Loaner ortho instrument sets

[Mark Becker]

I"m the manager of Sterile Processing in a 300 bed hospital. We receive many loaner ortho and neuro sets into our department. I plan to put a policy in place that makes the vendors and their reps responsible for making sure their trays are complete on arrival and exit from the hospital. We have vendors that want to charge us for the occasional missing instrument. Does anyone have a policy of this type in place?

[Mancebo]

Due to the occasional misplaced instrument we have implmented a loaner policy. Three issues led us to this direction.

1. Loaner instruments being accepted by surgery and flashed upstairs. Being sent to MP for decontamination and pick up. When rep comes to pick up, missing instrument noticed, and of course MP misplaced and is now responsible.
2. JIT Loaner instrumentation. Case is at 2pm and trays would come in along with rep at 1pm. Of course the physician was only told that MP refused to do the case.
3. Loaners staying at facility for three weeks. Post procedure the tray/s would stay in MP for a significant amount of time. After "X" time the rep would come to pick up only to notice an instrument has now somehow disappeared. OF course MP was responsible.

We created a policy along with a Loaner Paper work (a triplicate document containing Vendor Name & number, patient name / initials, procedure date, amount/ number of trays, time recieved, date recieved, recieved by) to protect the facility and make everyone more accountable. It covered the following areas:
1. Loaners are to be dropped off in MP. Only in MP. If not, MP is not responsible.
2. Loaners are to be dropped off at least 4 hrs before the procedure. If not take to surgery and explain to surgeons why trays will not be ready in time.
3. Loaner Paper work to be completed. One part stays in MP Loaner Folder. Second part stays with trays through entire process. Informs tray assembly techs, sterilization techs of how many trays are part of the loaner system. Facilitates the trays going through the process together. The third part is attached to the case sheet, when the case picker takes the case sheet, they will know the case needs loaners, and how many to look for.
4. Loaners to be accompanied by ISL's (instrument Set List). MP is responsible for checking in every instrument. It is our responsibilty to note any / all discrepencies. If NO ISL, we are not responsible for any misplaced instrumentation.
5. Loaners are to be picked up within 24 hours. After that point MP is not responsible for any instrumentation.
6. Misplaced instrumntation is to be noted before the trays leave the premises.

A copy of our policy was given to all surgerons, reps, surgery and administration. All reps inititialed the a "recieved" copy, and is kept in our loaner form for future reference.

Is it a lot of work? Yes! Is it worth the work? Yes! Have any instruments mysterously disappeared? Not since our New Policy.

Just my .02 cents. I know, more like .50 cents!!!

[carol1967]

I suggest that there should be an addition to that list. Sterilization instructions should be supplied for each loaner pan. If anyone isn't aware of this the ortho manufacturers have validated sterilization parameters for each of their sets and they are NOT always your standard cycle. I have an entire 3 ring binder of information that I have collected by contacting each manufacturer. I have also found the reps are not versed on the sterilization instruction. They dont' offer you this info, you have to ask. I have just gotten off the phone with the FDA with this concern.
Carol

[pixieduster]

I noticed that in your case, loaners are dropped off in the OR and flashed for use? Is that generally the way most hospitals do it? We also have the problem of loaners being dropped off 2 hours before the start of a case. We have even gotten as many as 8 dropped off at 8:30am for a case at 1:00pm.
Our "policy" (nothing in writing) has always been to run each tray through the washer, then sterilize, and then up to the OR. Time, and increased case loads have really been compromising this practice.
I'm interested in what everyone else is doing upon receiving loaners and processing them for use in the OR?

[sonny1388]

We have (and when I say we, I mainly mean myself and the previous C.S. Supervisor) completely abolished any loaner instrumentation being brought in and bypassing C.S. It used to be a fairly common practice to have the instruments go directly to O.R. for flashing. This hasn't happened in probably 4 years. Now, all loaners go to C.S. for decontam and sterilization before going up to the O.R. We are a pretty small hospital, so we don't have much of a problem getting any amount of loaners processed in 2.5hrs, but most of what we get in loaners comes in 2 days in advance. Part of it is because we are out in the middle of nowhere, and I think part of it is we have some really good reps for most of the cases we use loaners for.

Carol- Very impressed that you have gone through all of the work to get all of the sterilization parameters from all of those companies. I would love to do what I can to try to get that info posted, I am sure it could help a lot of hospitals and O.R.'s. Perhaps if we put our heads together we could come up with a way to post that info without a lot of effort (I couldn't imagine trying to type it all out!)

[doc7592]

Would your IS/IT dept scan them into a PDF format and post it that way?
Love ya.

[cindynrh]

Following is the policy that we have recently initiated at our facility. We have met with some resistance, but for the most part the vendors have been compliant and are working with us to meet our goal of providing the best possible product to our surgeons for the safety of the patients.

Prior to this, we had no written policy and a pretty big mess.

PURPOSE: To establish guidelines for the use of loaner instrumentation and implants for surgical procedures.

RESPONSIBILITY: Instrument Room Technicians/OR Staff

POLICY: To process surgical instruments and implants acquired from an outside source (i.e., consignment, rented, borrowed) in a timely manner. Loaner instruments are defined as instruments, implants, or trays the vendors provide to NRH on a temporary basis for a specific case. The sales representative usually brings in these instruments.

1. All loaner instrumentation brought into NRH for specific cases are delivered at least 24 hours prior to the scheduled procedure. If procedure is scheduled < 24 hours prior to the case, instrumentation must be brought in as soon as possible.

2. When the instruments are not in the surgery department within 24 hours of the procedure (except in the instance of an emergency case), an interdisciplinary form will be completed and turned into the manger of surgery and the surgeon of record will be notified of the occurrence

3. Vendors are required to provide invoice pricing on all products brought into the Surgical Services department at the time of delivery. This information is to be provided by listing the hospital price per item on the vendor packing list or other appropriate vendor documents and placing the form in the required location at the front desk in the department. Each instrument set brought in by a vendor receives a “no-charge PO” for tracking purposes. This purchase order is obtained from Material’s Management.

4. Any product left or used in the department without pricing being documented at the time of delivery, is not forwarded for issuance of a Purchase Order or payment.

5. All instrument sets/implants are signed in on the Loaner Instrument Sign In Form. This form is initiated by the Team Leader or designee and is completed throughout the process.

6. The Vendor provides a complete inventory list, “Inventory Count Sheet”, for all loaner sets brought in.

7. Both the Vendor Representative and the NRH Instrument Tech inventory instruments upon arrival. If Instrument Tech is unavailable, the Team Leader or designee assists the vendor rep.

8. In cases where the Vendor Representative is not present when the instruments are brought in, one of the above mentioned people inventories the set against the Vendor’s “Inventory Count Sheet” accompanying the instruments; however, NRH is not responsible for the inventory.

9. When there is no “Inventory Count Sheet” available and/or no Vendor Representative present to inventory the set, circle on the Loaner Instrument Sign In Form “No inventory sheet available; not responsible for incorrect inventory.”

10. The representative bringing in the consignment or loaner instruments is solely responsible for making sure the trays are complete and acceptable to the surgeon using them.

11. All consigned/loaner instrument sets are put through the entire sterilization process; starting with cleaning, decontamination/disinfection, washing in the automated washer, set up and finally, terminally sterilized in Central Supply or Surgery if there is not adequate time to send them to Central Supply ie. an emergency.

[carol1967]

Here is the info that I received from the instrument companies

[HRJohn]

Hi Mark,

Here is a link to a position paper on loaner instrumentation which was put together as a joint project of ASHCSP and IAHCSMM.

I'm in the process of re-writing my loaner policy as well, so this paper was very timely in helping me know what to include in the policy as per their recommendations


ASHCSP/IAHCSMM Position Paper on Loaner Instrumentation


Sybil Williams, CRCST, CHL,CST,ACE,BS President, ... ...s.In recognition of the need to systematically manage the loaner instrumentation and implants, the American Society for Healthcare Central Service Pro... ...ilities, to address the systematic management of loaner instrumentation and implants from acquisition to disposition. [/I]

http://iahcsmm.org/current_issues_Joint_paper_loaner_instrumentation. htm 61.0 k

[HRJohn]

Carol,

Excellent information on your pdf chart about sterilization cycle times on the loaner trays! :)

I actually started a thread on that topic, because it was hard for me to get consistent information on some of the manufacturers' recommendations.

http://www.iahcsmm.org/forum/showthread.php?t=412

Would you mind posting your chart on my thread as well? Or would you mind if I copy and paste it over there?

Thanks!

-John

[Michael Montgomery]

As you all already realize, loaner instruments coming into the organization need to be checked. But, is anyone requiring documentation that these instruments were processed properly following the last use? In other words, did those instruments all go to an SPD for wash and decontam following the last case before being brought into the next SPD ( your department) ?

I have a form but I am having a very difficult time with compliance.

I think if all SPD departmens across the country were "on same page" and demanded the same standard of care and processing ( already in Standards) the reps may not push back.

Your thoughts?

Mike

[Harvey Johnson]

Our written policy is to treat all loaner trays coming into our Department as if they are contaminated and process the same as if they were used in house..... cuts down on the paperwork and the worry....

[ferb03]

When they come to us we inspect them for bioburden, run them through the wash and sterilize per manufacturer's recommendations. When I run them through the wash I use a 40-minute cycle, others use a 30-minute cycle. Hope this helps.