Explanted Prosthesis Policy

[jinjaben]

I work as a Sterile Processing Tech in a small Oregon hospital and was wondering if anyone could help me out?
Recently the issue of removed prosthesis being given back to the patient has arisen, with concerns relating to infection control. For example components from a Total Knee were handed to me in decontamination and I was asked to clean them up and run them through the washer so they could be returned to the patient.
After examining them for processing and trying to remove tissue from them, I found it was impossible to clean off all the tissue due to the way the implant had been cemented. I questioned the whole process and presented the facts to my charge nurse who told me to go ahead and run them in the washer, which i did.
When the washer was done I examined them again to find that the tissue that I was unable to removed still remained but in a 'Cooked' state. I wrapped them up and presented them to the charge nurse who then in turn retuened them to the patient.
After talking to my manager about this I was very annoyed to find that we dont seem to even have a policy on this subject and I have a number of concerns with this whole process:-
1. The implants were removed due to infection.
2. When the prosthesis were removed from the wash they entered a sterile area, potentially contaminating it.
3. The prosthesis were given back to the patient still retaining tissue potentially spreading more infection.
4. Staff are being unneccessarily exposed to potential hazards.
Seeing as I have been given responsiblity to research this issue any thoughts on this subject would be very much appreciated. Also if anyone is able to post their existing policy that would be very helpful.
Thanks in advance.

[linnma]

I was under the impression that everything removed from a patient was to be sent to pathology for examination.After that the items could be sent back to Processing for proper cleaning, decontamination and return to the patient.

[barrhelv]

Have you checked AMI standards on this subject? We do not have a policy on this either.

[jinjaben]

No I haven't checked with AMI yet. Do you have a link to their webpage?
Thanks

[sonny1388]

Wow, never heard this come up before. Not sure why they would need to go to lab, I would imagine they send up samples for testing intra-op, but that is speculation. We do not currently have a policy so much as we have a process. All explanted implants are thoroughly cleaned with cement removed (as much as possible), peel packed and flashed for 10 minutes.

[SHIRLEEN VANOCKER]

I had the same concern at my current position. At previous employment, there was a policy that implants were not returned to patients, so I was a bit surprised that this was not the case everywhere. I would also be interested in any standards or recommendations addressing this.

[anon]

When you reprocess an explant are you not then reprocessing a single use device? The answer is yes and you are then in violation of FDA rules.

[sonny1388]

anon,
I think that you have a point, although I do not think that it is valid. When reprocessing an explant, we are talking about making the explant safe (as possible) for handling, not for reuse on a patient. Only if you are intending to reuse a single use device are you in violation, or more correctly, only if you reuse the item are you in danger of prosecution. So, perhaps we should term this "sterilization for handling" rather than "reprocessing".

[anon]

sonny1388,

You are correct in that we probably need to address this issue in different terms but let's address it in the reality for a technician. How far will you as a technician let this go? Think of this - sterilization for handling? ....you are refering to the handling for the patient in which the prosthesis was removed but what about the tech who is using some sharp device to chip away at the cement and ingrown tissue? (Wish that we had the staffing level to accomplish this task on a daily basis!) Think also of this - where do you draw the line? In all respects you literally just re-processed an SUD in the fact that you ran the item through the 'process'. And no it is not for re-use. But do you have the manufacturers' recommendation for the decontaminating and sterilization? In light of that answer (which I challenge...is a 'no') - you get a request to re-process a pacemaker generator...but of course it is for 'teaching purposes' only (and it probably truly is). What do you do now? One more...an orthopod inserts a screw and then decides it is not the correct length. He immediately 'explants' that screw. Any good scrub and circulator will remove the screw from the set and dispose of it in the appropriate sharps container. ...food for thought... the line must be drawn

[sonny1388]

The point you made that interests me the most is about the pacer generator. I have not seen one, nor been asked to reprocess one, but what DO you do? If they want to use it for teaching, is it better then to reprocess it as requested or let it be handled unsterile? The same goes for the implants, if the patient requests to have them back, are we to give them back unsterile? Surely it is their blood on the device, but who else may come in contact with the device? How about the departments that you are trasnsporting it through, including your own? As far as I know, the patient has bought those implants and if he/she requests them back, we are legally bound to return them. So what then? I am not trying to be combative or confrontational, I am really interested in your P+P on the subject. The explanted screw subject is as you stated and not a concern, they just need to be tossed.

[anon]

:) I don't find a great debate combatitive or confrontational. There are alot of issues that CSR departments face that have not been addressed on a national level.

To answer your question of what I do - any explant that crosses the threshold of our department is placed in the biohazard bin. Staff is instructed not to reprocess in any way. We have had PM generators come to us and we are asked to clean and gas sterilize. We do not have manufacturers instructions to do so and especially cannot guarantee safe handling for anyone because of this. If another department (OR or Cath Lab) wants to take on the task - then they can do so...just do not ask the CSR department - because we have drawn the line. It's interesting that when we took this stance that the vendor produced 'teaching' generators at no cost. As for our P/P - I'm told the organization has one and yet I have not been able to find it and no one has had the time to produce it for me. So I've chosen ...again ...to draw the line. If a surgeon has promised the explant to the patient - it is the surgeon's issue not the CSR department's and then I will challenge him/her with the same argument (although it's never gotten that far).

Sometimes taking a stand against the old mother of all sayings of ...'we've always done it....' is difficult. But it only takes a few times to get your point across and, really,the respect will come when you take the stand.

[sonny1388]

Now there is something I can agree with completely! At a conference/teaching session held by Nancy Chobin in Las Vegas in June, I learned how and when to look for manufacturer's instructions, and also that if an instrument comes apart, it should be cleaned and sterilized apart. You can imagine the uproar when I came back and implemented that practice! I am still struggling with some of the older nurses about "we've always done it that way" and "we don't have time to put things together".

[Tracy Humphreys]

At the previous facility that I worked at we put them through the washer decontaminator, however we did not do any chipping away of anything. It was then placed into a peel pack and sterilized and then given to the patient or their physician.

[djw]

It's interesting that this has come up for us at this time. We were told in no uncertain terms just this week that implants belong to the patient, period. They have paid for it, it belongs to them. We have always returned them when asked, but now it has gone a step farther. They will be offered to the patient at time of explant. This has become a policy. A while back, we argued with the same points that have been addressed-biohazard, etc., but were shot down. Part of this comes from patient empowerment-a good thing, in most instances. A patient had surgery and asked that their trash be saved so they could see that everything they were charged for was actually used on them. We had to comply-they've paid for it, it's theirs. This was an extreme case, but I am guessing that it is going to become more common with costs for patients going up.

[lovemyjob]

I also work in a small oregon hospital and we have to return all implants to the patient they paid for them and we only clean them as best we can and send them back to them with a lable saying not sterile and the patients name.

[CarlaS]

We have to send all items removed from a patient to the lab. I have had reps get them from the lab for analysis by the manufacturer but that took a good deal of paperwork for release. I don't believe we have had to deal with the issue of patients wanting their implants in recent history.

[JUNGLIISS]

supervisor CSPD.
I work in 2 major hospital in NYC and never had to deal with implant that as was remove from patients. now in my present job in Florida its a big deal i have to allocate staff and time to clean these item, and on days when decontam is very hectic it creates a problem. I hope they will change the system soon and let the techs in the OR clean these items since the surgeon made these promises.

Does any of them know what it takes to clean a bunch of cannulated screws that was cemented in a patient?

[sonny1388]

Junggliiss,
Good luck with that project! I am pretty sure that you will never get a screw filled with cement fully clean, especially inside the cannulations. Your best bet, imho, would be to get the outside as clean as possible, sonics them for as long as you have can spare the time, and then package them in decontam, double peel pack and flash.