Having My Say

On borrowed time:
Caveat emptor with loaner devices

As the educator for a major infection control products company in the United States, I interact with a diverse cross-section of healthcare professionals. During these interactions I am made aware of the latest "hot" topics — issues that everyone in the industry is talking about. Recently, I’ve noticed the "hottest" topic is loaners — the increase in their use and the concerns their use raises for the central service department. These concerns are illustrated in the following questions that have been posed to me:

"How can I verify my sterilization time for these items?"

"How did the company determine that the sterilization time is 30 minutes?"

"This tray has three levels — how can I get the bottom level clean? Do I take the items out of each level?"

"Why didn’t the representative bring the items in earlier? Two hours is not enough time to get them ready."

"These trays do not look clean."

"I didn’t even know loaners were needed for this case — how did they arrive?"

"Should I leave the lid on the trays when they go into the automatic washer?"

"The representative added items to the tray. Do these changes affect how it was validated for sterilization?"

"I have never seen this tray before. How do I clean and sterilize this tray?"

Why have loaners become such a hot topic? What is so frustrating about bringing in a set or sets of surgical (mostly orthopedic) instruments for a case?

A recent AORN Journal ¹ published the following questions from a reader: "Can you provide guidelines for borrowing instruments and equipment? Is using instruments or equipment brought in by a vendor covered by a different set of standards?"

The peer reviewed Journal’s response was summarized in its final two sentences: "The primary responsibility of a perioperative nurse is to protect patients from harm. By facilitating best practices for sterilization of borrowed instruments and equipment, perioperative nurse, will minimize patients’ risks associated with infection."

Hospitals’ perspective

To determine how hospitals obtain loaner instruments for surgical cases and the procedures they follow, I conducted a "snapshot survey" on loaners in December 2005. I emailed the survey to 50 various operating room (O.R.) and central service (CS) professionals and received 26 replies.

For the purposes of this survey, the term "loaner" is defined as a surgical instrument(s) or implant(s) borrowed by the hospital from a vendor for a specific surgical procedure. The instrument or implant must be returned to that vendor after use. (Infusion pumps, specialty beds, etc., were not addressed in this survey.) Below are the questions and the responses I received².

Orthopedic loaner survey

1. Does your hospital use loaners for surgical procedures?

100 percent — Yes

2. Does your hospital have a formal policy and procedure to follow concerning loaner instruments?

88 percent — Yes; 12 percent — No

All of the "No" replies stated they are in the process of developing some kind of policy.

(Please note that questions 3-7 are based on 23 responses — the three hospitals without policies did not respond.)

3. Do you feel the manufacturer of the loaned items provided proper cleaning information?

87 percent — Yes; 13 percent — No

4. Do you feel the manufacturer of the loaned items provided proper sterilization information?

30 percent — Yes; 70 percent — No

5. Do you feel the items that are requested or loaned when received by your staff are clean and safe to handle by staff?

35 percent — Yes; 65 percent — No

6. Do you receive any documentation that the items are clean or what process they underwent to be cleaned by the company before they were received by your hospital?

4 percent — Yes; 96 percent — No

7. Is your hospital policy followed when items are requested and brought into your hospital? (Respondents were asked to indicate what percentage of the time the policy is followed.)

100 percent of the time: 22 percent

80-99 percent of the time: 65 percent

60-79 percent of the time: 9 percent

Less than 60 percent of the time: 4 percent

Respondents were asked to describe some of the situations where the hospital’s policy was not followed. Responses included the following:

"Instruments came in too late."

"They just got the call to bring these items in for a case — arrived less than 24 hours in advance."

"When items are brought into the hospital and go directly to the O.R. instead of CS."

"When the hospital is not involved — event occurs between surgeon and the vendor."

"Weekends."

"Loaner items are not always available day before (in use someplace else)."

"Delivered/shipped to the O.R. directly."

"Surgeon talks directly to the manufacturer rep without communicating to Surgery or CPD
that a loaner will be used on a
specific case."

The survey results support comments I have heard that loaners — most often orthopedic — are a concern for everyone in the hospital, not just central service. There is much confusion among surgeons, O.R. and CS staff, and equipment manufacturers regarding loaners. Part of the problem is a lack of information.

In an effort to determine what information is available to hospitals regarding handling loaned surgical instrumentation, I conducted an Internet search on orthopedic instrument manufacturers.

The responses I found indicated that manufacturers’ information stresses user/hospital responsibility with regard to loaners. (Manufacturers’ names withheld). For example:

Hospital Responsibilities for Company X Loaner Sets:

1) Loaner sets should undergo all steps of decontamination, inspection, and terminal sterilization prior to their return to the sales representative.

2) Missing or damaged instruments from loaner sets should be brought to the attention of the operating room supervisor, to the director of the central supply department, and to the "Company X" representative to ensure that the next hospital will receive a complete set in workable condition.

Company X Representatives’ Responsibilities for Loaner Sets:

1) Ascertain that instrument sets are complete before delivery to, and following return from, the hospital.

2) Make sure that instruments are in good working condition.

3) Replace damaged or missing instruments and spare parts.

4) Take care that instruments are properly immobilized and protected during transit.

5) Inform hospital personnel that care instructions are available." ³

Company Y states the following:

"Health care personnel bear the ultimate responsibility for ensuring that any packaging method or material is suitable for use in sterilization processing and sterility maintenance."

Regarding sterility, Company Y states:

"Users should conduct testing in the health care facility to assure that the conditions essential to sterilization can be achieved and that specific configuration of the container contents is acceptable for the sterilization process and for the requirements at the point of use. ANSI/AAMI ST33: 1996 Guidelines for the Selection and Use of Reusable Rigid Container Systems for Ethylene Oxide Sterilization and Steam Sterilization in Health Care Facilities covers the selection and use of reusable rigid sterilization container systems. Guidelines are provided for cleaning and decontamination, preparation and assembly, sterilizer loading and unloading, matching the container system to the appropriate sterilization cycle, quality assurance, sterile storage, transport, and aseptic use." ⁴

Company Z’s loaners come with the following disclaimer statement:

"The instrument cases will allow sterilization of the contents to occur
in a steam autoclave utilizing a cleaning, sterilization and drying cycle that has been validated by the user
for the equipment and procedures employed at the user facility. Instrument cases do not provide a sterile barrier and must be used in conjunction with a sterilization wrap
to maintain sterility." ⁵

A comment posted on the IAHCSMM Forum regarding the condition of loaner instrument trays supplied by orthopedic companies stated: "As for the ones that are used by the ortho companies... well, they work okay for the most part. The companies themselves don’t seem to do a really good job of keeping them in good shape, the locks are missing on most and the inserts are usually in pretty bad shape." ⁶

Almost unanimously, manufacturers state that it is the hospital’s responsibility to make sure all items are clean and sterile. This then raises the question: Does the hospital verify all of the steps in its process when using loaners? The results of my surveys suggest that in many hospitals a lot of work needs to be done. There is a significant difference between what manufacturers and users think the manufacturer’s role is.

Standards and guidelines for loaners

The majority of U.S. hospitals look to key sources when writing policies: AAMI, AORN, CDC, JCAHO, OSHA, NIOSH, IAHCSMM and ASHCSP.

Although AORN and AAMI do not publish specific guidelines regarding loaned items, many AAMI documents contain sections that can be used when writing policies on loaners. Pertinent sections include:

AAMI guidelines also include references to the American Society for Testing and Materials (ASTM). ASTM International is one of the largest voluntary standards development organizations in the world — a trusted source for technical standards for materials, products, systems, and services. Known for their high technical quality and market relevancy, ASTM International standards have an important role in the information infrastructure that guides design, manufacturing and trade in the global economy.⁷

ASTM standards include:

Similarly, the AORN’s 2006 Recommended Practices contain sections that deal with packaging and tray weight, but lack any specific document pertaining to loaners. Like AAMI, the AORN suggests that manufacturers’ instructions be followed as provided.

ASHCSP’s and IAHCSMM’s joint position paper on loaners addresses many of the relevant concerns.

The National Institute for Occupational Safety and Health (NIOSH) has published information on lifting and provides a formula for calculating two-handed lift tasks. Certainly the lifting of surgical trays would fall into this category.⁸

Although I’ve focused on loaned surgical instruments (basically orthopedic) you cannot overlook that JCAHO requires hospitals to maintain a current inventory of all medical equipment, including rentals and loaned items. Hospitals are required to have a process in place for selecting and acquiring medical equipment. The hospital is responsible for all equipment in patient care areas. Thus, the issue of hospitals having policies regarding loaned surgical instruments falls under possible JCAHO review.

Issues regarding loaned surgical items are not unique to the United States; many countries are addressing these concerns. Canada’s working standard Z314.22-04 is called "Management of loaned, shared, and leased Medical Devices." In Switzerland, an article on how to manage loaned instruments can be found at www.swissmedic.ch. Australia has addressed the topic of loaners from an ergonomic point of view. The findings are available at www.sracansw.org.au/Loan_Sets/loan_ sets.html.

Hospital policies

The "snapshot survey" revealed two concerns — that instruments may not be clean upon arrival and that proper information on cleaning/sterilization is not provided.

Consider the methods used to transport orthopedic loaners into a hospital. The manufacturer’s sales representative usually transports the loaners via his or her car or van. The instruments are loaded into the vehicle, moved from hospital to hospital, and dragged from the parking lot into the department and directly into the O.R. As an example, Charles Hughes, educator for SPSmedical, told attendees at a CS seminar in Detroit about a hospital in California that received orthopedic loaner trays with sand in the instrument cases.

Interestingly, federal guidelines do cover the transportation of hazardous items. AAMI ST 35 states, "The procedures for packing and transporting contaminated items off site for processing must comply with applicable U.S. Department of transportation (DOT) and state regulations…the user is also responsible for processing the device according to the manufacturers recommendations." ⁹

Studies have shown that surgical instruments are dirty. At meetings I have heard many people express concern that the orthopedic instruments their hospitals receive appear dirty. If these orthopedic instruments are dirty, what is this "dirt?" Is it just something from the parking lot? If it is dried blood or some other form of bioburden, these instruments should be transported under the federal guidelines and follow OSHA regulations limiting occupational exposure to blood-borne pathogens. (29CFR 1910.1030 — along with following Title 49, parts 170 through 178 of DOT guidelines).

In light of these comments and findings, every hospital needs to ask, "What are we going to do to make sure the loaner instruments we receive are safe upon arrival for our staff to handle and process, as well as to prepare them for proper patient use? What do we do about instruments that are brought directly from another hospital and delivered to the Operating Room? If we did not clean them, then how do we know and document that simply flash sterilizing them will render them sterile?"

Sample hospital policies

The survey results indicated that some hospitals do have policies regarding loaners. The following excerpts are taken from actual policies:

"When there is no "Inventory Count Sheet" available or no Vendor Representative present to inventory the set, write on the "Loaner Instrument Received" form, "no inventory sheet available; not responsible for incorrect inventory upon return." ¹⁰

"Loaner instrumentation and implants that are left in the delivery area after the procedure are not the responsibility of the Medical Center. SPD staff has been instructed not to sign contracts accepting responsibility for trays of loaner instruments, equipment, or implants. All Loaner instrumentation and/or any other items needing sterilization should be accompanied with sterilization instructions, preferably on company letterhead.
All Loaner instruments will be washed prior to set-up when they are brought in from outside the facility….if the information is lacking, the instruments will not be accepted. Trays should
be clearly labeled in order to assist
the SPD staff in labeling the tray properly." ¹¹

"The vendor representative will deliver the loaner instrument trays or sets, the completed Sales Rep/Loaner Tray Form, the SPM labels, and the cleaning and sterilization instructions to Central Sterilizing Services’ (CSS) decontamination area… this must be done before 7 PM of the day before the scheduled date of the case." ¹²

"The Borrow/Loan Coordinator is responsible for taking all requests for the borrowing or loaning of supplies, equipment and instruments within our hospitals as well as those facilities outside that are approved participants. The Borrow Loan Coordinator completes tasks relative to the borrow loan process, including, but not limited to, physical check in and check out documentation process for borrow/loan receiving, vendor and courier pick-ups, preparation and packaging for sterilization. Checks all incoming instrument trays for completeness, according to count sheet provided by vendor, or in conjunction with vendor." ¹³ 

Some hospitals use dry-erase boards and shift reports to communicate and coordinate working with loaner instruments. Central service departments are known for their creativity.

Mike Murphy at the University of Iowa Hospitals & Health System recalled how he had to call a surgeon at home about a set of loaners that would not be ready for surgery the next day: "I have discovered that it really does not take much to call a surgeon at home. He would much prefer to be called there and asked a question than to come in, the day of surgery and have things be a mess. They are never happy to receive such a call but in this way it is a proactive action rather than reactive and this helps make us a part of surgery rather than being seen as the problem."

Teamwork and support can move mountains and positively affect a change for the better.

Dollars and sense

Currently, orthopedics constitutes a $12-billion market, and that market is poised for exponential growth.14 This is exciting, yet concerning, for manufacturers at every level.

"Approximately 20 percent of all surgeries require loaner kits. This inefficient program costs some of the largest manufacturers more than $50 million a year, with leading OEMs shipping more than 100,000 kits annually. Shipping alone can cost as much as $150 per round trip, while internal hourly labor rates of $80 or more can become untenable." ¹⁵

One manufacturer assesses hospitals a fee if the loaned items are returned dirty. Its loaner policy states, "This surgical instrumentation system is a loaner set. To ensure optimum sterility, your hospital is responsible for checking and cleaning this system prior to sterilizing and when returning to X Company. This surgical instrumentation system contains several cannulated instruments, which require special attention when cleaning. IMPORTANT: A $50 fee will be added to your invoice if the system is returned to X Company in an unacceptable condition." ¹⁶

Loaners do affect a manufacturer’s bottom line, as indicated in this passage from a company’s annual report: "The Company anticipates investing in future business growth, including business and product line acquisitions to supplement its current product offerings, loaner instrumentation for surgical implants in support of new product launches and future building expansions, including manufacturing facility expansions for certain divisions…. increased meeting costs and higher amortization expense associated with loaner instrument sets…." ¹⁷

Manufacturers are beginning to listen to their customers. An article that recently appeared in an orthopedic trade publication stated, "Manufacturers are also paying attention to how much instruments weigh…. a lighter weight also can appeal to the individuals who must carry entire instruments sets into the operating room.... it’s obviously easier for them to lift an 18 lb set versus one that’s 30 lbs." ¹⁸