Policy for Loaner/Consignment Trays

[Monarch]

I am interested in your policies for loaner/consignment trays.

What process is used for checking in and out of system?

Do you have guidelines set for amout of time prior to the case the instrument sets need to be at your facility for processing and biological confirmation?

Do you have a set amount of time when instruments need to be picked up or checked out of system?

How do you manage loss?

Do you require company reps to provide your facility with inventory sheets for content of loaner/consignment trays and do you validate the contents prior to use and at check out?

Any assistance with these topics would be greatly appreciated.

Thank you,
Ljohnson CPD Manager

[sonny1388]

Loaner sets are ALWAYS a problem, aren't they? We are a smaller hospital, so we don't have as much of this to deal with as some others, I am sure, but here's how we deal with it anyways. We require a minimum of 3hrs prior to an emergent case and 24hrs for a scheduled case for the loaners to arrive. There are exceptions, of course, but we stick to this as much as possible. We also do require count sheets for all sets. They are checked in according to these sheets, then inspected for peices that can be disassembled, anything that is broken, and for pan sturdiness (amazing how many pans are in disrepair). To speed up the process of recounting after the case, we also use autoclave tape to tape off open slots in the sets. For reference, we also take digital pictures of all of our sets, loaner and owned. We require that all loaner sets are shipped back or picked up 24hrs after a case. If an item can be shown to have been in the case prior to start and not returned, the hospital buys a replacement. We have saved quite a bit of money with the pictures, because they show whether or not an instrument was included in a set.

[Monarch]

Do you have written policies for this practice?

Also, do you have compliance issues from the Reps?

[sonny1388]

I went through our policy book to try and find one concerning this, and to my surprise, found none! I will be writing one soon.

We usually don't have compliance issues from the Reps, although it has been pretty close a couple of times. Our HowMedica Reps are REALLY good about this, they usually get our loaners in at least 48hrs in advance. Being as we are out in the boonies, I find that pretty impressive.

[dongordon]

IAHCSMM and ASHCSP together wrote a position paper on Loaner Trays.
You can find it on this website:
Go to "Member Services" on the home page and scroll down to "Current Issues." "Click" and it is 18 issues from the top entitled "ASHCSP/IAHCSMM Position Paper on Loaner Instrumentation".....click on the title.

It is an excellent document and I used it in preparing my policy on loaner trays.

Don

[Diane]

I had an incident today where a service rep brought in trays for a hip fracture. We did not have the time to wash and sterilize them before they were used. There were a total of tree trays. So of course they were all flashed. After the case they came to us and as we were putting them in the washer the service rep came in and told us just to run them through the sonic and he would have them flashed. As one of my co-workers were washing out the canulated things in the sink the rep said he didn't have time for that and took them out of the sink, put them in the tray and put them in our sonic. After they were done he packed them up and left and did not flash them at our facility. I told him that this was not a safe practice and he said he new that but I have to take them with me and I do not have time to wait. When I told my boss about this she told me that it was his problem if they are not clean. I disagree. She is going to call the company and also told us when we get trays from them again we will be on the look out for dirty instruments. We have no policy in regards to loaner trays so there was nothing I could do. What is some of your feelings on this incident?

[Tracy Humphreys]

I would call the company and tell them about the incident and let them know that the next time he brings in instruments to your facility without the correct amount of time to process them then you would inform the surgeon that the case will be delayed or cnacelled because of this. Once you inform the surgeon about what could happen without proper cleaning and sterilization to the patient he will be in line with you. If he disagrees than have him sign a paper releasing the hospital of all liability.
I also strongly suggest that you look at the position paper on loaners from IAHCSMM and creat a policy and have every vendor sign off on it. We are the experts in this area and we need to start taking a stand for what we know is right and the standards we work under.
I had this same incident happen to me and I finally took a stand and the facility and patients are better of because of it.

Tracy Humphreys BS, CSPDT, CRCST
CPD Manager

[pixieduster]

Tracy:
What would you say to a surgeon who you are worried does not realize the seriousness of how we process trays for cases? We have only one Ortho. surgeon right now and he schedules cases for after hours and sometimes Synthes trays are delivered directly to the OR and flashed for use. We never see them until the next morning to clean them for the Rep. to pick up. Some trays of course have implants. I do not want to cause anyone to get into trouble but it does not seem like rocket science to create a policy based on the one you suggested. Do I insist on one to my Supervisor to go directly to the OR Manager?

[lovemyjob]

how can your superviser let this happen without running a bio for the implants???

[cpdguy]

On loaners. I would do more than contact the company I would report hemto them to the FDA.

I have some sample polices on loaners if you would like and other information. Please contact me off line.

Loaners to me is a big problem and issue. I would NEVER LET THAT REP IN MY DEPARTMENT AGAIN.

Think about it they put that in their car and went to another hospital.

[lariles]

Not only do I have apolicy that adresses the time frame for the loaner trays to be in the department prior to the case (sets with implants 32hours min.)but I have policies regarding vendors and proof of compentecy with the products they represent.
In all, my vendors complained some at the begining but have conformed. It is key to get your orthopedic surgeons on board with the concept so they can back the department on a whole. We hold the trays with implants for the appropriate tiem and document when they are released early and why just as AAMI st 46 states.

[jrc]

If you want to get the heavy hitters behind you, go to Infection Control and Risk Management. When you explain the risks associated with improper processing of loaner trays, they will back you all the way in implementing a policy/procedure to ensure everything you get in from outside is processed properly before it touches a patient.



I told him that this was not a safe practice and he said he new that but I have to take them with me and I do not have time to wait. When I told my boss about this she told me that it was his problem if they are not clean.
Unfortunately, this is your problem, too. If he did that with the instruments leaving your hospital, it calls to question the cleanliness of those instruments when they arrived at your facility. I would wager your place is not the only one where he has done this.


I would NEVER LET THAT REP IN MY DEPARTMENT AGAIN.
Quoted for emphasis!


Once you inform the surgeon about what could happen without proper cleaning and sterilization to the patient he will be in line with you. If he disagrees than have him sign a paper releasing the hospital of all liability.
I am not an attorney, so I cannot give a qualified legal opinion on this, but it is my feeling that such a release of liability would not be valid. You cannot say, "I know this is wrong, but I will allow someone else to do it as long as they take the blame." If you know it is wrong and you allow it to happen, you are just as responsible as if you did it. I had to fight that same reasoning at my facility when I eliminated the procedure of removing instruments from aeration early. "But we made the nurse sign that she accepted all responsibility.":)

It is up to us in Sterile Processing to take the lead in making sure the same standards are met for all instruments. Just because your facility does not own them, does not mean they do not have to be processed the same way you do everything else. Our patients deserve no less.

[lisahuber]

Another thing to keep in mind is that when sales/service reps are in YOUR department they follow YOUR policies not the other way around. The reps know that when they bring things to us, we are then obligated to ensure that our patients and staff have instruments that are safe to use and so do the reps when they take them out - no exceptions!
The reps don't have to like it - they just have to do it YOUR way!
Good luck,
Lisa Huber

[Diane]

Well here it is October and we still do not have a policy in place in regards to loaner trays. At first I thought I had my director going on this but apparently not. It keeps getting put on the back burner. I even spoke with infection control and now she is out on leave. I was wondering if it would be proper to have the service reps sign a paper stating something like they are taking full responsiblity for the instruments due to the fact that they were not properly cleaned and sent through the sterilizer? And if you think this would be ok could someone help me please with wording? I really need to do something. :mad:

[Harvey Johnson]

Hi Diane,
Repeating Don Gordon's advice in an earlier submission, have you read the position paper on loaners developed by IAHCSMM and ASHCSP? Click to IAHCSMM's home page, click on more news and scroll to the loaner position paper heading. The contents clearly address decontamination and cleaning of used loaner instruments before releasing to vendor. It is a great template to use when developing your policy on loaners. I was able to create my department policy in a few hours. The O.R. and admin "powers that be" thought it was great!
Good Luck!

[ladyt1954]

I would like to know if you get loaner trays from the outside that are sterile already and if so are they re-sterilized after use to go back out that way? Is their a policy on this? My policy is that the trays are checked in, decontaminated and sterilized for surgery and then they go back out UNSTERILE..any feedback would be greatly appreciated.
Thank you

[Harvey Johnson]

Our Department policy reads:
Any loaners coming into our department are considered contaminated and irregardless of vendor wishes because of time, are processed through decontam. It is up to them and the doc's after coming through the wash if time is available to properly sterilize or if they need to flash. (all flashing is done upstairs by OR core people)
Otherwise how are you sure that arriving loaner tray has been sterilized according to manufacturer's instructions and transported in an environment to keep it so?
We decontaminate, process through the washer disinfector, then place loaner trays in an area for vendors to pick up. We do not resterilize trays to be picked up after procedure.

[Rod Brueggeman]

Every CS department should have a policy that states all loaner instrumentation used in your hospital must be cleaned AND terminally sterilized prior to leaving your department. If the reps don't abide then the reps qa dept needs to be contacted. Everyone knows that the reasons the reps are trying to turn the sets without proper cleaning is because the company is either unwilling to spend the money to have more sets available or the rep is uneducated or ignorant to the issue.

[Harvey Johnson]

Please help me understand why you think it is necessary to terminally sterilize loaner trays leaving the department. Isn't "safe to handle" processing sufficient? I have looked at positon papers (including the joint IAHCSMM/ASHCSP paper) and none mention a terminal sterilization step for loaners leaving the department. Seems like a waste of manpower and resources.

[jrc]

I agree, Soup. We will wash the sets and confirm they are complete, but we have better things to do than to sterilize a tray that is on its way out the door.

[sheper1]

All loaner trays coming in to our facilities are decontaminated wrap and sterilized by our staff. Loaners going out are decontaminated and set in an area for the reps to pick up we do not sterilize loaners sets that are leaving our facility. If you do your facility is taken on the liability that those trays are safe to use and I would not want to take the chance that another hospital would risk saving time by not reprocessing them as you do not know how the rep has handled or transported those sets.

[Rod Brueggeman]

The reason is simple - I am helping assure the next guy in line will have safe product to work with. It is common belief that trays are safe to handle after they have been throught the appropriate cleaning process and I also believe that. I however take the extra step to term when sending product out. It provides a "stop" in the process that I have control over. It also provides me with a tracking label so I have documentation showing what was done with the product when it was at my house.

[jrc]

Rod, as the guy who may get the set after you, I say thanks for looking out for me. I wish I had the time to spend sterilizing exiting loaner sets.

[Rod Brueggeman]

Your welcome - its not the manpower - it takes 3 minutes to load a term cart. Its whether you have the equipment or not.

[Harvey Johnson]

Rod, I appreciate the explanation and your desire to have instruments for the next guy as safe as possible.
How can you be sure the rep is continuing to handle the trays as terminally sterile once they leave your department?
I have seen the trunks and storage areas of a few rep's and delivery company vehicles, I wouldn't classify them as clean for instrument transport.
IMHO, term sterile before trays leave seems a waste of time and $$.

[Rod Brueggeman]

My point is this - I have eliminated all bioburden accumulated on the tray after it is cleaned and termed. Now it is a new cycle in the life of the sets with no chance of cross contamination. I like the fact that we do this but I understand how some places may not be able to.

[sheper1]

I see your point on the Bioburden but have to disagree on the no chance for cross contamination after the set leaves your facility the rep can contaminate the set giving the possibility of contaminating other sets when it gets to the next facility if they do not reprocess it.

[Rod Brueggeman]

Shep - I was referring to any bioburden picked up prior to us shipping it out. We have no control once it leaves our dept. Also you earlier referenced liability being assumed by the hospital because we term sterilized the product. No worries there. I am not making any sterility claims - the trays aren't even wrapped - they are only termed (sterilized in their primary containers only).

[sheper1]

That clears up the whole issue did not realize you were not wrapping them that is a completely different story.

[SHIRLEEN VANOCKER]

monarch, we have a written loaner policy at our facility. we basically do the same as indicated by sonny1388. we have had problems with reps a couple times wanting to speed up the process, and we have one rep who washes the instruments in a sink in/near the O.R. and then takes his instruments with him. We also have one surgeon who brings his own instruments with him, and does the same. Can we do anything about it? Not unless the O.R. management will back me up. Most of our reps now understand our process and will cooperate with us, but there's always the one, isn't there? One thing that we never allow, is for instruments to come in as loaner and not be inspected and processed thru decontamination. We have shown the O.R. what these look like when we get them, so we do have cooperation there...even on weekends and after hours. The area we struggle with is after the case is done and the reps wanting to "get going". Then ,like I said, this is very limited, most of the reps are pretty understanding about it. Loaners must be cleaned properly before use...I'm sure everyone has horror stories about what they have found on/in loaners!

[SHIRLEEN VANOCKER]

ladyt1954: Our policy is to decontaminate and sterilize all loaner instruments prior to use. If loaners are received already sterilized at another facility, we unwrap them, inspect, process thru decontamination and re-sterilize them. We also try to take pictures of all trays, so that when a rep says something is missing after a case, we have
"before" pictures to show that the item may or may not have been there.

[Robert Corley]

Here in our facility, our policy states as such: It is the Rep's responability to make sure the set is together, then we will wash and dry the set and check to make sure the tray is clean. Then the Rep is allowed to leave with the tray at this time. I do not believe that you have to sterilize the tray, because all CSS that get the tray next should treat it as dirty. Then they should have to wash and sterilize it. Any tray brought in to us is wash, dried, inspected, wrapped, and then sterilized. I hope this helps.:)

[ladyt1954]

Thank you everyone for your feedback.

[CSS TECH]

Every CS department should have a policy that states all loaner instrumentation used in your hospital must be cleaned AND terminally sterilized prior to leaving your department.
Rod's proposition makes a lot of sense! I think it's a general policy to sterilize instruments that are sent out to be repaired (unwrapped certainly!). Why not sterilize loaner trays before reps pick them up?