WASHINGTON — Texas adopted legislation in June requiring safety syringes and needles in health-care facilities, part of a wave of such laws that now cover five states, including California.
The effort is pushed by health-care unions that aggressively have campaigned for safety needles.
``I think there will be a dramatic effect'' on the plastics industry, said James Donegan, chairman of safety-syringe manufacturer Med-Design Corp. in Ventura, Calif.
``All the major players will have to change their current production and their current molds. ... Even bigger than that, you will see new companies popping up left and right,'' he said.
Some safety-syringe manufacturers say the state legislation will mean redesigned molds and opportunities for custom injection molders. But some plastics industry officials are not so sure.
Annually, about 600,000 health-care workers are victims of accidental needle sticks and several hundred die each year from diseases contracted as a result, according to government data and health-care unions.
On July 1, California began requiring safety needles in all its health-care facilities. Four other states have passed laws, New Jersey's awaits the governor's signature, 20 others are considering it and federal legislation was introduced in May.
A safety syringe prevents the needle from accidentally sticking someone after use by employing a sheath or shield that slides over it, or a retractable needle that slides back into the plunger. Some have break-off plungers that can cap the needle. Safety technology also is used on needles in catheters, intravenous products and blood-collection devices.
Safety-needle technology has been around for at least a decade, but the health-care industry only now is in the midst of a rapid conversion that is likely to cause some short-term shortages, observers said.
Still, custom injection molders are cautious because the safety-syringe market is dominated by major manufacturers like Becton Dickinson.
``The market has been around for so long and it's been nothing,'' said Tom Podesta, vice president of sales and marketing for Tech Group in Scottsdale, Ariz. ``With that new legislation, it may grow at a faster rate. I don't think it is something we will stake our future on.''
Tech is building multicavity injection molds for a safety-syringe maker now, and has been approached by inventors and start-up firms that have ideas but lack distribution channels or the money to compete against the large medical device makers, he said.
``I would assume if someone does have a home run, the [Becton Dickinsons] and Sherwoods are out there scouring the market and buying them up,'' Podesta said.
James Dolan, business manager for health care at Nypro Inc. in Clinton, Mass., said his company has seen more proposals in the past year. Nypro has several projects in development.
``Big players do self-manufacture in that market,'' he said. ``We've been looking at companies with interesting ideas,'' but knowing that they would have to compete against major device makers hurts their chances.
Drug-delivery devices probably offer a good niche for smaller safety-needle makers, he said.
Start-up manufacturers are having some trouble getting financing, said Julie Logothetis, president of Kahle Engineering Corp. in Orange, N.J. Kahle makes medical assembly equipment, and thinks that 50 percent of its business could be related to safety-needle production in several years.
Med-Design recently signed a licensing agreement with Becton Dickinson. Med-Design's product will require a new mold for a plunger, and a new mold for a plastic retainer to hold the needle and spring in the needle housing, Donegan said.
F. Ross Sharp, chief executive officer of safety-syringe start-up manufacturer Inviro Medical Devices Inc. in Vancouver, British Columbia, said the safety-syringe industry probably will not be able to produce enough product initially and will have to gear up quickly.
``It's a great opportunity for the plastics industry,'' he said.
Inviro still is commercializing its product, and is working with custom molder GW Plastics Inc. in Bethel, Vt., he said.
Safety syringes can be expensive, running 25-65 cents each, compared with 10-25 cents for standard syringes, syringe makers said. But safety needles are cheaper in the long run than testing staff and treating those who are infected, according to a May report from the Occupational Safety and Health Administration.
Hospitals' cost concerns helped keep the issue dormant until recently, Donegan said. And until 1994, federal regulators did not require comprehensive reporting of needle sticks, he said.
``Over the past few years, the health-care workers had absolutely no say over the products they would use,'' Donegan said. ``About two years ago, they dug their heals in and they demanded the change through legislative movement.''