Get sharp about safety
Daniels Sharpsmart collector
by Jeannie Akridge
No discussion of
needlestick injury trends would be complete without considering the
impact of the U.S. Needlestick Safety and Prevention Act of 2000 that
mandated the use of safety-engineered sharp devices. The legislation
also prompted the Occupational Safety and Health Administration (OSHA)
to revise its Bloodborne Pathogens Standard in 2001, strengthening
requirements for employers to identify and make use of effective and
safer medical devices.
Nearly a decade later, a study published in the December 8, 2008
issue of the Journal of Infection and Public Health1 examined
the effectiveness of federal legislation and regulations in reducing
healthcare workers’ (HCWs) risk of exposure to bloodborne pathogens.
Analyzing needlestick injury data over a 12-year period (1993-2004)
from a large network of U.S. hospitals using the Exposure Prevention
Information Network (EPINet) sharps injury surveillance program, the
researchers found a 34 percent decline in needlestick injury rates for
U.S. healthcare workers overall, and a 51 percent decline in
needlestick injuries for nurses.
While this is certainly welcome news, and proof-positive of the
value of safety devices, further examination shows that there’s still
much work to be done. Study co-author Jane Perry, associate director
of the University of Virginia Health System’s International Healthcare
Worker Safety Center, observed, "Overall, we’re not seeing much change
in the data over the last few years. In the year or two after the
legislation was passed, from 2001 to 2002, we saw a sharp drop in
injury rates for most device categories. However, the overall pattern
we’ve seen in the last five years is a stabilization or plateauing of
rates," she said, adding, "we did achieve a significant reduction in
injury rates, which we attribute to the law."
The JIPH study found that the largest reductions in injury
rates were for two device categories with the highest risk of
transmitting infections. These two high-risk device categories –
phlebotomy needles and I.V. catheter needles – showed reductions of 59
percent and 53 percent respectively. Perry noted that adoption of
safety devices for these applications has been particularly high, with
market penetration of 90 percent or more. "In the categories where
we’ve seen the highest adoption of safety devices, we’ve also seen the
most reduction in injury rates," she noted.
Marilyn Hanchett, R.N., infection control practitioner with the
Sinai Hospital Baltimore, Lifebridge Health in Baltimore, MD,
highlighted examples of sharps safety technology innovations. "There
are two very significant success stories historically that I’ve had
the opportunity to experience. Both changed the way I and many others
approached specific high-risk procedures. The first was
introduction of the Interlink needleless system, which changed the way
healthcare professionals intermittently accessed IV systems. It was
ground-breaking technology and although needle-free systems have
continued to evolve, that product remains in use. I was a bedside RN
when that technology was introduced and intermittent IV access has
never reverted to the previous methods of using unprotected needles.
Today many manufacturers offer needle-free products, but historically
I think it’s important to acknowledge Baxter’s role in changing not
only products but also our vision of what better sharps safety
practice could – and should - be."
Another noteworthy success story in sharps safety technology
development, described Hanchett, was the introduction of the StatLock
Stabilization Device, now available from
Bard. With the goal of
eliminating the use of sutures and suture needles for securing central
lines, this unique catheter securement technology "really changed the
way we looked at securing our IV catheters, especially PICCs," she
B. Braun Introcan Safety IV Catheter
Recently, Baxter launched its VITAL-HOLD catheter stabilization
device as part of a convenience kit combined with its V-LINK luer-activated
device. Vital-Hold locks catheters and lines securely in place,
helping to reduce unscheduled restarts compared to tape, thus
resulting in reduced risk of lost lines and associated needlestick
injuries. Baxter’s V-Link antimicrobial IV connector is coated both
inside and out with a proprietary VitalShield antimicrobial coating
that is designed to help prevent microbial contamination and growth of
pathogens in the device. This needleless IV access device features a
flat, swabable surface, translucent housing, and double-seal
protection - promoting standardized technique.
In 1992, ICU Medical Inc. introduced the CLAVE – a one-piece,
closed, needle-free connector. The unique design of the Clave ensures
compliance with needle-free policies because of its passive technology
which cannot accept a needle. The Clave requires no additional
components or adapters to access and requires no end cap for
sterility. This microbiologically closed system helps protect the
patient’s catheter from contamination that can otherwise lead to
The MicroCLAVE Neutral Displacement Connector from ICU Medical
helps maintain catheter patency with virtually no reflux of blood into
the catheter lumen either when connected or disconnected from an
administration device. The dedicated internal fluid path technology
provides a built in barrier to bacterial ingress.
Building on the successful design of the original Clave product,
ICU Medical recently launched the Antimicrobial CLAVE, the only
antimicrobial needle-free connector with dedicated internal fluid path
technology. Ionic silver has been infused into all fluid path contact
components which includes the internal cannula and split septum seal.
Also from ICU Medical, the Spiros (Closed Male Connector) is a
needle-free closed system for the transfer and mixing of hazardous
drugs. Upon disconnect the Spiros automatically self seals and closes
the system. The Spiros prevents drips or spills in the event of a
disconnection from a transfer device or IV set and protects against
Earlier this year,
Medegen Inc. announced that it had received
510(k) clearance from the U.S. Food and Drug Administration (FDA) for
its new MaxGuard Advanced Luer Activated needleless connector
featuring Agion Antimicrobial Technology. Medegen’s positive
displacement technology provides a bolus of fluid to clear the
catheter tip upon disconnection from the device. A translucent housing
provides for visualization of the fluid path allowing for complete
flushing of the device.
Safety systems from
B. Braun Medical Inc. include the ULTRASITE
Needle-Free IV System with positive displacement, designed to reduce
accidental needlesticks when injecting, aspirating, or infusing fluids
and medications; as well as the new Introcan Safety IV Catheter.
Even amidst such huge advancements, there’s always room for
improvement, suggested Chris Trauger, product manager, IV catheters
for B. Braun Medical Inc. For example, "with 90 to 95 percent of the
U.S. IV catheter market converted to a safety device, it looks like
we’re in compliance. And the statistics show that needlestick injuries
have gone down. The question is, can they go down even further?" he
challenged. "The goal should always be zero. Is that realistic? Maybe
not, but that should always be our goal to reach."
Accentuating the need for continuous awareness, in October 2008 the
California Division of Occupational Safety and Health (Cal/OSHA)
alerted employers in the healthcare industry about pre-filled syringes
containing one of the 2008-09 seasonal influenza vaccines, which were
packaged with conventional needles that lacked a safety feature to
protect users from needlesticks.
Gina Pugliese, vice president,
Premier Safety Institute, commented,
"Although OSHA issued a revision [to the Bloodborne Pathogens
standard] in 2001, it only impacts on workers in the U.S. and not
manufacturers. So healthcare workers must rely on manufacturers to
provide the needed safety devices."
Baxter's The VITAL-HOLD
catheter stabilization device
is used to lock catheters and lines securely in place.
VITAL-HOLD is latex free, packaged sterile, and the soft,
flexible design enhances patient comfort
"An issue that still remains is ‘user preference’," said Pugliese.
"OSHA specifies that the front line workers have to be involved in the
selection and evaluation of devices. So for pre-filled syringes, if
the safety device is incorporated into the device, the worker needs to
become familiar with activation of the safety feature after use. Field
evaluations conducted by the Premier Safety Institute of a number of
different types of safety syringes found that workers become familiar
with activation of safety features of syringes with less than five
uses. However, workers still have specific preferences on the type of
syringes that they prefer and many factors guide this preference,
including ease of use, active versus passive activation, right or
left-handed use, indication of activation, and suitability for a range
of uses across patient populations and procedures. It is preferred
that the safety feature be incorporated into the pre-filled syringe,
rather than as an ‘add-on’ to ensure use."
"User preference may also impact on selection of syringes used for
specific procedures," continued Pugliese. "In the situation where
syringes are included as a component of a procedure tray, some trays
are still available without safety syringes. Hospitals have the choice
to purchase trays without syringes and add their own safety syringe
based on user preference, purchase trays with standard devices (which
are often less expensive) and replace them with their own safety
syringes, or select trays that incorporate the safety syringe that
they are familiar with."
Inviro Medical’s InviroSNAP! Safety Syringe Flu Trays enable easy
influenza vaccine administration and are designed for convenient
access. Each sealed tray includes 25 unwrapped sterile syringes,
rather than 25 individually packaged, unopened syringes, reducing
waste and increasing labor efficiency in the administration of
influenza treatment. The InviroSNAP! Safety Syringes bridge the gap
between bulky retro-fitted designs and more expensive automatic
retractables. They function like a traditional syringe and are easy to
use while administering flu shots, but the devices are engineered with
a safety feature integral to the design. After using standard
technique to administer a medication dose, the clinician pulls the
plunger back, causing the needle to retract inside the barrel. The
plunger is then snapped off, permanently disabling the device.
Citing a recent licensing agreement between leading pharmaceutical
Solutions for the Unilife Ready-To-Fill retractable safety
syringe, Perry commented, "pre-filled syringes are increasingly in
demand in medicine because they eliminate the possibility of
administering the wrong dosage to patients and in many cases they’re
more time efficient. It’s good news that the industry is beginning to
recognize the need to package pre-filled syringes with safety needles.
I would expect to see an increasing array of sharps safety technology
developed for this market."
Sandel sharps safety products include Neutral
Zone instrument drape, Hands Free passing tray, safety scalpel
and safety scalpel handle.
"Overall there’s been a lot of success in implementing safety
devices in the U.S., with a high level of adoption in most healthcare
facilities. But one area where safety device implementation has lagged
is surgery," said Perry. "When you look at our overall data, it’s
clear that a large proportion of injuries occur in the surgical
setting. If 30 percent of needlesticks and percutaneous injuries come
from one clinical area, and that area has not shown much inclination
to adopt safety devices and practices, it’s going to effect the degree
to which rates can continue to decline. Thus, in our view, the major
factor in the plateau of sharps injury rates over the last five years
has been the lack of progress in the OR."
"As with many professionals, surgeons can be resistant to change,"
commented Lucy Reday, product manager,
Sandel Medical Industries. She
outlined several challenges in getting surgeons to adopt safety
"First, the vast majority of surgeons were never trained in the use
of sharps safety products (safety scalpels/handles and/or blunt suture
needles) and have been clinically successful for years without them.
"Second, the vast majority of injuries involve the staff and not
the actual surgeon. In addition, the historical belief has been that
such incidences are a ‘part of surgery’ and therefore should be simply
accepted (and potentially not reported).
"Third, many surgeons believe that changing to an engineered safety
device may compromise their clinical outcomes. Historically, safety
scalpels have been poorly designed relative to the surgeon’s needs and
requirements – [with the] wrong weight and feel, inability to utilize
their preferred choice of surgical blade, impaired visibility, etc.,"
The Change-A-Blade Safety Scalpel Handle from Sandel features a
metal neck that is identical to a standard reusable scalpel. This
frees healthcare facilities to utilize any #10, #11 and #15 standard
blade, enabling each surgeon to keep their tool of choice. A fully
retractable safety shield gives the surgeons uninterrupted
puncturability and unobstructed field of vision. Change-A-Blade is
weighted similar to a traditional #3 Scalpel Handle. An audible-click
indicates that the safety shield is fully engaged.
The BD Beaver Safety Cataract Knife, featuring a specially
designed, integrated retractable shield, is designed to minimize the
risk of accidental surgical blade injuries that could occur during all
phases of a surgical procedure: before use, during passing, between
steps of the procedure, after use or during disposal. The integrated
safety shield is easily activated by the user with just one finger,
through a spring-assisted slider that provides tactile and audible
feedback in both the shielded and unshielded positions. The single-use
knives are essentially the same size and weight as conventional
Suture needles are the second leading cause of needlestick injury
in the U.S., accounting for 22 percent of incidents. The use of blunt
suture needles, which Perry described as "sharp enough to get through
internal tissue, but not sharp enough to penetrate the skin and cause
a needlestick," has been endorsed by both the American College of
Surgeons and OSHA. Yet resistance remains high, in part due to
pre-conceptions about the devices by older surgeons who may have tried
first generation blunt suture needles years ago.
"One of the reasons for the relatively low adoption of blunt suture
needles has been lack of availability," said
Ethicon Products Company
Spokesperson Kristen Wallace. "Surgeons were looking for a greater
variety of suture/needle combinations. In April 2009, ETHICON expanded
the ETHIGUARD Blunt Point Needle product line by launching 30 new
product codes to address this issue."
Ethicon’s Ethiguard Blunt Point Needles are made from a
heat-treated, stainless steel alloy that delivers optimal strength and
ductility to resist bending and breaking. The blunt point geometry
allows for easy soft-tissue penetration with no more additional
bleeding or patient trauma than with a conventional taper needle.
Additional attributes include a ribbed and flattened body that affords
stability in the needle holder for improved protection against
slipping. Ethicon has also combined its Plus Antibacterial Sutures
(which kill bacteria and inhibit bacterial colonization of the suture)
with Ethiguard Needles to provide additional protection for both
surgeons and their patients.
Also from Ethicon, DERMABOND Topical Skin Adhesive is a liquid
bonding agent that holds many cuts, wounds and incisions together as
effectively as stitches do. The adhesive material in Dermabond also
forms a strong microbial shield to help protect wounds from bacteria
that may lead to infection as they heal.
ICU Medical’s Antimicrobial Clave and
"Another potential cause for low adoption is physician education,"
continued Wallace. "The practice of using sharp needles starts during
residency training. Exposing surgeons to the benefits of blunt suture
needles early on may impact adoption. The recommendation of universal
adoption from industry advocates such as the American College of
Surgeons (ACS) can help to lead the discussion."
Having a "champion" surgeon to lead sharps safety efforts can also
be a big help, said Pugliese. "There are many new safety scalpels that
perform equally to the reusable scalpels and samples from a variety of
different suppliers need to be evaluated by the surgeons. Regarding
blunt suture needles, the elegant research done by the CDC on their
efficacy was published in 1997 and surgeons reported no interference
with surgical procedures. I believe this is a matter of
re-introduction of these devices in the OR and again, a champion
Perry noted that along with safer devices, work practices that can
reduce either the use of sharps or the risks associated with them must
also be implemented. For example, employing a "no-hands passing" or
"neutral zone" technique for transferring scalpel blades among members
of the surgical team is an important practice that’s currently being
heavily promoted to help reduce the risk of injury.
According to David Skinner, vice president,
Inc., "OR teams are acutely aware of the ‘neutral zone’ and instrument
hand-off risk, yet transfer injuries are still too frequently
reported. Daniels’ Bladesmart receiving device was designed by OR
staff and develops further the neutral zone principle enabling safer
transfer of scalpels, suture [needles] and other sharp objects."
The Z-Friction Instrument Drape from Sandel is a flexile non-skid
bright orange material that serves as a noticeable neutral zone on the
sterile field, the Mayo stand or back table. Sandel’s Hands Free
Transfer Tray facilitates non-hands passing of scalpels and
instruments on the sterile field. Sandel’s Stretch-A-Tray expands to
accommodate instruments in a variety of shapes and sizes.
Disposing of risk
The final risk for injury during the lifecycle use of a needle or
other sharps occurs during, and after, disposal of the device.
Well-designed sharps containers placed in strategic locations, when
combined with best practices, can help protect healthcare workers,
patients and visitors from accidental needlesticks.
"The challenge is incorporating engineered passive safety features
in a user-friendly design, in a compact wall space at an affordable
cost point," said Skinner. "Even with extensive use of sharps safety
devices, 6-9 percent of sharps injuries are container-related, i.e.
via deposition, protrusion, bounce-out or penetration. These are
caused primarily by sharps containers with small openings, point-first
deposition, insensitive trays, and thin walls or closures."
Sharpsmart’s larger access, sensitivity, passive overfill
protection, pre-assembly, tamper-proof closure, strength, and
bracketry are the product of five years of engineered clinical
research. These passive safety features work 24/7 to protect staff,
are independent of contractor intervention, and have significantly
reduced sharps injuries (SI) in peer-reviewed studies, according to
Debra Gillmeister, director of healthcare services marketing for
Stericycle Inc., described how the "vertical drop" design of Stericycle Bio Systems containers allows for simple, single-handed
disposal of a wide variety of sharps, even including winged-steel
"butterfly" needles that are often hard to get fully inside of a
container due to their attached flexible tubing.
Stericycle’s Sharps Disposal Management Service, in which service
technicians provide regularly scheduled, pro-active change-out of the
Bio Systems reusable containers, can help alleviate challenges
associated with in-house management of disposable sharps containers.
"If you’ve got a disposable container, those containers [often] don’t
get changed out until they’re full, and that really creates an
opportunity for needlesticks," explained Gillmeister. "I’ve been in
facilities where I’ve walked into the soiled utility room and twelve
disposable containers are lined up against the wall – they’re not even
in the receptacle that they’re supposed to go into – with needles
sticking out of the tops of them, because nobody wanted to change the
containers out. So that is a real issue."
The Stericycle program helps ensure best practice for sharps
disposal, from making sure the right sized containers are installed in
the most appropriate locations at the proper height according to NIOSH
guidelines, to selecting the most suitable style of container for a
particular area. For example a "hamper top" lid that accommodates
larger sharps and medical devices may be preferable in the OR,
In an independent study of 52 Stericycle customer facilities, 100
percent of respondents indicated a significant decline in disposal
needlesticks, with 77 percent averaging 0 to 1 per year, which
Gillmeister attributes to the proactive change-out of containers by
Stericycle employees as well as user-friendly container designs.
"In a recent study involving 28 U.S. hospitals, Daniels
Sharpsmarts, when compared to non-user hospitals, were associated with
significantly less Total SI; an 81 percent reduction in
Container-associated SI; and a 23 percent reduction in
Inappropriate-disposal SI," said Skinner.
Not to be overlooked is the positive environmental impact achieved
with reusable containers.
Stericycle's Sharps Management Service
includes pro-active change-out of containers.
"Disposable sharps containers add plastic and cardboard to a
hospital’s sharps waste stream," said Skinner. "In two recent U.S.
studies, one of 11 hospitals and another of 103 hospitals, reusable
Sharpsmarts reduced the sharps waste stream by 4-6 tons per 100
occupied beds. In addition, Sharpsmart efficiency resulted in staff
having to exchange 30-50 percent less containers."
A Carbon Footprint Calculator posted on the Stericycle website,
www.stericycle.com, helps facilities gauge the impact of their
activities on the environment. Because the Stericycle containers can
be reused up to 600 times, a significant amount of plastic and
cardboard is diverted from landfills, thus reducing carbon dioxide
"An average 200-bed hospital using our system would have diverted
13,180 pounds of CO2 from the atmosphere per year," Gillmeister
illustrated. Using the calculator we learn that’s the equivalent of
679 gallons of gasoline, or 249 propane tanks. According to a running
total on the Stericycle website, "overall since the Bio Systems
container has been in existence we’ve kept more than 69 million
containers out of landfills," she said.
Just because a facility provides healthcare workers with sharps
safety devices does not ensure that the safety mechanisms will always
be activated. The clinician may be rushed and either forget or for
some reason consciously choose not to activate the safety feature, or
they might think the safety mechanism was activated when it wasn’t.
Trauger emphasized the role that "passive" safety devices such as
B. Braun’s Introcan Safety IV catheter can play in improving sharps
safety compliance. Whereas "active" sharps safety devices require the
user to do something to engage the safety mechanism in order to
protect the needle, passive devices provide automatic needlestick
protection without a change in technique.
For example, with B. Braun’s Introcan Safety IV Catheter, described
Trauger, "the needle tip is always protected, from the time it’s
removed from the catheter hub to the time it’s disposed."
Because truly passive devices cannot be bypassed, they not only
serve to protect caregivers administering treatment, but also
employees, patients and visitors who could potentially come in contact
with an exposed needle downstream after the procedure is completed.
Passive safety devices continue to grow in popularity as hospitals
grapple with ways to improve compliance and reduce needlestick injury
rates, acknowledged Pugliese. "Hospitals that have adopted safety
devices in all situations where there is a potential exposure to blood
and still experience needlestick injuries often see the injuries as a
result of non-activation of the device. So compliance with activation
is still an issue and what is influencing many hospitals to select
devices with a ‘passive’ activation feature where the needle is
covered automatically as part of the use of the device, such as
While Trauger estimated that 70 to 80 percent of the IV catheter
market is currently using an active safety device, "the passive safety
market is growing faster than any other segment within the IV catheter
The use of passive safety devices may indeed provide an added
safeguard, but Perry provided this caveat, "there are applications
where HCWs need to control the activation of the safety feature. The
most common example is giving incremental doses, as is done in
anesthesia. A device with a safety feature that automatically engages
when it is withdrawn from a patient would not be appropriate for this
type of procedure. We think there’s a need for choice in the
marketplace; no one kind of safety feature will fit all clinical
"Also, it’s important to note that very few safety devices are
truly passive – that is, the safety feature engages after use without
requiring any additional action on the part of the user. Devices are
sometimes marketed as ‘automatic’, but in fact usually require that
the user do something to engage the safety mechanism," she said.
Cautioned Trauger, "some products are marketed as passive, however
if the safety mechanism can be bypassed, the product is not a truly
passive safety device."
Another benefit of the B. Braun Introcan Safety IV Catheter is its
ease of use. Featuring a Universal Bevel design that accommodates a
variety of insertion angles, the B. Braun Introcan Safety allows for
easy, comfortable catheter insertion resulting in improved outcomes as
well as reduced risk. "The other way to reduce needlestick injuries is
to reduce the number of IV catheters being used or reduce the number
of insertion attempts a clinician performs on a patient," Trauger
explained. "Ultimately, it’s a best practice model consisting of safer
products, informed caregivers and consistent processes that will help
drive down needlestick injuries and reduce IV complications."
"Safety products are part of the solution but we cannot rely on
them to eliminate our exposure risk," said Hanchett. "You’ve got to
make sure that you have reinforcement and education programs in place
to combat the resistance of clinicians to changing habits and
behaviors. And you also have to strive hard for front of mind
awareness relative to protecting yourself. We need to be more careful.
The technology will certainly protect us up to a certain point, but we
have to be cognizant of our own safety."
"It really requires a vigilance that I think is very hard to
maintain when people are super busy and beset by so many other
competing and valid priorities," added Hanchett. "Which is more
important? Sharps safety, falls, medication errors, throughput issues
to relieve congestion in the ED and move patients through the system?
The list goes on and on. If sharps safety doesn’t remain a priority,
you will inevitably start to see an increase in exposure events."
"If we have learned nothing else since 1990, it is that with change
there has to be a top-down mandate," she emphasized. "We knew about
emerging sharps safety products before the OSHA Bloodborne Pathogens
Standard was implemented, but it took the federal government to
require it before the products were widely adopted. The same model
applies to individual institutions. Executive leaders and the senior
management must insist on the change. In fact, research shows us that
they must be champions of change. If they don’t believe in it, no one
Perry recommends that hospitals provide annual retraining on safety
devices used in the facility. "When it comes to safety devices,
training is key – and then retraining, to ensure that clinicians are
using the devices properly and to find out if any issues or problems
have arisen. Problems do arise with safety devices; a
particular brand may not be the most appropriate for a particular
clinical application. Also, certain clinical areas, such as nuclear
medicine, may require a safety device that is unique to that setting –
what we call a ‘niche’ application. In some cases, a safety device may
not yet be available for a particular procedure, in which case the
emphasis should be on safe work practices to reduce risk."
Also, "collecting needlestick injury data is essential for
monitoring safety device usage and to ensure they are being used
properly. The data can be used to analyze how and where injuries
occur, and design evidence-based strategies to prevent them," offered
Reporting of injuries and subsequent root cause analysis is key to
the ongoing success of any sharps safety program, stressed Pugliese.
"Hospitals need to do an analysis of every needlestick injury to
determine the cause and target prevention accordingly. For example, is
it failure to use a safety device when available, non-activation of
the safety feature, or a special situation that needs addressing, or
sharps container-related injuries?"
Hanchett suggested that eliminating non-safety products is critical
to reinforcing change. "When you replace a product, there is usually
some objection. But if you remove the opportunity to revert to
non-safety products, the objections typically decrease as staff modify
their habits to adopt the new technology. It is important to remember
that change is difficult. It is essential to provide on-going feedback
and reinforcement to support a sustainable, incremental change in our
awareness, attitudes and practice."
1. "The impact of U.S. policies to protect healthcare workers from
bloodborne pathogens: The critical role of safety-engineered devices,"
by Janine Jagger, Jane Perry, Ahmed Gomaa and Elayne Kornblatt
Phillips, Journal of Infection and Public Health, Volume 1,
Issue 2, Pages 62-71 (2008).