Janine Jagger, M.P.H., Ph.D., is Becton Dickinson Professor of Health Care Worker Safety and Director of the International Health Care Worker Safety Center at the University of Virginia Health System. Since the mid 1980s, Dr. Jagger has focused her work on reducing the risk health care workers face from exposure to the infected blood and body fluids of patients. Her research on the design features of needle devices associated with needlestick injuries has been nationally lauded. Dr. Jagger’s findings on needle risks were published in the New England Journal of Medicine in August of 1988; this research has been widely used by government and industry to promote and develop a new generation of protective needle devices. She also serves as a consultant to government agencies, private industry, non-profit organizations, and academic institutions in the areas of safety and safer needle and sharp medical devices. Dr. Jagger and a team of colleagues designed six patented safety needle devices, which earned the Distinguished Inventor Award of 1988 by Intellectual Property Owners, Inc.
Dr. Jagger is perhaps best known because she directed the development of the Exposure Prevention Information Network (EPINet), a health care worker exposure surveillance system. Since 1992, EPINet has been used to achieve national and international standardization for recording and preventing occupational exposure to bloodborne pathogens. More than 1,500 US hospitals have acquired EPINet. In addition, Dr. Jagger is the founder and editor-in-chief of Advances in Exposure Prevention, a bimonthly publication dedicated to preventing occupational transmission of bloodborne pathogens in the health care work place.
Dr. Janine Jagger discusses her research in epidemiology, the first of its kind:
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MedTech1: Tell me a bit about how you got started in the field of exposure prevention.
Dr. Jagger: My perspective has always been public health. Epidemiology is my research field. Applying epidemiology to public health problems has been the common thread throughout my professional career. Since 1978, I have been focusing my efforts on the field of injury prevention. At first, I was working in the field of automotive safety, which sounds like a far cry from needles. But there is a tremendous amount of overlap, and the injury prevention concepts are the same. I consider the work that I have been doing in the needle and sharp medical device field to be equivalent to airbags for needles: if there is a product that is associated with injuries, how can that product be modified to reduce the potential for injury? The focus that I was promoting in automotive safety—by continuing to improve the design of motor vehicles to make them less likely to injure occupants—is the same focus that I have been using for reducing risk of needlestick injuries.
MedTech1: How did you switch your focus from automotive injury to needlestick injury?
Dr. Jagger: It was very sudden and very dramatic. It happened in one day. In January of 1985, I attended a meeting of our hospital’s epidemiologists. Because I did not have any injury prevention colleagues, I kept company with the hospital epidemiologists. They raised the specter of needlestick injuries for the first time.
At the meeting they said, “We really have to do something about needlestick injuries. We have been seeing this problem for a long time but now we are getting injuries with needles that were used on AIDS patients.” The first red flags were going up on exposure to AIDS at that time. This cast a whole new light for our hospital epidemiologists on the importance of prevention needlesticks. One of my colleagues said to me, “We have tried everything we can think of and we really have not had much impact. This is a kind of injury, Janine. Maybe this is in your ballpark. Do you have any recommendations?” And I said what any of my colleagues in the injury control field would have said: “If it is a product-related injury, change the product to make it less injurious.” The reaction I got was very dramatic. It was obvious that this had not been considered in the field of infection control.
MedTech1: What were your next steps?
Dr. Jagger: One high-ranking colleague said, “We can’t do that. It’s not our business to change devices. Don’t waste our time.” I took that as a challenge and got together with some of my colleagues in an effort to demonstrate that the concepts were not far-fetched but were quite straightforward. My colleagues and I came up with some designs for safer needles, syringes, butterflies, and IV catheters. We submitted patent applications and ended up getting patents on seven safety devices.
I started having contact with medical device companies when the university patent office was making the rounds and showing our devices to different companies. That was when I got more deeply into the device issue. I am not trained to be an engineer or device designer. I am trained to be an epidemiologist. I immediately started collecting data. Every health care worker who reported an injury at the University of Virginia was interviewed by my group and asked, “What stuck you?” That question had never been asked before. We developed a huge inventory of the device categories that are involved in needlestick and medical device injuries. There are more than just needles involved. There are scalpels, glass, surgical instruments, microtome blades, and anything that is sharp and used in conjunction with human tissue.
After we made our inventory, we sifted through all the technology and classified it according to the principal design features. We boiled it down to some major device categories: injection devices, blood-drawing devices, vascular access devices, intravenous infusion, surgical instruments, and some laboratory equipment. I was trained in the area of automotive safety, so all of the strategies for bringing forth safer technology were learned in conjunction with that issue. There is a tremendous amount of friction between safety advocates and the automotive industry. I learned how to fight industry when I was working on automotive safety issues.
I gave my first major presentation in 1990 at the Sixth International AIDS Conference. The audience was huge. I said, “This is a device-related problem and here is the report card on the manufacturers.” Most of them did not have safety devices at that time. My speech was somewhat critical, but I was saying that the industry needs to take responsibility. I had prepared to be the aggressive safety advocate that I had learned to be in automotive safety. Immediately after the presentation, people from several companies said, “We need to talk.” It took me by surprise—“You mean we can talk?” When I saw that the medical device industry was eager to pursue this, I was astonished. But I prefer to work with people than against them.
From that point on, I began to work very closely with the medical device industry. Early on, companies supported the work in the development of EPINet, to help hospitals collect their needlestick and sharp injury data in a consistent way. Critical information on devices and device design would be automatically entered into the data so that a company could go to a hospital and look at their needlestick data and see if their products were involved with needlesticks. They could get data back on their products’ performance, whether positive or negative.
Our efforts snowballed, and what started out as a few pages of data collection forms in 1990 the most widespread surveillance system for health care workers’ exposures to blood in the world. Several countries have adopted EPINet as their national surveillance system.
MedTech1: How many hospitals contribute data to EPINet?
Dr. Jagger: We have a database of hospitals that includes 84 hospitals total, back to 1992. In any given year, there will be some hospitals coming in and some going out, so the number varies a bit from year to year. We have hospitals from different geographic areas, as well as large and small hospitals, teaching and community hospitals. We have a good national picture of needlestick injuries that we can build from our database.
MedTech1: Have you noticed since EPINet was introduced that the number of exposures to blood or bodily fluids has reduced?
Dr. Jagger: You have to look at that on a device-by-device basis. Some device categories have seen a massive transition. The most obvious one is in the intravenous infusion equipment area. In 1992, I addressed a request to Jim Benson, the current Executive Vice President of Technology and Regulatory Affairs at AdvaMed, who was the Head of the Center for Devices and Radiological Health at the US Food and Drug Administration (FDA) at that time. I asked the FDA to issue a national safety alert advising health care institutions to cease the use of needles with intravenous infusion equipment and to use instead needleless junctions and needleless syringes for accessing IV ports.
Submission of the national safety alert was a gratifying experience. That alert was issued in six weeks and went nationwide. It caused a dramatic impact on the transition away from using needles in IV lines. Those needles caused about 25 percent of needlesticks when the needle-based IV systems were in widespread use. So when hospitals abandoned that technology in droves, it was highly documentable in the data. This type of injury accounts for only about four percent of needlestick injuries now. We have been very successful in this area and EPINet shows it.
There are other device categories where the penetration of safety devices has been much slower and is much lower. Safety syringes have been much slower to be adopted. Syringes are a complicated medical device category. Because of their simplicity they are versatile and used for many applications. In addition to giving injections to patients, they are used in the pharmacy to mix drugs, used in the laboratory as tools. It is a ubiquitous product category. Not all applications of syringes are relevant to substitution with safety-engineered syringes. If they are not being used in a patient context, then it is not important for them to have the same safety mechanism on them. So it is difficult to track that product category because you are not sure what is being included. Also, there was much lower market penetration in that product category. There was no national safety alert; there was no regulatory push in that category. I think what happened is that hospitals have been slow to adopt this technology because they viewed it as optional.
Hospitals have been the biggest barrier to the adoption of safety-engineered needles and sharp devices. The medical device industry has been ahead of the curve all the way back to the late 1980s. They were putting safer devices into the marketplace before the regulatory agencies acknowledged the devices and included them in their regulatory statutes. The medical device industry has been pushing this technology through their usual marketing methods. Many of the devices are more expensive than conventional devices—not all of them, but some of them. They have been pushing against hospitals’ cost control resistance.
A contributing factor to the delay is that health care workers under the workers compensation system have limited legal rights. They cannot sue their employers for injuries with a conventional device when the hospital had refused to purchase a safer one. Worker compensation law precludes this. There has been little legal incentive for hospitals to buy safer devices. The potential consequences to the institution have been perceived as low.
The medical device industry has definitely risen to the occasion. There are more than 2000 issued U.S. patents in this field now. Several foreign companies have come here to take advantage of the market opportunity presented by the largest and most open medical device market in the world. Despite the motivation and investment of the medical device industry, progress has been slow. Finally, after years of saying please, I am relieved to be able to say, “Safety-engineered devices: not just a good idea – they’re the law.”
MedTech1: What are your biggest challenges in the years ahead?
Dr. Jagger: Monitoring compliance. If the consequences of non-compliance are minimal, hospitals may say, “What is our risk of not doing this?” I will be working with others to monitor compliance and to provide some incentives for institutions to comply.
Also, it is important to track the efficacy of this new generation of devices. We want companies to see how their devices are performing. We want more choices. We hope that there will be incremental improvements and reduced costs as the volume of the devices go up. Safety devices are extremely important to injury prevention but there are also other factors that will continue to be monitored. For instance, you can take the best safety syringe on the market and use it for an inappropriate purpose, like accessing the port on an IV line. Even a safety device can be used in inappropriate ways that will pose a risk to health care workers. Someone has to be monitoring the application of the technology to make sure that it is being used in the most effective manner.
The world is the next frontier. These developments are unique to the United States, which is the only country in the world with a law that requires that health care workers be provided with this protective technology. There is no doubt that our legislation has been noticed internationally and has had an impact on thought leaders in other countries. We will be working with other countries to set up EPINet surveillance networks to support their efforts to implement the safety strategies that we have implemented here.
Selection as MedTech Hero is significant to my research group and me. We are grateful to be recognized for our industry-wide contributions. My colleagues and I at the International Health Care Worker Safety Center have worked to raise the “safety bar” of the medical device industry that has been uniquely supportive in working with the safety community. Being selected MedTech Hero is a welcomed indication that my colleagues and I have had some success in doing that.
Health care workers and medical device manufacturers in the United States should be aware that we are the country that has been at the forefront of developing this new technology. Although I will never say that we have made progress fast enough, we are way ahead of anyone else. The efforts that we have gone to here in the United States to develop and market this technology and document its effectiveness will create a better work environment for health care workers around the world. We are the pioneers here and we can be very proud of the technology that has been developed. It will have consequences all around the world.
To learn more about Dr. Jagger’s work, visit the International Health Care Worker Safety Center home page.
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