President Clinton may have signed the monumental Needlestick Safety and Prevention Act a decade ago, but sharps injuries continue to occur at a rate of more than 300,000 a year. While no one discounts how this law fundamentally impacted and improved the safety of nurses and healthcare workers nationwide, it’s important to look back at where we were, how far we have come and what still needs to be done.

“The act itself was a milestone, then after that it kind of faded from everyone’s attention,” said Lynn Hadaway, M.Ed., RN, BC, CRNI, president of Lynn Hadaway Associates Inc. “The emphasis has gradually moved away from healthcare worker safety and patient safety has taken its place.”

Jane Perry

“Other healthcare issues, such as HAIs [healthcare associated infections], have emerged as frontburner issues, and to some extent, because of a lack of resources, occupational health and infection control employees may have to pick their battles or choose their priorities,” said Jane Perry, associate director, International Healthcare Worker Safety Center, UVa Health System - University of Virginia (Charlottesville).

A focus on a culture of safety should never exclude healthcare worker safety, emphasized Linda Groah, MSN, RN, CNOR, NEA-BC, FAAN, executive director/CEO, Association of periOperative Registered Nurses. “AORN believes that you cannot have or talk about patient safety without discussing employee safety also. They go hand in hand – whether it’s lifting a patient and having the right number of people there so the patient doesn’t get dropped or positioned improperly, all the way to sharps safety and appropriate attire for OR team members. We believe very strongly that they are together, they’re not separate.”

Commemorative events

To mark the 10th anniversary of the enactment of the Needlestick Act, UVa’s International Healthcare Worker Safety Center, with a grant from the CDC and additional support from BD, hosted a conference in early November with the goal of identifying remaining gaps and challenges in sharps safety technology and implementation, and to help chart a future path that is global in scale.

In other commemorative events, the American Nurses Association (ANA) hosted a briefing titled, “10 Years after Legislation Was Enacted, How Safe are Health Care Professionals from Sharps?” New ANA president Karen Daly, an early pioneer for sharps safety, joined several leading experts in needlestick prevention in sharing their experiences. With the goal of re-energizing the focus on sharps safety, ANA also re-launched its Safe Needles Save Lives campaign to educate nurses about the law and what they can do to prevent needlesticks and other sharps injuries.

Nancy Hughes

Nancy Hughes, MS, RN, director of ANA’s Center for Occupational and Environmental Health, commented, “Nurses and employers need to work together. Employers must provide a safe work environment and the safest tools while nurses need to advocate for the safe environment and utilize protections provided to them, under the Needlestick Safety and Prevention Act.

“Healthcare workers must know that they are required to report needlestick injuries – underreporting of injuries is a hindrance to investigating the root cause of incidents and trends, and identifying solutions. Institutional obstacles to reporting injuries must be addressed and eliminated. It is important to be able to identify those products that are linked to injuries so they can be removed from use and the manufacturer can redesign the product. Healthcare workers who sustain a needlestick injury must follow up on their treatment protocol, which includes completing recommended laboratory studies. During this stressful post-injury period, employers [need to] provide support.”

Added Hughes, “We also need a standardized way to collect data and to effectively analyze and report the results of that compilation of data. We need this to establish benchmarks and measure progress, and to be able to compare data among facilities, healthcare settings, and geographic areas.

“Healthcare employers must work with the medical device industry to ensure access to the safest devices globally and to foster innovation in safety engineered devices. All must be held accountable in the process,” stressed Hughes.

Gina Pugliese, RN, MS, vice president, Safety Institute, Premier healthcare alliance, described the steps involved in a root cause analysis: “In performing a root cause analysis it is important to ask ‘why?’ as many times as necessary to get down to the ‘root’ cause(s) of an event. Questions such as: what happened; how did it happen; when did it happen (at what point in the procedure) why did it happen; was the safe device activated (if not, was it during a point during the procedure when it should have been activated?), what can be done to prevent it from happening in the future can be helpful trigger questions to uncover contributing factors.

“Other factors to consider,” continued Pugliese, “include staff-related training, compliance with policy, competency, environmental factors (eg lighting, noise, interruptions) patient factors (eg, type of patient, any difficulties with performing the procedure, eg patient movement); type of device [(eg., brand, design, type of activation of safety featured (automatic, semi-automatic, manual); information on safety device activation or failure of safety device.] Resources for performing root cause analyses of needlestick injuries and reporting sharps injuries are included in the CDC’s Workbook for Designing, Implementing, and Evaluating a Sharps Injury Prevention Program and are publicly available for download or ordering at www.premierinc.com/needlestick.”

Linda Groah

Groah noted that AORN is developing a Sharps Safety Took Kit and has invited members of the Council on Surgical and Perioperative Safety (CSPS) – which includes all the key players who come in contact with patients in the OR: operating room nurses, surgical technologists, recovery room nurses, anesthesiologists, surgeons, nurse anesthestists and physicians assistants – to join the workgroup for its development.

The “toolkit” is planned for release at the AORN annual Congress in Philadelphia in March. “The idea is that it will have different tools that people can use to roll out sharps safety,” said Groah. For example, “a PowerPoint [presentation] for education, talking points for physicians – because physicians don’t have a lot of time to learn new techniques, we want to make these short and sweet. There will be posters that can be used in the operating room and we may even include streaming video of some people who have actually made the change from previous practices to what is now considered sharps safety. There will also be a policy and procedure template available that can be customized for a facility,” she said, adding that the toolkit could be applied “anywhere that sharps are used”, such as the emergency department, obstetrics, clinics and physicians offices.

Landmark studies

Two key studies published this past April highlighted significant issues that can serve as benchmarks moving forward. The first, published in Infection Control and Hospital Epidemiology: “Needlestick Injury Rates According to Different Types of Safety-Engineered Devices: Results of a French Multicenter Study,” was the first head-to-head comparison of safety-engineered devices to other safety technology devices. Involving 22 million safety devices used in 61 French hospitals over a two-year period, the study confirmed that passive, fully automatic safety devices offer significantly better protection against accidental needlestick injuries (NSIs) than early generation active safety technologies such as semi-automatic (push-button) devices or those with manually sliding shields or hinged caps. For intravascular catheters, the NSI rate for passive or fully automatic devices studied was 1.31 per 100,000 devices used, compared with 2.54 per 100,000 devices used for semi-automatic technology and 4.34 per 100,000 devices for manually sliding shield technology.

Tom Sutton

According to Tom Sutton, vice president, Vascular Access & IV Systems, B. Braun Medical Inc., “All of the studies in the past have focused on a specific safety feature or compared a safety device to a non-safety or conventional device. So the big deal about this study is statistical power, tracking millions of units across a two-year period, directly comparing the effectiveness of different safety technology types by the clinical category of use. The size and the scope is very significant because of the observations that can be made and what’s nice is that the researchers have captured the fact that there have been very distinct generations of technology.”

Sutton described how safety technology has evolved from the manual “sliding shield” devices of the late 80s and early 90s “that often took two hands and could cause as many injuries as it prevented,” to hinged, toppling shield devices “that were a nice step forward, but the user still had to remember to [activate] them in a timely fashion,” to push-button and spring “semi-automatic” devices, and finally to today’s fully automatic passive devices. “It’s a way of having the safety feature activate itself during the natural use of the device without the user having any extra step or action, so you get a higher rate of compliance,” he said.

Sutton noted that a truly passive device, such as B. Braun’s Introcan Safety IV Catheter, will not allow the user to bypass the safety mechanism. “If you have a push-button you can choose not to push the button or to delay the activation,” he cautioned.

Ana Stankovic

Ana Stankovic, MD, PhD, MSPH, world wide vice president, medical and scientific affairs and clinical operations, BD Diagnostics – Preanalytical Systems, noted that while BD offers first, second and third generation of safety blood collection devices (as well as a full range of safety products for injection and IV therapy), the company is seeking to exit out of conventional needles for blood collection. She described first generation safety devices as having an active safety mechanism that is designed to shield the needle after use but does not allow in-vein activation. Second generation devices also require active engagement but the safety mechanism is engaged while still in the vein. Third generation devices require no active engagement of the device and the needle is protected from the moment the needle is inserted into the patient.

“If you look at the frequency of needlesticks throughout the blood collection process,” explained Dr. Stankovic, “needlesticks most frequently occur between the moment that the needle is pulled out of the vein until the healthcare worker activates the safety feature. It may just be a second or two, but that is the most common situation in the blood collection workflow where the needlesticks occur.”

Lynn Hadaway

Hadaway noted that an especially appealing aspect of a passive safety device is that it doesn’t usually require nurses to change their technique in order to use the device and activate the safety feature. With many active devices, she noted, “There’s a learning curve that comes after training. The nurse has to perform multiple attempts with the device to actually master the technique, so patients are being stuck more as the nurse learns how to do it. There are more catheters wasted, there’s more time involved, more pain to the patient and you’re destroying the patient’s veins by these additional needlesticks.”

Added Sutton, “In the article, they pointed out that passive systems should be easier to transition to or use because it would require less training. Training is significant when it comes to an invasive technique where you’re placing a sharp within the body of the patient,” he said, noting that the ease-of-use and flexibility of a safety device plays a big part in the healthcare worker’s ability to master a new product and in turn greatly influences patient satisfaction.

“The Needlestick Protection law requires an annual review and update of the hospital’s Exposure Control Plan, and with the findings of this study passive technology should be strongly considered,“ Sutton remarked.

Added Dr. Stankovic: “You can have the best possible device, but if people don’t activate it or use it properly it’s not going to work [as a tool to reduce needlestick injuries]. There is a need for really good education, since the turnover rate of healthcare workers that participate in blood collection (nurses, phlebotomists, etc.) is very high. So there has to be the concerted effort to continuously educate and improve their knowledge about the risks [of NSIs], benefits [of safety-engineered devices] and new devices. We as manufacturers must continually strive to educate and inform customers about new products on the market.”

Janine Jagger, MPH, PhD, director, International Healthcare Worker Safety Center, applauded the landmark French study for its head-to-head comparisons of safety-engineered devices, but noted that the authors do not discuss the need for a variety of protective mechanisms on safety-engineered devices: “Different procedures require different features, including ones that are user-activated—for example, when giving incremental doses. It remains the case that, when it comes to safety devices, a variety of designs are still needed.”

The second study, published in the April issue of the Journal of the American College of Surgeons, “Increase in Sharps Injuries in Surgical Settings” by Jagger, et al, showed that despite a 31.6 percent decrease in sharps injuries in non surgical settings, there was a 6.5 percent increase in surgical settings. Most injuries were caused by suture needles (43.4%), scalpel blades (17%) and syringes (12%). Three-quarters of injuries occurred during use or passing of devices. Also noteworthy, surgeons and residents were most often original users of the injury-causing devices, while nurses and surgical technologists were typically injured by devices originally used by others.

Responding to the study findings, a “Table Talk” article in the October 2010 issue of the AORN Journal, “A Call to Arms to Prevent Sharps Injuries in our ORs”, explored issues surrounding adoption of sharps safety in the OR from the perspective of several key surgical team members, as well as reinforced CSPS and AORN endorsement of sharps safety measures including “double-gloving, blunt suture needles for fascial closure, and the neutral zone when appropriate to avoid hand passage of sharps.”

The AORN “Table Talk” article included a Surgeon’s Perspective from Ramon Berguer, MD, FACS, chief of surgery at Contra Costa Regional Medical Center in Martinez, CA, who was also a co-author on the JACS article. “What has become clear is that sharps injury prevention in the OR is a team effort in which the hospital administrators, surgeons and OR staff members play key roles,” stated Dr. Berguer, adding that “surgeons must be made aware of the effects of their decisions.”

Dr. Berguer is also working with AORN on the development of their sharps safety toolkit. Said Groah, “He is bringing the voice of the surgeon and sharing ideas on how we might at least neutralize their objections to double gloving and blunt suture needles.”

“There is no doubt that it takes cooperation from the entire surgical team to have a successful sharps safety program,” said Jennifer Barber, marketing communications specialist, Sandel Medical Industries LLC. “For the most part nurses and surgical technologists are eager to implement safety devices because they sustain 80 percent of the sharps injuries in the OR.The struggle has been getting surgeons to adapt to this change.”

Barber described Sandel’s approach to encouraging adoption of safe sharps devices. “One might find this intriguing but we do not recommend the use of safety scalpels in the OR setting. In general, the industry’s historical product offerings truly lacked surgical team support.

“What Sandel does offer is a safe replacement for the #3 scalpel handle called the Change-A-Blade,” she continued. “The Change-A-Blade has the same weight and feel of a regular #3 handle, but comes equipped with a retractable safety shield to cover the blade during passing and helps reduce the risk of injury. For the surgeon, this new safety design provides the same look and feel of historical scalpel handles.

“In addition, Change-A-Blade overcomes one of the key surgeon obstacles: ‘Do not tell me what blade to use, I want to use my normal surgical blade,’” continued Barber. “Since Change-A-Blade has the same metal neck as a #3 handle, it provides normal field of vision, uninterrupted puncture-ability and can be used with any #10, #11 or #15 blade. In addition, one can exchange the blade during the case (same as a standard #3 blade handle) as many times as necessary during the procedure while still providing a safe environment. The Change-A-Blade complies with OSHA requirements for ‘engineered safety devices’ and comes with a removable TIME OUT Sleeve.”

Responding to customer requests Sandel will be introducing a long handle Change-A-Blade in the near future, said Barber.

Ken Noseworthy

Another option in safety scalpels is Southmedic’s CABO (Cutting Above & Beyond Objections) Safety Scalpel Cartridge. According to Ken Noseworthy, vice president, sales, Southmedic, the CABO “gives the surgeon what he or she wants in a simple scalpel system, without compromise.”

He described the surgeon-friendly features of CABO: “Fits the surgeon’s favorite scalpel handle so the weight and feel does not change; the safety sheath retracts fully and does not impair the field of vision of the surgical sight; equipped with Southmedic’s premier Polymer Coated Blade which is the sharpest blade available, reducing the typical tissue drag and minimizing tissue trauma; is loaded and off-loaded intuitively as with a standard blade.”

Another new product to help promote OR sharps safety is Megadyne’s new Ace Blade Electrosurgery Cutting Device. When combined with the ACE Mode of the Mega Power Generator, ACE Advanced Cutting System cuts, coagulates and dissects with one instrument, reducing the need to pass scalpels and conventional electrosurgical blades back and forth. Cutting like a scalpel, without having a sharp edge, ACE allows surgeons to safely perform skin incisions with wound healing equivalent to a scalpel, the company noted.

The new PICC Wand Safety Introducer available from Teleflex Medical can help reduce risks associated with the Modified Seldinger Technique including accidental needlestick injury, loss of cannulation, vessel trauma, blood exposure, contamination of components and air and wire embolism. Using the new Accelerated Seldinger Technique, The PICC Wand combines an echogenic needle, nitinol wire, sheath and Dilator into an all in one safety introducer that eliminates the need to reach for separate components, improving sterile technique and reducing risk of needlesticks. The passive needle safety mechanism of The PICC Wand automatically shields the contaminated needle during the procedure, reducing the risk of accidental needlestick injury.

“Passive sharps safety is important because the safety device is automatically activated during the normal course of the procedure. This means that the healthcare professional will not have to remember to activate it,” said Jake Newman, director of vascular access marketing, North America, Teleflex. “The PICC Wand is the only safety introducer for PICC and Mid Line placement with passive sharps protection,” he added.

Gina Pugliese