By Rick Dana Barlow

In a perfect world, needle-safety purists might call for the total elimination of needles to prevent injuries in favor of a plethora of needle-free devices, including inhalers, jet injectors and transdermal patches, for drug delivery, infusions and blood collection.

Of course, in a perfect world, healthcare workers also would be able to effectively perform multiple tasks during realistic hours without making mistakes, paying rapt attention to everything they’re doing in a chaotic environment.

In the more practical world, however, needle use for many remains a fact of life – and that probably won’t change anytime soon.

But that hasn’t stemmed the tide toward needleless systems. In fact, surging demand for needleless systems, spurred on by federal and state sharps safety regulations, is blunting prices for the costlier devices. "These devices aren’t at the premiums they once were," noted Brad Poulos, executive director of the National Association for the Primary Prevention of Sharps Injuries and a former employee of BD, one of the world’s leading purveyors of sharps and sharps safety devices.

Depending on whom you ask, hospital conversions toward needleless systems for intravenous procedures, infusion therapy and blood collection range anywhere between 70 percent and 90 percent. Observers and analysts like NAPPSI’s Poulous and Amit Bohora, practice leader, medical devices, at the market intelligence firm Frost & Sullivan, peg it in the 70 percent to 75 percent range. Meanwhile, companies like BD and B. Braun Medical Inc. estimate it in the 85 percent to 90 percent range – but that represents just their own customers. Bohora indicated that in 2003, needleless systems represented a $215 million market segment with a 4.1 percent annual growth.

"We’ve already seen a lot of behavioral changes," said Greg Jones, B. Braun Medical’s marketing director of I.V. systems. "It’s been fairly well-entrenched in the clinical community, particularly in hospitals. We’ve done a fairly good job in educating clinicians about legislation and regulations, as well as the benefits of our product offerings."

The fragmented non-acute care market, however, consisting of physician practices, clinics and surgery centers, looms at the other end of the spectrum, precipitated largely by higher costs because they can’t buy in such greater volumes as hospitals. "Manufacturers don’t really have an economic incentive to get physicians on board yet," Bohora said. "They’ve concentrated on hospitals where they can move greater volume and market share."

While healthcare facilities in the past (hospitals much less so today) have used pricing as the primary excuse for not converting to needleless systems, that may be changing. And not for the reasons you might expect.

In the early 1990s, a California nursing union brought the needle safety movement into the national spotlight as nurses who suffered needlesticks and seroconverted to HIV and hepatitis B began sharing their heart-wrenching stories. They called attention to the need for a safer workplace that protected patients as well as the employees who cared for them. Their message was simple as it was logical. "Sure, needleless devices are more expensive but can you put a price on safety?" Shannon Gore, senior communications specialist at Abbott Laboratories’ Hospital Products Divison, rhetorically asked.

People typically used the reasoning that an average needlestick cost about $2,800, which accounted for the lab work, paperwork, and so forth, and if you multiplied that by the number of needlestick occurrences and compared that to the costs of safety-engineered needle devices, "you could determine how much it was costing you and whether it was feasible to pay extra for the safety devices upfront," Poulos said. Of course, if a healthcare worker seroconverted, all bets were off, he added.

But as the number of reported needlesticks continues to decline that argument is "getting tougher" to use, according to Poulos. The combination of regulations and a commitment to healthcare worker and patient safety has made an impact on providers. "You’ll speed until you see a cop and then you’ll slow down," Poulos noted. "If you know OSHA is coming and will cite you with fines for non-compliance then that will get administration’s attention. Some of it just involves the law and the teeth behind the law."

"Hospitals don’t want to be slapped with fines," Gore said. "We have a commitment to make healthcare facilities a safer place. We work very closely with our customer base to find appropriate solutions and partnered with them to stay in compliance."

Hospitals also use their adoption and implementation of needleless systems and other safety-engineered sharps devices as a recruitment tool to alleviate nursing and physician shortages, Poulos added. They promote themselves as safer workplaces, which makes them more attractive to prospective employees and to insurance companies.

Sticking It To Needles

Last year, Abbott Laboratories and BD both agreed to phase out selected products that used needles. For Abbott, that involved all manufactured and marketed intravenous sets that contained or required needles. The decision affected less than 20 percent of Abbott’s product base, according to Gore, because the majority of the I.V. systems and infusion therapy products the company made and marketed already were needle-free. "We’ve gone through the conversion process and have retained all of our customers in infusion therapy," Gore said confidently. But she admitted they haven’t reached 100 percent – just the vast majority of customers.

By second quarter of this year, all of those products will be marketed under the Hospira brand as Abbott succeeds in spinning off its Hospital Products Division, soon to be known as Hospira Inc., according to Gore.

BD, on the other hand, merely extended a strategy it had already put in place, phasing out a broad range of needle-based products, including I.V. catheters, winged needle sets, I.V. access systems, blood collection needles, blood collection tubes and lancet devices, as determined by market demand. BD could not respond to repeated requests for comment at press time.

Even B. Braun Medical Inc. acknowledged the "natural evolution and decline in the standard port I.V. set" but instead preferred "the clinician choose what I.V. infusion system and related needle-free technology they find appropriate for their needs," according to an official statement released by the company.

"Our needle-free direction has been going on for over a decade," Jones said. "Our directive continues to be needle-free. There’s no question about that. But we let our customers choose what I.V. products they want."

The provider push for more needleless systems has bred a business and economic rationale for manufacturers. "As the volume of safety products grows a company strains its manufacturing capabilities because it has to make both types of products," Poulos noted. "So converting manufacturing facilities to produce only safety lines to meet demand frees up capacity. And once one company does it the competitors tend to follow suit and that benefits the market."

Manufacturers aren’t only retooling their plants to control costs, which ultimately should lower prices to end users, particularly as demand rises, but they’re also moving production off shore and retooling plants in other countries, too, Bohora noted.

Yet those same companies are migrating internationally to meet what they perceive to be freshly sprouting demand in other countries, such as South Africa, Australia, France, Germany, the United Kingdom and Japan, Poulos noted.

"This all started because a nursing union in California convinced the government to adopt regulations," Poulos said, "and that moved a market. Now you’ve got manufacturers moving that to new markets. They responded to market demand and now have the capacity to expand and push that to new markets."