June, 2003
To Sterrad, with love
To the Editor,
Interscan Corporation is a leading manufacturer of toxic gas detection systems for many gases, including ethylene oxide (EtO). To properly applications engineer a gas detection system requires some familiarly with the processes involved. Thus, we have been reluctantly dragged into certain controversies regarding methods of sterilization.
An article entitled “Surgical preferences, sites driving sterilization trends” appeared in the April, 2003 issue of Healthcare Purchasing News, and although it did contain one paragraph addressing the limitations of hydrogen peroxide gas plasma (HPGP) sterilization, it still read like a love letter to Sterrad.
Notably, the advertisement on page 37 of the issue in question touts the one and only unassailable advantage of the Sterrad–its fast cycle time. While such advocacy is expected in an advertisement, your readers deserve better in the articles. Allow me to raise a few points…
1. By what defect in logic is central service throughput time the gold standard by which all things are to be judged? Much anecdotal evidence exists that correlates a significant increase in nosocomial infections with the replacement of EtO sterilization by HPGP. Admittedly, such cases are extremely difficult to prove. Bear in mind that no less an authority than the CDC has reported that nearly 2 million patients annually get an infection while being treated for another illness or injury, and nearly 88,000 die as a direct or indirect cause of this infection.
No responsible figure will deny that questions have been raised since the very introduction of HPGP sterilization as to its efficacy. Is it prudent to trade patient safety for processing speed?
Trust me. The patient couldn’t care less which process is more convenient for the hospital. He just wants to be sure that when the device goes inside him, it is sterile!
2. The article vaguely addresses the limitations of Sterrad’s current biological indicator, but if “Infection Connection” really cares about infection control, it might have gotten comments from recognized experts as to the wisdom of Sterrad employing Bacillus atrophaeus instead of Geobacillus stearothermophilus. Is there a third party biological indicator available?
3. The article does mention HPGP’s limitations with respect to long lumens, but is silent on the limitations regarding its use with metallic items of other than stainless steel or aluminum construction. The corrosive nature of the HPGP process should not be taken lightly.
4. Issues have been raised in the recent past concerning the ability of HPGP to penetrate to all areas of the load. Is this still a problem?
5. As to the operational safety of EtO versus HPGP sterilizers, the dangerous properties of both ethylene oxide and hydrogen peroxide are well known. No doubt, leakage can occur with both systems, although there is much less data extant on HPGP. Still, our technological civilization is full of dangerous items, from electricity to gasoline. When handled properly, the potential danger is greatly reduced.
Lest we forget, the single greatest benefit of science to humanity has been the use of “dangerous” chlorine to purify water. Would we replace chlorination with some other process solely because the alternative were safer for the water treatment employees?
6. Finally, I have to wonder about the juxtaposition of the item following this article, covering the indictment of former AbTox executives. Was this done to create some air of legitimacy to Sterrad?
AbTox ran afoul of the FDA for marketing a sterilizer that was never approved, as well as suggesting that it could be used on instruments that never received clearance. But AbTox also ran afoul of morality when an ophthalmic instrument, damaged by its system, caused blindness in an unlucky patient. Could the same damage have been caused by the Sterrad system?
Inquiring minds want to know.
Michael D. Shaw
Executive vice president
Interscan Corporation
Chatsworth, CA