Loaner instrumentation: processing the unknown

Thomas G. Winthrop

Use of loaned surgical instruments has become standard practice in many of today's hospitals because of high instrument costs and rapidly developing technological advances in surgical instrumentation. The American Society for Healthcare Central Service Professionals and the International Association of Healthcare Central Service Materiel Management recently issued a joint position statement on loaner instrumentation. (1) The statement addresses the need to develop standard operating procedures for the acquisition, accountability, and disposition of loaner instruments.

In most practice settings, staff members assume that all instruments or instrument sets coming into a facility will need to be reprocessed according to institutional policy. This does not mean, however, that a facility expects to receive contaminated instruments routinely. In fact, facilities expect all instruments to be thoroughly decontaminated before they arrive.

Walter Reed Army Medical Center, Washington, DC, receives or has on hand as "in-house loaners" (ie, instruments sets owned by the vendor or company but loaned to the hospital for a contractually agreed upon time period) approximately 300 instrument sets every month. These sets either are brought by a vendor representative or are sent directly from the vendor's headquarters. Sets that come from vendors' headquarters are assumed to be meticulously reprocessed, while those coming from a vendor representative may have been decontaminated just before delivery to the next facility.

COMPLICATIONS OF PROCESSING LOANER INSTRUMENTS

The issue of reprocessing loaner instruments has implications for infection control and patient, employee, and vendor safety because of the rise of multidrug resistant organisms, Creutzfeldt-Jakob disease, and bioterrorism threats. The question to ask when considering reprocessing loaner instrumentation is whether the sets have been properly decontaminated before they are issued to the next user. Many times, a procedure involving loaner instrumentation goes late, and the set may get a cursory wipe down or may be run through a flash sterilization cycle before being given to the vendor representative or courier. The set is then transported to the next facility where it may be received in any number of places including the logistics department, hospital front desk, OR, or central processing department, depending on time constraints and the courier's or vendor representative's familiarity with the institution. Additionally, many institutions do not perform quality improvement checks on the initial decontamination process other than a visual inspection before assembly. This may occur at both the lending and receiving facilities.

Each of these scenarios presents an infection control issue that may or may not be known to the hospital's infection control committee. To the untrained eye, these instruments may appear to be clean and to pose no health risk. Further, there is no documentation to say whether the instrumentation has been decontaminated and by what process.

THE PROJECT

Central processing department personnel at Walter Reed Army Medical Center conducted a two-month project to determine whether loaner instruments that came into the facility actually had been decontaminated. This included checking hard-to-clean instruments, especially cannulated reamers and drills. The loaner instrumentation was delivered in one of three ways:

* in shipping containers not marked as biohazardous material (Figure 1),

* in instrument cases that could be sterilized, or

* as loose instrumentation without any case or covering.

[FIGURE 1 OMITTED]

Some of the instruments coming from the vendor processing facility had sterilization indicators in each pan but were not accompanied by paperwork that indicated the method and parameters of the decontamination process.

Each set received was annotated as to its origin and whether it was delivered by a vendor representative or sent from the company's main distribution center. A visual inspection was performed first followed by a chemical test for blood residue.

The test kit came in a protective pouch that contained an indicator vial with a transparent cap, an activator vial with a green cap, and a cotton swab. If an instrument was wet, it was swabbed vigorously with the dry cotton swab. If the instrument was dry, the swab was moistened with a drop of clean, non-chlorinated water, and the sample area was swabbed vigorously (Figure 2).

[FIGURE 2 OMITTED]

The central processing employee then opened the indicator vial, which contained the liquid medium that reacts to the presence of blood, and transferred the liquid to the activator vial. He or she then placed the sample swab into the liquid in the vial, capped the vial and shook it at least five times, and observed the swab for 30 seconds. A color change of the liquid to blue-green indicated blood residue on the tested surface (Figure 3). In the presence of a large amount of blood, the entire quantity of indicator solution would change to dark blue. Tests were recorded on a tracking form as either negative (ie, clear); positive (ie, blue-green); or strongly positive (ie, dark blue). The name of the vendor company, type of instrument set, and type of instrument swabbed also were recorded.

[FIGURE 3 OMITTED]

All staff members were educated about the project including personnel working off-shifts. This was of particular importance because, in theory, those sets coming in later in the day had a higher probability of being contaminated because they were more likely to have been used in a procedure at another facility earlier that same day. The pressure to meet deadlines for delivery to another facility may increase the risk of less-than-optimal decontamination.

Of the 139 sets tested during the two months, 23 (16.5%) tested positive for blood residue. Even more informative was that of the 23 contaminated sets, 22 were hand-delivered by vendor representatives and only one set was sent from a main vendor processing facility. Six sets were visibly contaminated.

LOANER INSTRUMENTATION ISSUES

Three issues became apparent during the project. First, although loaner instrumentation is considered contaminated until it is processed by the receiving institution, it is unacceptable to release an instrument from the user institution if it has not been properly decontaminated, for example if a hasty flash sterilization has been performed in the OR or the instruments have simply been rinsed off in the OR decontamination room and given back to a waiting vendor representative. This is a major infection control concern that affects not only hospital organizations but vendors and ancillary personnel who may inadvertently come into contact with possibly contaminated instruments.

Second, the level of quality assurance in the decontamination process at each institution participating in loaner instrument acquisition must be assessed to determine if there is an ongoing quality assurance program checking the efficacy of the decontamination process. The Joint Commission has not mandated specific tests to determine the efficacy of the decontamination process; however, technology has advanced enough to produce reliable, cost-effective methods for testing the decontamination process. Working with the research and education sections of the vendor supplying the facility with enzymatic solutions for both the OR and central processing department enabled central processing department personnel to formulate an approach to quality testing of the decontamination process at a reasonable cost.

Central processing department personnel at Walter Reed Army Medical Center monitor the efficacy of the decontamination process weekly. A recent publication by the Association for the Advancement of Medical Instrumentation outlined the need to validate the decontamination process both for the manufacturer and central processing departments. (2,3) This validation process includes

* testing water Ph,

* testing the temperature for both cold and hot water cycles,

* checking ultrasonic equipment and instrument lumens, and

* checking for blood residue at the end of the decontamination process for both index washers and ultrasonic equipment.

Third, loaner instrumentation concerns affect not only the central processing department but also the OR, as loaner instruments may be delivered to the OR and flash-sterilized without going through a decontamination process when they are needed in an emergency. This may be more prevalent with smaller loan companies that do not possess sufficient inventory to assure timely delivery. The issue then becomes one of enforcing existing standard operating procedures (SOPs) that should require all loaner instrumentation to be processed through the central processing department, especially if the set contains implants that require a spore test before use.

As noted earlier, Walter Reed Army Medical Center maintains a large number of loaner instrument sets in-house. By monitoring loaner usage, it is possible to coordinate with vendors to provide in-house loaner sets based on frequent usage for set periods of time. This is a win-win situation, as the facility may eliminate the cost associated with frequent paperwork and have instant access to instrument sets for emergencies, and the vendor gains an edge over competing companies. This is a viable alternative to the use of loaners since it enables the institution to apply its own standards for decontamination while eliminating the stress of last minute or late deliveries that may jeopardize patient care. This may not be an option, however, if case volume is insufficient to justify having loaner sets in a facility's inventory. Walter Reed Army Medical Center maintains a special section for in-house loaner instruments, which enables personnel to better manage the many sets that may be required for a procedure.

A related issue not addressed in the project was the question "what constitutes loaner instrumentation?" This is of particular interest to ORs as well as surgeons because surgeons may have special instruments that they transport from their offices or from other facilities in which they work. This specialty instrumentation in many instances bypasses the central processing department and is flash sterilized in the OR.

FURTHER STUDY NEEDED

The results of this project indicate that a more centralized and systematic approach to handling loaner instrumentation needs to be in place. These results should be addressed by each institution's surgery, central processing, process improvement, and infection control departments, and meetings should be held to determine how loaner instrumentation will be handled. The practice of a surgeon going from one hospital to another with his or her own instrumentation should be considered under the auspices of a facility's loaner instrumentation guidelines. These guidelines should include not only the International Association of Healthcare Central Service Materiel Management's position statement recommendations but also guidelines that strengthen quality assurance in the decontamination process and mechanisms that coordinate the effective and timely procurement of loaner instrumentation. This involves creating policies that regulate the scheduling of emergency procedures, the release from quarantine of sets containing implants, and the handling and disposition of loaner sets after their use by the facility and before release to the vendor.

The loaner instrumentation issue also needs to be addressed by each hospital's infection control committee as it involves potentially contaminated equipment coming into the hospital on a regular basis. Many loaner sets also may involve electrical generator systems that are processed through the biomedical department first. Although not part of this project's focus, these generators are classified as loaner instruments but may be overlooked in the monitoring process. In many instances, the generators may be positioned near the surgical field and may not be wiped down after the procedure or may be packed up by the vendor representative after use but before the end of the surgical procedure. This violates standard OR cleaning policies that all flat surfaces must be wiped down with disinfectant after surgery.

Many hospital infection control committees may only be aware of the standards for biological testing of sterilization parameters and may not be aware of the loaner instrumentation coming through their doors. Additionally, although many vendors or hospitals may include an indicator in each set, the actual parameters under which decontamination took place are unknown. This is of particular concern if specialty instruments require different parameters for processing. This may include advanced technological instruments as well as power instruments.

RECOMMENDATIONS

A critical recommendation resulting from this project is that all loaner instruments coming from a vendor should be enclosed in biohazard containers. Second, some method of documentation on the decontamination process and quality assurance processes that are used by the institution should be included with each shipment, and designated receiving areas should be well-established by the hospital infection control committee, the central processing section, and the acquisition departments that process the requests. Third, institutions need to clearly define what qualifies as loaner instrumentation and include this in the SOPs for loaner instrumentation. This should be communicated not only to the central processing department and hospital infection control committee but also to the department of surgery so that everyone involved in the process understands the SOPs as well as the need for strict compliance with the standards.

Editor's note: The opinions expressed in this article are those of the authors and do not reflect the official policy or position of the Department of Defense or the US Government.

REFERENCES

(1.) ASHCSP/IAHCSMM position paper on loaner instrumentation. International Association of Healthcare Service Materiel Management. Available at: http://www .iahcsmm.org/current_issues Joint_paper_ loaner_instrumentation.htm. Accessed January 29, 2007.

(2.) Association for the Advancement of Medical Instrumentation. AAMI TIR12: 2004--Designing, Testing, and Labeling. Reusable Medical Devices for Reprocessing in Health Care Facilities: A Guide for Medical Device Manufacturers. Annapolis Junction, Md: Association for the Advancement of Medical Instrumentation; March 28, 2005.

(3.) Basile R, Kovach S. TIR 12: The device preprocessor's bill of rights. Healthcare Purchasing News Online. Available at: http://www.hpnonline.com/inside/December%2005/0512newsmaker1.html. Accessed January 29, 2007.

Lt Col Thomas G. Winthrop, RN, MSN, CNOR, AN, USA, was chief of the Central Materiel Service at Walter Reed Army Medical Center, Washington, DC, at the time this article was written. He currently is the chief nurse, 28th Combat Support Hospital, Mosul, Iraq.

Lt Col Barbara A. Sion, RN, MSN, CNOR, AN, USA, is the head nurse of the Central Materiel Service at Walter Reed Army Medical Center, Washington, DC.

Clifford Gaines, CRCST, is the supervisor and educator for the decontamination section of the Central Materiel Service at Walter Reed Army Medical Center, Washington, DC.

COPYRIGHT 2007 Association of Operating Room Nurses, Inc.
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