lubrication of instrument sets that contain implantables

[SHIRLEEN VANOCKER]

Recently, some of my staff attended an inservice. At this program one of the speakers suggested that sets containing implantables should not be subject to a lubricant cycle, as the lubricant leaves a "film" on the implants that could potentially cause adverse affects for the patient. Most facilities use equipment that has a programed lub cycle. The manufacturer makes the equipment this way, and lub is needed for general instrumentation. It's not even a remote consideration to remove all the screws, plates, etc. from the set before the washer process. THAT would be a nightmare! It would also be a nightmare to as well, remove the instruments and process separately. I have never heard of this concern in 30 years in this profession. Does anyone have a policy or information on this? My next step will be to contact the implant manufacturers to see if they have recommendations. I would appreciate any input, as my staff thinks we should act upon this, and I am not willing to make this drastic change without supportive documentation.

[jrc]

I would contact the manufacturer of the implants to determine their recommendations. You are required to follow what they say because that is how the FDA approved their implant for use. Doing anything else means you take on the role of "manufacturer of the medical device" in the eyes of the FDA. I would also contact the manufacturer of the lubricant solution. They may have something in their testing that shows if it is safe for use on implants.

This is one of the things that drives me nuts in my job. People make all kinds of wild claims about how something "may" be dangerous without consulting the science. If something is approved for use, there has been a lot of research done to get it to that point. Granted, sometimes we learn more about the dangers of things after several years (Vioxx), but it is irresponsible to spread rumors based on pure speculation.

[Harvey Johnson]

I agree with jrc.
Yesterday I questioned tray implant manufacturer reps about the issue and received blank looks.
Written washing instructions with the tray implants have no reference to avoiding lube and with 95% of washers having a lube injection on the final rinse, you would think they would be addressing the practice if it was a problem.
The speaker was probably thinking they could justify an inflated fee by poking sticks at sleeping dogs on the porch.....

[djw]

This subject has come up for us too, although it started 2 or 3 years ago. We were very aggressive in our quest for info, and to this day have not received a straight answer from any vendor. Reading the info on the brand of lube we use, it says it contains an antimicrobial, and the lube manufacturer says it is safe for implants. Question-why and how would they know that when the implant makers can't make that statement. Our solution-we run trays with implants on a utensil cycle-no lube. Hoping someone out there can get an answer we have been searching for, and share their info.

[sonny1388]

Sounds like an interesting question, and one I have not thought of before. We have always run our implantables the same as all of our other instruments, and have not seen any adverse effects. Also, I would imagine that the thin layer of lube comes off of the implants the same as it does the instruments while in use, so if it could potentially be a threat, we shouldn't be using it on any of our items. It wouldn't make sense to me to market or use a product on an instrument that would potentially harm the patient on implants or instrumentation.