Hospitals nationwide will have to use safer medical devices as a first-line defense against needlestick injuries to comply with a tough policy change by the Occupational Safety and Health Administration.
OSHA released the 263-page directive as instructions to workplace inspectors on Nov. 5 without warning, and the rules became effective immediately. They put teeth in a 1991 regulation to combat the spread of blood-borne diseases, including AIDS and hepatitis, on the job.
The OSHA action requires all healthcare providers, with a few exceptions, to use devices designed with safety in mind. These products, ranging from IV systems without needles to shielded syringes, must be part of a documented, ongoing plan to reduce workplace needlestick injuries and infections.
Proponents, particularly unions, have argued that these specially engineered supplies are critical to taming needlesticks, but opponents have said many of the devices aren't good enough or are too expensive to become standard equipment. Workers are injured by needles and other sharps between 590,000 and 800,000 times per year, according to estimates cited by OSHA.
The OSHA requirements mark a watershed in the movement to mandate the use of safety products in hospitals across the country.
"The time for all of the debate over safety devices is finished," said Janine Jagger, director of the International Health Care Worker Safety Center at the University of Virginia. "Now we just have to go ahead and do it."
The needlestick requirements mimic a California law, which has been enforced since July and has spawned similar legislation in more than 20 states (July 5, p. 36). Since then, federal legislation has also been proposed.
OSHA's rule would apply when states have weaker or no requirements. The administrative action may blunt further legislative fixes in Congress and in statehouses, some observers say.
The instructions to OSHA inspectors emphasize that healthcare providers are expected to use safer medical devices but that the choice of products is up to them.
Inspectors will check hospitals' procedures for evaluating and implementing these safety devices as well as employee training and work practices.
For most hospitals, complying with the OSHA requirements will mean quite a bit of work.
"I think it's going to wake up a lot of people," said Barbara DeBaun, manager of infection control at 613-bed California Pacific Medical Center, San Francisco.
Safety products generally cost more than the devices they replace, which means the change could shock some supply budgets. Training costs add to the conversion expense.
Richard Wade, senior adviser for communications at the American Hospital Association, said the association had no estimate for the industry's compliance cost.
"Whatever it is," he said, "it's probably appropriate."
In the short run, hospitals may have trouble finding adequate supplies because of limited production of the relatively new devices.
"There will definitely be industrywide capacity issues over the next 12 to 24 months," said Kevin Seifert, director of policy and new business development at BD, Franklin Lakes, N.J., a major supplier of the safety devices.
The extent of these bottlenecks will depend on how quickly OSHA enforces the rules. OSHA officials did not return repeated calls for comment.