Study Raises Ongoing Issue of Passive vs. Active Safety-Engineered Sharps Devices

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Any device that endeavors to protect healthcare workers from needlesticks and other percutaneous injuries is a benefit to the occupational safety and health agenda in healthcare institutions, but a recent study is asking clinicians to consider whether passive safety-engineered devices (SEDs) are most effective at reducing these types of injuries.

By Kelly M. Pyrek

Any device that endeavors to protect healthcare workers from needlesticks and other percutaneous injuries is a benefit to the occupational safety and health agenda in healthcare institutions, but a recent study is asking clinicians to consider whether passive safety-engineered devices (SEDs) are most effective at reducing these types of injuries.

Tosini, et al. (2010) sought to evaluate the incidence of needlestick injuries (NSIs) among different models of SEDs (automatic, semiautomatic, and manually activated safety) in healthcare settings by examined all prospectively documented SED-related NSIs reported by healthcare workers. During this multi-center study, conducted from January 2005 through December 2006 in 61 hospitals in France, hospitals were asked retrospectively to report the types, brands and number of SEDs purchased to help the researchers estimate SED-specific rates of NSI.

The researchers report that more than 22 million SEDs were purchased during the study period, and a total of 453 SED-related NSIs were documented; the average frequency of NSIs was 2.05 injuries per 100,000 SEDs purchased. Passive (fully automatic) devices were associated with the lowest NSI incidence rate. Among active devices, those with a semiautomatic safety feature were significantly more effective than those with a manually activated toppling shield, which in turn were significantly more effective than those with a manually activated sliding shield. The researchers conclude that additional studies are needed to determine whether the higher cost of SEDs could be offset by savings related to fewer NSIs and to a reduced need for user training.

Lynn Hadaway, MEd, RN, BC, CRNI, principal of Lynn Hadaway Associates, Inc., an expert in infusion therapy and vascular access, says that one of the key aspects of the study is that redirects emphasis back on healthcare worker safety, something she says has "fallen off the collective radar screen" even though there are more devices in use in healthcare than ever before and the problem of needlestick injuries persists.

"The study is significant because it compares the designs of safety devices so you are comparing safety to safety," Hadaway notes. "In the past we have seen studies that compared conventional, non-safety devices to safety devices. This is the first study that I know of that has looked at comparing different safety designs so the first time we have had a well-designed study with hard data that has addressed this issue. Conventional wisdom has told us that the fewest steps required, and the least amount of handling and manipulation of safety devices required, the better you will be. This data seems to offer a significant volume of evidence to support that and emphasizes that passive designs do reduce the number of injuries."

Hadaway continues, "I think the general consensus is the fewest steps required by the operator to do the procedure are also critical, such as when inserting a catheter. The fewest changes to the traditional technique, the more successful you are going to be. The passive devices do not generally require an additional step you must take to activate the safety mechanism, therefore you use your traditional method for holding the skin and making the venipuncture and advancing the catheter; in other words you don't have to make any changes to your technique when using most of the passive devices. When you have an active device, then it is likely that busy healthcare workers overlook this step; they can get in a hurry and forget that step. When you give them an option to ignore the safety mechanism, it is quite likely that they will. But if it doesnt require a change in technique and it's a comfortable procedure and there's no active step that has to be done to engage the safety device, everyone is safer."

There are numerous reasons why safety devices do not prevent NSI. As Tosini, et al. (2010) explain, "SED-associated NSIs may occur through mechanical failure of the safety feature, incomplete activation, user noncompliance, or an inherently risky activation procedure. Not all devices used for different types of invasive procedure have undergone the same degree of technical improvement, and SEDs of different generations coexist in the marketplace. Broadly speaking, SEDs are in two categories: active devices that require one- or two-handed activation by the healthcare worker after use and passive devices that are automatically operated throughout the use of the device."

The researchers classified SEDs according to the passive or active nature of the safety activation mechanism. Active devices were then subdivided into those with a protective sliding shield, those with a protective needle shield aligned to the bevel-up position and toppling over the needle, and those with a semiautomatic safety feature (such as an automatic safety feature requiring one-handed activation by pushing a button or a plunger).


Among the active SEDs, those with a manually activated protective sliding shield were significantly less effective than those with a toppling shield, which in turn were significantly less effective than those with a semiautomatic safety feature. Passive devices included in the study, self-retracting lancets (seven different brands), intravenous catheters (two different brands), and insulin pen needles (1 brand), were associated with the lowest NSI incidence rate. Self-retracting lancets accounted for 97 percent of the total number of passive devices purchased and for 40 percent of the number of NSIs by passive devices. SEDs with manually activated safety features were associated with 10.7 times more NSIs than SEDs with semiautomatic or automatic safety features.

The researchers also investigated the circumstances of the 453 NSIs according to safety feature activation. According to their study:

-- 168 NSIs (37.1 percent) occurred during the invasive procedure (while introducing needle, by accidental needle withdrawal during procedure, or during needle withdrawal at the end of procedure) before activation of the safety feature was appropriate or possible, and these were assessed as not preventable by the SED used by the injured healthcare worker.

-- 133 NSIs (29.4 percent) occurred during activation of the safety feature.

-- 106 NSIs (23.4 percent) involved user failure to activate the safety feature after completing the invasive procedure.

-- 46 NSIs (10.2 percent) occurred after activation of the safety feature, of which nearly half (18 of 46) were due to incomplete activation by the user and the remainder; (28 of 46) were due to failure of the safety feature (as declared by the healthcare worker involved).

Tosini, et al. (2010) report that almost 40 percent of the NSIs in their study occurred while the devices were being used, meaning before activation of the safety feature was appropriate or possible, and note, "All SEDs documented in the study address the risk of exposure after an invasive procedure in the time between needle withdrawal and needle discard into a sharp objects container, even though successive generations of devices have allowed increasingly easy and increasingly early activation of safety, thus reducing the risk. Nevertheless, in a global approach to prevent HCW exposure, the risk during procedure has to be taken into account in future development of safety designs moreover, the statistical significance between NSI rates related to the different types of SEDs remains unaffected even if NSIs that occur during invasive procedures are not taken into account to calculate NSI rates."

The researchers acknowledge the implications of their study: "We found that some SEDs were more effective than others in preventing NSIs. Knowledge of the most effective designs is important, both to guide the choice among available devices and to help manufacturers develop new safety technology for sharp objects. Our systematic analysis of device-specific rates of NSI suggests that SEDs with automatic or semiautomatic activation of the safety feature are more effective than SEDs that require full user intervention. Indeed, SEDs with automatic or semiautomatic safety features were 10 times less likely to be associated with NSIs than were devices in which activation of the safety feature was fully manual. SEDs with a push bottom or plunger were significantly safer than those with a toppling shield, which, in turn, were significantly safer than those with sliding protection."

The study emphasizes the ongoing need for healthcare worker education, as the researchers found that one-third of NSIs took place during activation of the safety feature. As Tosini, et al. (2010) explain, "Accidents of this type, peculiar to these devices, seem to result from incorrect user activation of the safety mechanism rather than from failure of the device itself. This type of error may be due to inadequate information for and/or training of healthcare workers. SEDs are more complex than their conventional equivalents and usually necessitate specific training, particularly in how to activate the safety mechanism at the end of the invasive procedure. One-tenth of NSIs took place despite the safety feature having been activated. In half of these cases, the user reported that the device had failed, whereas the remainder were due to incomplete activation by the user. Thus, more than one-quarter of NSIs were due to non-activation or incomplete activation of the safety device and could have been avoided."

The efficacy of SEDs can be influenced by the acceptance of the devices by healthcare workers, as well as factors such as the design of the device, training provided before and after introduction of the device, ease of use, changes in technique, the perceived risk of occupational infection, and patient safety issues, the researchers say. They add that active devices are often impacted by healthcare workers' concerns for patient safety or comfort, thus reducing the efficacy of SEDs because healthcare workers could delay activation or rate the device as being more difficult to use.

While the study does not list brand names, clinicians tend to cultivate a preference over time and it can be challenging for them to switch products if patient outcomes indicate the need to do so. "From what I have seen, nurses especially are impacted by change, as it is their tech-nique that is affected and how they learned to do procedures such as venipuncture," Hadaway says. "The product and their technique must merge. It's a very personal learning curve when you change from one product to another and must get used to a new process."

Another challenge is keeping clinicians from developing a false sense of security when using SEDs; they must understand that these devices must be operated correctly for some of the safeguard mechanisms to kick in. "This issue goes to a healthcare worker's attitudes, beliefs and values, and how well the education process has done the job of convincing healthcare workers that they are at risk and how they can protect themselves," Hadaway says. "It's not the high-risk patients that you know about that are of concern, it's the number of patients whose status is unknown. It has to become personal for them. I think one of the most effective ways of driving home the message of the need for sharps safety is listening to other clinicians who have actually contracted an infectious disease from a sharps injury. One of the cases that brought the issue home to me years ago was a nurse working in a blood bank who was using a syringe needle to puncture through the thick rubber stoppers on the test tubes. She stuck herself and contracted hepatitis, and was giving her presentation shortly after her second liver transplant. When you from clinicians who have contracted hepatitis from a needlestick or someone who has become HIV positive after a sharps injury, you hear their emotional angst sees how their lifestyle has changed and you empathize because it could easily be you in that same situation. When you educate clinicians about sharps injuries, you must bring it down to where they live, and explain how it will change their lives forever."

Hadaway says she hopes clinicians will take the study to heart and incorporate knowledge from it into their daily processes and product evaluation efforts. "I hope that people will read it and understand it. Unless there is some active process within each facility to bring this data to the level of the staff nurses, they may never see it," she says. "There must be some active educational process with this information incorporated into the bigger picture. With training and education cut to the minimum today I don't know how many hospitals can actively get involved with this data. Sharps safety has fallen off the radar screen, We worked long and hard to get the needlestick legislation and it's been 10 years since the bill was signed and people think, 'Well, that problem is solved and we can move on to the next one.' But it's not solved. Engineering controls on devices certainly help, and now we know that the engineering control design has a huge influence on outcomes, but there are still practice controls that require a change in behavior."

Hadaway says it's critical for clinicians, healthcare institutions and manufacturers not to lose the momentum that was created by the signing of the Needlestick Safety and Prevention Act of 2000. "In the 1990s, we were working so hard to get the legislation signed, and there was so much emphasis on sharps-safety issues," she says. "When the legislation was enacted, all of the emphasis dwindled off. You don't see the same level of activity now as you did 10 years ago from anyone, whether it's clinicians, healthcare facilities, professional organizations or manufacturers. There is a distinct lack of education on sharps safety out there currently; at the Decennial meeting in March, there was a small section on healthcare worker safety and a few things on needlesticks, but not the huge emphasis like there was on patient safety. We have to get that emphasis on sharps safety back, not taking away from patient safety, but simply promoting a culture of safety that includes healthcare workers and patients so that it's not one or the other."

Reference: Tosini W, Ciotti C, Goyer F, Lolom I, LHe´riteau F, Abiteboul D, Pellissier G and Bouvet E. Needlestick injury rates according to different types of safety-engineered devices: Results of a French multicenter study. Infect Control Hosp Epidem. Vol. 31, No. 4. April 2010.


Specialized IV Teams Help Guard Against CRBSIs

By Kelly M. Pyrek

No conversation about infection prevention and control would be complete without considering a recent development in some hospitals that is driven by the economic downturn the disbandment of specialized intravascular teams.

"With the economic crisis we have all felt, hospitals have experienced downsizing in staff development and infection control departments, as well as IV teams, and there has been an emphasis on shifting responsibilities back on the staff nurse," says Lynn Hadaway, MEd, RN, BC, CRNI, principal of Lynn Hadaway Associates, Inc., an expert in infusion therapy and vascular access. "They just don't have the support mechanisms that they used to." Hadaway explains further, "IV teams are being disbanded but they are the ones doing key clinical procedures putting in peripheral catheters, making venipunctures, and providing infusion therapy. But these practices are almost like commodities now they are being considered as tasks that any nurse should be able to do. Healthcare institutions are assuming these practices are included in nurses scope of practice, that they don't need any special skills and it's just the way it's done."

Hadaway says this is an assumption with potentially deadly consequences for patients. "What we are seeing is that staff nurses, people just out of nursing school working in med/surg positions, have received little or no education about infusion therapy when they were in school because its frequently not included in basic nursing curriculum. There may be a few nursing schools that have given them some exposure but for the most part it's not there, so you arrive at your first job without the skills and knowledge of basic principles required to keep you and your patient safe when you are making these venipunctures. Hospitals are disbanding or cutting back on specialized teams and dumping tasks on staff nurses who are already overworked and stretched to the max, working overtime just to finish their assignments."

She points to an unpublished study presented at the Decennial meeting from a large teaching institution in the Midwest in which researchers noticed a potential connection between more difficult patients and more unsuccessful peripheral sticks, so much so that they had to call in a PICC team, which led to an increase in the number of unnecessary PICCs, which led to a higher rate of bloodstream infections. "Once they began to trace this chain of events, they documented it and won back two full-time employees for their IV team," Hadaway says. "In another session at Decennial, an epidemiologist said his facility disbanded its IV team, saw more sticks and more PICCs, then had an increase in BSIs from PICCs so they stopped using PICCs altogether. That didn't make sense, but that was their response. It's a matter of who is the most appropriate person to be doing this, based on the patient's acuity, difficulty, and choosing the most appropriate vascular access device for that patient so that you cut down on the number of needles in the system to begin with."

This chain of event including excessive venipunctures -- is a dangerous escalation that jeopardizes patients and exposes healthcare workers to injury. "Right now we are still relying on data that is about 12 years old regarding the sheer number of venipunctures needed to establish one successful IV site," Hadaway says. "A study from Shands Hospital from 1998 found that 2.18 attempts was the average number to establish a site, and it ranged from one to 14 venipunctures. Venipuncture proficiency rates are not being addressed by hospitals. They eliminate the IV team but they are not paying attention to what the skill level of the remaining staff is. How many more nurses and catheters are we using now to establish one site? Then if you can't establish a peripheral site that means we have wasted all their peripheral veins with all of these unnecessary sticks. Now that we are only relying on a central venous catheter, we have to use that for everything, including all blood draws, because there are no peripheral veins available. We are using it for all of these manipulations, which are increasing our risk for catheter-related bloodstream infections."

Sophie Harnage, RN, BSN, clinical manager of infusion services at Sutter Roseville Medical Center in Roseville, Calif., agrees that specia-lized teams are the key to avoiding complications and infections when inserting and handing lines. "I believe a specialized team must own these lines, from insertion to maintenance to discontinuation," Harnage says. "In our program, we dont even let floor nurses discontinue lines. Our team does site checks everyday, observing and educating wherever and whenever possible. We are annoying, but that is what it takes to prevent infections," Harnage adds with a laugh. "I dont think infection preventionists have enough time or manpower to do this, and they are not infusion or vascular access experts; however, they are powerful when connected with a PICC nurse."