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IV Insertion Safety Devices: Evaluating Both Safety andClinical Performance
By Michael Garvin
There are few people who would argue that safety syringes andother medical devices cannot, if properly introduced into a healthcare setting,reduce needlestick injuries. It is important, though, not to lose focus thatsafety medical devices are still required to perform in the treatment process ofa patient. Clinicians should not sacrifice device performance because the devicehas a safety feature integrated into its design. The purpose of this article isto provide information and guidelines on how one can ensure the best balancebetween clinical performance and staff safety concerning intravenous (IV) safetycatheter technology.
On April 18, the federal Occupational Safety and Health Administration (OSHA),established the "Final Rule for Occupational Exposure to BloodbornePathogens: Needlestick and Other Sharps Injuries." The new safetyregulation affects all hospitals, physician offices, and other organizationsthat deliver patient care and whose healthcare workers are at risk foroccupational exposure to human blood and body fluids.
The intent of the new law and implementation regulation is to mandate the useof safety devices that have shown to be effective at reducing needlestickinjuries in the clinical setting. OSHA can now impose monetary fines on anyhealthcare facility that is not using an appropriate safety IV catheter.
IV Safety Catheters: A Solid Case for Success
"Theinjury and disease conversion data is very clear," says Jane Perry,associate director of the International Healthcare Workers Safety Center at theUniversity of Virginia. "The greatest potential for acquiring anoccupational bloodborne disease is in the use of hollow bore medicaldevices." Data gathered by the EPInet needlestick injury database indicatesthat the top four leading devices involved in serious bloodborne pathogenneedlestick exposures were hollow bore devices.
Past research efforts have only focused on comparing safety devices to theirconventional counterparts for determining their effectiveness in reducingneedlestick injuries. The time has come to conduct research on specific types oftechnologies and products. Without solid scientific research on theeffectiveness of the various safety designs, healthcare workers (HCWs) will nothave the necessary information to make good decisions on purchasing theseproducts.
One of the debates that might be settled if safety-product efficacy datawould be discussed is "passive activation" vs. "cliniciancontrolled" safety devices. Passive safety devices require no distinct andseparate step to activate the safety feature of the device. There is no languagein either the federal OSHA bloodborne pathogen (BBP) standard or the CalOSHA BBPdirective that mandates passive technology features. It is unclear whether theperceived demand for passive activation safety devices stems from clinicians,the regulatory community, or the product manufacturers; there is noevidence-based research that proves passive activation devices provides a higherdegree of safety than clinician-controlled devices. If this were true, then onecould argue that passive-activation technologies would provide a higher level ofsafety.
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 preferableto one that is passive in some cases."
"Each device must be considered on its own merit and ability to reduceinjuries."
The guidelines clearly understand that selecting passive activation alone mayeliminate IV catheters that have been proved effective at reducing needlestickinjuries. In addition, clinicians may not want a device that takes away controlof when the safety mechanism is activated, since activation of the safetyfunction impairs the devices' performance by sheathing or retracing the needle.Clinicians may be more comfortable in controlling the activation of the safetyfeature.
"Safety" devices should only carry that moniker if they have provento effectively increase the level of safety. If they do not, the industry isspending money for no benefit. Only more product-specific, clinical-basedresearch 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 keyto answering that question is to better understand the query. What does thephrase "right IV catheter" really mean? It should mean what productoffers both an acceptable level of safety and provides the highest level ofclinical performance. If you do not assess the safety and clinical performanceof an IV safety catheter, you are not identifying the right IV catheter for yourorganization. Clinical performance should never be sacrificed for safety.
Janis Bowles, director of material management at the San Joaquin MedicalCenter in Bakersfield, CA, describes the process that she and her associatesused to find the perfect IV catheter.
"We assembled a multidisciplinary team of representatives of departmentsthat managed IV lines." Bowles says. "We had 13 nurse 'validators' indifferent departments and units. All nurse validators attended a class onproduct clinical trial procedures. These same people worked with themanufacturers' representatives to initiate the clinical trials. They alsocollected data on the performance of the products. Within a month of the startof the trials, we had made the decision to convert to the safety products.Within a month after that decision we were 'blitz converting' the entirefacility."
Criterion for Safety and Clinical Performance
Clinicalvalidation is the only true way of knowing if your staff will use a safetyproduct. No safety device will generate lower needlestick injuries if the staffis 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, "Ijust started this job in IV therapy recently. I used to work in the homehealthcare unit where we did not use safety IV devices. Now I use only safetydevices and the feel of it is a bit different. My fellow workers tell me to giveit time and you get used to the safety devices and then they feel natural. I'mnot quite there yet."
One tool that can assist in the process of conducting clinical validations isto have a list of criteria one might use to assess safety IV catheters,featuring evaluation characteristics as developed by NIOSH. Thesecharacteristics address both the safety and performance criteria for asafety-engineered IV catheter. Since there is not currently a safety IV catheteron the market that offers all of these options, the institution must determinewhich items are most critical to accomplish their therapies.
Rapid flash response, for example, is essential for a clinician to know ifthe needle is positioned effectively. Performance criteria items such as ease ofinsertion also are important. Factors that affect ease of insertion include thesharpness of the bevel, the needle tip integrity, the "lie distance"between the end of the bevel and the tip of the catheter tubing, and theresistance of the device as it is inserted and positioned in the vein. Inaddition to these criteria, clinicians will be served best by IV catheters thathave a flash-chamber fill rate comparable to standard IV catheters. Clinicianswill want products that incorporate materials that resist kinking, so that thedevice 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 tothe safety device's ability to improve clinical outcomes, be cost efficient, andeffectively in reducing needlestick injuries.
There are a number of reasons why a facility decides to convert to safety IVcatheters. Barb Johnson of Gunderson Lutheran Hospital in LaCrosse, Wis hasprobably the best reason.
"We converted to safety IV catheter after attending a conference where Iheard Linda Arnold speak," Johnson says. "Linda was a new nursinggraduate who had stuck herself and contracted AIDS. The safety catheters havebeen 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 standardIV catheter. You want to make sure that the catheter has a very sharp bevel foreasy insertion. We wanted a higher level of safety but did not want to give upperformance 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. Agood starting point is to use a set of predetermined criteria that encompassboth safety and clinical performance. By asking the right questions and lettingyour clinicians trial the device, you stand a good chance of finding thee rightsafety IV catheter that not only meets both the safety and clinicalrequirements, but one that will be used by your staff.
Michael Garvin is safety manager for the University of Iowa Hospitals andClinics.
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