The problem of wet packs has been around since we first started using steam sterilizers to process reusable medical devices. It is imperative that you and your staff immediately take steps to eliminate wet packs if the problem ever arises in your facility. Not only will wet packs damage the devices/instruments inside, even worse, the waterborne pathogens in the moisture can cause a patient infection. Additionally, and equally dangerous, the residual moisture has the potential to contaminate the entire load.
The subject of wet packs came up again with the FDA’s recent warning letter to the manufacturer of “One Tray” for their off-label recommendations (Novo blog). The warning letter expressed significant concerns by the FDA about the promotion of One Tray for “terminal sterile storage and terminal sterile storage with retained moisture.”1
The FDA’s warning letter citing concerns over sterile storage with retained moisture in a tray prompted a lot of comments on AAMI’s Member Discussion Board. One such member comment on the AAMI Member Discussion Board came from Eddie who made a great observation and then asked an important question:
“When I started in CSP 10 years ago our sterilizers normal dry time was 20 minutes and most manufactures would just reference the AAMI standards. Today more and more manufacturers are calling out for 30 minute dry times as a minimum. I’ve often wondered if there was push back because of the fact that there are so many locations that don't have good steam so the manufacturers accommodate them with longer recommended dry times. As other AAMI members have mentioned (and as I found out when talking to our plant engineer) most people are not aware of the importance of the quality of the steam. Like our plant engineer said (and I agree 100% with him) we did not know that the quality of the steam could be the cause of wet packs.
So my question is why would steam quality not be the responsibility of the sterilizer manufacturers? It seems to me that the manufactures could easily add an Armstrong Steam QM-1 steam quality monitor their equipment and monitor each and every load. If the steam quality, along with the vacuum, time and temp are not met the load would be automatically aborted.” CSR Manager, ___________ Hospital, ________, PA2
These comments and great question generated this very informative response:
“The issue of steam quality has been addressed in sterilizer installation instructions for about 35 years, although the verbiage has been somewhat unclear. The instructions and requirements have been ignored by pretty much any and all installation resources. Ever since the AAMI ST79:2017 revision, there are requirements in place that meet the requirements in the sterilizer installation instructions. The benchmark now exists. The understanding of the need to meet them and how seemingly minor issues can cause non-conformance is not widespread. It is growing, but this is still the last uncontrolled variable in steam sterilization.” Managing Director, Quality Processing Resource Group LLC, Glen Allen VA3
Another AAMI member posted her most recent experience with wet packs. The episode with random wet packs has a lot of valuable information and insight for all of us:
“Yesterday we started to have random wet packs. I got to experience firsthand the pain caused by this defect and the impact it has on the work flow, not to mention the intense "hair on fire" environment it created. We immediately started to audit everything processed though the autoclaves and popped open a few suspect sets along with some random ones. We gave the O.R. the heads up to increase their inspection for signs of moisture and spread the word that we needed all the defective packs and trays so that we could conduct problem solving.
The ‘old school’ thinking immediately started to surface from the staff (add more dry time, crack times longer, etc.). Basically, we were trying to solve the problem without first knowing the problem and we were trying to do so without any data. After some more discussion with my staff, I headed to the boiler room. The first response from the operator was nothing has changed and the boiler was not changed over from Lead to Lag. Then the plant engineer approached and he told me they did some re-piping to the automatic blowdown lines. He also said that the boilers were not blown down for a short amount of time and the time they started their work coincided with our first wet pack. They finished their work at noon and guess what....our random wet packs went away.
A few great things occurred as a result of this event. The CSP awareness and attention to detail to catch the defect; the benefit of working closely with the plant engineer; conformation how critical steam quality is to our processes.” Operations Supervisor, Sterile Processing, _____________ Medical Center, _________OH4
So what should you and your staff do if you suddenly begin to get wet packs? First, you should immediately stop processing any further loads in that particular sterilizer. Second, you need to have a service technician investigate and solve the underlying issue/problem. Third, have the sterilizer manufacturer’s service technician help identify what maintenance or training is needed to reduce/eliminate the potential for wet packs in the future. Finally, make sure that all of the necessary preventative maintenance on all of your sterilizers is done moving forward.
Lastly, if you experience wet packs for the first time, ask yourself the following questions:
- Did any new users use the autoclave recently?
- Were the sterilization cycle parameters (time, temp, dry time, etc) modified in any way?
- Was the load properly packed during the last cycle?
- Did the facility lose power and/or steam supply recently?
- Did something change in the way the load was prepared or processed?5
October 2, 2019
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