I am looking for advice on the following:-
If the Steriliser leaks steam from the doors during the cycle, can we still distribute the "processed" items if all other parameters are met and the chemical integrator "passes"??
I would appreciate any help in this matter.

Regards, Tony Mc Loughlin.

Dear Anthony

I thind it should be think as Sterilized, because the main parameter which measure the sterilized result is temperature and process time (hold on sterilize temp), and as you can continue sterilize the package, so the leakage steam is not a lot, and for prevacuum sterilizer, only achieved to the pointed pressure, it could step into next phase, the sterilizer could finish all phase and met all paramter it needed. I think it could be used as sterilized.

of course, you'd better run B-D test and Biochemical test for ensure.

Hardaway Liu
Getinge International AB (Beijing office)

Dear,

EN 554: Validation and routine control of sterilization by moist heat answers your question in clause 6, Process control and monitoring.
6.2.4. says: Whenever the efficacy of the sterilization process or the integrity of the packaging is in doubt, the sterilized load shall be regarded as non-sterile.
This is the fact in the case you describe.

Kind regards,
Wim Renders

p.s. what's the result of the Bowie-Dick test?

Dear Tony,

If steam is leaking out, you can be assured that during deep vacuums (required during the air removal and drying stages) air is leaking in. This would lead to a failure of the Bowie/Dick test and the vacuum leak test.

In the UK it would also be detected by an air detector system that would automatically fail the cycle if the leak was excessive.

A leak during the drying stage of the cycle would not have passed through the bacteria-retentive filter, with the potential risk of re-contaminating the load.

I would certainly not assume that the load was sterile.

Regards,

John Weldrake
Theme Leader - Sterilizer and Washer-disinfector Training
(Decontamination of Re-usable Medical Devices)