Hospitals and healthcare facilities in the US are required under the Needlestick Safety and Prevention Act, to provide workers with safety engineered sharps devices as well as to include end users in an annual review of available products. In addition, a recent focus on safe injection practices takes into account contamination risks for both patient and caregiver.

"There are a variety of risks associated with needlestick injuries – for the user, the patient and the institution," said W. Craig Turner, chairman and CEO of MedPro Safety Products. "Healthcare workers face a great deal of risk with the transfer of bloodborne pathogens, including hepatitis B, hepatitis C and even HIV, resulting from a needlestick injury. Patients are at risk of cross-contamination during re-use of a device. In addition, the direct employer cost of a needlestick injury ranges from $3,000 to $5,144 for a high-risk needlestick injury."

With a decade passed since enactment of the Needlestick Act, the Occupational Safety & Health Administration (OSHA) is now reviewing comments submitted by the public to determine how they can better serve and protect healthcare workers from injury. Certainly, there have been numerous successes associated with the Act, as seen in the overall decline in sharps injury rates since its introduction. But for certain types of sharps injuries, and for some care settings, progress is less significant, arguably even stagnant. What’s more, those advocating for sharps safety may find themselves struggling to keep the issue at the forefront amid a multitude of competing priorities.

Working in the public policy and government relations office at BD, Elizabeth Woody is aware of the challenges facing today’s healthcare practitioners and infection preventionists. "They’re operating in an increasingly complex infection prevention and control environment and the threat of needlestick injuries isn’t necessarily receiving the same level of focus as it once did, or as it did around the time that the legislation passed. With all sorts of other infection risks out there, healthcare associated infections like MRSA and C. difficile obviously are getting the majority of attention in healthcare facilities. As new clinical professionals and occupational health professionals enter the field they don’t have the benefit of all the education and training materials that were developed around the time the needle safety legislation passed 10 years ago."

CareFusion SmartSite needle-free valve

Changes in the location of care present another challenge for sharps injury reduction efforts. "Over the last 20 years there’s been a steady migration from the hospital to the non-hospital setting," Woody continued. "It’s estimated that healthcare workers in the non-hospital settings account for about 60 percent of the healthcare workforce today. And while we’ve seen significant adoption of safety engineered devices in the hospitals, we’ve seen a lack of adoption of safety engineered devices in non-hospital settings. As professionals are moving from hospitals to non-hospital settings, they’re moving into a riskier environment in terms of the potential for needlestick injuries."

Andrew McLean, strategic marketing, injection business, BD Medical, added, "What we’re seeing today is a more challenging reimbursement and cost environment in healthcare in general, and that’s resulting in some structural changes in the marketplace. One of those changes is this rapidly increasing trend of Integrated Delivery Networks (IDNs) and hospitals acquiring primary care physician’s offices as well as ambulatory care surgery centers. The data we see [is that] these alternative care sites are much less compliant with the Bloodborne Pathogen Standard when compared to hospitals."

McLean urged those in procurement, occupational safety and health, and infection prevention at IDNs and other multi-facility healthcare organizations to consider all facilities under their ownership when assessing compliance to sharps safety regulations.

Tom Sutton, vice president, Vascular Access & IV Systems, B. Braun Medical Inc., acknowledged the lack of urgency often seen in regards to sharps compliance in outpatient settings. "While certain products have been adopted well in the alternate care settings, it’s still an area that often doesn’t feel that it needs to comply quite as much as the acute care facilities."

Bernie Vezeau, product manager for ACE blade, Megadyne, described how failure to comply with sharps safety regulations can impact hospitals financially and otherwise. "If hospitals don’t have those programs in place, some of the fines could range up to $75,000. Furthermore, they’re now looking at if hospitals willingly overlook sharps safety programs the government is now saying they might go after people for negligent criminal charges."

Lynn Hadaway, M.Ed., RN, BC, CRNI, president of Lynn Hadaway Associates Inc., commented, "In the US, we have the law mandating that employers provide these safety mechanisms but in other countries, it’s still not mandated, it’s voluntary. We have proven here in the states that percutaneous injuries are greatly reduced when you have access to the safety devices."

Earlier this year the Centers for Disease Control and Prevention (CDC) released a Guide to Infection Prevention in Outpatient Settings: Minimum Expectations for Safe Care. A section of the guide is devoted to injection safety practices to prevent transmission of infectious diseases between patients and healthcare providers during preparation and administration of parenteral medications, urging the use of safety devices to reduce sharps injuries to workers and safer practices to prevent harm to patients, including caution to never use the same syringe for multiple patients, never reuse a syringe to enter a medication vial or solution, never use a single-dose vial for more than one patient, and never use IV fluid or tubing for more than one patient.

"The new guide was developed in large part due to the outbreaks of hepatitis B and hepatitis C that have occurred over the last ten years that have affected patients," Woody explained. "Patient to patient transmission of bloodborne pathogens which have primarily occurred because of the re-use of syringes and the misuse of medication vials, that’s what was behind the guidance. The elements of the guide have all been articulated previously. Their recent re-release reflects CDC focus in this area."

MedPro Safety Vacuette

Several organizations have banded together recently to promote and explore injection safety best practices. For example, representatives from the Food and Drug Administration, Centers for Medicare & Medicaid Services and the Joint Commission, along with 200 public and private stakeholders, highlighted the need for safe injection practices at an open meeting sponsored by the Premier healthcare alliance in collaboration with the Safe Infection Practices Coalition held on April 26, 2011. 3M Healthcare also hosted an International I.V. Global Leadership Summit in Minneapolis this May.

"Some of the devices actually allow for some unfortunate practices," Sutton cautioned. "Using a device, removing the needle and then reinserting the needle, can cause the catheter tip to slice off in the patient’s venous system, which can cause serious complications. Some of these active devices actually allow for the needle to be reinserted, which promotes a dangerous practice that can lead to potential catheter embolisms."

He explained that a device like B. Braun’s Introcan Safety Catheter does not allow users to bypass the safety mechanism, nor does it allow for re-use.

The key message for purchasing managers," said McLean, "is that you need to be aware of what products your alternate site locations are purchasing, and ensure there is compliance with the OSHA Blood Borne Pathogens Standard and the Federal Needlestick Safety & Prevention Act. OSHA has recently announced a new emphasis program targeted at injection safety issues and compliance, so these issues are increasingly coming to the forefront."

Safety engineered sharps devices in which the safety mechanism is automatically deployed during the normal use of a device (also called passive devices), are one way to prevent caregivers from bypassing the safety mechanism, and have been shown in many cases to provide improved protection from needlesticks compared to "active" devices that require the user to engage the safety mechanism in order to activate it.

Turner, MedPro, explained, "Since the Federal Needlestick Safety & Prevention Act, a concerted effort has been made to move from unprotected needles to active safety devices. However, needlesticks are still occurring at an alarming rate due to the requirements of current safety devices by the user, resulting in the transfer of bloodborne pathogens. The active safety devices on the market, including sliding shields and retractables, still require additional action by the healthcare worker, and when they are not used properly, have the same risks as unprotected hollow bore needles."

"MedPro’s focus is on true passive technology that allows for needlestick protection during normal course of use, without sliding sheaths or pressing buttons," he continued. "This ease of use provides both the provider and the patient with increased levels of safety. True to our focus, the Tube-Touch design provides protection during use as opposed to activated protection after use. During the normal course of a procedure, the user is confident that the needle is covered and the chance of a needlestick injury is virtually eliminated."

"When the first vacuum tube is inserted into the device, prior to vacuum puncture, the spring-loaded safety shield is deployed to rest on the patient’s skin during the procedure. At the conclusion of the procedure, as the needle is removed, the shield continues to slide over the end of the needle and lock in place. This shield offers constant protection and deploys without requiring any additional steps from the user outside of normal blood collection practice. MedPro’s Tube-Touch patented technology offers healthcare professionals the safety of a blood sample collection product with a truly passive needlestick prevention feature." 

Unifill syringes ready for filling

Stephen Allan, vice president of marketing and communications, Unilife Corporation, noted, "For needlestick injuries, risks include continued use of standard non-safety devices or the non-activation or improper use of devices with safety mechanisms. FDA and OSHA both stated that devices with passive, integrated safety features are desirable and preferred. However, many safety syringes currently on the market do not have passive, integrated features. Many use ancillary safety products instead, that must be attached or can be voluntarily removed by the operator. Others have manual safety mechanisms that require the operator to undertake a secondary action, typically after the completion of the dose, to initiate the safety feature."

"If you look at the annual reports issued by the State of Massachusetts¹ regarding the reported rates of needlestick injuries relating to syringes/needles in healthcare facilities since 2002, you will find interesting trends, including: The actual number of recorded injuries each year has remained largely stable since 2002, when OSHA first began to enforce compliance with the bloodborne pathogens standard. Safety syringes have been consistently responsible for more than two-thirds of all reported syringe-related injuries since 2006."

"The fact that safety syringes are now causing the majority of all syringe related injuries underlines the need for use of more advanced safety products in healthcare facilities," Allan emphasized. "These results, to some extent, may also be due to increased rates of reporting. However, it is clearly apparent that current safety syringe technologies continue to put healthcare workers at risk of harm."

"Reports from independent authorities, such as ECRI, give a clear preference for safety products that have a pre-removal activation feature, meaning that the safety feature is activated while the needle is still inside the patient to virtually eliminate risk of needlestick injuries. Safety products such as needle guards, which are attachable onto the syringe and require manual activation, do not enable pre-removal activation."

With Unifill safety syringes from Unilife, passive (automatic) safety features are fully integrated inside the barrel and the speed of needle retraction is easily controlled. Allan noted that initial production of the US-manufactured Unifill syringe is underway, with initial sales to pharmaceutical companies to commence this month.

According to Allan, "Sanofi has paid Unilife approximately $40MM in exclusivity fees and quarterly industrialization milestone payments in exchange for the access right to negotiate the purchase of the Unifill syringe within the therapeutic classes of anti-thrombotic agents and vaccines until 2014. We are also in discussions with a significant number of other pharmaceutical companies exploring the use of the product in other therapeutic drug classes."

Another area that has become a recent focus in sharps safety is the risk of blood exposure through splashes or splatters. At the 2011 Infusion Nurses Society (INS) Annual Convention and Industrial Exhibition held in May in Louisville, KY, Hadaway presented results from a literature search sponsored by B. Braun in which she and her colleagues culled hundreds of studies looking at the risk of peripheral IV needlestick injury versus mucocutaneous exposure (MCE) to bloodborne pathogens.

"The goal was to identify all of the risks to the healthcare worker and to the facility where they work," Hadaway explained, "looking at differences between percutaneous injury and mucocutaneous injuries specifically with the insertion of a short peripheral catheter. We did a comprehensive, systematic literature review using an integrated approach. We didn’t limit it to a certain type of research design."

In all, 187 English-language articles were included in the final report. "I do not find any evidence in the literature where there have been any reports of splashes of blood from a short peripheral catheter insertion and those blood splashes during that insertion procedure reaching the face, the eyes, mouth, nose, ears."

"We do need more data on MCE, we need to focus on this risk and do some more assessment on it." She added, "We don’t have a good understanding of how blood splashes when we’re putting in peripheral catheters. What is the distance and direction of those blood splashes? Is it enough to reach the face of the person putting it in? We don’t know."

What the literature does continue to show, said Hadaway, "For a sharps injury we know that the hollow bore blood filled needles used to access veins and arteries still carry the greatest risk. Those events are more frequent and the risk of disease transmission is probably greater."

Sutton advised, "Yes, blood splashes are a concern, but in and of themselves, they’re not a very effective way of transmitting bloodborne pathogens. If you really want to make sure you doing the most you can to protect healthcare workers, make sure you’re using the most effective technology in preventing needlesticks."

Allan, Unilife, described the risk for blood splatter present in certain types of devices, "Some types of retractable syringes with non-controlled speeds of retraction when the mechanism is activated outside of the body of the patient, pose potential nontraditional risks of harm, including aerosolization (splatter)."

"Many healthcare facilities have policies seeking to protect healthcare workers against the risk of infection associated with aerosolization. The ideal scenario to minimize the risk of splatter is to activate the safety mechanism inside the body of the patient, with the operator able to control the speed at which the needle is encapsulated," he said.

McLean contended that there is still a risk of blood exposure during a peripheral IV catheter insertion. "Exposure to blood is still viewed as ‘part of the job’ when it doesn’t have to be. The BD Nexiva closed IV catheter system makes safety safer. It not only protects clinicians from the risk of needlestick injuries but also from blood exposure."

Sharps injuries in the operating room continue to pose a challenge for a number of reasons, not the least of which is the degree to which surgeon preference plays a role in the adoption of safety devices such as safety scalpels and blunt suture needles.

"Getting the OR to adopt safer practices and safer devices is still an area that needs work," remarked Sutton, B. Braun.

Megadyne’s ACE Blade Electrosurgery Cutting Device

Woody noted that several comments submitted to OSHA mentioned non-compliance with sharps safety regulations in the operating room. "There was a recently published study that concluded that despite the Standard, sharps injuries obtained in the operating room actually increased by 6.5%, while non surgical sharps injuries decreased by 31.6% over the same time. In response to that AORN recently released a new sharps safety toolkit to their membership."

Vezeau, Megadyne, added, "Seventy-five percent of the time, it’s not the primary person (the person who’s using the device) who gets cut, it’s through the exchange of instruments."

According to Vezeau, the likelihood of a surgeon or nurse being stuck with a scalpel or other sharp device through the passing of instruments isn’t dependent on the experience level of the surgeon or the operating team.

As one surgeon shared with him, "When I work with someone who knows my style very well and they anticipate my next move, they’ll often start to pass me a scalpel before I’m ready for it and I’ll turn around and I’ll get stuck. Because we work together very well, they know my next move, but they move sometimes a little faster than I can. Alternatively, I may get a brand new nurse who may not know what I want, and I get frustrated and a little impatient. I’ll reach for the scalpel and that person will catch it and try to hand it to me at the same time and then they’ll cut me. Regardless of whether the person I work with knows me really well or if it’s the very first time I’ve worked with them, there’s a good chance I’m going to get cut, just because of the exchange of instruments."

"Surgeons who are brand new have been cut," said Vezeau, "and some that have been around for 30 years have been cut."

One way to help reduce sharps injuries due to instrument transfer is through the use of passing trays and neutral zones.

Stephanie Barth, marketing communications specialist for Sandel Medical, explained, "OSHA’s Bloodborne Pathogens Standard requires ‘the use of engineering and work practice controls to eliminate or minimize employee exposure to bloodborne pathogens.’ Neutral zones and hands-free transfer are two more ways to help prevent sharps injuries besides using safety scalpels or a safety scalpel handle. Both techniques are recommended by The Association for periOperative Registered Nurses (AORN)² and The American College of Surgeons (ACS)³."

Barth described tools available from Sandel to help facilities comply. "Sandel’s Z-Friction Drape and Stretch-A-Tray increase compliance by providing a neutral zone for the passing of sharps so that hand-to-hand transfer is eliminated and the risk of sharps injuries is reduced," said Barth. "The Z-Friction Drape keeps instruments in place without magnetizing them and is bright orange to stand out on the sterile field. The Stretch-A-Tray has specially designed walls to keep instruments inside and expands to accommodate longer instruments. It has finger grips to use while holding and adhesive on the bottom to stick in one place. Stretch-A-Tray is also bright orange to stand out and designate the area for sharps."

Sandel’s Z-Friction Drape, Stretch-A-Tray and Change-A-Blade Safety Scalpel

Also from Sandel, the Change-A-Blade Safety Scalpel Handle offers protection from scalpel injuries by providing a protective shield to cover the blade, just as safety scalpels do, at the same time eliminating a common surgeon’s objection to using a safety scalpel, explained Barth. "The difference between the Change-A-Blade and typical safety scalpels is that Change-A-Blade allows surgeons to use their choice of blade. Change-A-Blade also allows for the blade to be changed as many times as needed throughout a procedure. Change-A-Blade is virtually the same weight as a traditional scalpel handle and provides the same unobstructed field of vision."

Eliminating sharps devices whenever possible is also a key safety objective for the OR. For example, Megadyne’s Ace Blade Electrosurgery Cutting Device offers an alternative to traditional safety scalpels. 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, noted Vezeau. 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 ACE blade is being used as part of a new sharps safety initiative at Tennessee’s Cookeville Regional Medical Center which includes a mandate that for any incision longer than one-inch surgeons must use an ACE blade.

"The nice thing is, regardless of how much you cut, the ACE blade stays sharp throughout the entire procedure," said Vezeau. "So the surgeon can use one blade throughout the entire procedure." To put that into context, he explained how a plastic surgeon who was performing surgery to remove excess skin from a bariatric patient was able to make the equivalent of 15 feet of incision using just one ACE blade whereas the same surgery would have required as many as ten scalpels because of the dulling that occurs. The time savings was significant as well, he noted.

He added that surgeons are generally very comfortable using ACE blade "because it’s a cautery blade that they’ve been using for years and they keep their tactile sensation."

Megadyne is also conducting research to determine whether ACE blade carries less infection risk than scalpels, due to the ability of the heat of the blade to eradicate pathogens. "Orthopedic surgeons have already told us that they’re convinced that they’re going to get a lower rate of infection, using an ACE blade versus a scalpel."

In addition, Megadyne is looking at whether the ACE blade can reduce post operative pain at the surgical site due to the fact that the blade cauterizes nerve endings which reduces sensitivity compared to a scalpel.

Once a sharps device is used, whether it be a safety engineered device or other, what happens to it next can have as much of an impact as it does during its use. If a device’s safety mechanism isn’t activated there is risk that a environmental services employee or other non-users of the device may inadvertently be injured by the device.

"An important factor to also consider is the injuries that occur to non-users … housekeepers, maintenance personnel, waste management," Woody remarked. "There are definitely data that indicates they suffer from needlestick injuries. These are healthcare facility employees who don’t have the opportunity to participate in the selection of products, but product selection potentially has a huge impact on them."

Looking even further down the life cycle of a sharps device, most used needles and other sharps will end up in a landfill negatively affecting the environment.

BD RecyKleen sharps collectors

Ranjeet Banerjee, vice president, BD Medical - Medical Surgical Systems, estimates that the direct sharps waste is upwards of 150 million lbs. per year. With the long-term objective of reducing the environmental impact of its products at each stage of the life cycle, the BD ecoFinity Life Cycle Solution program was designed to help healthcare facilities reduce the materials that go into landfill, ultimately converting a waste stream into a resource stream.

"We started looking at, how can we provide a comprehensive, integrated solution to injection safety?" said Banerjee. "It has three elements: clinical, environmental and financial. For the clinical component we must ensure safety for the patients as well as the healthcare worker. The environmental component layers environmental safety on the patient and healthcare safety. And thirdly, you can dream of any solution, but if it’s not affordable, it’s not practical."

"How do we provide a secure and reliable environment across the end-to-end injection delivery process that ensures safety for the healthcare worker, for the patient, for the community and the environment while we lower total healthcare costs? That’s our vision."

References:

1. Sharps Injuries among Employees of Acute Care Hospitals in Massachusetts, 2002–2007; Laramie, Pun, Fang, Kriebel and Davis; Infection Control and Hospital Epidemiology; Vol. 32, No. 6 (June 2011), pp. 538-544.

2. http://www.aorn.org/docs_assets/55B250E0-9779-5C0D-1DDC8177C9B4C8EB/A33331A5-17A4-49A8-866909AF7F01B91D/AGS_Sharps_Injury_Prevention_in_the_Perioperative_Setting.pdf