Alere Notice – Ebola Virus
Reason for Notice
The ongoing outbreak of Ebola Virus Disease (EVD) in West Africa, and confirmed cases in several other countries, have raised questions among our customers regarding appropriate decontamination of Alere-distributed instruments used to test specimens from known or suspected EVD patients. The purpose of this communication is to reinforce decontamination procedures to be used for Alere instruments and to advise of precautions Alere is taking in the interest of public safety.
Alere Instrument Decontamination
While Alere instruments have been designed for the testing of specimens containing potentially infectious disease agents, they have not been specifically evaluated on Ebola virus specimens, and Alere cannot provide absolute assurance that dispersion of infectious disease agents, including Ebola virus, is completely prevented during specimen testing or in cases when an instrument is misused or malfunctions. Cleaning procedures specified in the applicable instrument user manuals should be followed, Universal Precautions for the handling of blood and other potentially infectious materials should be observed at all times, and biological waste should be disposed of in accordance with facility, local, state and federal policies and regulations.
Alere urges you to consult and follow the specific recommendations for infection prevention and control related to EBV as outlined on the following websites:
- WHO Global Alert and Response (GAR) at http://www.who.int/csr/disease/ebola/en/
- CDC Interim Guidance for Specimen Collection, Transport, Testing, and Submission for Persons Under Investigation for Ebola Virus Disease in the United States CDC at http://www.cdc.gov/vhf/ebola/hcp/interim-guidance-specimen-collection-submission-patients-suspected-infection-ebola.html
- CDC Interim Guidance for Environmental Infection Control in Hospitals for Ebola Virus at http://www.cdc.gov/vhf/ebola/hcp/environmental-infection-control-in-hospitals.html
- OSHA Fact Sheet for the Cleaning and Decontamination of Ebola on Surfaces at https://www.osha.gov/Publications/OSHA_FS-3756.pdf
- NIH Ebola Virus Disease: Information for U.S. Healthcare Workers http://www.nih.gov/health/ebola.htm
Please be advised that, in the interest of public safety, Alere is taking the temporary measure of not accepting clinical samples, instruments or devices from the Western African nations that are experiencing cases of Ebola, including Guinea, Liberia, and Sierra Leone. Additionally, Alere entities will not accept clinical specimens known to be positive for Ebola virus or any instruments/product known to have been used in the testing of Ebola-infected specimens, regardless of their origin. Alere will continue to monitor the situation and will update this policy as necessary following relevant guidance from governmental agencies.