President Clinton's signing of broadly supported federal needlestick legislation came off without a hitch last week, but compliance with the new law may leave hospitals and other healthcare organizations feeling the pinch.
The law mandates that hospitals and other healthcare facilities use safety-engineered sharps and needleless systems. The statute amends the Occupational Health and Safety Administration blood-borne pathogens standard, making law what had been enforceable OSHA directives in effect since November 1999.
President Clinton signed the Needlestick Safety and Prevention Act Nov. 6.
The act "makes clearer the responsibility of employers to lessen the risk of injuries to workers from contaminated sharp devices," Clinton said in a statement. But a shortage of the devices may make compliance difficult.
"The industry doesn't have the depth and the breadth of the product line that you really need," said Linda Akiens, interim director of procurement services at 437-bed University of Texas M.D. Anderson Cancer Center in Houston. Akiens said this shortage "causes a nightmare" for hospitals.
Franklin Lakes, N.J.-based needle giant BD confirms that manufacturers aren't yet ready for healthcare facilities to convert to the new products.
The industry is already prepared for conversion in two areas where the risk is greatest--blood collection devices and intravenous catheters, says Kevin Seifert, Becton Dickinson vice president of advanced protection technologies. But it may not have enough supply to meet the demand for syringes, he said.
BD is halfway through a three-year, $300 million conversion process to meet demand, Seifert said. BD expects to complete the process by the end of 2001.
Though BD's development of safety-engineered products began more than a decade ago, Seifert said, the real scrambling in the industry occurred with passage and quick implementation of California's needlestick legislation in 1998.
"I think everybody was really caught off guard," said Gina Pugliese, director of Chicago-based Premier's Safety Institute.
Seifert said the industry will be able to manage demand for syringes if the conversion of facilities is spread out over the next year, but shortages are likely to occur if all providers rush to make the change in the next few months.
Seifert noted that only 25% to 30% of all syringes used by healthcare institutions come in contact with bodily fluids and need to be safety engineered. He said if providers use safety syringes only when necessary it would help manufacturers better meet demand.
Given the potential shortage, if employers can demonstrate in an OSHA inspection that they have made good faith efforts, OSHA inspectors will "take that into consideration," an OSHA spokeswoman said.
Premier's Pugliese isn't convinced.
"It is very difficult to get all the OSHA people singing off the same song sheet," Pugliese said. "It will be important for hospitals to document what they are doing and how they are doing it."
The legislation takes effect in nine months, but OSHA said the new law won't change its approach toward compliance.
Inspectors have been citing offenders since the agency put its directives in place a year ago, an OSHA spokeswoman said.
Another potential difficulty for hospitals will be managing two separate inventories--possibly forcing caregivers to switch back and forth between different products--until there is enough stock to convert entirely to the safety products.
The legislation exceeds the OSHA directives requiring safety-engineered sharps and needleless systems. It also requires institutions to maintain a sharps injury log and involve workers in selection and evaluation of new safety-engineered devices.
Janine Jagger, director of the International Health Care Worker Safety Center at the University of Virginia, said the savings associated with reducing needlestick injuries are difficult to estimate, but noted that the cost of medical tests required after any accidental needlestick injury is about $600.
The new law also bears a still-unknown added cost for hospitals. Richard Wade, the American Hospital Association senior vice president for communications, said there is no industrywide assessment of the cost impact, but rough estimates range between a 10% to 30% cost increase for affected items.
Sue Tyk, director of materials management at four-hospital Columbia-St. Mary's Hospital System in Milwaukee, said compliance with the new needlestick law will cost an added $100,000 in her system.
The legislation was supported by the AHA and labor unions and received bipartisan support as identical bills passed the House of Representatives and Senate last month. Service Employees International Union figures found 600,000 to 1 million healthcare workers are accidentally stuck by needles each year. More than 1,000 people annually contract a serious infection from needlestick injuries.