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Letters & E-mails
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Publish Date: October 10, 2007

Setting the Record Straight on Ozone
Re: "The Newest Alternatives To Steam" (The New Science of Infection Prevention, May Special Edition, page 18). This article was of great interest to healthcare providers who are seeking better alternatives for low-temperature sterilization. However, we have noted some inaccuracies regarding your discussion of ozone technology.

  • You quote a consultant as saying "Unless the makers of the ozone technology can significantly reduce cycle times, they are going to have a very difficult time in the U.S. market." This opinion is without scientific support. American health organizations are seeking the optimal balance between time and costs with sterilization in order to be more cost-effective and profitable. When you consider comparative cost and cycle times as well as biological and chemical indicators, user costs increase between manufacturers.
  • You state that "The ozone sterilization process has some materials-compatibility limitations." Materials compatibility and process limitations exist for all low-temperature sterilizer alternatives. This is not unique to ozone.
  • You report that "According to the manufacturer labels, ozone can disinfect single stainless lumens with an inside diameter of 2mm and no longer than 250mm, lumens with an inside diameter of 3mm or larger and no longer than 470mm, and those with an inside diameter of 4mm and no longer than 600mm." The use of the word "disinfect" is inaccurate. The 125L Ozone Sterilizer provides a sterility assurance level of 106, utilizing geobacillus stearothermophilus in a self-contained biological indicator OZO-TEST, and sterilizes these items as per the FDA's 510(k) product-claim clearance.
  • You report that "workers might need to wear respiratory protection when working around [ozone technology]." This statement is inaccurate. The 125L Ozone Sterilizer does not require respiratory protection. The FDA market clearance summary report for the 125L (available on the FDA Web site) addresses PPE (personal protection equipment) requirements as follows:

?? Ozone is generated within the sterilizer to provide an efficient sterilant without the traditional concerns regarding transporting, handling and disposing of toxic chemicals.

?? No exhaust gas ventilation duct is required in a room that is adequately ventilated. Ozone that is created inside of the vacuum chamber is rapidly converted back to oxygen, making the 125L Ozone Sterilizer the most environmentally friendly of low-temperature sterilization alternatives.

While there is no perfect or ideal low-temperature sterilization system, ozone, EtO and hydrogen peroxide gas plasma are all viable low-temperature sterilization alternatives. Finally, a cost-benefit analysis should always be included in a decision to purchase a new low-temperature sterilizer.

Simon Robitaille, PEng, MSc, MEng
Vice President, Operations and Research Director
writeMail("[email protected]")

Bryant C. Broder, ACSP
Sterilization Product Manager
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Thanks for the Drug Guide
Re: 1st Annual Manager's Guide to Surgical Drugs (July Special Edition). We would like to thank the Outpatient Surgery Magazine staff for producing an excellent resource for outpatient surgery. This special edition presents excellent information for seasoned and new employees at our outpatient surgery center.

Wayne Marler, RN, CNOR
Clinical Specialist
South Alabama Outpatient Services
Enterprise, Ala.
writeMail("[email protected]")

Fraud in Billing for Anesthesia Services
Re: "Our Small Acts of Fraud" (June, page 96). There is no fraud in billing for anesthesia services rendered outside of the OR, such as for the insertion of venous or arterial lines, or for performing regional blocks. According to the methodology of the Relative Value Guide of the American Society of Anesthesiologists, base points include compensation for the pre-op workup and the readying of the anesthesia workplace, be it in the OR or elsewhere, and for a post-op visit. Not included in the base point value is any face-to-face time providing anesthesia-related services. That clearly includes the cannulation of a vein, regardless of where that procedure takes place. In consideration of such services taking place outside of the OR and not in a continuous time block, Medicare expressly allows for the billing of discontinuous time. If in preparation for surgery and after having concluded the pre-op interview, physical exam and discussion of the anesthesia plan with the patient, an anesthesiologist starts lines or blocks in the holding area, his time deserves compensation, and billing for it is not fraud.

H.A. Tillmann Hein, MD
Diplomate, American Board of Anesthesiology
Southwest Anesthesiology Consultants
Dallas, Texas
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Adam Dorin, MD, replies: The concept of routine pre-op billing that I mentioned in my guest editorial is separate from that of "procedures outside the OR" that Dr. Hein mentions in his letter. The ASA Manual on Medicare Compliance, as well as the pronouncements of ASA lawyers, state that routine pre-op history and physical and the routine IV placed in the pre-op area isn't billable as separate time as they're considered to be part of the base units for a case. For billing purposes, this means that in general, but not always, the anesthesia start time should be the same as the time entering the OR.

References from the Federal Register and Medicare Carrier Manual
42 C.F.R. ? 414.46(a)(3) MCM ? 15018.G.[Anesthesia Times]
42 C.F.R. ?? 414.46(a)(1) and 414.46(f)(2).[Routine Pre-op w/u]
MCM ? 15047 [Anesthesia Consultations]
MCM ? 15506 [Anesthesia Consultations]

When Anesthesia Fails
Re: "Raising Awareness of Anesthesia Awareness" (June, page 42). Anesthesia awareness has been a long-standing research interest of mine, practically from my first day in anesthesia when I asked my consultant how he knew the paralyzed patient was unconscious when all we were monitoring was blood pressure and pulse. I did not believe his answer, but it is still largely the same answer today - 25 years later.

Ian F. Russell, B Med Biol (Hons), MB ChB, FRCA
Department of Anaesthesia
Hull Royal Infirmary, Hull University
Hull, England
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