Comments on: FDA, ECRI Institute post lists of alternatives to STERIS Corp.’s System 1 sterilizer http://www.medcitynews.com/2009/12/fda-posts-list-of-alternatives-to-steris-corp-s-system-1-sterilizer/?utm_source=rss&utm_medium=rss&utm_campaign=fda-posts-list-of-alternatives-to-steris-corp-s-system-1-sterilizer MedCity News Sat, 11 Feb 2012 15:17:29 +0000 hourly 1 http://wordpress.org/?v=3.2.1 By: Lawrence F Muscarella, PhD http://www.medcitynews.com/2009/12/fda-posts-list-of-alternatives-to-steris-corp-s-system-1-sterilizer/comment-page-1/#comment-45697 Lawrence F Muscarella, PhD Wed, 23 Dec 2009 20:45:36 +0000 http://www.medcitynews.com/?p=16765#comment-45697 With interest I have followed Ms. Vanac's columns on the recent rebuke of the STERIS System 1, which the FDA calls a “violating device.” While the list of alternative reprocessing devices posted by the FDA is of interest, arguably of equal or more interest to health care practitioners, clinicians and patients (and veterans) alike are the answers to the following germane questions: (1) The FDA two weeks ago (circa December 10th, 2009) questioned Steris's published statement that the continued use of the STERIS System 1 warrants no changes in clinical practices. What specific changes in clinical practice (e.g., informed patient consent?) are the FDA and health care organizations - including the ECRI Institute, which Ms. Vanac's column discusses - therefore recommending? Ms. Vanac's article notes that "Last week, ECRI Institute, a nonprofit organization that seeks to apply scientific research to improve patient care, posted its recommendations, as well as a side-by-side product comparison chart, to help hospitals find alternative devices." For context and background information, ECRI has been a stauch supporter of the System 1 (refer to the front page of both the "Wall Street Journal," dated 12-24-04, and "Investors Business Daily," dated 02-14-00) and, just before the FDA issued its order two weeks ago to stop using the System 1, the ECRI Institute upheld the System 1's dubious "sterilization" claim and published this past summer a recommendation to continue using the STERIS System 1 (without informed patient consent), despite the FDA censure of this device. While employed by ECRI in 1993, I discussed with it my concerns about the System 1 and its misleading labeling claims and increased risk of disease transmission, but to no avail. (2) In response to well publicized endoscope-disinfection breaches and the potential for as many as 10,000 veterans to have been exposed to HIV and the hepatitis C virus, last summer the Veterans Administration's Office of Inspector General (OIG) conducted unannounced inspections at 42 VA facilities, to determine whether they were in compliance with accepted infection-control standards. (Note: Although the STERIS System 1 has been and was at the time of these inspections standardized throughout the VA system of medical facilities, this Office's report, oddly, makes no mentioned of the adulterated and misbranded STERIS System 1 and its ubiquitous use throughout the VA.) What is the VA's current position on the continued use of the System 1, if for only 3 to 6 more months? Is the VA mandating informed patient (veteran) consent and clinician notification, per the Food, Drug and Cosmetic Act's explicit provisions via-s-vis the use of such an "investigational" device? With interest I have followed Ms. Vanac’s columns on the recent rebuke of the STERIS System 1, which the FDA calls a “violating device.”

While the list of alternative reprocessing devices posted by the FDA is of interest, arguably of equal or more interest to health care practitioners, clinicians and patients (and veterans) alike are the answers to the following germane questions:

(1) The FDA two weeks ago (circa December 10th, 2009) questioned Steris’s published statement that the continued use of the STERIS System 1 warrants no changes in clinical practices.

What specific changes in clinical practice (e.g., informed patient consent?) are the FDA and health care organizations – including the ECRI Institute, which Ms. Vanac’s column discusses – therefore recommending?

Ms. Vanac’s article notes that “Last week, ECRI Institute, a nonprofit organization that seeks to apply scientific research to improve patient care, posted its recommendations, as well as a side-by-side product comparison chart, to help hospitals find alternative devices.”

For context and background information, ECRI has been a stauch supporter of the System 1 (refer to the front page of both the “Wall Street Journal,” dated 12-24-04, and “Investors Business Daily,” dated 02-14-00) and, just before the FDA issued its order two weeks ago to stop using the System 1, the ECRI Institute upheld the System 1′s dubious “sterilization” claim and published this past summer a recommendation to continue using the STERIS System 1 (without informed patient consent), despite the FDA censure of this device. While employed by ECRI in 1993, I discussed with it my concerns about the System 1 and its misleading labeling claims and increased risk of disease transmission, but to no avail.

(2) In response to well publicized endoscope-disinfection breaches and the potential for as many as 10,000 veterans to have been exposed to HIV and the hepatitis C virus, last summer the Veterans Administration’s Office of Inspector General (OIG) conducted unannounced inspections at 42 VA facilities, to determine whether they were in compliance with accepted infection-control standards. (Note: Although the STERIS System 1 has been and was at the time of these inspections standardized throughout the VA system of medical facilities, this Office’s report, oddly, makes no mentioned of the adulterated and misbranded STERIS System 1 and its ubiquitous use throughout the VA.)

What is the VA’s current position on the continued use of the System 1, if for only 3 to 6 more months? Is the VA mandating informed patient (veteran) consent and clinician notification, per the Food, Drug and Cosmetic Act’s explicit provisions via-s-vis the use of such an “investigational” device?

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