IV Insertion Safety Devices: Evaluating Both Safety andClinical Performance

July 1, 2001

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.

For a complete list of references click here