The STERIS System 1:

1. STERIS to discontinue sales of the controversial SYSTEM 1.  (1-20-09)
2. STERIS System 1 FDA Warning letter (May 15, 2008).
3. FDA Notice and Recommendations about the STERIS System 1 Processor.

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4. FDA Notice: Concerns About the Steris System 1 Processor. December 3, 2009.
5. Steris "Dear Customer" letter, dated December 4th, 2009.
6. Steris "Dear Customer" letter, dated December 6th, 2009.
7. FDA:  Alternatives to the STERIS System 1.

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8. The transcript of the FDA's conference call. December 10, 2009.
9. Report:  STERIS System 1 could cause ’serious injuries’ to patients. 12-5-09.
10. Report:  FDA warns doctors, hospitals not to use STERIS System 1. 12-4-09.
11. Steris System 1 Processor: Extension of Recommended Time Period. (2-2-2010).
12. FDA letter to endoscope manufacturers about the STERIS System 1. 2-22-10. (The text of this FDA position is quite similar to that which Dr. Muscarella published several months earlier in this article.)

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13. Dr. Muscarella's comments about the STERIS System 1, on the front page of The Wall Street Journal (Dec 24, 2004); Investor's Business Daily (Feb 2, 2000).

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14. Q-Net: Part 1:  The Discontinuation of the STERIS System 1.
15. Q-Net: Part 2:  A Position Statement - The Use of Adulterated, Misbranded Devices.

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16. FDA and CDC Public Health Advisory (1999): Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System.

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17. FDA Obtains Consent Decree to Stop Marketing of the STERIS System 1. 4-20-10
18. The STERIS System 1's Certificate of Medical Necessity (CN).
19. FDA warning letter: The STERIS System 1 is adulterated and misbranded. 5-15-08

Other advisories, Alerts, Notifications:

1. FDA Public Health Notification:  Updated Information on Custom Ultrasonics, Inc., Endoscope Washer/Disinfector. July 16, 2007.
2. Custom Ultrasonics in compliance, resumes operations.  May 8, 2007.
3. Custom Ultrasonics agrees to stop manufacturing washer-disinfectors until it corrects problems. February 7, 2007.

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4. FDA Safety Alert: Warning Regarding the Use of the AbTox Plazlyte™ Sterilization System. April 13, 1998.
5. FDA:  The Abtox is an "adulterated" and "misbranded" device. July-August 2006

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6. FDA Public Health Notification: Reprocessing of Reusable Ultrasound Transducer Assemblies Used for Biopsy Procedures. Issued: June 19, 2006.

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7. State of California, Department of Health Services. Inadequate reprocessing of semicritical instruments:  Recommendations for reprocessing of rigid laryngoscopes. Issued: April 30, 2007 (AFL 07-09).

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8. VA Patient Safety Alert. Transrectal ultrasound transducer assembly, Models 8808 and 8551, manufactured by B-K Medical Systems, Inc., Wilmington, MA. April 3, 2006.

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9. CDC.  Pseudomonas aeruginosa Infections Associated with Transrectal Ultrasound-Guided Prostate Biopsies --- Georgia, 2005. MMWR Weekly July 21, 2006 / 55(28);776-777.

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10. FDA and CDC Public Health Advisory: Infections from Endoscopes Inadequately Reprocessed by an Automated Endoscope Reprocessing System (1999). Also: Read a critique of this FDA-CDC Public Health Advisory.

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11. A Safety Alert on the design of GI endoscopes, published by ASGE-SGNA. April 28, 2005.

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12. California Department of Health Services. An endoscope reprocessing alert. September 20, 2004.

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13. CDC. Bronchoscopy-Related Infections and Pseudoinfections -- New York,  1996 and 1998. MMWR July 09, 1999;48(26);557.

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14. CDC. Nosocomial Infection and Pseudoinfection from Contaminated Endoscopes and Bronchoscopes -- Wisconsin and Missouri. MMWR October 4, 1991;40(39);675-8.

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15. Medical Device ALERT. Flexible and rigid endoscopes. MDA/2004/028       United Kingdom: June 23, 2004.

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16. Another Medical Device Alert. Flexible endoscopes. MDEA(NI)2004/34       United Kingdom: July 7, 2004.

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17. Alert Medical Devices. Endoscope reprocessing. M.D.A. No. 114 (Health Canada).

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18. Advisory Notice: Infection control for Creutzfeldt-Jakob disease (Australia; 1996) 

1. ASP's EvoTech 08-08.
2. VA Patient Safety Alert: Recall of STERIS C1160 Universal Flexible Processing Trays used with the STERIS System 1 Sterile Processing Systems ( March 12, 2008).
3. Q-Net: Recall of Olympus bronchoscopes (Part 1)
4. Q-Net: Recall of Olympus bronchoscopes (Part 2)
5. FDA recall notice - March 20th 2002

1.  Cidex OPA:

• FDA Enforcement Report: Cidex OPA Recall.
• Possibility of sensitization to Cidex OPA Solution.
• Important information on the use of Cidex OPA
• ASP ALERT:  Label change for Cidex OPA (04-23-04)
• ASP ALERT:  A second notice about the label change for Cidex OPA (01-03-05)
•      1. Product Alert:  Cidex and Cidex OPA Solution Test Strips
•      2. Customer letter, dated September 24, 2003.
•      3. Daily quality control test procedure.
• Cidex OPA Instructions for Use (04/04)

1. Pity the poor drug makers. Brandweek 1-29-07.
2. AbTox execs get prison after patients are blinded. The Daily Herald  Sept. 14, 2006.
3. Executive gets 10 years for illegal sterilizer. Chicago Sun-TImes  Sept. 13, 2006.
4. Q-Net's Review of AbTox (April 1998)
5. FDA Safety Alert (April 13, 1998)
6. CDC's MMWR (April 24, 1998) 

1. Olympus position statement on the use of the STERIS Reliance EPS.
2. Olympus position statement on the use of the STERIS System 1.
3. Pentax position statement on the use of the STERIS Reliance EPS.

For a list of news reports about outbreaks, <click here>.

A list of Olympus's safety alerts and position statements.