EFHSS Questions and Answers - Question Q00625

we are packing the gauze in small pouches for dressing

which more imprtants the external indicators(strip) or the internal indicators for the peel pouch? is there any standers tell that must be use chemical indicatore in each package even its includs external indicators?

Dear Ahmad

Chemical Indicator is not an indication of the quality & Goodness of sterilization Process, it is only an indicator to show that the material included have been subjected to sterilization.
Once you have indicator outside no need to have inside indicator and vice versa.
Some chemical indicators are introduced inside long tubes or some thing similar to check that steam or Gas have been entered inside this tube and was able to change the color of indicator, but again it is not indication of the quality of sterilization

Best Regards
IYAD ALAMLEH
CISA s.r.l.-Middle East
Regional Manager

Dear Ahmed,

The indicator on the pouch is only used to show that the product have been through a sterilization process.
Chemical indicators used in strips or spots are not an obligation but can be used in addition to the parametric release (autoclave report, embarked probes...) as described in ISO 14937.
Of course there is no recommendation at all to use one strip indicator in each pouch.

Ahmed

All chemical indicators are classified into different classes which are determined by their performance and characteristics. ISO 11140 - 1 classifies chemical indicators into 6 different classes of indicators.

Class 1 indicators which include autoclave tape or the spots you have on the outside of pouches and reels are simply there to determine whether an item has been through a sterilization process or not and therefore do not provide any assurance as to the effectiveness of that process.

However a class 4,5 or 6 internal chemical indicator used inside the pack, pouch or wrapped item offers a great deal more security to the enduser again obviously this security is determined by the classification of the indictor. The most obvious steps for you in determining your decision would be to obtain a copy of ISO 11140-1 and verify for yourself the added security offered by using internal chemical indicators. It is your choice. This decision has to be taken in the light of your objectives as a CSSD manager - which is to prove that Sterility Assurance Levels have been obtained in each and every item sterilized. Many Cssd manager s will use internal chemical indicators as part of this assurance and there are many that don't as they believe full validation of the process, process parameters, load and load configuration is sufficient.

I hope this helps in someway - should you need further technical information please do not hesitate to contact me.

Peter

Dear Mr. Omaish,
unfortunately, i red misinclination up to Mr.Peter Newson's respond to your query. Actually, chemical indicators printing on the pouches are only displaying whether the pack has been exposed a sterilization process, or not. In order to measure quality of the sterilization cycle you have to use a Class 4 multiparameter CI, at least. Even i have not recognized a standart relating to add a indicator in every pack to be sterilized, i offer you put the indicator each pack of you to avoid loading failures. Incorrect colur change enables you to observe unstrile pack, because sometimes every part of the sterilizer chamber may not have same conditions.
Whenever you have a point to clearfy, i am ready to support you, as i could do.
www.elit-cssd.com

Dear Ahmed,

I would suggest that you look into getting rid of these packs altogether as it is financially more viable to buy them pre-packed and Sterile. I have found that labour costs alone would demonstrate this, though there have been many studies done to prove this. There are many companies now that provide these type of products thus keeping prices competetive.


Regards,

Tony Mc Loughlin
HSSD Manager