IV Insertion Safety Devices: Evaluating Both Safety and Clinical Performance
By Michael Garvin
There are few people who would argue that safety syringes and other medical devices cannot, if properly introduced into a healthcare setting, reduce needlestick injuries. It is important, though, not to lose focus that safety medical devices are still required to perform in the treatment process of a patient. Clinicians should not sacrifice device performance because the device has a safety feature integrated into its design. The purpose of this article is to provide information and guidelines on how one can ensure the best balance between clinical performance and staff safety concerning intravenous (IV) safety catheter technology.
On April 18, the federal Occupational Safety and Health Administration (OSHA), established the "Final Rule for Occupational Exposure to Bloodborne Pathogens: Needlestick and Other Sharps Injuries." The new safety regulation affects all hospitals, physician offices, and other organizations that deliver patient care and whose healthcare workers are at risk for occupational exposure to human blood and body fluids.
The intent of the new law and implementation regulation is to mandate the use of safety devices that have shown to be effective at reducing needlestick injuries in the clinical setting. OSHA can now impose monetary fines on any healthcare facility that is not using an appropriate safety IV catheter.
IV Safety Catheters: A Solid Case for Success
"The injury and disease conversion data is very clear," says Jane Perry, associate director of the International Healthcare Workers Safety Center at the University of Virginia. "The greatest potential for acquiring an occupational bloodborne disease is in the use of hollow bore medical devices." Data gathered by the EPInet needlestick injury database indicates that the top four leading devices involved in serious bloodborne pathogen needlestick exposures were hollow bore devices.
Past research efforts have only focused on comparing safety devices to their conventional counterparts for determining their effectiveness in reducing needlestick injuries. The time has come to conduct research on specific types of technologies and products. Without solid scientific research on the effectiveness of the various safety designs, healthcare workers (HCWs) will not have the necessary information to make good decisions on purchasing these products.
One of the debates that might be settled if safety-product efficacy data would be discussed is "passive activation" vs. "clinician controlled" safety devices. Passive safety devices require no distinct and separate step to activate the safety feature of the device. There is no language in either the federal OSHA bloodborne pathogen (BBP) standard or the CalOSHA BBP directive that mandates passive technology features. It is unclear whether the perceived demand for passive activation safety devices stems from clinicians, the regulatory community, or the product manufacturers; there is no evidence-based research that proves passive activation devices provides a higher degree of safety than clinician-controlled devices. If this were true, then one could argue that passive-activation technologies would provide a higher level of safety.
However, in the National Institute of Occupational Safety and Health (NIOSH) guidelines, the following is noted in the discussion of passive vs. clinician-activated devices:
"A safety feature that requires activation by the user may be preferable to one that is passive in some cases."
"Each device must be considered on its own merit and ability to reduce injuries."
The guidelines clearly understand that selecting passive activation alone may eliminate IV catheters that have been proved effective at reducing needlestick injuries. In addition, clinicians may not want a device that takes away control of when the safety mechanism is activated, since activation of the safety function impairs the devices' performance by sheathing or retracing the needle. Clinicians may be more comfortable in controlling the activation of the safety feature.
"Safety" devices should only carry that moniker if they have proven to effectively increase the level of safety. If they do not, the industry is spending money for no benefit. Only more product-specific, clinical-based research can answer the question of effectiveness.
How To Find the Right Safety IV Catheter
So, how do you find the right safety IV catheter for your facility? The key to answering that question is to better understand the query. What does the phrase "right IV catheter" really mean? It should mean what product offers both an acceptable level of safety and provides the highest level of clinical performance. If you do not assess the safety and clinical performance of an IV safety catheter, you are not identifying the right IV catheter for your organization. Clinical performance should never be sacrificed for safety.
Janis Bowles, director of material management at the San Joaquin Medical Center in Bakersfield, CA, describes the process that she and her associates used to find the perfect IV catheter.
"We assembled a multidisciplinary team of representatives of departments that managed IV lines." Bowles says. "We had 13 nurse 'validators' in different departments and units. All nurse validators attended a class on product clinical trial procedures. These same people worked with the manufacturers' representatives to initiate the clinical trials. They also collected data on the performance of the products. Within a month of the start of the trials, we had made the decision to convert to the safety products. Within a month after that decision we were 'blitz converting' the entire facility."
Criterion for Safety and Clinical Performance
Clinical validation is the only true way of knowing if your staff will use a safety product. No safety device will generate lower needlestick injuries if the staff is not properly trained in its use and will use the safety device appropriately. There is a learning period with even the best of the safety devices.
Cathie Knight of Grant Medical Center in Columbus, Ohio explains, "I just started this job in IV therapy recently. I used to work in the home healthcare unit where we did not use safety IV devices. Now I use only safety devices and the feel of it is a bit different. My fellow workers tell me to give it time and you get used to the safety devices and then they feel natural. I'm not quite there yet."
One tool that can assist in the process of conducting clinical validations is to have a list of criteria one might use to assess safety IV catheters, featuring evaluation characteristics as developed by NIOSH. These characteristics address both the safety and performance criteria for a safety-engineered IV catheter. Since there is not currently a safety IV catheter on the market that offers all of these options, the institution must determine which items are most critical to accomplish their therapies.
Rapid flash response, for example, is essential for a clinician to know if the needle is positioned effectively. Performance criteria items such as ease of insertion also are important. Factors that affect ease of insertion include the sharpness of the bevel, the needle tip integrity, the "lie distance" between the end of the bevel and the tip of the catheter tubing, and the resistance of the device as it is inserted and positioned in the vein. In addition to these criteria, clinicians will be served best by IV catheters that have a flash-chamber fill rate comparable to standard IV catheters. Clinicians will want products that incorporate materials that resist kinking, so that the device will not frequently need to be replaced due to performance failures.
Finally, beyond the initial performance and safety activation factors, outcomes should be considered. Among others, consideration should be given to the safety device's ability to improve clinical outcomes, be cost efficient, and effectively in reducing needlestick injuries.
There are a number of reasons why a facility decides to convert to safety IV catheters. Barb Johnson of Gunderson Lutheran Hospital in LaCrosse, Wis has probably the best reason.
"We converted to safety IV catheter after attending a conference where I heard Linda Arnold speak," Johnson says. "Linda was a new nursing graduate who had stuck herself and contracted AIDS. The safety catheters have been very effective at reducing injuries at our hospital."
She goes on to examine the functional performance of the device.
"We looked for a product that approximates the insertion of a standard IV catheter. You want to make sure that the catheter has a very sharp bevel for easy insertion. We wanted a higher level of safety but did not want to give up performance and ease of use in the process."
Safety is a critical issue in healthcare but so is the treatment of patients. The two goals can be effectively blended into safety IV catheter selection. A good starting point is to use a set of predetermined criteria that encompass both safety and clinical performance. By asking the right questions and letting your clinicians trial the device, you stand a good chance of finding thee right safety IV catheter that not only meets both the safety and clinical requirements, but one that will be used by your staff.
Michael Garvin is safety manager for the University of Iowa Hospitals and Clinics.
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