Letter from Shelley Berkley to Governor Kenny Guinn, May 5, 2006, regarding patient safety issue (4 pages); enclosure from Department of Veterans Affairs

SHELLEY BERKLEY 1ST DISTRICT, NEVADA COMMITTEES: I N T E R N A T I O N A L R E L A T I O N S SUBCOMMITTEE ON EUROPE AND EMERGING THREATS 4 3 9 CANNON HOUSE OFFICE BUILDING WASHINGTON, DC 2 0 5 1 5 ( 2 0 2 ) 2 2 5 - 5 9 6 5 FAX: ( 2 0 2 ) 2 2 5 - 3 1 1 9 shelley. be rklev? mail-house.gov Congress of the United States Washington, DC 20515-2801 SUBCOMMITTEE ON MIDDLE EAST AND CENTRAL ASIA T R A N S P O R T A T I O N A N D I N F R A S T R U C T U R E SUBCOMMITTEE ON AVIATION 2 3 4 0 PASEO DEL PRADO SUITE D 1 0 6 LAS VEGAS, NEVADA 8 9 1 0 2 ( 7 0 2 ) 2 2 0 - 9 8 2 3 FAX: ( 7 0 2 ) 2 2 0 - 9 8 4 1 www.house.aov/berklev SUBCOMMITTEE ON HIGHWAYS, TRANSIT AND PIPELINES V E T E R A N S ' A F F A I R S RANKING MEMBER, SUBCOMMITTEE ON DISABILITY AND MEMORIAL AFFAIRS May 5, 2006 CAUCUS TASK FORCES: CHAIR, TAX AND BUDGET TASK FORCE CO-CHAIR, GAMING CAUCUS CO-CHAIR, STOP DUI CAUCUS The Honorable Kenny C. Guinn Governor State of Nevada 101 North Carson Street Carson City, NV 89701 Dear Governor Guinn: I regret to inform you of a patient safety issue that has been discovered in the veterans healthcare system. I have been notified of possible problems in the cleaning and disinfecting of B-K Medical Urology Transducers used for prostate biopsies. Due to sterilization problems, there is a minute chance that patients who had this device used on them could have been exposed to the hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV). The Department of Veterans Affairs National Patient Safety Center identified this problem and the regions that are affected have been alerted. The VA Southern Nevada Healthcare System is one of the affected groups. All veterans who had the procedure performed with the device are being notified and will receive free hepatitis B virus, hepatitis C virus and human immunodeficiency virus (HIV) tests. However, because the risk of improper cleaning and disinfecting of this transducer is not isolated to VA facilities, I wanted to alert you so that you can take appropriate actions to minimize the risk of this problem in Nevada. I believe that part of my role as a public official is to protect the health and well-being of our community. Although there is a very small probability of a patient contracting the hepatitis B virus, hepatitis C virus or human immunodeficiency virus (HIV), it is important that this information be passed on to every patient who has had a prostate biopsy performed with this transducer. I encourage you to share this information with the appropriate people. I have enclosed the Patient Safety Alert from the Veterans Health Administration on this device. For additional information on this matter, I encourage you to contact Dr. James P. Bagian, MD, PE, Veterans Health Administration Chief Patient Safety Officer and Director of VA National Center for Patient Safety at (734) 930- 5890 or John Bright, Director, VA Southern Nevada Healthcare System at (702) 636-3010. Thank you for your attention to this important matter. Sincerely, SB:ts Enclosure: Patient Safety Alert PRINTED ON RECYCLED PAPER cc: Michael J. Willden Lawrence Matheis Executive Director Executive Director Nevada Department of Health & Human Nevada State Medical Association Services 2590 Russell Road 505 East King Street, Room 600 Las Vegas, NV 89120 Carson City, NV 89701 Dr. Donald Kwalick Alex Haartz Chief Health Officer Administrator Clark County Health District Nevada State Health Division 625 Shadow Lane 505 East King Street, Room 201 Las Vegas, NV 89106 Carson City, NV 89701 Dr. James P. Bagian Dr. Bradford Lee VHA Chief Patient Safety Officer Nevada State Health Officer Director, VA National Center for Patient 505 East King Street, Room 201 Safety Carson City, NV 89701 Department of Veterans Affairs PO Box 486 Bill Welch Ann Arbor, MI 48106 President/CEO Nevada Hospital Association 5250 Neil Road, Suite 302 Reno, NV 89502 DEPARTMENT OF VETERANS AFFAIRS UNDER SECRETARY FOR HEALTH Washington DC 20420 In Reply Refer I OX Andrew C. von Eschenbach, MD Acting Commissioner of Food and Drugs Food and Drug Administration 5600 Fishers Lane Rockville, Maryland 20857 Dear Dr. von Eschenbach: I am writing this letter to bring to your attention a sjtoationjhat may place patients throughout the United States in jeopardy^ This problem was brought to my attention by a recent reprocessing problem thlt was identified with a B-K Medical ultrasound transducer used for prostate biopsies. We have reviewed manuals pro^ceci by B-K Medical for the 8808 and 8551 models, as well as B-K's general manual for transducers. We believe that the manuals are inadequate with respect to their clarity of instructions concerning cleaning, disinfection, and sterilization. The sections of the manuals pertaining to these important topics simply do not make clear what steps are needed to make each component of the 8808 and 8551 devices safe for re-use. Determining what the manufacturer recommends literally requires hours of study and access to the general transducer manual in addition to the manual for the 8808 or 8551 device. Over the last several weeks, we have worked with the manufacturer as well as staff at the Centers for Disease Control and Prevention (CDC) and FDA to determine what should be done Our primary contact at FDA has been Dr. David Buckles, and the interaction has been constructive and helpful. Our internal reviews culminated in the release of a VA Patient Safety Alert on April 3. 2006. On April 5, two officials from my office, Dr. Lawrence Deyton and Dr. James Bagian, briefed the staff of the House and Senate Committees on Veterans Affairs on the Alert and the associated background information. The Alert is enclosed and is also available on our Web site at www. patientsaf ety. gov/. The lack of clarity in the B-K manuals can result in patients being exposed to bacterial and viral pathogens. In 2005, CDC reported an outbreakjw.ilha.sjm|la?device sty* that led to acute bacferiai infections and sepsis in four patients. Because of a specific instance in which a biopsy needle guide was found to be grossly contaminated, we are presently offering Hurnan Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus testing to patients at tne i ogus vA Medical CenTer (VAMC} near Augusta, Maine. We are presently polling other VAMCs to determine if the problems with reprocessing these devices are widespread. Page 2 Andrew C. von Eschenbach, M.D It is unfortunate that this situation occurred. I would like to ask you to re-examine the processes that the FDA takes to ensure that the manuals and instructions for reprocessing (cleaning, disinfecting, and sterilizing) devices approved for marketing are adequate to provide for proper care for our patients. The VA stands ready to work with you in trying to develop a process whereby you can achieve this as we feel it is of paramount importance. A good first step might be to work together to review the instructions for the B-K 8808 and 8551 devices. The person to follow-up with regarding this topic is our Chief Patient Safety Officer, Dr. James Bagian. Dr. Bagian can be reached at (734) 930-5890 or iames.baqian@va.gov. Sincerely, lonathan B. Perlin, MD, PhD, MSHA, FACP Enclosure