a thorough inventory, inspection, scrubbing, and sterilization of the instruments so they will be ready for use. The instruments may be obviously contaminated or their cleaning and decontamination status may be unknown. There may be no inventory of what has been loaned or information about processing requirements for use, they may arrive without a container to house them, and they may not arrive within an adequate time frame to facilitate proper processing. Unfortunately, these problems have become commonplace in hospitals and ASCs.
The increase in the number of ASCs, the corresponding increase in procedures scheduled, and the increasing sophistication of procedures being performed in these centers requires more specialized instrumentation. Purchasing instruments to accommodate these procedures can strain the budget in any type of health care facility; using loaner instruments is one solution to decrease costs. Along with that benefit is the burden of taking proper care of these instruments meticulously so that the quality of patient care is maintained. In addition, protocols must be in place for preparing instruments for return to the manufacturer's representative or the loaning facility.
Arrival of Loaner Instruments
The Association for the Advancement of Medical Instrumentation (AAMI) and AORN have recommendations and guidelines for the control of loaner instruments, and AORN's Perioperative Nursing Data Set provides interventions specifically to ensure that aseptic technique is followed in regard to loaner instrumentation.1, 2, 3 The process begins when the instruments or equipment arrive and includes the handling and processing of newly manufactured loaner items (ie, loaned from a manufacturer rather than another medical facility). All shipping cartons should be received outside patient care areas. External shipping boxes may have high microbial contamination because of environmental exposure during transport, and they should not be handled in patient care areas to avoid creating a source of contamination.
After checking the packing slip, the person receiving the instruments should check the facility's order form and match it against the invoice accompanying the instruments to make sure that the correct items have arrived. The person receiving the instruments also should ensure that the manufacturer's instructions for use and an inventory list have been included. The receiving person then sends the instruments and processing instructions to the sterile processing department where personnel inventory the instruments and equipment and document what has arrived. This can be accomplished by using a loaner instrument and equipment inventory checklist (Table 1). Each item must be accounted for and its presence transcribed onto an instrument count sheet to be sent with the instruments for processing and then forwarded to the OR. Inspecting the shipment ensures that there are no obvious instrument defects and that damage did not occur during shipment.
Table 1. Loaner Instrument and Equipment Inventory Checklist
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Conditions during transport are unknown. How the instruments were last cleaned and decontaminated also is unknown. Surprises such as debris on the instrument are best identified in the decontamination room, not during surgery (Figure 1, Figure 2). Personnel must sort the instruments, disassemble all moving parts, and inspect the instruments for defects to ensure their proper working order. Decontamination before sterilization also is necessary to remove bioburden that may be present from previous use and to remove substances such as oils and lubricants that can remain on items during the manufacturing process. Personnel involved in handling and cleaning surgical instruments and devices must wear personal protective equipment (PPE), consisting of an impervious gown, nitrile gloves, head cover, and face mask with eye shield or face mask with goggles during this process, as the presence of bloodborne pathogens must be assumed.
Figure 1.
Loaner instrument that arrived dirty.
Figure 2.
Dirty swabs from lumens of loaner instruments.
Loaner instruments should arrive at least 48 hours before the scheduled procedure. Instruments may become damaged during transport from facility to facility, instruments may be missing parts, or they may require special cleaning and sterilization. Any instruments that are found to be damaged on arrival must be replaced and their condition documented. Damaged instruments cannot be used and must be returned to the loaner facility or manufacturer. Devices with lumens or ports may present challenges because they can require special cleaning agents and devices to adequately clean them. A variety of brushes with different sized bristles are needed to ensure contact with the inside lumens. Sometimes even the tiniest brush will not fit through a lumen; a syringe and needle can be used to flush the lumen in these situations.
Cotton swabs also help clean hard-to-reach places. Friction is needed to loosen soil. Power equipment often requires special attention.4, 5 The manufacturer's instructions must be checked to see if the equipment can be immersed in water or cleaning solutions. Some pieces of power equipment may require special cleaning agents that are not immediately available. The earlier the loaner instruments and equipment arrive, the sooner problems or handling issues can be resolved.
Instruments and their sterilizing containers or trays also must be treated with cleaning agents recommended by the device manufacturer after sorting and decontamination. Personnel must open, soak, wash, rinse, and dry the instruments and their containers or trays. Manual cleaning may be the only cleaning process available, and personnel should use a “three-sink method” to wash, rinse, and put the instruments through a final rinse.5 An automatic washer or ultrasonic or manual cleaning may be used individually or in combination during this process.
Separating sharp instruments from other instruments is essential to minimize the risk of injury to personnel. When loaner instruments arrive the morning of surgery or are required because of an “add-on” case, the OR schedule should be adjusted if at all possible, and the procedure postponed for a minimum of five hours to allow time to process the instruments. This time frame may vary depending on the number of loaner trays received and the sterilization parameters required.
Although the implant trays may be loaned, the facility purchases any implants (eg, plates, screws) that are used and then returns the rest of the set. If implant sets are to be sterilized, a process challenge device that contains a biological indicator (BI) must be included with the implant set and the results obtained before the set or implant is released.1 If the set must be used before the BI results are available, a premature release form must be completed. This form ensures that staff members can trace the implant to the specific patient on whom it was used; when the BI results are available, the results can be documented accordingly. If a loaner implant tray is not received in a timely manner or an emergency occurs requiring use of the implant before routine sterilization can be accomplished, flash sterilization may be necessary. This is less than ideal. AORN's “Recommended practices for sterilization in the perioperative practice setting” states, “Flash sterilization should not be used as a substitute for sufficient instrument inventory.”2(p651) This includes loaner instruments or implants that are delivered late. Emergency situations allowing premature release and flash sterilization should be defined in the facility's policies.
Packaging and Sterilization
Central processing personnel must dry, organize, and return cleaned and decontaminated instruments to their sterilizing containers and follow the manufacturer's instructions for sterilizing. If loaner instrumentation is being received for the first time, the sterilizing containers must be validated before sterilization (ie, tested specifically for use in the type of sterilizers owned by the facility). If the loaning facility or instrument manufacturer cannot provide proof that the trays have been validated for use in the facility's sterilizers, the instruments must be removed from the incoming instrument sterilization container and placed in a sterilization container owned and validated by the facility.
Implants must have a BI test pack that includes a class V chemical integrator included in the container.1 All loads containing implantable devices should be quarantined until the BI results are known, which can take approximately three hours. An external chemical indicator (CI) (ie, steam sterilizer tape) should be used on the outside of each wrapped tray.1, 2 If the instruments are packed in a rigid container, the container should be closed and a tamper-evident seal with a CI on it should be applied.1, 5 This processed indicator will change color upon exposure to steam. With all proper internal CIs and BIs in place, the trays can be wrapped.
Personnel should apply a label to wrapped trays using a non-toxic marker on the autoclave tape.2 At Bergen Ambulatory Surgery Center (BASC), Saddle Brook, New Jersey, central processing personnel fold the count sheets with the ink facing inside and attach them to the outside of the trays and containers. This prevents any transfer of ink to the instruments or containers (Figure 3). The presence of ink on instruments or containers poses a theoretical risk of a reaction in some patients; therefore, a non-toxic marker should be used.2
Figure 3.
Wrapped instrument tray with count sheet attached.
After they are completely processed and packaged, the loaner instruments can be sterilized. Some surgeries may require the use of four or five instrument trays. These trays in turn may have four or five different sterilization cycle requirements. In addition, power equipment could require extended exposure and drying time.4, 5 Sterilization parameters are one more reason to make every attempt to obtain loaner instruments and equipment as soon as possible.
Postprocedure Processing
All loaner instruments must be inspected, terminally cleaned and decontaminated, and terminally sterilized before they are returned to the lender. Loaner instruments and equipment are cleaned and sterilized using the same protocols that were used before the procedure. Personnel must ensure that all parts are accounted for and an inventory is repeated and documented. After the instruments are cleaned, personnel terminally sterilize the unwrapped instruments. After the instruments have cooled enough to be handled, personnel transport them from the processing room to the area where they are repackaged in their original shipping boxes, if available, and readied for return to the loaner facility.
One final important step is that personnel must document all steps taken to process the instruments. At BASC, personnel complete a form called the Certificate of Decontamination (Table 2). This form documents that all the proper steps have been taken to ensure the delivery of decontaminated instruments. It ensures the loaner facility that the instruments are safe to handle; furthermore, the receiving facility is ensured that there is a reduced risk for the transmission of infectious agents. At BASC, the sterilization record book kept in the central processing department is used to document that all parameters for sterilization were met. The processing person signs his or her name and the representative who claims the instruments also must sign his or her name. If instruments are to be shipped, a copy of the Certificate of Decontamination is included in the shipping container. One important aspect of the form is the notation at the bottom of the page that states “These instruments are NOT suitable for immediate use in a sterile procedure.” Finally, a tag is attached to the instrument trays that says, “Loaner instruments—These instruments are safe to handle but are NOT ready for patient use,” thereby alerting the receiving facility of their status (Figure 4). All documentation is kept in the sterile processing room in a special binder labeled Loaner Instrument and Equipment Inventory Checklist. These records are kept along with all sterilization records for a period of at least one year (Figure 5).
Table 2. Certificate of Decontamination
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Figure 4.
Loaner instruments prepared for return with a red tag alert.
Figure 5.
Central processing staff member documenting in the Loaner Instrument and Equipment Checklist binder.
All health care centers are accountable and responsible for following proper instrument processing protocols. Doing so ensures that transmission of bloodborne pathogens is kept as low as possible and that instrument defects and damage are reduced. This is accomplished by strict adherence to the standards established by the AAMI and AORN.1, 2 Ambulatory surgery facilities have the same responsibility as any facility performing surgical interventions to follow proper instrument and equipment processing protocol.
Conclusion
At BASC, adhering to the established protocols for processing and sterilizing loaner instruments and equipment and the use of the Certificate of Decontamination has helped us to achieve the goal of ensuring patient safety. The Certificate of Decontamination was presented to the Infection Control Committee. This has helped personnel ensure:
Commitment to handle loaner instruments in an efficient and careful way can ensure better patient care, reduced costs for institutions, and improved patient and employee safety.
Examination
Processing Loaner Instruments in an Ambulatory Surgery Center
Purpose/GoalTo educate perioperative nurses about guidelines for processing loaner instruments.
Behavioral ObjectivesAfter reading and studying the article on processing loaner instruments in an ambulatory surgery center, nurses will be able to
Answer Sheet
Processing Loaner Instruments in an Ambulatory Surgery Center
Event #09106
Session #1117
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Program offered May 2009; The deadline for this program is May 31, 2012.
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Learner Evaluation
Processing Loaner Instruments in an Ambulatory Surgery Center
This evaluation is used to determine the extent to which this continuing education program met your learning needs. Rate these items on a scale of 1 to 5.
Purpose/GoalTo educate perioperative nurses about using loaner instruments.
ObjectivesTo what extent were the following objectives of this continuing education program achieved?
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References
- ANSI/AAMI ST 79:2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities . Arlington, VA: Association for the Advancement of Medical Instrumentation; 2006;
- Recommended practices for sterilization in the perioperative practice setting . In: Perioperative Standards and Recommended Practices . Denver, CO: AORN, Inc; 2009;p. 641–670
- In: Petersen C editors. Perioperative Nursing Data Set . Rev 2nd ed.. Denver, CO: AORN, Inc; 2007;p. 24–28
- Recommended practices for cleaning and care of surgical instruments and powered equipment . In: Perioperative Standards and Recommended Practices . Denver, CO: AORN, Inc; 2009;p. 611–635
- Chobin N. Release criteria for implants. Presented at: A Program for Ambulatory Care Facilities—Infection Control and Sterilization Standards; June 3–4, 2009; Somerset, NJ.
New! Complete this CE activity online at aorn.org/CE
indicates that continuing education contact hours are available for this activity. Earn the contact hours by reading this article and taking the examination on pages 867–868 and then completing the answer sheet and learner evaluation on pages 869–870. The contact hours for this article expire May 31, 2012.The 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 potential conflicts of interest in publishing this article.This program meets criteria for CNOR and CRNFA recertification, as well as other continuing education requirements.AORN is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation.AORN recognizes this activity as continuing education for registered nurses. This recognition does not imply that AORN or the American Nurses Credentialing Center approves or endorses products mentioned in the activity.AORN is provider-approved by the California Board of Registered Nursing, Provider Number CEP 13019. Check with your state board of nursing for acceptance of this activity for relicensure.
PII: S0001-2092(09)00106-9
doi:10.1016/j.aorn.2009.02.002
© 2009 AORN, Inc. Published by Elsevier Inc All rights reserved.
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