Becton Dickinson, one of the largest manufacturers of medical supplies, dominates the US market in disposable syringes and needles. In 2005, a nurse, Maryann Rockwood (a fictional name), used a Becton Dickinson 5cc syringe and needle to draw blood from a patient known to be infected with HIV (Human immunodeficiency virus). Ms. Rockwood worked in a clinic that served AIDS patients, and she drew blood from these patients several times a day. After drawing the blood on this particular day, she transferred the HIV-contaminated blood to a sterile test tube by sticking the needle through the rubber stopper of the test tube, which she was holding with her other hand. She accidentally pricked her finger with the contaminated needle. She is now HIV positive. A few years earlier, in 2000, Becton Dickinson had acquired exclusive rights to a patent for a new syringe that had a moveable protective sleeve around it. The plastic tube around the syringe could slide down to safely cover the needle.
The Becton Dickinson 5cc syringe used by Maryann Rockwood in 2005, however, did not yet have such a protective guard built into it. The AIDS epidemic has posed peculiarly acute dilemmas for health workers, including doctors and nurses. Doctors performing surgery on AIDS patients can easily prick their fingers with a scalpel, needle, sharp instrument, or even bone fragment and can become infected with the virus. The greatest risk is to nurses, who, after routinely removing an intravenous system, drawing blood, or delivering an injection to an AIDS patient, can easily stick themselves with the needle they were using. Needlestick injuries occur frequently in large hospitals and account for about 80 percent of reported occupational exposures to HIV among health care workers. It was conservatively estimated in 2005 that about 64 health care workers were then being infected with HIV each year as a result of needlestick injuries.
Although the fear of HIV had heightened concerns over needlestick injuries, HIV was not the only risk posed by needlestick injuries. Hepatitis B can also be contracted through an accidental needlestick. In 2000, the Centre for Disease Control (CDC) estimated, on the basis of hospital reports, that each year at least 12,000 health care workers are exposed to blood contaminated with the Hepatitis B virus, and of these 250 die as a consequence. Due to underreporting, however, the actual numbers may be higher. In addition to Hepatitis B, needlestick injuries can also transmit numerous other viral, bacterial, fungal, and parasitic infections, as well as toxic drugs or other agents that are delivered through a syringe and needle.
The total statistics on needlestick injuries in 2005 are disturbing, although the exact incidence of contamination is unclear. It was estimated that each year, in the United States alone, between 800,000 and 1 million needlestick injuries occurred in hospitals – of these, between 60,000 and 300,000 resulted in Hepatitis B infection. By one estimate, the risk of contracting HIV from a known contaminated needle could be as high as 1 in 1000, and the risk of contracting Hepatitis B, a serious and often life-threatening condition, could be as high as 1 in 6. These estimates would imply that as many as 600 to 1000 health care workers were at risk of contracting HIV and as many as 100,000 were at risk of contracting Hepatitis B.
Several agencies stepped in to set guidelines for nurses, including the American Nursing Association, the CDC, the Environmental Protection Agency (EPA), and the Food and Drug Administration (FAD), who all developed such guidelines. The most comprehensive guidelines were issued by the Occupational Safety and Health Administration (OSHA), who on December 6, 2001, required hospitals and other employers of health workers to (a) make sharps containers (safe needle containers) accessible to workers, (b) prohibit the practice of recapping needles by holding the cap in one hand and inserting the needle with the other, and (c) provide information and training on needlestick prevention to employees. The usefulness of these guidelines was controversial. Nurses work in high-stress emergency situations requiring quick action, and they are often pressed for time both because of the large number of patients they must care for and the highly variable needs and demands of these patients. In such workplace environments, it is difficult to adhere to the guidelines recommended by the agencies.
For example, a high-risk source of needle sticks is the technique of replacing the cap on a needle (after it has been used) by holding the cap in one hand and inserting the needle into the cap with the other hand. OSHA guidelines specifically warned against this two-handed technique of recapping and instead required that the cap be placed on a stable surface and the nurse use a one-handed spearing technique to replace the cap. (Note that recapping the needles in this more time consuming way presented no risk of needlestick injury to the user). As noted above however, nurses are often pressed for time (and are keenly aware of the added danger of walking around with an uncapped needles) and tend to take the ‘two-handed recapping shortcut’ when no suitable surface is readily available for the safer one-handed capping technique.
This fact is known to Hospital administrators, who regularly warn against such practices, and offer ongoing training and retraining opportunities to their nursing staff. Several analysts suggested that the peculiar features of the nurse’s work environment made it unlikely that needlesticks would be prevented through mere guidelines alone: The problem was not the worker, but the design of the needle and syringe. Experts on needlestick injuries argued that, rather than trying to teach health care workers to use a hazardous device safely, the focus should be on the hazardous product design and that a whole new array of devices in which safety is an integral part of the design was required. Regulators also urged manufacturers to provide the health care worker with devices in which safety was built into the design.
The risks of contracting life-threatening diseases by the use of needles and syringes in health care settings had been well documented since the early 1980s. Well over half of all the needles and syringes used by U.S. health care workers since 1980 were being manufactured by Becton Dickinson. Despite the emerging crisis, however, Becton Dickinson decided not to modify its syringes, although it did include in each box of needled syringes an insert warning of the danger of needlesticks and of the dangers of two-handed recapping. On December 23, 2000, the U.S. Patent office issued patent number 4,631,057 to Charles B. Mitchell for a syringe with a tube surrounding the body of the syringe that could be pulled down to cover and protect the needle on the syringe. At the time, at least four other patents for needle-shielding devices existed. As Mitchell noted in his patent application, those devices all suffered from serious drawbacks. One of them would not lock the protective cover over the exposed needle, one was extremely complex, another was much longer than a standard syringe and difficult to use, and a fourth was designed primarily for use on animals.
It was Mitchell’s assessment that his invention was the only effective, easily usable, and easily manufactured device capable of protecting users from needlesticks, particularly in emergency periods or other times of high stress. Unlike other syringe designs, Mitchell’s was shaped and sized like a standard syringe so nurses already familiar with standard syringe design would have no difficulty adapting to it. Shortly after Mitchell patented his syringe, Becton Dickinson purchased from him an exclusive license to manufacture it. A few months later, Becton Dickinson began field tests of early models of the syringe using a 3cc model. Nurses and hospital personnel were enthusiastic when shown the product.
However, they warned that if the company priced the product too high, hospitals, with pressures on their budgets rising, could not buy the safety syringes. With concerns about HIV rising fast, the company decided to market the product.
In 2001, with the field tests completed, Becton Dickinson had to decide which syringes would be marketed with the protective sleeves. Sleeves could be put on all of the major syringe sizes, including 1cc, 3cc, 5cc, and 10cc syringes. However, the company decided to market only a 3cc version of the protective sleeve. The 3cc syringes account for about half of all syringes used, although the larger sizes-5cc and 10cc syringes-are preferred by nurses when drawing blood. This 3cc syringe was marketed in 2002 under the trademarked name Safety-Lok Syringe. It was promoted as a device that “virtually eliminates needlesticks.” The 3cc safety syringe with the protective sleeve was sold in 2001 to hospitals and doctors’ offices for between 50 and 75 cents. By 2003, the company had dropped the price to 26 cents per unit. At the time, a regular syringe without any protective device was priced at 8 cents per unit and cost 4 cents to make. Information about the cost of manufacturing the new safety syringe is unavailable but is estimated at between 13 and 20 cents each.
The difference between the price of a standard syringe and the price of the safety syringe was an obstacle for customers. To switch to the new safety syringe would increase the hospital’s costs for 3cc syringes by a factor of three. An equally important impediment to adoption was the fact that the syringe was available in only one 3cc size, and it was perceived to be of limited application. Hospitals are reluctant to adopt and adapt to a product that is not available for the whole range of applications the hospital must confront. In particular, hospitals often needed the larger 5cc and 10cc sizes to draw blood, and Becton Dickinson had not made these available with a sleeve.
For 5 years, Becton Dickinson manufactured only 3cc safety syringes. During that period, Becton Dickinson did not license its new safety syringe technology to another manufacturer that might have produced a full range of syringe sizes. Most hospitals and clinics, including the medical facility where Maryann Rockwood worked at drawing blood from many patients with Hepatitis B or HIV, did not stock the Becton Dickinson safety syringe. Most nurses in the United States continued to use unprotected syringes. Maryann Rockwood sued Becton Dickinson, alleging that, because it alone had an exclusive right to Mitchell’s patented design, the company had a duty to provide the safety syringe in all its sizes, and that by withholding other sizes from the market it had contributed to her injury. The case was settled out of court.