Safety-Needle Manufacturers Finally Reaping Rewards

Originally Published MDDI March 2005

NEWSTRENDS

Erik Swain

Adapting to a new piece of legislation or a new set of regulations is not something that happens overnight. It often takes years of preparation before the user community embraces the products and procedures associated with the new rules. But once adoption reaches critical mass, the rewards for those who made changes to their products can be great. This appears to be the case five years after the passage of the Needlestick Safety and Prevention Act of 2000.

Device companies that make sharps products, such as Becton Dickinson and Co. (BD; Franklin Lakes, NJ), B. Braun Medical Inc. (Bethlehem, PA), and Baxter Healthcare Corp. (Deerfield, IL), invested time and money to revamp their product lines after the legislation was passed. In some cases these efforts had begun even earlier, after the Office of Safety and Health Administration issued a new standard on bloodborne pathogens. Many companies began making changes when it became apparent that Congress would pass a needlestick-prevention law.

They did not recover their expenses right away, because it took time for hospitals and other healthcare facilities to come up with conversion plans. But now, five years later, that sweat has paid off for quite a few in the field, as many of the safety products developed in those efforts have been adopted at high rates, and new ones continue to hit the market. For example, Braun recently announced that it won a contract with Premier Inc., a group purchasing organization that supplies more than 1500 healthcare facilities, for its line of Introcan Safety IV catheters.

Among other things, the legislation and OSHA regulation require hospitals to “use safer medical devices, such as sharps with engineered sharps injury protections and needleless systems,” as well as to implement other engineering controls. In addition, frontline nonmanagement healthcare workers must be involved in the evaluation and selection of devices.

These requirements appear to have spurred adoption. For example, BD reports that before 2000, 25% of the IV catheters it sold were safety systems. Likewise, 5–10% of the injection syringes it sold were safety systems. Those figures are now at 90–95% and 60–65%, respectively. Both BD's medical products division and its diagnostic division report similar trends across product lines. Safety-product revenues jumped from less than $100 million before 2000 to almost $700 million in 2004. That progress, however, was years in the making.

BD started developing a strategy by the early 1990s and was running with it a few years before the legislation passed. “We spent about $300 million in capital to retool and redesign our plants that we projected would make high volumes of safety products,” says Bill Kozy, president of BD Diagnostics. “That involved a significant amount of resources over a 2–21¼2-year period. It wasn't that we changed products, but that we ramped up production of safety products we had already developed.”

In conjunction with production and marketing efforts, the firm had to get involved in education programs to encourage adoption. “We go into a major hospital, train 10–15 people on the proper use of the devices, and then they become trainers for the rest of the hospital,” said Kozy.

Those educational programs seem to have worked, too. “The hospital environment for blood collection is pretty much completely converted,” said Kozy. “Most of the locations that have not converted are alternate-site locations such as nursing homes.” Personnel at most hospitals, he said, have become very astute about why safety products should be used and what their value is. A goal now is to get alternate-site personnel to that same level of knowledge.

Many hospitals, too, did extensive preparation even before the law was passed. “We have been working on this since well before 2000,” says Robyn Cooke, director of advocacy and public policy operations for the American Hospital Association (AHA; Chicago). “We were very much in favor of that legislation passing, and we remain very committed to the safety of our patients and employees.”

AHA has been particularly active in helping its members set up the processes to select and evaluate devices required by the legislation, she says. “A primary requirement is that a team is put together that includes frontline workers,” she says. “It has to look at all the devices available in the marketplace and do testing.”

Cost has not been as much of a factor relating to adoption as might have been expected, says Gary Cohen, president of BD Medical. “In the 1990s, users were always comparing the cost of safety devices to devices without safety features. Now, the relevant comparison has become the cost of one safety device to that of another. And that consideration comes after others, such as whether the product functions well for its purpose.”

Butch de Castro, senior staff specialist for occupational health for the American Nurses Association (Silver Spring, MD), agrees that performance considerations should come first and, in most cases, do. He notes that the give-and-take between hospital administrators, healthcare workers, and device manufacturers has been fruitful.

“We promote the idea that it should be up to the frontline staff,” he says. “Hospitals should go with what they prefer to use and are comfortable with. We need to educate folks in charge of purchasing supplies to understand these needs. A lot has been accomplished, but there is still more to do.”

Indeed, he says, one particularly successful educational program has been the Training for Development of Innovative Control Technologies (TDICT) Project, which involves collaboration between frontline personnel, designers of safety devices, and industrial hygienists.

The mostly successful process of converting the market to safety sharps devices did not come easy. But its lessons of early preparedness and educational collaboration across the entire spectrum of healthcare could be useful for other sectors that are dramatically affected by a change in laws or regulations.

Copyright ©2005 Medical Device & Diagnostic Industry