Orthopedic Loaner Trays

[Anthony Campano]

At the recent seminar in Cleveland, we had a discussion forum that opened and ended with Orthopedic Loaner tray sterilization issues.

The concensus was that somehow the manufacturers had bypassed the FDA and AAMI guidelines and rewritten their sterilization parameters. The parameters have created conformity difficulties within the Central Service community nationally and the tone at the forum from the panel was that a change would be best initiated through the overwhelming voice of the user group.

How are you dealing with this issue? How are we going to address this issue as a community?

[Guest]

I thought that it was FDA that put the pressure on the manufacturers of instruments/trays to do the validation testing because of the weight-density isuues and new tray composition.

We have adopted a 10 minute exposure cycle for routine sterilizing and we treat the small percent of instrument trays that exceed 10 minutes case by case.

This enables us to satisfy the changing cycle recommendations and the most efficient use of our sterilizers. We would need too many sterilizers if we did one or two items in a cycle.

[cpdguy]

FYI,
IAHCSMM was present at the latest AAMI meeting on this subject. i would suggest getting the latest info on what has taken place from the home office. They should be able to put you in contact with the peoplw who were at the meeting.

They do a great job providing input at AAMI from a users point of view.

[Guest]

There has been a trend in recent months from manufacturers of different instruments whereby they state that their equipment needs to be sterilized in a pre-vac cycle for 8, 10, 15 minutes. The reason is because their containers for these instruments are made of different materials. They have validation tests that prove that their sterilization times are correct. My question to them is where and from whom did they get a BI that was rated for 8, 10, 15 minute kill cycle? I

I have looked far and wide and I can't seem to find any of these magical BI's that the manufacturers somehow have gotten their hands on.

Can anyone shed some light on this subject?

[Chuck Hughes]

Instrument manufacturers or their contracted testing laboratories (like SPSmedical), use innoculated product along with conventional BIs (usually paper spore strips) to validate these extended cycles; because, due to the complexity and/or density of their trays, "normal" cycle parameters are not enough to document 10-6 sterility. Therefore, this is not a situation where a magic BI is needed, but rather a situation where a BI or Class 5 integrating indicator is needed inside these specific trays.

My recommendation is as follows: 1) Perform product testing with multiple BIs and Class 5 integrating indicators inside these trays per AAMI ST46 to verify your equipment is capable of sterilizing at the instrument mfg's extended cycle parameters with your specific load configuration(s). 2) Thereafter, select a commercial BI test pack that was FDA cleared for use with longer cycles (some have been and some have not) for routine testing of your sterilizer, and always include a Class 5 integrating indicator inside these instrument sets. 3) In-service the OR (and all other depts who receive these sets) as to the issues with complex or heavy instrument sets and reinforce the importance of them to observe the Class 5 integrating indicator for proper processing, upon opening and before using the set(s).

Feel free to contact me offline to discuss further!

Chuck Hughes
General Manager/Educator
SPSmedical Supply Corp.
1-800-722-1529