Infection Connection

Safe handling of biohazards
and sharps
When getting the point means missing the point

In a healthcare worker (HCW)’s day, a routine event can, in the twinkling of an eye, turn into a life-changing, even life-ending, event. A needlestick can ruin more than just the moment; it has the potential to destroy the HCW’s life and to devastate their loved ones. It can result in serious, sometimes fatal, infection with bloodborne pathogens such as the hepatitis B or C viruses and the human immunodeficiency virus (HIV).

The National Institute for Occupational Safety and Health (NIOSH) advises that the "primary route of exposure to bloodborne pathogens is accidental percutaneous injury caused by needlesticks . . . In the United States, approximately 800,000 needlesticks occur in hospitals annually—an average of one injury every 10 seconds.¹

Data gathered by the CDC National Surveillance System for Hospital Health Care Workers (NaSH) "show that "38% of percutaneous injuries occur during use and 42% occur after use and before disposal. . . . 10% to 25% occurred when recapping a used needle. . . . Although recapping by hand has been discouraged for some time and is prohibited under the OSHA Bloodborne Pathogens Standard [29CFR 1910.1030] unless no alternative exists, 5% of needlestick injuries in NaSH hospitals are still related to this practice."²

The extent of percutaneous injuries and exposure to bloodborne pathogens is so alarming that NIOSH issued an Alert requesting assistance in preventing needlesticks in the workplace.2 The Alert states: "Improved engineering controls are often among the most effective approaches to reducing occupational hazards and therefore are an important element of a needlestick prevention program. The Alert suggests "eliminating the unnecessary use of needles, using devices with safety features, and promoting education and safe work practices for handling needles and related systems."

Industry has answered NIOSH’s call for assistance with a variety of innovative products engineered for safe use and disposal of sharps.

Inject-Safe Bandages, LLC, Jacksonville, IL, is one of those companies. "We have a product that is going to change the way people think about infection control," said Chuck Jennings, CEO. "The Inject-Safe Bandage is a pre-procedure process that prevents exposure to bloodborne pathogens and enhances the safety of any injection system. The bandage, which can be applied by the HCW or the patient, is a membrane through which the injection is administered. The bandage is self-sealing, so pathogens can’t get in or out. The needle is wiped clean as it’s withdrawn from the injection site. The patch doesn’t eliminate needlesticks, but it prevents exposure to bloodborne pathogens by preventing splatter."

A bonus is that, at 44 cents or less per bandage, it’s cost-competitive with other bandages. Jennings said that use of Inject-Safe bandages eliminates the need for HCWs to wear gloves, which may reduce the cost of injection. By far its most attractive quality is that it serves as a simple, effective means of infection control by protecting the caregiver from exposure to bloodborne pathogens.

Other companies have focused on making the design of the syringe safer. The search for a safer product led to the development of SharpShield, launched in June 2006, by Devon Medical, King of Prussia, PA.

John Iona, president and CEO, outlined four key elements that are important to consider when evaluating a safety syringe: (1) efficacy, (2) standard operating protocol, (3) one-time use, and (4) cost-effectiveness. He explained how SharpShield meets those requirements. "With the SharpShield, after the medicine is administered but while the needle is still sub-epidermal, a protective sheath moves in place to cover the needle; so, there is no blood spatter, unlike auto-retractable syringes. If an auto-retractable is activated sub-epidermally, it can cause trauma in the patient’s arm beyond the needle point. Nurses have a fear of pushing too hard and harming the patient; so, typically, they will activate the safety feature after removal of the needle. This can cause blood splatter."

"Very little pressure is required to activate SharpShield’s safety device. It’s true single-handed use, the way HCWs have traditionally been taught to use syringes. No extra steps are introduced. After the protective sheath moves in place, the plunger locks to ensure one-time use. No one will get accidentally stuck by a needle. Our vision is that the notion of needlesticks and SharpShield will be mutually exclusive of one another," said Iona.

An FDA-accredited, third-party reviewer of product submissions conducted a simulated-use clinical testing on SharpShield. Iona said that, when participating nurses were asked if they would definitely recommend this new device, an overwhelming number, over 80% of nurses surveyed, said they would definitely recommend SharpShield. Conversely, when asked the same question about a well-established, industry-leading, auto-retractable syringe, only 27% said they would definitely recommend the retractable. "Demand has been overwhelming, monumental," said Iona. "We’re working hard to get samples in hands of end-users."

Another area in which Iona expects the SharpShield to have an impact is cost-effectiveness. "There are no springs involved, which means there is no metal in it. No metal enables us to manufacture it at less cost." At the time of writing, Iona told Healthcare Purchasing News that "the price point is still under development and can’t be quoted, but it will positively disrupt the industry."

The American College of Surgeons’ "Statement on Blunt Suture Needles"³ says, "Cuts or needle-stick injuries occur in 1% - 15% of operations. The most common cause of suture needle injury is suturing fascia, during which 59% of all suture needle injuries occur." The statement suggests that surgeons use blunt needles; however, Jerry Brecher, president and CEO, SuturTek Inc., North Chelmsford, MA, said the problem with blunt needles is that doctors don’t like to use them, for clinical reasons and because they can still puncture gloves.

"Hospitals have invested heavily over the years in safety devices, but the operating room (O.R.) is a black hole when it comes to safety products. We have a product that solves an unmet need," declared Brecher. "Surgeons really enjoy using the 360o Fascia Closure Device. Once they use it, they don’t want to go back to suturing by hand."

The 360^o Fascia Closure Device consists of a needle sheathed by a sterile, disposable, plastic cartridge. The device’s trigger is squeezed twice to place a stitch. "Needlesticks during fascia closure are no longer a problem, because the sharp point of the needle is never exposed," explained Brecher. "It’s been used in thousands of cases without one needlestick."

The 360^o Fascia Closure Device is in use at Sacred Heart Hospital, Eau Claire, WI. The device’s ability to protect staff from needlesticks was highlighted in the hospital’s newsletter recently.⁴The director of surgical care also noted that, because the 360o Fascia Closure Device usually allows for faster closure, patients may spend less time under anesthesia. He also expressed belief in the device’s cost-effectiveness, because the part of the device on which the cartridge is loaded is reusable.

Another plus, said Brecher, is that "Surgeons like it because they don’t have to change technique; they use the same standard curved needle they’ve always used. It’s designed for left- or right-hand use and fits even small hands well. Even for someone with little experience, the device delivers the same high-quality closure surgeons are used to."

Referring to the 800,000 needlestick injuries sustained annually, cited above, the NIOSH document on "Selecting, Evaluating, and Using Sharps Disposal Containers," says, "Studies have shown that many of these injuries occur after a sharp (needle or other sharp object) is used; as many as one-third of all sharps injuries have been reported to have occurred during disposal activities."¹ The NIOSH document also "recommends containers on the basis of a site-specific hazard analysis . . . and establishes criteria and provides tools for evaluating the performance of sharps disposal containers."¹

Jim Shaw, director of marketing, BD Sharps Disposal, Oceanside, CA, highlighted the importance of adhering to these published criteria: "According to NIOSH,1 the lives of HCWs and the general public are put at risk when sharps collectors are not selected, installed, and monitored according to specific, measurable criteria. One of the most important factors to consider is that sharps collectors are safety engineering controls. As such, sharps collectors should be used in all healthcare facilities and chosen based on NIOSH criteria for design. Once clinical users have determined which sharps collectors are most appropriate for their needs, other considerations can be made, including environmental concerns and cost."

Shaw pointed out: "Disposal-related sharps injuries most often occur as HCWs look to locate or access sharps collectors; therefore, sharps collectors should be selected and located to best accommodate the unique needs and procedures of each facility and each department. Because the safest choices of sharps-collector designs and applications require a good understanding of clinical considerations in each department, healthcare facilities should evaluate vendors based on their ability to provide clinical support and resources to manage conversion planning and implementation effectively."

Shaw explained how use of BD’s Sharps Disposal System can result in fewer injuries: "HCWs who evaluate BD sharps collectors will find maximized visibility to collector fill-levels, which helps prevent overfill, and counterbalance doors that are sensitive enough and large enough to passively drop the sharps waste they use, while providing the ‘guards that prevent hands from entering’ and ‘security against tampering’ that NIOSH call for.¹"

"While hospitals who use BD sharps collectors often find that the designs of our products help them address risk factors such as overfill and tampering," continued Shaw, "it is more than just products that are needed. Hospital ergonomics can play a vital role. BD helps facilities determine the best placement of sharps collectors within each environment and provides clinical education of all staff to help reinforce best sharps-handling practices. HCWs need the right sharps-collector products, placements, and work practices to reduce risk, and BD’s Sharps Disposal System focuses on delivering all three."

Shaw related a success story: "The success of the University of California, Davis Medical Center, is a great example of successful needlestick reduction. This facility implemented BD’s sharps-collector products, as well as NIOSH placement and work-practices criteria, which BD sales staff helped identify and install. The result, in the first year alone, was a significant drop in disposal-related needlesticks to employees."

Tyco Healthcare Kendall, Mansfield, MA, also shared a success story. "We have a study showing how one particular facility used our SharpStar container to reduce needlestick injuries. After using our sharps disposal product for 8 months, there were only 2 needlestick injuries," related Steve Blazejewski, vice
president of the SharpSafety Division. "Later, the facility used a competitor’s product for 6 months; during that time, there were 6 sharps injuries. As a result, the facility reinstituted the Kendall product, and needle-stick injuries were dramatically reduced, with no needlestick injuries in a 14-month period."

Tyco Healthcare Kendall covers the spectrum of sharps safety with over 400 item codes in the safety hypodermic, IV access, phlebotomy, and disposal categories; yet, they feel the issue is not just about products. "We take a holistic approach in providing safety-needle and safety-disposal solutions," said Blazejewski. "It’s not just one product that can improve the industry issues related to reduction, elimination, and prevention of needle-stick injuries," explained Blazejewski. "Healthcare facilities around the country, around the world, should be focusing on a variety of initiatives aimed at im-proving the problem of needlestick injuries."

To this end, Tyco Healthcare Kendall has developed programs aimed at making it easier for HCWs to meet requirements laid out by organizations such as NIOSH, the Joint Commission on Accreditation of Healthcare Organizations, and the Occupational Safety and Health Administration. "We offer programs like SmartOne, which is a safety-compliance analysis," said Blazejewski. "It’s a customized program in which we work collaboratively with doctors, nurses, and other HCWs to asses their performance in meeting safety standards. SmartOne allows us to provide valuable guidance, free of charge, to our partner hospitals, to ensure they are not just meeting but exceeding the regulatory and governmental aspects of safety."

Blazejewski emphasized the importance of doing your homework when selecting products with the aim of reducing sharps injuries. "There are a variety of guidance documents that have been published to help users objectively decide what factors should be used when evaluating and selecting sharps containers. The NIOSH document on selecting and evaluating sharps disposal containers1 identifies four key criteria, (1) function, (2) access, (3) visibility, and (4) accommodation, to help users select the right product for use at the right time by the right person. If those requirements aren’t met, a needlestick can occur, which can cause devastating socio-economic implications to an HCW. There’s lost time, lost productivity, and, worst-case scenario, the potential for acquiring a disease caused by a bloodborne pathogen. When an HCW receives an accidental needlestick, the injury must be reported. They must tell how it happened, explain the situation in which it happened, identify the product used at the time, and describe the type of procedure that was taking place. The HCW may need prophylaxis treatment to prevent a potential infection. It costs a minimum of $3,000 per needlestick injury. Worst-case scenario, if the HCW contracts HIV, hepatitis, or one of the other 23 major bloodborne pathogens, it could cost hundreds of thousands of dollars for treatment. Implications are large. Minimizing or eliminating that statistic is a major goal for healthcare." HPN

1.Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. Selecting,

2.Centers for Disease Control and Prevention. National Institute for Occupational Safety and Health. Alert: Preventing needlestick injuries in health care settings. DHHS (NIOSH) publication no. 2000-108. November 1999. http://www.cdc.gov/niosh/2000-108.html.

3.American College of Surgeons. Statement on Blunt Suture Needles [ST-52]. Bulletin of the American College of Surgeons 2005;90[11].

4.Sacred Heart Hospital. Progressive new surgical technology increases safety & reduces cost. Tempo August 28, 2006.

What makes a sharps safety device "effective’?

by William A. Hyman, Department of Biomedical Engineering, Texas A&M University

The OSHA definition of a "sharp with engineered sharps injury protection" includes the specific language that the device "effectively reduces the risk of an exposure incident"1.

It is appropriate to consider what "effectively" should mean in this context. At a minimum effective must mean that the device design includes the ability, at least in principle, to reduce the risk by preventing exposure to the used needle. However if this ability exists only in principle, but is not likely to be realized in actual practice, then no reduction in real risk will occur. Such a device should not be considered effective.

Therefore the only useful interpretation of "effectively" is that the device actually does reduce risk in the real world of clinical applications, under real conditions, and when being used by real people. This further means that a built-in or add-on sharps safety feature must be shown to actually reduce inadvertent sharps injuries in order for it to meet a reasonable standard of effectiveness. In this regard if the feature actually eliminates the sharp, then effectiveness can be assumed. However if the feature requires volitional manual activation, as in most safety syringes and some IV access devices, the actual effectiveness must be demonstrated. Needleless IV systems provide an example of the actual elimination of the sharp element. However they also illustrate the danger of introducing new hazards while eliminating others in that needleless systems have been implicated as having an increased infection risk compared to the older needle based systems2, and in allowing inappropriate connections of other lines to the IV line.

The important prerequisites for real world effectiveness include (a) technical features that at a minimum are capable of reliably achieving protection from the used sharp, and (b) that the means of use of the safety feature is consistent with how the device is actually used including the full scope of the user’s tasks in addition to the task element of activating the safety feature. The latter issue represents consideration of what the real task of the clinical practice is rather than a "task fantasy" in which the only thing that needs to be done is to properly use the safety feature. For a "safety" syringe the task fantasy might read as: "Safety syringe use always occurs under conditions when the user’s full and undivided attention is devoted to the task of activating the safety system, such that the patient on which the syringe was used, nor any other patient, requires their attention, that they are fully and functionally trained, and they are not fatigued, distracted, stressed or overworked. In addition the user will not see any reason to ignore or disable the safety feature." In this regard the application of the common recommendation for safety syringes that one-handed use is preferred must consider how the user gets that hand from the position required to operate the syringe to the position required to operate the safety mechanism. The clear preference is that the need for challenging manipulations is undesirable since they will readily tempt the use of the other hand to aid in the manipulation. The user might also be tempted to put the device down in order to pick it back up with the other hand position, or decide not to activate the safety feature at all. In each of these alternatives the theoretical effectiveness would not be achieved. Even if a change in hand position is not clearly required, the manipulations necessary to activate the safety feature (e.g. engaging the palm) may still be challenging and unrealistic. Thus a former baton twirler might be able to do it, whereas the average person could not. In addition, the safety feature should not interfere with the normal use of the device. I was recently told of a hospital situation in which the nurses when surveyed said a post-use syringe cover that stuck out from the base of the needle was "easy to use". It was subsequently discovered that the nurses where cutting off the safety apparatus prior to using the syringe because the safety accessory got in their way. Here the device could be said to be easy to use…if they were going to use it.

Frequent failure to use a safety feature is a clear indication that the safety feature is not effective in the facility. Evidence of compliance failure for safety needles for example might include direct observation, ongoing needlesticks, or the presence of disabled or unused safety features in sharps containers. When such observations are made it is essential to determine if the device design is not acceptable in real use, if the users are not adequately trained, if the users have a real or perceived reason not to use the safety feature, or if there is a lack of compliance with reasonable standardized procedures.

• If the design is at fault, a different device should be selected from those available with the understanding garnered from the experience with the device that is to be replaced. This might include both new products, and products previously reviewed but not selected.

• If the users were not adequately trained, then there is a clear need for further training. However it must be remembered that training, more training and re-training when there are underlying fundamental problems is not likely to achieve successful use and compliance.

• If there is a real reason not to use the safety feature then, again, the selection of the device must be questioned and an alternative device selected. If there is just a perceived reason not to use it, this perception must be evaluated and dispelled, if it is really wrong. However, perceptions are very hard to overcome, and therefore at a minimum the perception must be carefully listened to, and the myths convincingly debunked.

• If there is simply a lack of compliance with a clearly studied and promulgated policy, then workplace supervision and discipline must be enhanced. It can never be acceptable for there to be open and known failures of the staff to follow appropriate procedures. However there should always be clear mechanisms for formally challenging procedures and seeking change.

One ongoing challenge with safety feature effectiveness is that for low incidence events it may be very difficult to determine valid evidence of decreases, or even increases, of these events after a new device is introduced. However this does not mean that a safety improvement should be assumed just because a device with alleged safety features has been introduced. While statistically valid evidence is challenging, anecdotal evidence is available and adverse incidents should always be investigated to determine if the event was caused in whole or in part by the failure of a safety feature to truly be effective.

Devices with safety features are introduced, and in some cases mandated, with the sincere belief, at least on the part of the hospital, that their use will reduce the number of adverse events. A device that achieves this goal can be said to be effective. A device that seems to have the capability to achieve this goal based on its technical capability, but which does not actually achieve the goal under real world conditions is not effective. When the latter is observed action is indicated to either bring performance up to theoretical effectiveness, or to change products if theoretical effectiveness cannot be achieved because the product fails to meet actual user needs. HPN

References

1. OSHA Bloodborne Pathogens regulation, 1910.1030(b): Definitions

2. Neddleless Connectors and Bacteremia: Is There a Relationship?, Marilyn Hanchett, ICT, 9 (11), 22-31, 2005