I have read Linda Clement’s article "Cracking the steam sterilizer door: Dispelling the myth," published in your May 2007 issue. I have also read Ray Taurasi’s CS Questions on the subject, published in June 2007. As a sterilizer manufacturer, we agreed with Linda and recognize that Ray is representing the many healthcare users with equally valid comments. Users of healthcare sterilizers should not have to "crack the door" at the end of a vacuum steam sterilizer cycle. Having said that, we also understand that the many variables experienced at each location, from the quality of the steam supply to the sterilizer performance and finally wrapping and loading techniques (good and not so good).

The term "cracking the door" is dated. It goes back to the time when sterilizers had compression seal doors (Radial Arm Locking). Today’s sterilizers have active gaskets that automatically seal via steam pressure and unseal/retract via water pressure. At the end of a cycle for today’s sterilizer, there is a gap between the head ring and door plate that allows heated vapor to escape. In essence, the door "cracks" automatically.

The better term for the time inside the sterilizer would be called "Bake Time." Let’s stop using the term "cracking the door" and start recognizing that if bake time is needed, it’s because there is an issue with the steam, the sterilizer or loading techniques. All the things that are done to achieve a "dry" load are simply compensations for undiagnosed problems (i.e., wicking material on shelves, bake time, either pre-bake or post-bake).

Thank you, Linda and Ray, for bringing the subject up and creating user dialog and awareness. I would also suggest that the "cracking the door" topic be used as a springboard to discuss the need for a CS quality initiative for repeatability for each load to include knowing that the steam meets certain performance standards, that the sterilizer has documented evidence it is maintained per the manufacturers instructions and that each load is produced the same and loaded the same. Repeatability is the foundation for all device manufacturers’ quality systems. It should be no less for the production of sterile products for patient use.

As always, I read HPN from cover to cover. As evidence of that, I would like to comment on this issue on page 82 [July 2007, Letters to the Editor].

Those that object to ‘cracking’ seem to forget that the items in the load have been subjected to 250 degrees of heat. Although there is a cool down time in the cycle, it is far from being able to cool down the packages to a point that they can be safely handled. Furthermore, putting a hot item on a cool surface can cause undue condensation in the package rendering it to be viewed as non-sterile and not suitable for use. This condition is not seen in CS but rather when the package is opened at its point of use.

Recently, AAMI has published a new document on Sterility Assurance. One of the changes that has received attention is in reference to the use of rigid containers. According to the new standard, instrument sets that weigh as much as 25 lbs are permissible. From experience, I know that many CS personnel had problems coping with sets that weighed 16 lbs. Can you imagine how much more difficult it would be for them to handle hot containers weighing 25 lbs?

I don’t believe that the answer to the problem should be left to the sterilizer manufacturer, but rather should be referred to one of the CS societies.

I totally enjoy HPN and read it every month. However, I want to address the two questions that Ray Taurasi answered in the [May 2007 "CS Questions CS Answers" column].

First, in New Jersey the NJ State Department of Health and Senior Services requires that hospitals have to provide hospital-laundered scrubs for people who work in Central Service (CS) as well as other areas. So I would make sure that anyone who works in CS check with their home State to see if they are regulated.

Second, I want to clarify something about certification. In order to be certified you need to pass either the IAHCSMM or CBSPD exam and maintain CEU’s to recertify each year. As of now NJ is the only State that requires people working in CS to be certified. New York is implementing that in 2008, although I do not know if it will read the same. Yes, it is a cost depending on who pays for the CEU’s, your facility or yourself. However, long term the rewards will be there. In New Jersey, certification has made a difference in many hospitals by giving an incentitive for being or getting certified as well as increasing the starting pay for new employees not certified. Also, I believe if we are licensed we would be recognized more. The key to this is not only having a champion to fight for you in each facility but by having one National Organization that could help our cause.