CLDF Title
Home | Contact Us | Bookmark
HBV HE HCC HCV
About CLDF Centers of Educational Expertise  
CME Dinner Meetings Telewebs Webcasts Slide Library Abstract Library Conference Highlights
 
Back  
 
Reuters Health Information (2006-05-25): CDC urges some allograft recipients to undergo testing for infectious diseases

Public Health

CDC urges some allograft recipients to undergo testing for infectious diseases

Last Updated: 2006-05-25 14:07:18 -0400 (Reuters Health)

NEW YORK (Reuters Health) - Inaccurate record keeping, ineligible donors, and failure to screen donor tissue for infectious diseases have led the US Centers for Disease Control and Prevention to recommend that recipients of tissue implants supplied by Biomedical Tissue Services, Ltd, (BTS, Fort Lee, New Jersey) undergo testing for infectious diseases.

Dr. M. Malarkey, from the US Food and Drug Administration (FDA), and associates report that, late last year, an investigation of BTS by the FDA revealed that information regarding cause, place or time of death did not match information from the donors' death certificates. They also found sloppy recovery methods that failed to control contamination of the tissue.

As reported in the Morbidity and Mortality Weekly Report for May 26, approximately 25,000 BTS-recovered tissue products had been sent to five tissue processors and then distributed in all 50 states and internationally between June and October.

In October, BTS and the five processors that had received the tissues were ordered to issue a recall of all unused product recovered by BTS.

The recall letters sent to the clinicians and healthcare facilities that had bought the products included a recommendation by the FDA and CDC that tissue recipients be notified of the recall and offered testing for HIV, hepatitis B, hepatitis B, and syphilis.

In January of this year, the US Food and Drug Administration ordered BTS to cease manufacturing and distributing all cells, tissue, and cellular and tissue-based products. Most of the products were bone or demineralized bone matrix, skin, and soft tissue such as tendons and fascia lata.

Then in March, the FDA found out that some of the blood samples submitted for disease screening were not from the alleged donors.

The CDC advises that the involved patients whose tissue implants had been in place for longer than 6 months be tested. Patients who received less than 6 months earlier can also be tested, but they should be retested after the 6-month mark.

Those who test positive should undergo confirmatory or supplemental testing, the authors note, and positive test results be reported to local or state health departments, the tissue distributor, FDA's MedWatch program (http://www.fda.gov/medwatch) or the CDC (phone number 800-893-0485).

Patients who do not know where their allografts had come from should ask their physicians, according to the report. If physicians don't know the source of the tissue, they should contact the facility or distributor that provided the tissues, or call their state or local health department.

Mor Mortal Wkly Rep CDC Surveill Summ 2006;55:564-566.

 
 
 
 
                 
 
HBV
Webcasts
Slide Library
Abstract Library
 
HE
CME Dinner Meeting
Webcasts
Slide Library
Abstract Library
 
HCC
Slide Library
Abstract Library
 
 
HCV
Webcasts
Slide Library
Abstract Library
 
CLDF Follow Us
   
 
About CLDF
Mission Statement
Board of Trustees
Board of Advisors
CLDF Supporters
 
Other Resources
Liver News Library
Journal Abstracts
Hep C Link to Care
 
Centers of
Educational Expertise
Regional Map
     
   
  The Chronic Liver Disease Foundation is a non-profit organization with content developed specifically for healthcare professionals.
© Copyright 2012-2014 Chronic Liver Disease Foundation. All rights reserved. This site is maintained as an educational resource for US healthcare providers only.
Use of this Web site is governed by the Chronic Liver Disease Foundation terms of use and privacy statement.