IIBMS- Becton Dickinson and Needle Sticks
Case – 4 IIBMS- Becton Dickinson and Needle Sticks IIBMS – Becton Dickinson and Needle Sticks During the 1990s, the AIDS epidemic posed peculiarly acute dilemmas for health workers. After routinely removing an intravenous system, drawing blood, or delivering an injection to an AIDS patient, nurses could easily stick themselves with the needle they were using. “Rarely a day goes by in any large hospital where a needle stick incident is not reported. “ In fact, needlestick injuries accounted for about 80 percent of reported occupational exposure to the AIDS virus among health care workers.2 It was conservatively estimated in 1991 that about 64 health care workers were infected with the AIDS virus each year as a result of needlestick injuries.3 AIDS was not the only risk posed by needlestick injuries. Hepatitis C, and other lethal diseases were also being contracted through accidental needle sticks. In 1990, the Center for Disease Control (CDC) estimated that at least 12,000 health care workers were annually exposed to blood contaminated with the hepatitis B virus, and of these 250 died as a consequence.4 Because the hepatitis C virus had been identified only in 1988, estimates for infection rates of health care workers were still guesswork but were estimated by some observers to be around 9,600 per year. In addition to AIDS hepatitis B, and hepatitis C, needlestick injuries can also transmit numerous viral, bacterial, fungal, and parasitic infection, as well as toxic drugs or other agents that are delivered through a syringe and needle. The cost of all such injuries was estimated at $400 million to $1 billion a year.5 Several agencies stepped in to set guidelines for nurses, including the Occupational Safety and Health Administration (OSHA). On December 6, 1991, OSHA required hospitals and other employers of health workers to (a) make sharps containers (safe needle containers) available to workers, (b) prohibit the practice of recapping needle by holding the cap in one hand inserting the needle with the other, and (c) provide information and training on needlestick prevention and training on needlestick prevention to employees.6 The usefulness of these guidelines was disputed.7 Nurses worked in high-stress emergency situations requiring quick action, and they were often pressed for time both because of the large number of patients they cared for and the highly variable needs and demands of these patients. In such workplace environments, it was 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 warned against this tow-handed technique of recapping and recommended instead that the cap be placed on a surface and the nurse use a one-handed “spearing” technique to replace the cap. However, nurses were often pressed for time and, knowing that carrying an exposed contaminated needle is extremely dangerous, yet seeing no ready surface on which to place the needle cap, they would recap the needle using the two-handed technique. Several analysts suggested that the nurse’s work environment made it unlikely that needle sticks would be prevented through mere guidelines. Dr. Janine Jaegger, an expert on needlestick injuries, argued that “trying to teach health care workers to use a hazardous device safely is the equivalent of trying to teach someone how to drive a defective automobile safely…. Until now the focus has been on the health care worker, with finger wagging at mistakes, rather than focusing on the hazardous product design…. We need a whole new array of devices in which safety is an integral part of the design.”8 The Department of Labor and Department of Health and Human Services in a joint advisory agreed that “engineering controls should be used as the primary method to reduce worker exposure to harmful substances.”9 The risk of contracting life-threatening diseases by the use of needles and syringes in health care setting had been well documented since the early 1980s. articles in medical journals in 1980 and 1981, for example, reported on the “problem” of “needle stick and puncture wounds” among health care workers.10 Several articles in 1983 reported on the growing risk of injuries hospital workers were sustaining from needles and sharp objects.11 Articles in 1984 and 1985 were sounding higher-pitched alarms on the growing number of hepatitis Band AIDS cases resulting from needle sticks. About 70 percent of all the needles and syringes used by U.S. health care workers were manufactured by Becton Dickinson. Despite the emerging crisis, Becton Dickinson decided not to change the design of its needles and syringes during the early 1980s. To offer a new design would not only require major engineering, retooling, and marketing investments but would mean offering a new product that would compete with its flagship product, the standard syringe. According to Robert Stathopulos, who was an engineer at Becton Dickinson from 1972 to 1986, the company wanted “to minimize the capital outlay” on any new device.12 During most of the 1980s, therefore, Becton Dickinson opted to do no more than include in each box of needles syringes an insert warning of the danger of needle sticks and of the dangers of two-handed recapping. On December 23, 1986, the U.S. Patent office issued patent number 4,631,057 to Norma Sampson, a nurse, and Charles B. Mitchell, an engineer, 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. It was Sampson and Mitchell’s assessment that their invention was the most effective, easily usable, and easily manufactured device capable of protecting users from needle sticks, particularly in “emergency periods or other time of high stress”13 Unlike other syringe designs, theirs was shaped and sized like a standard syringe so nurses already familiar with standard syringe designs would have little difficulty adapting to it. The year after Sampson
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