Sterilization of Explants

[rayaverill]

Our surgeons routinely give the original implanted hardware back to the patients to take home. We are debating with our nurses as to wether they should be "Flash" sterilized before returning to the Patient or just cleaned.

I have a tendency to lean toward common sense, i.e; if we focus all of our efforts on cleaning surgical instruments in decontam and rendering them safe to handle, What is the difference if we clean the "Explants" as well as we do our surgical instruments? Ultra sonicing with enzymematic detergent and brushing if there is bone or debri is acceptable.

Our challenge is we have OR staff that demand "Flashing". Obviously we are writing our policy and I would appreciate all you'alls comments about what you are doing and why..

Thanx,
Ray

[chipmoore]

Hi Ray,
Provide yourself and the facility with at least some legal protection, clean and then sterilize. The bigger issue would be why give the implant back, period.
Chip Moore
Rochester, NY
retired but involved

[rayaverill]

hey Chip, thanks for your response. Unfortunately there is no state or federal regulation that prevents the surgeon from giving the explants back to the patients.

[ruthanne]

Some patients love to have the implant back just because they think it's cool. I even saw one woman make a plate into a lapel pin.

But in my opinion, Chip is right. For safety they should be cleaned and sterilized before they're allowed out the door.

[Tim Brooks]

To make thinks legal we need the implant device manufacturer to provide us with written re-sterilization approval and the process used to decontaminate. But let’s educate our surgeons that we cannot support this process any longer. Shouldn’t need to say this however we also cannot give them hand washed contaminated implants in a bag. All it will take is one child opening an implant at home, putting in their mouth or cutting themselves, not a great picture but it will happen, Murphy’s Law.

[Angel]

We run ours thru our washer disinfectant before we give them back to the OR for the patient.

[ldp]

We wash and sterilize the items before they are returned to the surgeon to give to the patient.

[allis]

I think it would be better that the O.R. washes those explants, flashes them and then return them to the patients. In my 13 years working in SPD, it happened once that we had to reprocess a plate that was being returned to a patient.

[khere]

To make thinks legal we need the implant device manufacturer to provide us with written re-sterilization approval and the process used to decontaminate. But let’s educate our surgeons that we cannot support this process any longer. Shouldn’t need to say this however we also cannot give them hand washed contaminated implants in a bag. All it will take is one child opening an implant at home, putting in their mouth or cutting themselves, not a great picture but it will happen, Murphy’s Law.

Keep in mind the explanted implants (say that 5 times fast) belong to the patient. They paid for them. Legally by not returning them it can be considered theft. It is much the same as not returning patient purchased crutches, braces, etc. It is a medical device prescribed for them, purchased by them, and then removed from their body. They don't get a refund.

At our facility we remove all bioburden from the implant, thoroughly disinfect and finally sterilize the implants. Once that has been completed, we label the package as used implants, indicating they cannot be reimplanted, and then give them to the physician (not directly to the patient) and assign them to return them to the patient.