New guidance for manufacturers of biological indicators that monitor sterilizers used in health care facilities recently was released byu the FDA. Also, there is a need for the manufacturers to describe in detail the biological indicators they manufacturer. The guadance is located at the following URL www.fda.gov/OHRMS/DOCKETS/98fr/01d-0193-gdl0002.pdf
By: Haranath Bapuji
A laboratory with China’s national disease control and prevention center was found to be the source of the outbreak of Severe Acute Respiratory Syndrome (SARS) during April and May of 2005.
Health officials declared at a meeting held by the Ministry of Health at Chinese Center for Disease Control and Prevention, that laboratory infection was to blame for the outbreak. The ministry in cooperation with the Ministry of Sciences and Technology conducted an investigation. Chinese Vice-Premier Wu Yi was also present at the meeting.
Officials said poor lab safety management and irregular operations by professionals resulted in the pollution of a laboratory. SARS virus infection to some of the lab staff members, which constitutes a major accident, was due to negligence.
According to a report The Diarrhea Virus Laboratory under the Institute of Virus Diseases of the center was found to have conducted SARS virus research, and adopting untested methods to kill the virus in an ordinary lab. The lab failed to report to higher authorities the fact when unusual health conditions were detected among some of their staff members.
The Ministry of Health said it has decided to accept the resignation of the director, Li Liming and a vice-director of the Chinese Center for Disease Control and Prevention, a long with the head of the Diarrhea Virus Laboratory.
Vice-Premier Wu Yi stated in the meeting, to which staff members of the center attended, that the accident, caused harm to the health of people and damage to the social and economic development. It is the combined responsibility of the Party and the central government to handle the accident.
The importance must be given to the health and safety of scientific researchers. Proper efforts should be made to prevent it from happening again. China would step up its necessary efforts to formulate laws and regulations on laboratory bio-safety, and improve work conditions for researchers to protect their health and safety and prevent the spread of disease.
A total of nine people were confirmed as SARS patients during April and May. The nine cases included two from Anhui Province, east China and seven from Beijing. Beijing reported China’s first suspected SARS case of this year on April 22 and the patient surnamed Li and a 26 year-old girl surnamed Song was declared diagnosed SARS patients the next day.
Song, a medical student from Anhui Medical University, was then presumed to have contracted the disease when serving as an intern at the Beijing-based Institute of Virus Diseases under the center from March 7 to 22. Li apparently caught the disease when taking care of hospitalized Song during March 29 and April 2. Song’s mother who was taking care of song died of SARS.
A medical researcher surnamed Yang, 31, with the institute was reported as a suspected case of SARS on April 23. The outbreak had been contained by May 22. One diagnosed SARS patient died and eight others recovered and were discharged from hospital before May 22.
As a rescue measure to outbreak, an expert team was set up consisting of members from China’s Academy of Military Medical Sciences, and Beijing and national disease prevention and control centers. The team has made epidemiological investigations into the two cases and interviewed all the staff working at the laboratory of Virology Institute.
A total of 5,327 cases of SARS were reported in 2003 in 24 provincial areas on the mainland, including 349 deaths. Finally the disease was under control in mid August of that year.
Centers for Disease Control (CDC) opened its office in Ethiopia in 2001 with the view to responding to HIV/Aids pandemic in the country. Dr Julie Gerberding, the director of CDC, addressing the press conference on Monday at the Hilton Hotel said that the United States had allocated 43 million dollars to Ethiopia in 2004 in support of the national effort to fight the HIV pandemic in the country.
This support program includes fourteen other countries to benefit from U.S. President’s Emergency Plan for AIDS Relief. The director highlighted the commitment of the U.S. government to assist Ethiopia in its effort to fight the HIV/Aids pandemic in the country.
Gerberding signed a project agreement worth 1.6 million birr in support of HIV/Aids voluntary counseling and testing services throughout Addis Ababa, during her official visit in Ethiopia. The initial phase was to establish four-satellite VCT centers at different parts of Addis Ababa along with a new mobile VCT service.
Dr. Gerberding also donated laboratory equipment, which includes a DNA analyzer, autoclaves, incubator, microscope, Elisa reader and computers and supplies worth 6 million birr to the Ethiopian Health and Nutrition Research Institute (EHNRI).
It is believed that the equipment will support the rollout of the national Anti-Retroviral drug treatment Program that the drug Ministry of Health, HIV/Aids prevention and Control Office, and Drug administration and control Authority have proposed in partnership with U.S. agencies.
To ensure proper help in supporting the national blood transfusion service and to establish eight new blood banks in the country, the Director donated 21.5 million birr to the Ministry of Health and 2.8 million birr to the World Health Organization (WHO), last Tuesday.
She said the effort should be made to assist voluntary testing for HIV/AIDS in the country by emphasizing the need for high political figures in the country to undergo HIV test.
Gerberding met government officials, including the Prime Minister, and discussed health issues and bilateral cooperation of the two countries with them.
Taddesse Wuhib, country director of CDC-Ethiopia, said on his part that HIV infection in Ethiopia was declining. He said the effort being made by different stakeholders to combat HIV transmission in the country was encouraging.