Questions and answers - Letters - Letter to the Editor

To the Editor,

Thank you for publishing my letter, "STERRAD rebuttal," in Healthcare Purchasing News (September 2003, pg. 66). The esteemed Dr. Martin Favero did answer some of my questions, but, alas, skipped over a few, and raised some others. In consideration of brevity, I will comment only on the points that seem of greatest interest.

1. Dr. Favero states, quite categorically, that "... there has been no increase in nosocomial infections due to the replacement of EtO with hydrogen peroxide gas plasma (HPGP) or the STERRAD System." With all due respect, I would challenge him to produce data demonstrating this bold contention.

2. In the same paragraph, Dr. Favero proudly proclaims the laundry list of microorganisms that are killed with his system, but ends the sentence with the rather ludicrous assertion that the STERRAD system is "nontoxic." Such a description would seem paradoxical in light of the detailed Material Safely Data Sheet for hydrogen peroxide, available on Sterrad's own website.

3. Dr. Favero, scientist that be is, should be move careful with the use of numbers. He declares that "... more than 23.3 million processing cycles have been safely run to date." The only possible way to confirm such a sweeping statement would be in either track and evaluate all patient out comes that were related to these cycles, or, at the very least, provide biological indicator records on a statistically significant percentage of these cycles. Since STERRAD touts a once per-day BI, I seriously doubt that his contention could even remotely he proven.

And, given that there are many thou sands of medical devices extant, how does testing on "more than 1500 devices" prove that "The STERRAD system is compatible with most medical devices and surgical instruments ..."?

4. Further to the once per day BI, I would assume that this practice is justified by the notion of parametric release, but this seems oddly invoked as loads will vary greatly in hospital operations, when compared to loads at medical device manufacturers.

5. Finally, in the "most disturbing aspect" of my letter, I referred to the patient injuries caused by the now defunct AbTox system. Dr. Favero did explain in his letter that the STERRAD system does not use peracetic acid, and could not have caused similar injuries. This, of course, is true. Nevertheless, it does beg the question as to why AbTox felt it necessary to add peracetic acid to its HPGP system in the first place.

Michael O. Shaw

Executive vice president

Interscan Corporation

Chatsworth, CA

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