Medical Device Company reaching out

[sterilityking]

Hello. I work for a medical device company. I would like to know the problems you are facing with the cleaning and sterilization recommendations for reprocessing reusable devices offered by medical device companies. When responding, please consider the following question?

Are the recommendations clear, logical, and feasible?
Do they meet your requirments?
Are the recommendations too brief or too long in text?
What what you like to see in cleaning and sterilization recommendations offered by medical device companies?
Do you receive the package inserts or QINs when you receive a new reusable device(s)?
Do the QINS offer you enough information to reprocess instruments?
What has been most frustrating with medical device companies' recommendations?

Your responses will be greatly appreciated and will be used toward future recommendations offered by my company?

[carol1967]

The instructions that I have received have been clear and complete. They are cycles that we are capable of running. My concern is the inconsistancy of the cycles. We sterilize many different sets and with the information that I have collected I have come up with 7 different cycles. Our sterilizers can only be programmed for 4 cycles. Changing these programmed cycles increases the chance for error. Several companies have recommended 90 minutes dry time. This ties up our sterilizer for an hour longer than our regular cycles and certainly slows work flow. I would like to see a consistant cycle for complex instrument sets. I think the manufacturers should work together to develop a cycle that is safe for these sets instead of 7 different cycles.

[SPD Gal]

AMEN!!!

I think you speak for many of us. For years the manufactures have pretty much followed a standard of 4 min pre-vac sterilization 20 to 30 minute dry time. On occasion I would see a 10 minute cycle.

Now I see 7 minutes, 40 minutes, 15 minutes, are they trying to get out of backing there products by having us fail?

Many are frustrated by this and have spoken about it at many meetings including IAHCSMM conference. the FDA requires documentation before they will do anything but most of us are not filling out the medwatch paperwork and run out of time to do all this tracking. I think we just hope the FDA will step in before someone gets hurt because of all the confusion.

SOMEONE PLEASE STOP THE MADDNESS!!!