Bio-Plexus Supports Petition Calling for Immediate Ban of Unsafe Medical Needles.Business Editors/Health & Medical Writers BIOWIRE2K VERNON, Conn.--(BW HealthWire)--Dec. 1, 2000 Bio-Plexus, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :BPLX), a leader in the design, manufacture and marketing of safety medical needles and other products, today announced its support of the petition filed yesterday by Public Citizen, a consumer group, and the Service Employees International Union (SEIU SEIU Service Employees International Union SEIU Special Education Intake Unit SEIU Secondary Education Interdisciplinary Unit SEIU Software Engineering Institute Union ) with the Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) calling for the immediate ban of unsafe medical needles to protect health care workers from contracting deadly diseases from accidental needlesticks. The petition urges the FDA to remove from the market all unsafe intravenous catheters, blood collection devices, blood collection needle sets (also known as butterfly syringes), glass capillary tubes and intravenous infusion equipment. The petition also asks the FDA to issue performance standards to ensure that similar unsafe devices do not enter the market. In the petition it was reported that U.S. health care workers sustain 590,000 needlesticks annually. (Some sources believe that the number of needlesticks that actually occur is seriously understated.) The petition also stated the following: that of the 55 confirmed cases of occupational HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. transmission, 49 cases involved sharp object injuries such as needlesticks; an estimated 100-200 health care workers die annually from hepatitis B Hepatitis B Definition Hepatitis B is a potentially serious form of liver inflammation due to infection by the hepatitis B virus (HBV). It occurs in both rapidly developing (acute) and long-lasting (chronic) forms, and is one of the most common chronic ; and hundreds annually contract hepatitis C Hepatitis C Definition Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild. . Public Citizen and the SEIU properly note that the incidence of death and suffering from these diseases is unnecessary because safer alternatives to commonly used needle technology currently exist, such as self-blunting needles. The petition further states, "The AIDS epidemic has generated renewed interest in worker safety in this area, and the result has been the development of a number of well-designed, FDA-approved devices that have been demonstrated to reduce the incidence of needlesticks to workers by as much as 90%, depending on the device. The Occupational Safety and Health Administration Occupational Safety and Health Administration (OSHA), U.S. agency established (1970) in the Dept. of Labor (see Labor, United States Department of) to develop and enforce regulations for the safety and health of workers in businesses that are engaged in interstate (OSHA OSHA n. Occupational Safety and Health Administration, a branch of the US Department of Labor responsible for establishing and enforcing safety and health standards in the workplace. ), which has developed a Bloodborne Pathogens Standard focused primarily on changing work practices, admits that `as many as 60 percent of needlestick injuries would be unaffected by improved work practice procedures.' For the FDA not to ban the more dangerous alternatives is to abdicate ab·di·cate v. ab·di·cat·ed, ab·di·cat·ing, ab·di·cates v.tr. To relinquish (power or responsibility) formally. v.intr. To relinquish formally a high office or responsibility. its responsibility to protect those who care for the nation's sick and dying." Bio-Plexus manufactures safety needles using its patented PUNCTUR-GUARD(R) technology, which greatly reduces the risk of accidental needlesticks by internally blunting the needle prior to its removal from the patient. The Company has been at the forefront of marketing safety devices designed to save lives since 1991. John S. Metz, President and Chief Executive Officer of Bio-Plexus, stated, "In calling on the FDA to take action, Public Citizen and the SEIU are echoing the sentiments of the many dedicated health care workers who are exposed to the danger of accidental needlesticks. We wholeheartedly whole·heart·ed adj. Marked by unconditional commitment, unstinting devotion, or unreserved enthusiasm: wholehearted approval. whole support their petition. This is a matter of high importance and high visibility, as evidenced by the recent signing into law of The Needlestick Safety and Prevention Act by President Clinton. In addition, 17 states have enacted needlestick legislation regarding the use of safety engineered needle-based medical devices." Bio-Plexus, Inc. (NASDAQ:BPLX), designs, develops, manufactures and holds U.S. and international patents on safety medical needles and other products under the PUNCTUR-GUARD(R), DROP-IT(R), and PUNCTUR-GUARD REVOLUTION(TM) brand names. In studies by the Centers for Disease Control (MMWR MMWR Morbidity & Mortality Weekly Report Epidemiology A news bulletin published by the CDC, which provides epidemiologic data–eg, statistics on the incidence of AIDS, rabies, rubella, STDs and other communicable diseases, causes of mortality–eg, , January 1997) and ECRI ECRI European Commission against Racism and Intolerance ECRI Emergency Care Research Institute ECRI Economic Cycle Research Institute (Health Devices, June 1998 and October 1999) PUNCTUR-GUARD(R) needles ranked highest in safety of all devices studied. Accidental needlesticks number about one million per year in the United States and can result in the transmission of deadly diseases including HIV and Hepatitis B and C. NOTE: THIS PRESS RELEASE MAY CONTAIN FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF THE PRIVATE SECURITIES LITIGATION REFORM ACT The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and OF 1995. FORWARD-LOOKING STATEMENTS MAY BE IDENTIFIED BY THE USE OF SUCH TERMINOLOGY AS "BELIEVES," "EXPECTS," "MAY," "WILL," "SHOULD," "ANTICIPATES,""PLANS," "ESTIMATES," AND "INTENDS" OR DERIVATIONS OR NEGATIVES THEREOF OR COMPARABLE TERMINOLOGY, OR DISCUSSIONS OF STRATEGY THAT INVOLVES RISKS (KNOWN AND UNKNOWN) AND UNCERTAINTIES. THE COMPANY'S ACTUAL RESULTS MAY DIFFER MATERIALLY FROM THOSE PROJECTED IN THE FORWARD-LOOKING STATEMENTS AS A RESULT OF, AMONG OTHER FACTORS, GENERAL ECONOMIC CONDITIONS AND GROWTH IN THE SAFETY MEDICAL PRODUCTS INDUSTRY, COMPETITIVE FACTORS AND PRICING PRESSURES, CHANGES IN PRODUCT MIX, PRODUCT DEMAND, RISK OF DEPENDENCE ON THIRD PARTY SUPPLIERS AND FINANCIERS, ABILITY TO OBTAIN FINANCING, AS WELL AS OTHER FACTORS DESCRIBED FROM TIME TO TIME IN THE COMPANY'S PERIODIC REPORTS FILED WITH THE SECURITIES AND EXCHANGE COMMISSION OR DISCUSSED IN OTHER PRESS RELEASES ISSUED BY THE COMPANY. THE COMPANY UNDERTAKES NO OBLIGATION TO UPDATE OR ADVISE UPON ANY SUCH FORWARD-LOOKING STATEMENT. |
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