OSHA Expands Accidental Needlestick Guidelines

Safety needle legislation that began in California in late 1998 and by mid-1999 had spread to 20 states around the country has now mandated the use of safety needles in virtually every health care facility in the United States. The Occupational Health and Safety Administration (OSHA) directive issued last month is the culmination of nearly 10 years of legislative lobbying by health care safety organizations and device manufacturers and is the harbinger of greater product utilization for companies like Med-Design Corp., Ventura, Calif.

As reported in the August, 1999, issue of Health Industry Today, Med-Design is one a group of device manufacturers promoting the use of safety needles for humanitarian reasons, with its eyes understandably fixed on the bottom line.

Safety concerns dating back nearly 25 years prompted the development of the safety syringes. Accidental needlesticks were said to have caused hundreds of deaths by the accidental transmittal of HIV and hepatitis, but because safety syringes were about three times as expensive as conventional needles, the uptake by health care providers was slow.

But after workers' unions mounted emotional campaigns: (“You're costing lives to save the price of a postage stamp!”), the grass roots campaign sprouted.

James Donegan, Med-Design chairman and CEO, called the legislation important for both his company and health care workers across the nation who have been facing the risk of accidental needlesticks by using conventional, potentially unsafe medical needles. “We believe they (OSHA Compliance Directives) will result in the total conversion of the medical sharps market to available and approved safety engineered needle products within a very short period of time,” he said.

The Compliance Directives became effective upon their announcement.

Upping the standards

The new Compliance Directives — “Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens” &#mdash; are a dramatic development in the medical device market. The directives will cover virtually all employees in the U.S. who have occupational exposure to blood or other potentially infectious materials.

In addition to recording and reporting all incidents of accidental needlesticks, every employer must now establish an Exposure Control Plan that documents the evaluation and implementation of appropriate, commercially available and effective engineering controls designed to eliminate or minimize exposure to bloodborne pathogens.

OSHA also is encouraging employers to involve their health care workers potentially exposed to accidental needlesticks in the selection of the safety devices and to improve the quality of the selection process.

Med-Design, said Donegan, sees the OSHA directive as especially appealing since in a number of health care worker focus groups the company's products have received high ratings from nurses and other providers.

The company says that ease of use, degree of protection and overall acceptability are the product's strengths.

BD (Becton Dickinson) Franklin Lakes, N.J., is the major player in the industry. Safety Syringes, Inc., Carlsbad, Calif., Retractable Technologies, Inc., Little Elm, Texas, Terumo of Japan, and Wyeth-Ayerst Laboratories, Inc., Wayne, Pa., are among Med-Design's competitors.

Down To Basics

OSHA defines “engineering controls” as using safer medical needles to prevent accidental needlesticks before, during or after a procedure. Required features, which are consistent with Med-Design products as well as a number of other safety needles currently on the market, include a fixed safety feature that provides a barrier between the hands and the needle after use and allows or requires the worker's hands to remain behind the needle at all times; a safety feature that is an integral part of the device and not an accessory; a safety feature that is in effect before disassembly and remains in effect after disposal to protect users and trash handlers, and for environmental safety; and a safety feature that functions as simply as possible, requiring little or no training to use effectively.

OSHA has identified nearly 30 classifications of health care workers that have potential exposure to accidental needlesticks, beginning with physicians and nurses and including dental workers, home health care workers, diagnostic employees, fire fighters, law enforcement personnel and waste collectors. Their places of employment include physician and dental offices, clinics, laboratories, blood banks, plasma centers hemodialysis centers, nursing homes, education and correctional facilities and funeral homes and mortuaries.

In other words, virtually all health care employers and employees in the United States are included in the directives.

The Window of Opportunity

Med-Design Corp., as one of a relatively limited number of medical device companies focused exclusively on the design and development of safety needles, sees itself in a strong position to play a leading role in providing health care workers with a range of safety engineered needle products. Med-Design currently has a portfolio of 21 safety needle devices, covering applications with the risk areas of blood collection, infusion therapy, injection and insertion.

The company, says Donegan, “anticipates significant market demand for its safety engineered needle products.”

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