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By Kelly M. Pyrek
Capitalizing on the momentum created by a 2010 conference, a new consensus statement released this spring focuses on the future of the prevention of needlesticks and other sharps-related injuries and creates a road map for achieving improved occupational health and safety among healthcare workers.
The document, "Moving the Sharps Safety Agenda Forward in the United States: Consensus Statement and Call to Action," was drafted by members of the steering committee for the conference, “Tenth Anniversary of the Needlestick Safety and Prevention Act: Mapping Progress, Charting a Future Path,” held in 2010 and sponsored by the International Healthcare Worker Safety Center (IHWSC) at the University of Virginia. The recommendations contained in the consensus statement are based on the presentations, panels and informal discussions that took place at the conference. The speakers and participants represented a broad range of stakeholders relevant to the issue of sharps safety, including clinicians, researchers, and healthcare administrators, as well as representatives from government agencies such as NIOSH, CDC and OSHA, as well as professional associations and the medical device industry.
The consensus statement acknowledges that although the U.S. has led the efforts to address risks to healthcare workers from occupational exposures to bloodborne pathogens -- including regulatory and legislative measures such as OSHA's Bloodborne Pathogen Standard and the Needlestick Safety and Prevention Act (NSPA) and improved device design by introducing safety-engineered technology -- preventable sharps injuries and blood exposures continue to occur in U.S. healthcare settings. As the consensus statement notes, "In an increasingly complex and changing healthcare environment, we need a renewed commitment to achieve further progress."
Janine Jagger, MPH, PhD, director of the IHWSC and research professor of medicine at the University of Virginia, hopes the consensus statement can be used by infection preventionists to advance their facility's sharps safety agenda. "Each relevant party should look at the document and see what remains to be applied at the front lines of healthcare and bring these issues to the decision-makers in their institution," Jagger says. "For instance, safety policies in the operating room should be near the top of everyone's list. The consensus statement can be a point of departure for identifying safety policies and devices that remain to be implemented there. At the institutional level the evaluation process for selecting new products should be given a fresh look to assure that more effective products have not been overlooked and that an appropriate level of worker input has been maintained. They should review whether devices that are used together are compatible with each other. It's an opportunity for a top-down assessment of safety devices and policies and for renewing the discussion of safety with frontline healthcare workers to insure their input when device decisions are made.”
The Current State of Sharps-Related Injuries
Data from two large, multihospital sharps injury surveillance networks provide a picture of where sharps-injury rates stand today -- the EPINet Sharps Injury Surveillance research group (EPINet-SIS) coordinated by the IHWSC and the Massachusetts Sharps Injury Surveillance System (MSISS), maintained by the Massachusetts Department of Public Health (MDPH). In 2007, a total of 29 hospitals (one each from Nebraska, Pennsylvania and Virginia, the rest from South Carolina) contributed data, with an aggregate of 951 sharps injuries (SIs) reported and an average injury rate of 28 SIs per 100 occupied beds. In Massachusetts, all hospitals are required to report sharps injury data to the MDPH; this was mandated by a state law in 2001, and collection of data began in 2002. For 2008, 99 hospitals contributed data, with a total of 3,126 SIs reported and an average SI rate of 17.2 per 100 licensed beds. For both EPINet-SIS and MSISS, rates varied according to teaching status and hospital size, with substantially higher rates typically seen for teaching hospitals and hospitals over 300 beds (with the two being closely correlated (i.e., teaching hospitals tend to be large hospitals).
According to the consensus statement, nurses sustained the largest share of injuries in both EPINet and MSISS data—34 percent and 38 percent, respectively. Sharps injuries occur most often in the surgical setting (EPINet: 36 percent; MSISS: 32 percent) and patient rooms (EPINet: 23 percent; MSISS: 22 percent). A large proportion of injuries are sustained by workers other than the original user of the device. In EPINet-SIS data from 2007, 30 percent of sharps injuries were sustained by such workers, including clinicians, housekeepers, laundry and waste management personnel, and even administrative staff.
As the document notes, "Clearly, we still have much room for improvement. The data show that while the U.S. has been successful in significantly reducing sharps injury risk to healthcare workers in most hospital settings, challenges remain, particularly in surgical and non-hospital settings. Healthcare is increasingly being provided outside of hospitals, such as practitioners’ offices and clinics, patient homes, rehabilitation centers, and long-term care facilities. This shift is expected to continue well into the future; yet these are the very settings in which enforcement of the BPS has been weakest and implementation of safety-engineered devices, according to market data, has been lowest. We believe that our healthcare workers represent a critical national resource, and that we should do everything we can to protect them from harm while they care for others. We also believe that healthcare worker safety is a crucial component of patient safety, and of the overall safety and quality of the healthcare environment."
Jagger emphasizes that although there is more progress to be made, we must not lose sight of the accomplishments made by the healthcare industry working together to address sharps injuries.
"Despite the fact that with this consensus statement we're focusing on what still remains to be done, I think we should recognize that we have come a long way, and integration of safety devices is one aspect of it in the overall reduction in risk of bloodborne pathogens to healthcare workers," Jagger says. "In the past 20 years there have been tremendous progress made, and all of the parties involved deserve some encouragement and congratulations for their participation in bringing about tremendous change. For example, It's remarkable how the entire medical device industry has stepped up to the plate because we were asking them not just for a new device, but for a whole new generation of devices. And the retooling of industry has been massive."
Let's take a look at the recommendations contained in the consensus statement:
1. Improving Sharps Safety in Surgical Settings
A study published in 2010 showed that despite the revised Bloodborne Pathogens Standard and advances in sharps safety technology, sharps injuries in surgical settings from 2001 to 2006 increased by 6.5 percent, while injuries in all other hospital settings decreased by 31.6 percent. The study also indicated that the majority of injuries in the surgical setting are caused by suture needles and scalpel blades, with a significant proportion sustained during instrument passing and after use. The consensus statement says that blunt suture needles, which can prevent injuries during suturing of internal tissue and fascia—injuries which account for about one-third of suture needle injuries overall—are currently vastly underutilized by U.S. surgeons, despite recommendations from the American College of Surgeons (ACS), the Association of periOperative Registered Nurses (AORN), and other professional associations.
"We are focusing on what is still left to do, and much of it is very feasible to accomplish," Jagger says. "It's not that these things are difficult to do but they are things that have been overlooked, especially in the operating room. There are so many well-conceived strategies that have yet to be fully implemented. That's one area in which I would like to see real institutional pressure brought to bear because that's the toughest part of the institution in which to get change. So infection preventionists need to engage the decision-makers in the OR. The device decisions made by the surgeons affect everyone else in the operating room; you have more injuries from suture needles to operating room staff than to surgeons but it's the surgeons' choice of device that is made. Surgeons need to take into consideration their responsibility to staff. I think that is the most difficult consideration of all -- the consideration for the patient is primary, but there is also consideration for the surgical technique and what is convenient for the surgeon to use, and the consideration of the surgeon of the safety of OR staff. Institutional leadership in taking those perspectives into consideration is needed."
Jagger suggests that a solid cost argument can help infection preventionists get the attention of their facility's administrators so that safer instruments such as blunt suture needles are implemented in the surgical suite, especially when sharp suture needles cause such a high proportion of injuries in the OR. "Some ammunition that has not been used is that blunt suture needles are the one safety device where you have net cost savings in prevention of injuries because the cost of the blunt needles is so close to the cost of the sharp needles -- all of the prevention becomes tangible savings with every needlestick averted.," Jagger explains. "People always bring up the cost of safety devices as an issue to overcome, and this is one device category where they have the cost issue on their side. So going to the OR manager and administration and showing the cost argument is an unused type of leverage which should be a big opportunity for infection preventionists. This is the one device where you have real net savings, so hammer that message home."
The recommendations from the consensus statement are:
- Institutions adopt a site-specific sharps safety policy for the OR. Such a policy should mandate the availability, training, and use of specific sharps safety devices and implementation of risk mitigation strategies outlined by the ACS and AORN. When available and reasonable, users should be able to choose between several comparable and effective safety devices or personal protective equipment (scalpels, gloves, goggles, etc.) to suit their individual work practices, body sizes, and comfort. Sharps safety should not be an individual choice, since many injuries are sustained by workers other than the original users (and choosers) of devices.
- Surgeons, OR nurses and other surgical personnel work cooperatively to develop sharps safety standards and practices that are consistently implemented and followed in all surgical environments.
- Professional groups and manufacturers join forces to encourage the use of blunt suture needles for appropriate applications.
- OSHA place greater emphasis on Bloodborne Pathogen Standard compliance in surgical settings by evaluating overall adoption of safety devices to eliminate or minimize exposure risks. For example, compliance officers should determine if a facility encourages the use of blunt suture needles when clinically appropriate.
2. Understanding and Reducing Exposure Risks in Non-Hospital Settings
The consensus statement reports that personnel in non-hospital settings account for about 65 percent of the U.S. healthcare workforce. While safety-engineered devices are in widespread use in most hospitals, data show that their use in non-hospital settings (including home healthcare, long-term care, doctors' offices and ambulatory surgery centers) has been much less consistent. The consensus statement explains further that "Valid and reliable sharps injury data from non-hospital settings is limited; a critical need exists for data that specifically target these different environments, each of which has a unique risk profile. Studies by two research groups, one examining exposure risks to home healthcare workers and the other risks to paramedics, have begun to fill in the overall picture, but more such setting-specific studies are needed."
The recommendations from the consensus statement are:
- Health and Human Services agencies such as CDC/NIOSH and other government and non-governmental agencies and professional organizations support epidemiological research that evaluates risks to workers in a wide range of non-hospital settings.
- OSHA promote regional emphasis programs that focus on enforcement of the Bloodborne Pathogen Standard in non-hospital settings; further, that other relevant groups, such as accrediting and licensing bodies and healthcare and workers’ compensation insurers enhance compliance incentives for non-hospital employers.
- Professional organizations and medical product distributors for non-hospital care settings collaborate to make sharps safety a priority and ensure that appropriate devices and educational and training materials are available which are targeted for workers in these settings.
3. Involving Frontline Healthcare Workers in the Selection of Safety Devices
Anecdotal evidence suggests that frontline healthcare workers are not consistently involved in the selection of safety devices. However, the Bloodborne Pathogen Standard requires that workers— those who will actually be using the devices—be included in annual device evaluations. Also, hospitals may be inclined to base decisions about safety devices on cost, but cost alone cannot be the main criteria for selection. An OSHA Letter of Interpretation, issued in 2002, states that “selecting a safer device based solely on the lowest cost is not appropriate. Selection must be based on employee feedback and device effectiveness.” The consensus statement says that "Employers should make input from workers a priority in selection criteria, and need to weigh the relative efficacy of different safety devices for particular applications. Which devices do workers prefer and why? Have improvements been made in device technology? At a time when the pressure to reduce healthcare costs is intense, it is important to keep these user-oriented questions at the forefront of device selection."
The recommendations from the consensus statement are:
- Organizations representing healthcare workers educate members about the legal obligation of employers to include frontline workers in the selection of safety devices. Members need to be encouraged to participate in this process.
- Hospital and healthcare employers consistently involve frontline healthcare workers in the selection and evaluation of safety devices, as is their obligation under the Bloodborne Pathogens Standard. Employers also need to enlist frontline workers in regular and systematic assessment of the devices currently in use in their institution, to ensure such devices are appropriate and, according to OSHA, “eliminate or minimize employee exposure” to the “lowest feasible extent.”
- NIOSH or another government agency consider funding research to assess whether and to what extent the requirement to include healthcare workers in the device selection process is being met in facilities across the country, and the ways in which this is being done. This research could provide the basis for developing a model program for frontline worker participation in device selection and evaluation.
4. Addressing Gaps in Safety Devices
As the consensus statement notes, "Safety device technology has continued to evolve over the past decade; however, unmet needs remain for many clinical procedures and these gaps need to be addressed. Care settings and device categories for which safety is lacking or choices are limited include nuclear medicine; dentistry and home care; longer-length needles used for bone marrow, bariatric, biopsy, spinal, epidural, and acupuncture procedures; needle extenders for cervical injections; ophthalmic blades; and arterial-line catheters. Greater innovation and more variety are needed, especially for surgical safety devices given the high risk of exposure and relatively low adoption of safety devices in this setting. We also need to encourage continued development of non-needle-based solutions for the delivery of medications, which eliminate sharps injury risk altogether."
The recommendations from the consensus statement are:
- Professional organizations partner with device manufacturers to assess and prioritize device needs for specific clinical applications, to monitor progress in closing existing gaps, and to identify future needs.
- Manufacturers partner with surgeons and surgeon groups to develop suture and scalpel safety designs that both reduce risk and are comfortable and intuitive for surgeons to use. Also, companies that provide pre-packaged surgical and procedure kits must ensure that devices included in these kits comply with the Bloodborne Pathogen Standard.
5. Enhancing Education and Training
According to the consensus document, EPINet data from the past two decades have consistently shown that sharps injury rates in teaching hospitals are significantly higher than those for non-teaching hospitals. Although the reasons for this are multi-factorial, it does suggest the need to reevaluate and expand training related to bloodborne pathogens and sharps injury prevention in medical and nursing schools throughout the U.S. Additionally, data from both EPINet and MSISS show that safety devices are a significant source of sharps injuries (although at a much lower rate compared to non-safety devices). Again, the reasons for this can vary, but include not activating the safety mechanism because of insufficient training on how to use the devices. The document notes, "Making training accessible to all can be challenging, particularly when trying to reach shift workers or those in non-hospital settings. Innovative educational tools using a variety of media and settings, including hands-on device 'labs' where users who feel the need for further practice beyond initial training can do so on models, are needed to address the wide range of settings in which healthcare is practiced and sharp devices are used."
"I think the different job categories in healthcare have mutually exclusive training programs so you must look at every relevant job category to see what level of instruction that healthcare professionals receive," Jagger advises. "Phlebotomists, surgical residents and medical students each get their own kind of training and it's very unequal. So for instance, phelbotomists generally will get very specific training related to safety but then you have medical students perform blood draws and they have only had 'see one, do one, teach one,' which is the equivalent of nothing. A blood draw can be a very risky procedure, so the training issues are important ones to address."
The recommendations from the consensus statement are:
- CDC/NIOSH, OSHA, and/or other appropriate government agencies partner with medical, nursing, and allied health schools and accrediting bodies to develop standardized curricula on bloodborne pathogen exposure prevention and the selection and use of safety-engineered devices. Such training is an essential part of the education of all healthcare professionals (both at the beginning of and throughout their careers).
- Healthcare employers provide instruction on an annual basis for all potentially exposed clinicians and other workers (including service workers and purchasing agents) on the appropriate use and disposal of safety devices that are available in their facility, as mandated by OSHA. Such training provides a forum for addressing questions and issues that arise as new devices are introduced.
- Employers, professional educators, manufacturers and employee representatives collaborate to develop training strategies that can be widely applied when new devices are introduced, so that frontline healthcare workers know how to properly use and dispose of them. As a result of the leadership of our partners in the federal government and a variety of stakeholders, the U.S. has made tremendous progress in protecting healthcare workers from exposure to bloodborne pathogens. Other countries look to the Bloodborne Pathogen Standard and NSPA as models for their efforts to address this critical component of occupational safety in healthcare facilities. While we celebrate the progress we have made, we must acknowledge the gaps that exist and redouble our efforts to ensure that all healthcare workers, regardless of the setting in which they practice or the procedures they perform, are offered the same level of protection from sharps injuries and exposures to bloodborne pathogens.
While infection preventionists are focusing their sharps safety efforts close to home, it's worthwhile to remind ourselves that from a global perspective, the U.S. must continually strive for improvement.
"We have been able to make some direct comparisons to other nations and we are really the cutting-edge country in terms of sharps safety," Jagegr says. "We've introduced more technology faster and we have made its use mandatory, so we have been ahead of all other countries in that regard. However, we have propagated our surveillance methods such that we can do direct comparisons among countries and what we have found every time, that compared to a country relatively equivalent to ours in terms of economic status, we have significantly higher injury rates per healthcare worker and per bed. This has always been a shock to us and to people in other countries because they expect us to have the lowest rates. So there is definitely something about our healthcare system that requires closer analysis. In the U.S. we have made huge efforts to compress healthcare into shorter periods of time; the average length of hospital stay is lowest in the U.S. compared to any other country. That means that we have invasive procedures that are performed within a shorter timeframe, so healthcare workers are handling more sharps devices under time-pressured circumstances and that translates to a higher risk of injury. Healthcare workers in the U.S. are at higher risk of injury than healthcare personnel in other countries because they have to perform more needle-based and invasive procedures. Because of this higher risk inherent in our healthcare system, I think we owe it to our healthcare workers to provide them with the technology that will afford them the best protection."
Expert Shares Thoughts on Consensus Statement
Elise Handelman, MEd., COHN-S, an occupational and environmental health consultant, is co-chair of the steering committee for the conference, “10th Anniversary of the Needlestick Safety and Prevention Act: Mapping Progress, Charting a Future Path” in November 2010 where the Consensus Statement and Call to Action were drafted. She shares her thoughts on the significance of this document:
“The Consensus Statement and Call to Action is the result of reflective, analytical and insightful thought by some the most notable researchers on this topic in the world. The conference where these recommendations were developed occurred in an atmosphere of creativity and openness that I have rarely seen.
She adds, "The recommendations are well grounded in research, they are feasible and compelling. For those who are committed to further prevent sharps injuries, this Consensus Statement and Call to Action provides a roadmap to get that done.
"My best hope is that practitioners, regulators, academicians, employers, professional organizations and manufacturers will use the solid ground of these recommendations to support them in their stand against bloodborne pathogen diseases and the tragedies that result from unintentional needlestick injuries."
The Sharps Safety Marathon: A Run Against Apathy
By Mary Foley, PhD, RN
This year marks a decade since U.S. healthcare facilities were required by federal law to comply with strengthened provisions in the Bloodborne Pathogens Standard to protect healthcare workers at risk of needlestick and sharps injuries.
I was honored to be part of the early struggle to secure the passage of these laws, and their enforcement by OSHA. During my career as a nurse, I was one of the many healthcare workers to combat the emerging HIV-AIDS epidemic during my work at Saint Francis Memorial Hospital in San Francisco in the 1980s. I later stepped up to secure the passage in California of the first state-based laws in the U.S. mandating the use safety medical devices.
During the 1990s, I joined other nursing and healthcare advocates to campaign for the adoption of the Federal Needlestick Safety and Prevention Act. This was a marathon-length effort by healthcare safety advocates. It was also a race against apathy.
After being elected president of the American Nurses Association (ANA), I was proud to stand alongside my colleagues in the Oval Office of the White House when President Bill Clinton enacted the Act into law in 2000. At the time, it seemed to us that we had finally crossed the finish line.
We were wrong. The race continues, and the end isn’t near.
There is no question that needlestick injuries have declined during the last 10 years within some areas. However in many other key areas, the risk of harm has not been significantly reduced.
For example, recently published data for reported needlestick injuries in Massachusetts healthcare facilities during 2010 found that slightly more than half of all incidents still involved devices that did not have a safety feature. Meanwhile, in some high-risk categories such as needles and syringes, the overall number of recorded needlestick injuries has remained largely stable since 2002, with safety engineered devices now causing a record 75 percent of all injuries.
I believe that particularly in recent years, the topic of sharps safety has once again begun to evoke apathy. Many within our industry feel as though it has slid down the list of healthcare list of priorities.
Many healthcare organizations including the University of Virginia's International Healthcare Worker Safety Center, the American Nurses Association and Safe in Common are now aligning together to fight apathy. We believe it’s time to generate new momentum behind the promotion and strengthening of Federal laws, raising awareness of needlestick safety and utilizing safer engineering controls.
As a result of these early efforts, the need to prevent needlestick injuries is now beginning to re-enter the national conversation. But now, as it was before, it’s still a race against apathy.
More programs and campaigns are needed to keep professionals up-to-date about needlestick and sharp injuries and to stimulate knowledge about new and better devices that have been created but not properly introduced into healthcare facilities.
Promoting a safer environment for staff and patients, and sharing safety messages and information about innovative products that align those two priorities will go far to helping eradicate apathy and optimizing protection to those at risk of harm.
One of the most important things healthcare personnel can do as they work each day is to help others learn how to care for themselves. By carrying that baton through the marathon, they will be better prepared to care for others.
Fighting apathy also needs to begin in the workplace. The healthcare environment needs to engage frontline personnel to hear their concerns and ideas surrounding innovation that will reduce the risk of needlestick injury and improve their safety.
The Consensus Statement and Call to Action generated by the International Healthcare Worker Safety Center and the ANA in March 2012 was an excellent step towards identifying the key risk areas for healthcare personnel exposure to bloodborne pathogens.
Outlined within the consensus statement are five pivotal areas that healthcare personnel today and tomorrow must rally around:
• Improving sharps safety in surgical settings
• Understanding and reducing exposure risks in non-hospital settings (which include physicians’ offices, clinics, home healthcare, and an array of other settings)
• Involving frontline workers in the selection of safety devices
• Addressing gaps in available safety devices, and encourage innovative designs and technology
• Enhancing worker education and training.
To support those pillars, healthcare personnel need to align with the myriad of professional organizations advocating on their behalf for better needlestick standards. That’s where organizations like Safe in Common can help.
We recognize that personal safety isn't front of mind for healthcare students and personnel. They are instead focused on taking good care of their patients. Too often, they put their own safety in second place.
There is an increased institutional focus on preventing injuries due to patient lifting and positioning. Due consideration also needs to be given to violence in the workplace. But these worthy initiatives should not come at the cost of ignoring exposures to bloodborne pathogens.
Needlestick and sharp injury exposures require a combination of activities by professional, purchasers, employers, and manufacturers. When that coalition works together on education, better equipment, and safer work practices, and sharing knowledge about devices that are available with better designs to provide a passive protection whenever possible (meaning the worker does not have to consciously activate safety features but the safety is built in) then there will be improvements and less apathy.
I encourage all healthcare personnel and safety advocates to take the Needlestick Safety Pledge.
Mary Foley, PhD, RN, is chairperson of Safe in Common, a non-profit organization established to enhance and save the lives of U.S. healthcare personnel at risk of harm from needlestick injuries. For more information visit
Tips for Compliance
All U.S. healthcare facilities are required to comply with the regulations of the Bloodborne Pathogens Standard (BPS), which aims to protect healthcare personnel at risk of harm from needlestick injuries and other potential transmission routes for infection. Healthcare facilities should eliminate the risk of needlestick injuries wherever possible - not just comply with minimum standards.
Keeping healthcare personnel safe from needlestick injuries requires teamwork across all levels of an organization, strong awareness regarding safety procedures, vigilance from all staff and a continuous pursuit of accessing the safest, simplest equipment.
Below are 10 suggestions to help maximize levels of protection provided to healthcare personnel within your facility:
1. Multi-Disciplinary Team Involvement: Healthcare facilities should establish multi-disciplinary leadership teams that include representatives of all occupations identified as being at risk of harm.
2. Equipment Selection Criteria: Not all safety devices are equal. To comply with the BPS, an employer must use engineering and work practice controls that will "eliminate or minimize employee exposure" (Sec. 1910.1030(d)(2)(i)).
- Passive versus Active: Passive devices remain in effect before, during and after use. Active devices however require the worker to activate the safety mechanism. Devices with passive safety features are typically preferred for use.
- Integrated versus Accessory: Integrated devices have built-in safety features. Accessory safety devices have features that are external to the device and must be carried or affixed fixed to a device; this design is less desirable.
3. Regular Meetings to Review Areas of Risk: Review of areas of risk from needlestick injuries more than just once per year.
4. Record Specific Details of Reported Injuries: Healthcare personnel should be encouraged to report needlestick injuries whenever they occur; detailed records should be maintained of all occupational exposures.
5. Require Proper Training on New Equipment: Healthcare facilities should request on-site training during the evaluation and implementation of new safety equipment.
6. Review Risk for Drug Delivery Systems such as Prefilled Syringes: In addition to hypodermic needles and syringes, drug-device combination products, such as prefilled syringes or procedural kits may represent a risk for occupational exposure within a healthcare facility.
7. Don’t Make Equipment Purchasing Decisions Based Solely on Upfront Cost: Selection must be based on employee feedback and device effectiveness.
8. Seek to Minimize Sharps Disposal Volumes: When selecting safety equipment, take into account the size of a safety device after use, to minimize disposal volumes.
9. Report Adverse Events to the FDA: The Manufacturer and User Facility Device Experience can be a beneficial reporting tool for healthcare facilities seeking to improve the safety and simplicity of medical devices.
10. Needlestick injuries represent only one potential transmission mode for infection with bloodborne pathogens. Healthcare facilities should embrace a culture of safety that seeks to minimize the risk of occupational exposure in all areas.