By Kelly M. Pyrek
Editor's note: This article originally appeared in the March 2020 issue of Healthcare Hygiene magazine.
Twenty years ago, the federal Needlestick Safety & Prevention Act (NSPA) of 2000 was signed into law with the hope that it could bring new awareness to the dangers of occupational exposures and percutaneous injuries in the healthcare environment.
“Since the NSPA of 2000 was signed into law the issue has received greater focus from occupational health and infection prevention staff,” says Angela Laramie, an epidemiologist with the Massachusetts Department of Public Health. “Hospitals are continuing to convert to using devices with sharps injury prevention features across the hospital, including devices in pre-packaged kits. In Massachusetts, after seeing an initial decrease in sharps injury rates in MDPH licensed hospitals from 2002 to 2010 that was statistically significant, sharps injury rates between 2010 and 2015 have plateaued.”
To review, the NSPA revised the Occupational Safety and Health Administration (OSHA)’s standard regulating occupational exposure to bloodborne pathogens and sought to further reduce healthcare workers' exposure by imposing additional requirements upon employers regarding their sharps-related procedures. OSHA's regulations modified the definition of "engineering controls" and added definitions for the terms "sharps with engineered sharps injury protection" and "needleless systems;” required employers to consider and implement new technologies when they update their exposure control plan; required employers to solicit employee input with respect to appropriate engineering controls; and required employers to maintain a sharps injury log.
“It is important to note that the NSPA in and of itself is not enforceable in healthcare facilities,” emphasizes Amber Hogan Mitchell, DrPH, MPH, CPH, president and executive director of the International Safety Center. “Rather, it required OSHA to incorporate additional requirements in its Bloodborne Pathogens Standard, including more specific requirements for the use of device with sharps injury prevention (SIP) features, annual frontline employee evaluation and selection of those devices, and maintaining a sharps injury log. After 2000, we saw reductions in injuries overall, but in the last several years, injuries have started to increase, especially among physicians using suture needles and nurses using disposable syringes. These are two areas where we must remain diligent about capturing injury data, evaluating safer devices and work practices, and reducing the numbers of injuries.”
For one commonwealth, at least, there has been an increase in the percentage of injuries reported involving devices with engineered sharps injury prevention features over time. “In 2002 in Massachusetts, 26 percent of all injuries occurred with devices with sharps injury prevention features. Excluding suture needles, the percentage is 32 percent,” Laramie says. “In 2015, 45 percent of injuries occurred with devices with sharps injury prevention features. If we exclude suture needles that figure increases to 57 percent. This may be seen as a proxy for use of such devices, in which case it is appropriate that we are seeing an increase in the proportion of injuries with these devices. The goal is to eliminate use of devices without sharps injury prevention features, in which case all injuries would occur with devices with sharps injury prevention features.”
Laramie continues, “What we need to address is the efficacy of the devices with sharps injury prevention features. Not all mechanisms are equally effective at reducing risk of injury. We have spent the better part of two decades educating hospitals and enforcing regulations that require use of devices with sharps injury prevention features. The next step is to make sure that the devices being used are the ones that most effectively minimize the risk of exposure.”
Last year, the Association of Occupational Health Professionals in Healthcare (AOHP) released the findings of the EXPO-S.T.O.P. (EXPOsure Survey of Trends in Occupational Practice) 2016 and 2017 surveys in the AOHP Journal (Vol. 39, No. 1). AOHP's EXPO-S.T.O.P. is an electronic survey designed to ascertain the incidence of sharps injuries and mucocutaneous blood exposures among healthcare workers in U.S. healthcare facilities.
The 2016 and 2017 overall results for all hospitals participating in the survey document a significant increase in blood exposure incidence over the 2011 results.
“It is alarming that data from the last three surveys have shown a year-by-year significant increase in sharps injuries (SI), and that the 2017 rate is almost back to the 2001 rate,” said survey co-author Terry Grimmond of Grimmond & Associates Microbiology Consultants, in a statement released at the time the survey results were announced, “These increasing rates validate that the significant decrease in sharps injuries in the years immediately following the Needlestick Safety and Prevention Act of 2001 has not been sustained.”
Conclusions documented in the EXPO-S.T.O.P. 2016 and 2017 report include:
- The significant rise in SI incidence with the 2016 and 2017 surveys indicates that current strategies have not been successful in reducing national SI rates.
- There is an urgent need to adopt more aggressive exposure reduction strategies.
- Large exposure databases, detailed databases of SI mechanisms, and research on SI mechanisms, SED effectiveness, and effective training are required, as well as continued publication of strategies proven to reduce exposure incidence.
Complacency about sharps injuries and occupational exposures could explain these trends, as could the overall busyness of clinicians that can eclipse prevention strategies.
“Injuries among physicians have been on the rise the last several years, specifically when performing suturing procedures,” Mitchell says. “It is important that surgical teams identify when injuries are occurring, so that they can evaluate safer options – devices with sharps injury prevention features and/or eliminate sutures/needles where they can. Some examples would be evaluating alternate devices for skin closure (staples, zipper closures, adhesives, etc.) and evaluating the use of blunt tip suture needles for internal fascia where acceptable.”
Mitchell continues, “Among nurses, since injuries with disposable hypodermic needles are the most frequent, it is important that users are evaluating devices and implementing ones that they have deemed the most effective. It is also critical that they activate the safety mechanisms immediately after use and dispose of that device into a sharps container. According to EPINet data, the largest numbers of syringe injuries are occurring when using needles for insulin or vaccinations. Evaluating safer devices for these procedures, especially since they occur so frequently, is essential. Data shows that more than 65 percent of SIP mechanisms are not activated when an injury occurs. Since about one-quarter of all injuries occur to non-users, activating SIP mechanisms protects not only the clinical user, but also anyone that may come into contact with it downstream (EVS, waste haulers, laundry personnel, SPD, etc.).”
Overall numbers of injuries are increasing no matter the device type used, Mitchell emphasizes.
“As mentioned, in 2018 35 percent of all employees reporting injuries through EPINet are using devices with SIP features; 65.7 percent of those are from devices where the SIP feature has not been activated. Though the purchase of devices with SIP features may be increasing year over year, compliance dictates that frontline, non-managerial employees are evaluating, considering, and implementing safer devices on an annual basis; that those SIP features are activated; and that the device is disposed of immediately into a sharps containers. To compare this to infection prevention strategies, consider it a ‘sharps safety bundle’ approach that mimics the industrial hygiene hierarchy of controls.”
Laramie has seen first-hand the data coming out of healthcare facilities and notes that a few practice areas of the hospital are still problematic for occupational exposures and SIs.
“Operating and procedure rooms continue to be the work area where the greatest number of reported sharps injuries are occurring,” Laramie says. “In Massachusetts, operating and procedure rooms consistently account for the greatest number of reported sharps injuries, with 44 percent of sharps injuries in 2015 occurring in operating or procedure rooms. Inpatient units, excluding the ICU, have consistently accounted for at least one fifth of sharps injuries over time with 20 percent occurring on inpatient units in 2015. In large hospitals, the most sharps injuries occur in operating and procedure rooms (47 percent), while in small and medium sized hospitals, injuries occur most frequently on inpatient units, excluding the ICU (25 percent).”
Laramie continues, “Operating and procedure rooms present particular risks, from passing and handling of surgical instruments often lacking sharps injury prevention features, to working in crowded or low-light environments. Use of devices with sharps injury prevention features, including blunt suture needles and scalpels with protective covers will minimize risk of injury. Work practice controls such as hands-free passing, verbal cueing and use of the neutral zone, as well as double gloving, and making sure that sharps disposal containers are of adequate size and appropriately located will also minimize risk of injury among workers. Similarly, on inpatient units, increased use of devices with engineered sharps injury prevention features, along with an adequate number of sharps containers that are within reach of the point of use and are not more than three-quarters full will minimize risk of injury. In both settings, eliminating the use of sharps by using alternative methods for medication delivery or wound closure would also minimize risk of injury.”
Given the immense opportunity to educate around mitigating sharps injuries, Infection preventionists can play a critical role in preventing occupational exposures.
“Given the preventable nature of a great majority of workplace exposures and SIs, the importance of the role of infection prevention staff cannot be overstated,” says Karen Daley, former president of the American Nurses Association and nationally recognized expert on sharps safety. “Keeping staff safe from bloodborne pathogens exposures requires vigilance, open communication and promotion of practices that are known to contribute to sharps safety in patient-
Daley continues, “Vigilance against trends contributing to injuries is always an important part of prevention. Infection preventionists can play a critical role as they support and assist staff to guard against complacency around injuries. There is a also need for transparency and communication between infection preventionists and direct care staff as root cause and data trend analyses are conducted following injuries. One example of an identifiable trend amenable to mitigation strategies is staff failure to properly activate sharps safety mechanisms. Periodic data analysis may also identify unsafe work practices that contribute to injuries. Injury trends as well as results from root cause analyses need to be brought to the attention of direct care staff for feedback as well as management and administration as part of efforts to reduce worker injury and exposure risk.”
Daley emphasizes that Infection preventionists can also help reduce occupational exposures and SIs by promoting employer compliance with legal requirements under the NSPA which revised the 1991 Bloodborne Pathogens Standard: “Federal OSHA regulations require that healthcare employers provide safety-engineered devices to prevent SIs; review and update exposure control plans to reflect changes to safer and more effective technology to reduce injuries; maintain a sharps injury log; and seek input from direct users of sharps on engineering and work practice controls.”
The ANA’s SIP Stakeholder Group, which is comprised of sharps safety experts and advocates, is currently focused on a variety of strategic activities to help reduce Sis, Daley says. “Efforts include promotion of safe OR pilots, simplification and standardization of acronyms and terminology used relative to safety-engineered sharps devices and updating of the 2010 Consensus Statement recommendations,” she adds.
One of the issues that the ANA’s SIP Stakeholder Group and others are working on is addressing inconsistent and confusing terminology used to describe devices with sharps injury-prevention features.
“There are a variety of terms used to describe devices with engineered sharps injury prevention features,” confirms Laramie, “ranging from the OSHA phrase ‘sharps with engineered sharps injury protections’ to ‘safety-engineered devices- or the colloquial ‘safety devices.’ The broad term ‘safety device’ doesn’t explain how it is safer or for whom the safety feature is intended (patient? healthcare worker?). This becomes more confusing in the international realm, where in addition to needing devices that have sharps injury prevention features for healthcare workers and the general public, reuse prevention features are also important.”
As the NSPA first noted, “Since publication of the BBP standard, a wide variety of medical devices have been developed to reduce the risk of needlesticks and other sharps injuries. These ‘safer medical devices’ replace sharps with non-needle devices or incorporate safety features designed to reduce the likelihood of injury.”
In 1998, OSHA solicited information on occupational exposure to bloodborne pathogens due to percutaneous injury and based its recommendations in part on the responses to its inquiry into what was happening in healthcare facilities. Congress was prompted to act in response to growing concern over bloodborne pathogen exposures from sharps injuries and in response to recent technological developments that increased employee protection.
The revised standard added "Sharps with Engineered Sharps Injury Protections" and defined this term as "a non-needle sharp or a needle device used for withdrawing body fluids, accessing a vein or artery, or administering medications or other fluids, with a built-in safety feature or mechanism that effectively reduces the risk of an exposure incident." As the NSPA noted, this term encompassed a broad range of devices that make injury involving a contaminated sharp less likely, and includes syringes with a sliding sheath that shields the attached needle after use; needles that retract into a syringe after use; shielded or retracting catheters used to access the bloodstream for intravenous administration of medication or fluids; and intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a needle that is housed in a protective covering.
The revised standard also added the term "Needleless Systems," which was defined by the NSPA as "a device that does not use needles for: The collection of bodily fluids or withdrawal of body fluids after initial venous or arterial access is established; the administration of medication or fluids; or any other procedure involving the potential for occupational exposure to bloodborne pathogens due to percutaneous injuries from contaminated sharps." Needleless systems, according to the NSPA, provide an alternative to needles for the specified procedures, thereby reducing the risk of percutaneous injury involving contaminated sharps. Examples of needleless systems include intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a blunt cannula or other non-needle connection, and jet injection systems that deliver subcutaneous or intramuscular injections of liquid medication through the skin without use of a needle.
The NSPA modified the definition of "Engineering Controls" to include as examples "safer medical devices, such as sharps with engineered sharps injury protections and needleless systems." This change clarified that safer medical devices are considered to be engineering controls under the standard. The term "Engineering Controls" includes all control measures that isolate or remove a hazard from the workplace, encompassing not only sharps with engineered sharps injury protections and needleless systems but also other medical devices designed to reduce the risk of percutaneous exposure to bloodborne pathogens. Examples include blunt suture needles and plastic or mylar-wrapped glass capillary tubes, as well as controls that are not medical devices, such as sharps disposal containers and biosafety cabinets.
The revised Exposure Control Plan requirements outlined by the NSPA made clear that employers must implement the safer medical devices that are appropriate, commercially available, and effective: “No one medical device is appropriate in all circumstances of use. For purposes of this standard, an ‘appropriate’ safer medical device includes only devices whose use, based on reasonable judgment in individual cases, will not jeopardize patient or employee safety or be medically contraindicated. Although new devices are being continually introduced, OSHA recognizes that a safer device may not be available for every situation. If a safer device is not available in the marketplace, the employer is not required to develop any such device. Furthermore, the revised requirements are limited to the safer medical devices that are considered to be ‘effective."’’ For purposes of this standard, an ‘effective’ safer medical device is a device that, based on reasonable judgment, will make an exposure incident involving a contaminated sharp less likely to occur in the application in which it is used.”