By Kelly M. Pyrek
More than 30 years after the advent of HIV/AIDS, healthcare workers are still lacking in awareness, education and training about the threat of bloodborne pathogen exposure from needlesticks and other sharps-related injuries. Joining other notable sharps safety and occupational health experts across the country in championing an ongoing safety agenda is Mary Foley, PhD, RN, chairperson of the non-profit organization Safe in Common (SIC). Foley is the director of the Center for Nursing Research and Innovation at the University of California San Francisco (UCSF) School of Nursing. A registered nurse for more than 35 years, Foley was one of the first healthcare workers to combat the emerging HIV-AIDS epidemic during her work at Saint Francis Memorial Hospital in San Francisco during the 1980s.
Through Safe in Common, Foley has been addressing healthcare workers, healthcare stakeholders and policy-makers about the risks healthcare workers face every day on the job. Consider these statistics:
OSHA says 5.6 million workers in the U.S. healthcare industry are at risk of occupational exposure to bloodborne pathogens via needlestick injuries
The CDC says that 385,000 needlestick injuries and other sharps-related injuries are sustained annually by hospital-based healthcare personnel.
Including other non-acute healthcare facilities, it is estimated that 600,000 healthcare personnel incur a needlestick injury each year in the U.S.
According to unpublished data from the CDC, 40 percent of injuries occur after use and before disposal of sharp devices, 41 percent of injuries occur during the use of sharp devices on patients, and 15 percent of injuries occur during or after disposal
As part of its ongoing mission to eliminate needlestick and sharps injuries in healthcare, earlier this year SIC issued its "Top 10 Golden Rules of Safety." This set of guidelines was outlined in conjunction with supporters to unify the industry around efforts to fight needlestick injuries and raise awareness about effective prevention techniques.
"We gathered some key opinion leaders such as Janine Jagger, Gina Pugliese, June Fisher and Barbara DeBaun, people who have been working in occupational safety for many years and remain passionate, as well as some new people added to the mix such as Angela Laramie, people who were advising us to keep pushing this rock up the hill," Foley says. "It requires grabbing people's attention, finding a message and keeping a tight focus. And we realized we had this gift of these thoughtful people whose expertise goes very deep, and because of that we wanted to give additional prioritization to what will it take to move this forward and take that rock up the hill and close this agenda and bring greater safety to more people across the healthcare field."
The top 10 list is predicated on making injuries a "never event" and dictates that personnel using or purchasing sharps consider the following rules:
The design and activation of the safety mechanism is automatic and will not interfere with normal operating procedures and processes
The device is intuitive and requires no additional steps for use than equivalent standard/conventional device
The contaminated, non-sterile sharp will be rendered safe prior to removal or exposure to the environment
Activation of the safety mechanism does not require the healthcare worker to undertake any additional steps during normal process/protocols providing patient care
Activation of the safety mechanism will not create additional occupational hazards (such as aerosolization, splatter, exposure to OPIM, etc.)
Activation of the safety mechanism does not cause additional discomfort or harm to the patient
The device will be ergonomically designed for comfort, allowing for automatic one-handed use during all stages of patient procedure
The safer engineering control is available in sizes and iterations appropriate for all areas of use relevant to the patient care needs
Disposal of safety device will not increase waste disposal volumes but should incorporate designs to reduce waste
The used safety device will provide convenient disposal and mitigate any risk of reuse or re-exposure of the non-sterile sharp
These rules reflect the requirements mandated by the federal Needlestick Safety and Prevention Act (NSPA) and the Occupational Safety and Health Administration (OSHA)'s Bloodborne Pathogen Standard. The NSPA changed the Bloodborne Pathogens standard under the Occupational Health and Safety Act to provide increased protections to workers from exposure to BBPs and infections. The same year (2000) that the NSPA was signed into law, the Centers for Disease Control and Prevention (CDC) estimated that anywhere from 62 percent to 88 percent of sharps injuries potentially could be prevented through use of safer medical devices.
According to interpretation by the American Nurses Association (ANA), the NSPA requires employers to use work practice controls and safer needle devices that are engineered to eliminate or minimize exposure to bloodborne pathogens resulting from needlestick injuries. Employers must:
Demonstrate that they are reviewing new technology that can reduce risk of exposure to bloodborne pathogens by updating exposure control plans and documenting the decision-making process on implementing such technology.
Maintain a sharps injury log to track the type and brand of device used, the department or area where the incident occurred, and an explanation of the incident. The log must be maintained in a manner to protect the confidentiality of the injured employee.
Solicit input from employees responsible for direct patient care in the identification, evaluation and selection of effective safety devices and work practice controls, as part of the ongoing exposure control plan development process. Efforts to encourage staff input must be documented in the plan.
"The Top 10 Golden Rules of Safety represent the world as we would prefer to see it and summarizes what those who are active in this campaign have worked on for years," Foley explains. "We want healthcare workers to think of the activation of safety devices in a more automatic or passive manner and how important that is, especially knowing the data that says healthcare personnel are not activating the safety features or do not even know they exist. I speak to a lot of people in industry who say healthcare workers don't want to take the time to be safe, and that's crazy -- they don't want to stick themselves with a contaminated needle or bring an infection into a patient's room. Rather than assume it is the worker who is the problem, let's move this up the hierarchy of control and let's look at the principles of good engineering and design, and product use. The golden rules help to more definitively explain these concepts. We have passive activation of safety mechanisms, which is automatic, but we also need more intuitive components to these devices. In other words, the safety device shouldn't make you learn how to use it if it works correctly and with that automatic protection put into place. So as we started building those top 10 rules, we approached the task as if we ran the world and what would our device categories look like. SIC's consultants made intensive efforts, almost akin to qualitative research, as well as conducted in-person interviews with all of our key opinion leaders and then synthesized the findings and that's how the top 10 golden rules were created."
These Top 10 Golden Rules of Safety were released at the annual meeting of the Association for Professionals in Infection Control and Epidemiology (APIC) in June. Foley says the rules were met with resounding acceptance from members of the healthcare community who agree that more needs to be done, especially in the operating room and other high-risk areas, to protect personnel.
"For the first time, the most experienced healthcare leaders have joined together to outline the rules for what it takes to keep all healthcare personnel safe and free of injury," says Barbara DeBaun, RN, MSN, CIC, improvement advisor for Cynosure HealthCare environments, who helped advise SIC. "With these rules, we're getting the industry thinking about where we are and where we need to go to make safety a priority and injuries a never event."
To test the degree to which safety engineering controls have evolved, SIC evaluated whether the sharps devices on display at APIC's annual meeting were safe, simple and secure as outlined in the Golden Rules standards. SIC gauged attendees' opinions on safety devices during the event and found that, although infection preventionists in attendance at APIC generally accept the "safe, simple, secure" measures, the sharps devices currently available and on display meet the criteria outlined in the Golden Rules. Only nine percent of the 27 devices reviewed received a perfect 10 and exactly half had a passing grade of seven or higher. Some 41 percent had dismal scores of two to four.
Overall, the devices available at APIC scored well on two criteria:
The safer engineering control is available in sizes and iterations appropriate for all areas of use relevant to patient care needs (95 percent)
The used safety device will provide convenient disposal and mitigate any risk of reuse or re-exposure of the non-sterile sharp (86 percent)
Significant development effort remains against three essential criteria:
Activation of the safety mechanism does not require the healthcare worker to undertake any additional steps during normal processes providing patient care (32 percent)
The device is intuitive and requires no additional steps for use than equivalent standard or conventional devices (41 percent)
The contaminated, non-sterile sharp will be rendered safe prior to removal or exposure to the environment (48 percent)
Many of APIC's attendees are actively involved in device evaluation for healthcare use and consider products "as is" presented to them by industry sales representatives. SIC is measuring progress against a desired future or "should be" state. The gap explains why there has been considerable but incomplete progress in reducing percutaneous exposures to healthcare workers to roughly half of the levels estimated by the CDC prior to enactment of the Needlestick Safety and Prevention Act of 2000.
"Handwashing, surface disinfectant and devices designed to identify and eradicate bugs are prevalent, but there is lack of attention on devices aimed at healthcare worker safety and patient safety needs to prevent sharps injuries," says Foley. "It was disappointing that so few safety devices have emerged that protect the patient and healthcare worker before, during and after the use of the sharp."
"At this year's annual APIC meeting, most people in the exhibit hall were talking about hand hygiene and electronic surveillance systems," Foley adds. "I spoke to a few sharps safety device manufacturers but there weren't many there -- it's not a climate where the conversations are taking place anymore. When I spoke to manufacturers they said they are getting nowhere when they go to the facilities, as no one is interested in looking at their products and purchasing is just not happening. So what I think has happened is that the workload of that infection preventionist or employee health nurse has taken up all of their bandwidth. They are fully occupied in getting infection rates down or buying some new technology and they don't have time to address sharps safety with staff. We are hearing that facility sharps safety committees are almost non-existent, and we know the annual review of equipment and exposure control plans has really dropped off in many facilities."
Foley says that manufacturers have shown diligence in bringing to market improved devices, but fewer facilities than ever seem to be interested in them. "Manufacturers have been busy inventing better products since the federal law went into effect, and there are some good products out there, much better than the first-generation products introduced in 2000," Foley says. "But those first-generation products are what you will still see, in many cases, in the workplaces. I see many products that were initially introduced to meet the law and they are still there, and there's no conversation taking place about the newer, the better, the improved devices. Part of the challenge is if you introduce a new product, then you have to teach healthcare personnel about it and you have to evaluate it, and that's a workload I don't think infection preventionists or employee health nurses have the resources with which to undertake. That's why a thousand needlesticks a day are still happening across the country."
To help counteract a lack of information and awareness about sharps safety, SIC has held three online conferences in its "Unfinished Agenda" series in the last year or so, where some of the nation's foremost experts convene to explore how the healthcare community is preventing needlestick and sharps safety issues that plague healthcare. These online conferences helped to foster widespread industry awareness for safer working environments and examine resources and measures that can better promote and strengthen the NSPA.
"We are not done with our agenda, and that's where we are taking our conversations with our online conferences," Foley adds. "For some, the glass is half full; for others, it is half empty. For those who have suffered a needlestick injury, it is broken," said Foley. "We understand the very personal trauma of exposure, both to patients and to personnel, who become patients themselves. We believe that occupational exposure should be a 'never event,' completely eliminated by superior engineering controls and education. Until we reach zero exposures to both patients and staff our agenda will remain unfinished."
Foley continues, "In the world of policy, one of the messages that I have learned is if everything is a priority, then nothing is. When we say 'Let's make it safer out there,' well, that is the goal but we aren't being very clear about how to get there. I think the processes and the steps involved need to be explained more clearly because we are communicating these messages not just to healthcare workers but also policy leaders and regulators who we are hoping will step up and be more aggressive about the enforcement of what I consider to be a very good law. I still think the Needlestick Safety and Prevention Act is excellent, if it were fully implemented and fully enforced. The areas where we have seen a lack of fulfillment of that promise has been in the continuous review of exposure control plans and the introduction of new safety devices. It is amazing to see what is in the marketplace yet it's not being introduced and used in healthcare for the most part."
Foley says she would like to see greater emphasis on protecting healthcare workers alongside an equally robust patient safety agenda. She says that the synergy between the two cannot be forgotten in the push toward quality improvement and pay-for-performance in this healthcare reform era. "Patient-related adverse events and infections are on the 'never' list and if they happen you won't be paid for them. So institutions have galvanized time, attention and resources to prevent these 'never events' and secure their reimbursement. I was part of the National Quality Forum work that created those 'never events' -- I remember well the consensus process on deciding what harm should not happen to a patient if we are doing our work well. I think about how that evolved and one of the ways we may be able to prod healthcare leaders right now would be to say, 'Why is it OK for patients to not be harmed, but you don't have the same motivation for protecting healthcare workers?' Would we see additional attention to this topic again? I think so. We must have work environments that are safe for patients and healthcare workers. Those facilities that attend to both sides of that safety equation create a more engaged workface and a better patient outcome. When there is a lot of data coming out about the correlation of those findings, the relationship is clear -- I think it's timely for us to say OK, let's finish this work and apply the same rules to worker safety as we do to patient safety because you have to pay attention to both sides of that.
An experience at APIC crystalized the need for more forums in which to discuss these issues, Foley says. "While we were at APIC a new infection preventionist came to the SIC booth and said to me, 'I have no idea where to find information on safer devices or what's new or where or how to shop for them,'" Foley recalls. "Here was someone who would like to do the right thing and there is no support for that. We hope to continue to bring people together and bring the product manufacturers in and open that dialogue so there can be a better exchange of information and educational materials. We want to be a vehicle to make some of these introductions, get people connected and introduce the newer generation of devices."
Foley points to SIC's online conferences as a way to re-introduce sharps safety issues to those who have been working in healthcare for a while, as well as introduce to those new to the field, the science behind needlestick and sharps injuries. "To create these conferences we went back to the history of the NSPA and the principles behind design innovation and human factors engineering," Foley says. "We took it to the origins of the conversations about sharps safety and started to layer on top of this concepts about safety climate and education, building on Janine Jagger's consensus statement. We looked at how important it is to identify and prioritize the areas of unmet need, and what we began to understand is that the folks who have been working in this arena were overjoyed that someone else was talking about it. And we were excited to know that we had an audience that wanted to learn more. We then moved our discussions along the continuum of the science and the big picture, taking apart that big picture and looking at aspects of what we call the unfinished agenda."
That so-called unfinished agenda includes addressing what Foley sees as a lack of proper education and training about safe devices and practices, even in medical and nursing schools' curricula nationwide.
"From a nursing perspective I have worked with a number of faculties and students and they have said they are not learning about sharps safety -- no one showed them how to use safety-engineered devices, and when they are injured, they have been discouraged from reporting it. People like Barb DeBaun and I have shared with students our stories from the 1980s, and all of the students are from the post-AIDS era -- they don't have the deep-seated fear of an infection from HIV or hepatitis B. But safety from bloodborne pathogen exposure is still so critical and it is not consciously taught. Principles of safe use of sharps devices are not introduced so it's no wonder that healthcare workers aren't activating the safety devices -- they don't even know what they are there for and have not been instructed in their safe use. So that really became clear and we realized that the critical next step would be to set some priorities, and that led to the top 10 golden rules. We will keep the momentum going and keep the topic of sharps safety alive."
Foley says that a finished agenda "would be a dream come true," and adds, "If we were to see a dramatic turnaround in the products available, a huge uptake in information and education, have a turnaround in purchasing, and see a re-energized compliance with OSHA and NSPA mandates, then we could probably say, maybe we are at the last chapter. But right now I am still not satisfied. I feel we have to honestly warn people that harm still exists and healthcare workers will needlessly be injured if nothing is done about it. I plan to do a public policy briefing in the near future because I think we have to take this message to Congress to let them know what's wrong -- the NSPA is a good law but it's not working. With the work we are doing I think we will be able to give them a deep insight into what to do, how problems should be fixed, and what should come next to address the unfinished agenda."