Study Shows Needlestick Injuries...On the Gradual Decline

June 1, 2003

Study Shows Needlestick Injuries...On the Gradual Decline

By Kelly M. Pyrek

The Centers for Disease Control and Prevention (CDC) estimated
that the nation's approximately 10 million healthcare workers (HCWs) face as
many as 384,000 percutaneous injuries (PIs) annually. A Government Accounting
Office (GAO) report estimated several years ago that at least 69,000
needlesticks in hospitals could be eliminated through use of sharps safety
devices.

"Gradual but steady" is the way experts are
characterizing the adoption by healthcare facilities of these safety-engineered
sharp medical devices in an ongoing effort to reduce the occurrence of PIs.
Making use of sharps safety devices mandatory were the Needlestick Safety and
Prevention Act of 2000 and the Occupational Safety and Health Administration's
revised Bloodborne Pathogen Standard. Clinical trials comparing safety devices
to conventional devices have demonstrated various benefits of the new technology
and have shown downward trends in the number of needlesticks reported
nationally.

June 2003Experts say this is encouraging, but there has been a lack of
documentation showing the impact of the needlestick act and the
safety-engineered devices in a multi-hospital sharps injury surveillance
network. To that end, the International Healthcare Worker Safety Center (IHWSC)
at the University of Virginia looked at data from its EPINet Multi-hospital
Sharps Injury database and compared needlestick injury rates from 1993 and 2001
from a network of participating EPINet hospitals. The study, published in the
IHWSC's Advances in Exposure Prevention (Vol. 6, No. 3, 2003), focused on
nurses' needlestick reporting actions and data from teaching hospitals

"Nurses represent the occupational group sustaining the most needlestick
injuries and the most stable group in terms of reporting patterns," says
Jane Perry, director of communications at the IHWSC. "We found an overall
51 percent decrease in sharps injuries for conventional and safety
devices."

According to the study, the overall PI rate declined from 19.5 PIs per 100
occupied beds in 1993 to 9.6 PIs per 100 occupied beds in 2001.

"From 1999 to 2001 there was a 35 percent decline in needlesticks, which
is good news, but there's always more to be done," Perry adds. "But
this definitely shows the right trend. It shows that hospitals have gotten the
message and are taking the need to convert to safety devices seriously.

Perry says that although the Needlestick Safety and Prevention Act and OSHA's
revised Bloodborne Pathogen Standard have continued to raise awareness and
ensure compliance, the trend toward elimination of PIs began early in the 1990s.

"The downward trend started with OSHA's 1991 Bloodborne Pathogen
Standard," Perry says. "At the time there was some movement on safety
devices but healthcare facilities pretty much saw them as being optional. In
1999 OSHA revised its compliance directive for bloodborne pathogens and that's
when the agency stated for the first time safety devices were mandatory and
compliance was enforceable. Current data reflects a cumulative effect of the
three actions: OSHA's revised directive in 1999, the Needlestick Safety and
Prevention Act in 2000 and the revised BBPS in 2001. Congress and OSHA have made
it clear it is not optional and facilities are getting that message."

In a study that examined the prevalence of safety needle devices and factors
associated with their adoption, National Institute for Occupational Safety and
Health (NIOSH) researcher Raymond Sinclair, PhD, and colleagues collected and
analyzed data on the adoption of safety engineered devices in 494 U.S. hospitals
from 1999 to 2000. The study showed that although 83 percent of the sample
reported adopted some kind of safety device, this adoption was inconsistent
across types of devices. All of the units in 52 percent of the facilities had
adopted needleless intravenous delivery systems, but the hospitals used other
types of engineered safety devices less often. Predictors of adoption, according
to Sinclair's study, was cost, as well as the size of the hospital and the
presence or absence of state legislative activity on the PI issue.

The researchers concluded that smaller hospitals may require special
encouragement and assistance from outside sources to adopt expensive
risk-reduction innovations such as engineered sharps safety devices. The
researchers said that although safety devices are the mandated and preferred way
to protect HCWs from needlesticks, complete adoption of this technology depends
on the support of the social systems in which it is used and the people who use
it.

While just one needlestick is too many, Perry says there must be an
appreciation of just how much effort goes into sharps safety compliance and how
change is gradual.

"I think we should remain very optimistic and not look it as still
having too many needlesticks," she adds. "We want to reduce them as
much as possible but when you talk to people who are actually trying to do so in
their facilities, you realize how complicated it is -- especially when involving
frontline healthcare workers. Ideally, they should have been doing this 10 years
ago, not in the last year or two; however, it takes time for facilities to do a
full-scale conversion to sharps safety devices. There will be some residual
needlesticks that occur during use, and needlesticks can occur with safety
devices, especially ones where the safety device isn't activated. These numbers
are very good and we think we will continue to see a decline."

When it comes to conventional devices, disposable syringes caused the
greatest number of PIs to nurses in the 1993 (38 percent) and 2001 (40 percent)
EPINet data; in 1993 the PI rate was 6.8 per 100 occupied beds, while in 2001,
the rate declined by 59 percent to 2.8 per occupied beds. There were 1.78 PI
injuries from needles on IV lines per 100 occupied beds in 1993, while there
were no injuries in 1991, a dramatic decrease some attribute to the widespread
implementation of needleless and recessed IV systems that were created after the
1992 safety alert issued by the Food and Drug Administration.

The study also showed that PIs were reduced for nearly all conventional
needles that injure nurses, including intravenous catheters (55 percent
decrease), phlebotomy needles (70 percent decrease), prefilled syringes (62
percent decrease), winged steel needles (55 percent decrease), and lancets (87
percent decrease). PIs caused by suture needles decreased by 5 percent.

These decreases are due in part to manufacturers introducing new and improved
sharps safety devices, Perry says.

"I think we will continue to see new safety devices flood the market.
Not just needles, but new sharps-disposal containers," Perry says. "We
continually update the safety device list on our Web site (www.med.virginia.edu/epinet)
I also think the manufacturers are doing an amazing job with training; of
course, it is in their best interest that their products be used correctly and
safely. In terms of continuing to develop better safety devices, I think more
passive devices should be considered. (IHWSC director) Janine Jagger has pointed
out that we need to see more passive safety designs where appropriate. There are
some devices, like syringes, where you wouldn't want a fully passive design
because they are used for a lot of different purposes. You have to look at
particular uses, as there is no one blanket answer for passive devices. In
general, passive is good; we see the number of injuries that occur during
disposal that if the safety mechanism was activated you wouldn't have those
injuries. Presumably, passive mechanisms would prevent those injuries. I think
we would like to see the trend go toward more passive designs but taking into
consideration what the devices are used for."

In 1993, when nurses were asked whether the device that injured them was a
safety design, 4 percent said yes. In 2001, 25 percent said yes. In 1993, the PI
rate for all safety devices was .75 per 100 occupied beds; in 2001 it was 2.3
per 100 occupied beds. By contrast, the PI rate for all conventional devices
declined from 18.75 per 100 occupied beds in 1993 to 7.3 per 100 occupied beds
in 2001. Perry cautions healthcare professionals not to misinterpret these
findings.

"It's a matter of correctly interpreting the data," Perry says.
"It reflects an increased use in safety devices. You have to keep in mind
the total picture and that there has been a decrease in injuries. The data says
because there was a decrease in use of conventional devices and an increase in
safety devices, the overall sharps injury rate has gone down. We separated the
conventional and the safety data in the 1993/2001 comparison and found a sharp
decrease in injuries from conventional devices and an increase in injuries from
safety devices. You can look at that and say, 'What's the problem there?' but
our interpretation is because there's a lot fewer conventional devices being
used, you see this dramatic decrease in the sharps injury rate. As more safety
devices are used, we'll see an increase in injuries from safety devices. Some
injuries will be hard to eliminate even with the use of safety devices -- the
injuries that occur during use. You must look at that data in context with the
overall decline -- that's not to say there are some safety devices that couldn't
be better designed. Included in that data is the fact the safety mechanism
simply wasn't activated."

According to a separate 2001 study undertaken by the IHWSC, the safety
mechanism was not activated in 71 percent of the usage, and 57 percent of the
injuries occurred before the safety mechanism was activated. Perry says
education can help cut down on safety device-related injuries.

"When it comes to safety mechanisms causing injury, I wouldn't say it's
anyone's fault; in some cases it may be that a healthcare worker just didn't
want to take the time to activate it," Perry says, "although the time
it takes is miniscule. Some people just haven't received the training they
need."

Perry recalls her own experience with a nurse who hadn't received training on
a safety device. "When I went to my doctor's office for an annual
examination, the nurse who drew my blood used a safety butterfly needle. After
she drew the blood she just put the butterfly device into the disposal container
without activating the safety mechanism. I pointed out to her that it was a
safety device, but she hadn't been there the day they did the training so she
had no idea how to use it. Healthcare facilities pay good money for safety
devices and healthcare workers don't know how to use them. It takes constant
inservicing and follow-up for people you missed, plus more follow-up for even
more people you missed. Facilities should also get rid of conventional devices
when they convert to safety devices so HCWs don't have the option of falling
back on the conventional devices."

Perry admits that training can be a formidable process.

"Facilities must make sure that all potential users of the safety device
receive training. A big facility might use three or four different safety
devices for different purposes or in different clinical settings, so it's a big
job and it takes time. Of course, you need cooperation from staff. There are
HCWs who don't want the training and that's a sizeable hurdle to overcome."

Perry likens sharps safety compliance to handwashing compliance -- it's an
uphill battle in either situation.

"With handwashing, you must keep doing the training and constant
reminders. With sharps safety, if you don't have conventional devices, they are
forced to use the safety devices. I have heard stories about hospitals that face
all this complaining about how HCWs can't use safety devices. I recall reading a
letter published in a medical journal written by a surgeon infected with
hepatitis C. He said that regarding precautions like double gloving, until he
was infected and learned he actually infected a patient, he thought he could
never operate with double gloves. After it all happened, somehow he could do it,
and I think that's often the case -- when you are forced to change your risky
behavior, you readjust."

In the 1993/2001 study, PIs to nurses from conventional devices occurred most
frequently in patient rooms, followed by ORs, intensive care units and emergency
rooms.

"Wherever you have the most needle-related procedures being done, that's
where you will see the most needlestick injuries," Perry says. "There
also are disposal-related injuries and injuries that occur in every part of the
hospital." The study showed decreases in PI rates for each aforementioned
setting: 65 percent, 50 percent, 79 percent and 54 percent, respectively.

When it comes to procedure-related rates, PIs from conventional devices
occurred most frequently while giving injections; these rates decreased by 39
percent, according to the 1993/2001 comparison. The study showed a 50 percent
decrease for drawing venous blood; a 59 percent decrease for starting IVs, and a
96 percent decrease for saline flushes. The 1993/2001 comparison showed that PIs
from conventional devices occurred most frequently during use or between steps
of a multi-step procedure (32 percent in 1993 for both categories combined and
31 percent in 2001). Rates in these combined categories decreased by 61 percent
from 1993 to 2001.

"It will be interesting to look at the rates again in a year or two and
see what the latest trends are. If this pattern of injury decreases continues,
it looks like we are really tackling this problem."


BD Plans to Discontinue Conventional Needle Sales in the U.S.

FRANKLIN LAKES, N.J. -- Becton Dickinson and Company (BD) announces plans to
discontinue U.S. sales of many conventional needles and other sharps devices
across a range of product categories. This action coincided with the second
anniversary of the April 18, 2001 compliance date for the Federal Needlestick
Safety and Prevention Act and reflects the progress made by U.S. healthcare
facilities in transitioning to safety-engineered designs.

"In the past 15 years, the medical device manufacturing industry has
introduced a continuous stream of safety-engineered sharps device innovations
designed to protect healthcare workers from injuries," said Edward J.
Ludwig, chairman, president and CEO of BD. "Healthcare facilities have made
great progress in the change-over to safety-engineered designs. Based on this
progress, BD is now able to discontinue the sale of many conventional sharps
devices without disrupting patient care or clinical practice."

BD estimates that U.S. hospitals have transitioned 80 percent of their sharps
product usage from conventional to safety-engineered designs in IV catheters,
needleless IV connectors, blood drawing needles, winged needle sets and lancet
devices. The level of transition is lower for syringes and needles, surgical
blades, scalpels and other categories of devices utilized for specialty medical
procedures. Across all product categories, the overall level of transition to
safety designs remains lower in clinics and physicians' offices than in
hospitals.

BD sales consultants are prepared to work with healthcare facilities to help
ensure a smooth transition.


Abbott Laboratories' Infusion Therapy Product Line to Go Needleless This
Month

ABBOTT PARK, Ill.--By this month, Abbott Laboratories will phase out all IV
sets that contain or require needles, as part of the company's continued
commitment to improving patient and healthcare worker (HCW) safety. By no longer
manufacturing and marketing these products, the company expects millions of
needles to be eliminated from the U.S. healthcare system, further protecting
HCWs against needlestick injury and blood exposure. Abbott will use a
needle-free technology across its entire line of infusion therapy products.

"Needles cause needlesticks. If you eliminate the needles, you eliminate
the risk," says John Arnott, vice president, hospital business sector,
Hospital Products Division, Abbott Laboratories. "For more than four
decades, HCWs had little, if any, needle-free alternatives. Today, new
technology allows us to provide innovative products that offer protection
against needlestick injuries."

Julie Naunheim-Hipps, a nurse from Glendale, Mo., knows first-hand the risks
that needle-based products pose. In 1999, Naunheim-Hipps contracted hepatitis C
from a needlestick injury and has since been actively involved in passing state
needlestick safety legislation.

"My injury may have been prevented had I had access to products designed
to reduce needlesticks," says Naunheim-Hipps. "Abbott's decision to
phase-out the use of needles in certain products is a major step forward in
protecting HCWs. Needleless products also help hospitals comply with new federal
needlestick protection regulation."