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Needlestick Injury Rates According to Different Types of Safety-Engineered Devices: Results of a French Multicenter Study

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  • Institut Alfred Fournier, Paris, France

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To evaluate the incidence of needlestick injuries (NSIs) among different models of safety-engineered devices (SEDs) (automatic, semiautomatic, and manually activated safety) in healthcare settings. This multicenter survey, conducted from January 2005 through December 2006, examined all prospectively documented SED-related NSIs reported by healthcare workers to their occupational medicine departments. Participating hospitals were asked retrospectively to report the types, brands, and number of SEDs purchased, in order to estimate SED-specific rates of NSI. Setting. Sixty-one hospitals in France. More than 22 million SEDs were purchased during the study period, and a total of 453 SED-related NSIs were documented. The mean overall frequency of NSIs was 2.05 injuries per 100,000 SEDs purchased. Device-specific NSI rates were compared using Poisson approximation. The 95% confidence interval was used to define statistical significance. Passive (fully automatic) devices were associated with the lowest NSI incidence rate. Among active devices, those with a semiautomatic safety feature were significantly more effective than those with a manually activated toppling shield, which in turn were significantly more effective than those with a manually activated sliding shield (P < .001, chi(2) test). The same gradient of SED efficacy was observed when the type of healthcare procedure was taken into account. Passive SEDs are most effective for NSI prevention. Further studies are needed to determine whether their higher cost may be offset by savings related to fewer NSIs and to a reduced need for user training.
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infection control and hospital epidemiology april 2010, vol. 31, no. 4
original article
Needlestick Injury Rates According to Different Types of Safety-
Engineered Devices: Results of a French Multicenter Study
William Tosini, MD; Ce´line Ciotti, RN; Floriane Goyer, RN; Isabelle Lolom, MSc; Franc¸ois L’He´riteau, MD;
Dominique Abiteboul, MD; Gerard Pellissier, PhD; Elisabeth Bouvet, MD
objectives. To evaluate the incidence of needlestick injuries (NSIs) among different models of safety-engineered devices (SEDs) (au-
tomatic, semiautomatic, and manually activated safety) in healthcare settings.
design. This multicenter survey, conducted from January 2005 through December 2006, examined all prospectively documented SED-
related NSIs reported by healthcare workers to their occupational medicine departments. Participating hospitals were asked retrospectively
to report the types, brands, and number of SEDs purchased, in order to estimate SED-specific rates of NSI.
setting. Sixty-one hospitals in France.
results. More than 22 million SEDs were purchased during the study period, and a total of 453 SED-related NSIs were documented.
The mean overall frequency of NSIs was 2.05 injuries per 100,000 SEDs purchased. Device-specific NSI rates were compared using Poisson
approximation. The 95% confidence interval was used to define statistical significance. Passive (fully automatic) devices were associated
with the lowest NSI incidence rate. Among active devices, those with a semiautomatic safety feature were significantly more effective than
those with a manually activated toppling shield, which in turn were significantly more effective than those with a manually activated sliding
shield ( , x
2
test). The same gradient of SED efficacy was observed when the type of healthcare procedure was taken into account.P!.001
conclusions. Passive SEDs are most effective for NSI prevention. Further studies are needed to determine whether their higher cost
may be offset by savings related to fewer NSIs and to a reduced need for user training.
Infect Control Hosp Epidemiol 2010; 31:402-407
From the departments of Infectious Diseases (W.T., E.B.) and Occupational Medicine (D.A.), Bichat University Hospital, the Group for the Prevention
of Occupational Infections in Healthcare Workers, Xavier Bichat Faculty of Medicine (W.T., C.C., G.P., F.G., I.L., D.A., E.B.), and the Centre de Coordination
de la Lutte contre les Infections Nosocomiales (CCLIN) Paris Nord (F.L.), Paris, France.
Received June 24, 2009; accepted September 10, 2009; electronically published February 22, 2010.
2010 by The Society for Healthcare Epidemiology of America. All rights reserved. 0899-823X/2010/3104-0013$15.00. DOI: 10.1086/651301
The introduction of disposal containers for sharp objects and
the introduction of safety-engineered devices (SEDs) have
substantially reduced the incidence of needlestick injury
(NSI). SEDs are sharp devices with an integrated safety feature
designed to shield the needle or nonneedle sharp object after
use.
1
In the United States, the Needlestick Safety and Pre-
vention Act was adopted in November 2000, shifting the focus
from behavior to devices and requiring the use of SEDs to
prevent exposure to bloodborne pathogens as well as the
documentation of all NSIs. In France, SED use is officially
recommended.
2
Compared with conventional devices, SEDs have been
shown to reduce the risk of NSIs by 22%–100%.
3-7
Prospective
multicenter studies performed in France in 1990 and 1999–
2000 by the Accidental Blood Exposure Study Task Force
(GERES), a not-for-profit university-based research group for
the prevention of occupational infections among healthcare
workers (HCWs), showed a 4-fold reduction in NSIs dur-
ing the 1990s, largely due to the introduction and widespread
use of SEDs.
8
As SED use grows, the proportion of NSIs due to these
devices increases. For example, in a New York City tertiary
care center, 27% of reported percutaneous injuries were as-
sociated with SEDs during the 2001–2002 postintervention
period.
1
Likewise, the GERES survey in 2000 showed that 23
(18%) of 130 documented NSIs were due to SEDs.
8
SED-
associated NSIs may occur through mechanical failure of the
safety feature, incomplete activation, user noncompliance, or
an inherently risky activation procedure. Not all devices used
for different types of invasive procedure have undergone the
same degree of technical improvement, and SEDs of different
generations coexist in the marketplace.
9
Broadly speaking,
SEDs are in 2 categories: active devices that require 1- or 2-
handed activation by the HCW after use and passive devices
that are automatically operated throughout the use of the
device.
needlestick injury rates and safety-engineered devices 403
A French regulation (a decree on May 4, 1994, that trans-
lated a European directive into French legislation) states that
employers are responsible for staff safety with regard to bi-
ological risks. A ministerial circular published in 1998 lists
the elements for a multidimensional preventive program that
is to be performed in the hospitals.
2
This list includes the
requirement to use SEDs and to train HCWs in their use.
Nevertheless, to date there are no reference standard criteria
for labeling a device as “safety-engineered,” and manufac-
turers usually market new devices as safety engineered with-
out reproducible criteria. The effect of a new SED on NSI-
risk reduction can be determined only in routine healthcare
settings, through lengthy studies with adequate statistical
power. Very few authors have compared the efficacy of dif-
ferent SEDs that are used for the same invasive procedure.
10,11
GERES, with support from the French agency for health prod-
uct safety (Agence Franc¸aise de Se´curite´ Sanitaire des Produits
de Sante´), therefore conducted a multicenter survey to assess
and compare the frequency, incidence rates, and circum-
stances of NSIs associated with different SED designs.
methods
This multicenter survey took place from January 1, 2005,
through December 31, 2006, in a network of French hospitals
that agreed to participate, on a voluntary basis, for a period
of one year (either 2005 or 2006) or 2 years (2005 and 2006).
We focused only on devices equipped with a needle. Hospitals
were eligible if, during the study period, they purchased SEDs
that incorporated an integrated safety feature designed to
shield the needle after use.
Routine surveillance of blood and body fluid exposure, in
hospitals that agreed to participate, was conducted on the
basis of the voluntary reporting of exposures by HCWs to
the occupational medicine department of their hospital. Thus,
all NSIs involving such SEDs that were reported voluntarily
by HCWs to their occupational medicine department during
the study period were documented prospectively during 2005
and 2006 by using a standardized anonymous questionnaire
described elsewhere
12-14
and routinely used for blood and body
fluid exposure surveillance in hospitals in France. The fol-
lowing circumstances were recorded: the task during which
the NSI occurred, the type and brand of device involved, the
cause of injury, and whether the safety mechanism was ac-
tivated. Each participating hospital was asked retrospectively
at the end of each year of the study (2005 and 2006) to report
the types, brands, and numbers of SEDs purchased during
the whole year. The latter number was used as the denom-
inator for SED-related NSI incidence rates, expressed per
100,000 units purchased. SEDs were defined as recommend-
ed in the 1998 French ministerial circular
2
and in GERES
guidelines.
15
The choice of SEDs and the training of HCWs in their use
took place before and apart from the study and were left to
the discretion of each hospital; the occupational health de-
partment and the nosocomial infection control committee
are responsible for the application of the ministerial guide-
lines in each hospital.
2
We classified SEDs according to the
passive or active nature of the safety activation mechanism.
Active devices were then subdivided into those with a pro-
tective sliding shield, those with a protective needle shield
aligned to the bevel-up position and toppling over the needle,
and those with a semiautomatic safety feature (ie, an auto-
matic safety feature requiring 1-handed activation by pushing
a button or a plunger). With regard to phlebotomy devices
(ie, a phlebotomy needle or winged steel needle attached to
a vacuum holder further including a needle inside the holder
that is adapted to be received by a vacuum tube or a blood
culture bottle), NSIs involving the needle located inside the
holder were excluded, because SEDs focus on the needle de-
signed to penetrate the skin.
Data were analyzed using Epi-Info, version 6.04d (Centers
for Disease Control and Prevention). Device-specific NSI rates
were compared using Poisson approximation. The 95% con-
fidence interval (CI) was used to define statistical significance.
results
Sixty-one hospitals participated in the study, of which 40 par-
ticipated in both 2005 and 2006. The hospitals consisted of 54
public and 7 private institutions located throughout France.
The participating hospitals totaled approximately 43,000 beds
in 2005 and 33,000 beds in 2006.
A total of 504 NSIs due to SEDs were reported during the
2-year survey period, representing 9.8% of all NSIs reported
during that period. Full information was available for 475 of
these NSIs, of which 453 were SED-related as defined in
Methods. More than 22 million SEDs were purchased during
the study period, and a mean of 6 different safety devices
(range, 1–14) were available in each participating hospital.
Forty different SEDs were identified, of which 22 were as-
sociated with documented NSIs. Table 1 shows the NSI in-
cidence rates for each type of SED. The mean overall fre-
quency of NSIs was 2.05 injuries per 100,000 SEDs purchased.
NSI incidence rates are shown in Table 2 according to the
type of safety system. Among the active SEDs, those with a
manually activated protective sliding shield were significantly
less effective than those with a toppling shield, which in turn
were significantly less effective than those with a semiauto-
matic safety feature ( , x
2
test). Passive devices in-
P!.001
cluded in the study, self-retracting lancets(7 different brands),
intravenous catheters (2 different brands), and insulin pen
needles (1 brand), were associated with the lowest NSI in-
cidence rate. Self-retracting lancets accounted for 97% of the
total number of passive devices purchased and for 40% of
the number of NSIs by passive devices.
SEDs with manually activated safety features (the first 2
rows in Table 2) were associated with 10.7 times more NSIs
than SEDs with semiautomatic or automatic safety features
(the last 2 rows in Table 2). (For SEDs with manually activated
404 infection control and hospital epidemiology april 2010, vol. 31, no. 4
table 1. Needlestick Injury (NSI) Incidence Rates According to the Type of Safety-Engineered
Device
Type of device
No. of
devices purchased
No. of
NSIs reported
No. of
NSIs/1 #10
5
devices purchased
Insulin pen needles 22,540 0 0.00
Lancets 8,624,518 2 0.02
Arterial blood syringes 624,946 7 1.12
Prefilled syringes 4,342,861 55 1.27
Vacuum tube blood-collection devices 2,248,630 48 2.13
Fistula needles 45,156 1 2.21
Injection needles and/or syringes 184,207 5 2.71
Intravenous catheters 1,801,107 68 3.78
Winged steel needles 4,176,912 257 6.15
Implantable port needles 62,003 10 16.13
table 2. Needlestick Injury (NSI) Incidence Rates According to the Type of Integrated Safety Feature
Type of safety feature
No. of
devices purchased
No. of
NSIs reported
No. of
NSIs/1 #10
5
devices purchased (95% CI)
Active device
Manually activated protective sliding shield 5,829,655 303 5.20 (4.61–5.78)
Manually activated protective toppling shield 3,266,450 96 2.94 (2.35–3.53)
Semiautomatic safety feature 4,161,295 49 1.18 (0.85–1.51)
Passive device
Automatic safety feature 8,875,480 5 0.06 (0.01–0.11)
note. CI, confidence interval.
safety features, there were 4.39 NSIs per 1 #10
5
devices
purchased [95% CI, 3.96–4.82 NSIs per 1 #10
5
devices
purchased], and for SEDs with semiautomatic or automatic
safety features, there were 0.41 NSIs per 1 #10
5
devices
purchased [95% CI, 0.30–0.52 NSIs per 1 #10
5
devices
purchased].) The same gradient of SED efficacy was observed
when the types of procedure were taken into account, as
shown in Table 3.
Finally, we investigated the circumstances of the 453 NSIs
according to safety feature activation. One hundred sixty-
eight NSIs (37.1%) occurred during the invasive procedure
(while introducing needle, by accidental needle withdrawal
during procedure, or during needle withdrawal at the end of
procedure) before activation of the safety feature was appro-
priate or possible, and these were assessed as not preventable
by the SED used by the injured HCW. One hundred thirty-
three NSIs (29.4%) occurred during activation of the safety
feature. One hundred six NSIs (23.4%) involved user failure
to activate the safety feature after completing the invasive
procedure. Only 46 NSIs (10.2%) occurred after activation
of the safety feature, of which nearly half (18 [39.1%] of 46)
were due to incomplete activation by the user and the re-
mainder (28 [60.9%] of 46) were due to failure of the safety
feature (as declared by the HCW involved). The circum-
stances of the NSIs are shown in Table 4 according to SED
design and the phase of the invasive procedure.
discussion
During this 2-year multicenter survey, 453 fully documented
NSIs that involved SEDs were reported. The overall NSI in-
cidence rate was only 2.05 injuries per 100,000 SEDs pur-
chased, in keeping with the rate of 2.9 injuries per 100,000
SEDs purchased that was observed in the previous GERES
study
8
and also with other published data.
16
The SED-specific
NSI rates found here were lower than those reported else-
where with conventional devices (2.1 vs 2.7–4.9 NSIs/1 #
10
5
vacuum tube collection devices purchased; 3.8 vs 8.5–
15.8 NSIs/1 #10
5
catheters purchased; 6.2 vs 10.1–13.2 NSIs/
1#10
5
winged steel needles purchased)
8,17,18
and were similar
to those observed in the 2000 GERES survey and elsewhere.
For example, the NSI rate associated with intravenous cath-
eters was 3.6 NSIs/1 #10
5
intravenous catheters purchased
in the GERES 2000 survey
8
and 3.78 NSIs/1 #10
5
intrave-
nous catheters purchased in the present study. Likewise, the
NSI rate associated with resheathable winged steel needles was
6.15 NSIs/1 #10
5
resheathable winged steel needles pur-
chased in the present study, and 6.41 NSIs/1 #10
5
resheath-
able winged steel needles purchased in an American study of
such devices.
19
We found that some SEDs were more effective than others
in preventing NSIs. Knowledge of the most effective designs
is important, both to guide the choice among available devices
needlestick injury rates and safety-engineered devices 405
table 3. Procedure-Specific Needlestick Injury (NSI) Incidence Rates According to Safety-Engineered Device Design
Invasive procedure
No. of NSIs/1 #10
5
Devices Purchased (95% CI)
Active device
Passive device
With manually
sliding shield
With manually
toppling shield
With semiautomatic
safety feature
Arterial and venous blood sampling 5.72 (4.96–6.49) 2.89 (2.30–3.47)
Vascular catheterization 4.34 (3.24–5.44) 2.54 (0.51–4.58) 1.31 (0.00–2.80)
Subcutaneous injection with prefilled syringes (LMWH) 3.08 (1.47–4.69) 1.05 (0.73–1.38)
note. Empty cells represent devices unavailable or rarely used at the time of the study. CI, confidence interval; LMWH, low-molecular-weight heparin.
table 4. Timing of Needlestick Injury (NSI) Relative to Activation of the Safety Feature and According to Safety-Engineered Device
Design
Timing of injury
No. (%) of NSIs
Active device
Passive
device
With manually
sliding shield
With manually
toppling shield
With automatic
safety feature
Before activation was possible or appropriate 114 (37.6) 28 (29.2) 26 (53.1) 0 (0)
During activation 91 (30.0) 39 (40.6) 3 (6.1) 0 (0)
After activation (incomplete activation or failure of the safety feature
a
) 21 (6.9) 8 (8.3) 12 (24.5) 5 (100)
Not activated after procedure 77 (25.4) 21 (21.9) 8 (16.3) 0 (0)
Total 303 (100) 96 (100) 49 (100) 5 (100)
a
As declared by the user.
and to help manufacturers develop new safety technology for
sharp objects. Our systematic analysis of device-specific rates
of NSI suggests that SEDs with automatic or semiautomatic
activation of the safety feature are more effective than SEDs
that require full user intervention. Indeed, SEDs with auto-
matic or semiautomatic safety features were 10 times less
likely to be associated with NSIs than were devices in which
activation of the safety feature was fully manual. SEDs with
a push bottom or plunger were significantly safer than those
with a toppling shield, which, in turn, were significantly safer
than those with sliding protection. According to the manu-
facturers’ instructions, most active devices with a sliding
shield require 2-handed activation, whereas most active de-
vices with a toppling shield require 1-handed activation. NSIs
seem to be more frequent when the user’s passive hand is
required to approach the needle and when the activation
mechanism is not sufficiently intuitive. Passive devices are
associated with the lowest NSI incidence rates. In particular,
self-retracting lancets (passive devices for capillary blood sam-
pling) had by far the lowest NSI incidence rate of all the types
of SED studied here (0.02 NSIs/1 #10
5
self-retracting lancets
purchased), in keeping with previous reports.
8,20,21
New im-
plantable-port safety needles had the highest NSI incidence
rate (16.1 NSIs/1 #10
5
implantable-port safety needles pur-
chased). However, the use of nonsafety needles was associated
with much higher rates of NSIs in the GERES surveys con-
ducted in 1990 (410 NSIs/1 #10
5
devices purchased), when
no safety devices were available, and also in 2000 (25.0 NSIs/
1#10
5
devices purchased), when accessory safety devices
were available to protect the passive hand (spatulas for hand-
free stabilization of the implantable port during withdrawal
of Huber needles) and when training in best practices had
improved.
8
One would expect NSI rates associated with devices with
different activation mechanisms to correlate with the risks
inherent in the procedure for which they were designed. Nev-
ertheless, the gradient of NSI rates associated with different
safety features was unaffected when the type of invasive pro-
cedure was taken into account (injection with prefilled sy-
ringes, vascular catheterization, and arterial/venous blood
sampling). A reference study conducted by the Centers for
Disease Control from 1993 through 1995 showed a reduction
in phlebotomy-related NSIs ranging 23%–76%, depending
on the SED tested.
10
Three different SEDs were tested, cor-
responding to each of the 3 subgroups of active devices in
our classification: a winged steel needle with a protective slid-
ing shield and 2 vacuum tube blood-collection devices, one
with a protective toppling shield and the other with an au-
tomatic safety feature activated by pushing the tube. Inter-
estingly, the same gradient was observed in this study (3.1
NSIs/1 #10
5
purchased devices with the manually sliding
shield, 1.2 NSIs/1 #10
5
purchased devices with the manually
toppling shield, and 0.9 NSIs/1 #10
5
purchased devices with
the semiautomatic safety feature). Moreover, a study con-
ducted in a university hospital showed that a passive safety-
designed intravenous catheter was more effective than an
active IV catheter with a semiautomatic safety feature.
11
Almost 40% of the NSIs in our study occurred while the
406 infection control and hospital epidemiology april 2010, vol. 31, no. 4
devices were being used, that is, before activation of the safety
feature was appropriate or possible. The corresponding rate
in the CDC study was 59%.
10
All SEDs documented in the
study address the risk of exposure after an invasive procedure
in the time between needle withdrawal and needle discard
into a sharp objects container, even though successive gen-
erations of devices have allowed increasingly easy and in-
creasingly early activation of safety, thus reducing the risk.
Nevertheless, in a global approach to prevent HCW exposure,
the risk during procedure has to be taken into account in
future development of safety designs, as is the case, for in-
stance, during suture procedures, by the use of blunt suture
needles. Moreover, the statistical significance between NSI
rates related to the different types of SEDs remains unaffected
even if NSIs that occur during invasive procedures are not
taken into account to calculate NSI rates. Almost 25% of
NSIs occurred between the end of the procedure and device
disposal, owing to user failure to activate the safety feature.
The 1997 CDC survey showed a rate of 18% for this type of
accident.
10
One-third of NSIs took place during activation of
the safety feature. Accidents of this type, peculiar to these
devices, seem to result from incorrect user activation of the
safety mechanism rather than from failure of the device it-
self. This type of error may be due to inadequate information
for and/or training of HCWs. SEDs are more complex than
their conventional equivalents and usually necessitate specific
training, particularly in how to activate the safety mechanism
at the end of the invasive procedure. One-tenth of NSIs took
place despite the safety feature having been activated. In half
of these cases, the user reported that the device had failed,
whereas the remainder were due to incomplete activation by
the user. Thus, more than one-quarter of NSIs (124 [27.4%
of 453]) were due to nonactivation or incomplete activation
of the safety device and could have been avoided.
Many factors can contribute to user acceptance of SEDs,
which may also influence the efficacy of SEDs. These include
the design of the device, training provided before and after
introduction of the device, ease of use, changes in technique,
the perceived risk of occupational infection, and patient safety
issues. Devices with fully manual safety features can be ac-
tivated only after needle withdrawal. Active devices in which
an automatic safety feature is activated during withdrawal
may reduce injuries occurring during this phase. Neverthe-
less, HCWs’ concerns for patient safety or comfort
10
may
reduce the efficacy of such SEDs, because HCWs may delay
activation or rate the device as being more difficult to use.
Passive devices, which do not rely on user activation, seem
to be more effective. Moreover, studies of retractable intra-
vascular devices have shown that active SEDs with semiau-
tomatic safety features generate more blood splatter into the
environment than do nonsafety and passive safety devices.
22-24
This study has several limitations. First, the sample size for
some devices or designs was too small for valid comparisons.
In addition, NSIs are sufficiently rare to necessitate prohib-
itive sample sizes in some circumstances: for example, if the
baseline injury rate for a given device is 5 injuries per 100,000
devices, then the sample size required to show a 50% re-
duction in NSIs is one million devices.
25
Another limitation
is the reliance of this survey on self-reported injuries. The
methodology of the survey did not enable the authors to
assess underreporting. Nevertheless, the SED-specific NSI
rates found here were similar to those obtained in the GERES
observational study conducted in 2000
8
and in other stud-
ies.
16,19
Such data underscored the low level of underreport-
ing of NSIs. It is unlikely that the extent of underreport-
ing varied according to the type of SED. Also, our use of the
number of devices purchased rather than the number of de-
vices actually used is another possible source of bias. Nev-
ertheless, it is noteworthy that our calculated NSI rates are
consistent with those reported elsewhere.
Despite these limitations, we provide clear evidence that
passive SEDs are more effective than active SEDs for NSI
prevention. Passive devices require no input from the user,
and this is particularly important when healthcare personnel
are working long hours or night shifts, as well as in emergency
situations, all of which are associated with a higher rate of
NSIs.
26-28
Furthermore, passive devices eliminate the need for
elaborate training. Although the cost of fully automated SEDs
can be an obstacle to their use, this drawback might be offset
by lesser training requirements and by cost savings associated
with a reduction in NSIs (eg, serological tests, counseling,
postexposure prophylaxis, time off work, and treatment).
participants
Hoˆpital d’Albi; CH de la Re´gion Anne´cienne, Annecy; Hoˆpital
Prive´ d’Antony; CH V. Dupouy, Argenteuil; CH H. Mondor,
Aurillac; CHG de Bastia, Etablissement Helio Marin, Berck
sur Mer; CHU J. Minjoz, Besanc¸on; Institut Bergonie, Bor-
deaux; CHU Morvan La Cavale Blanche, Brest; CH de Brive;
CH de Cadillac; CH de Caen; Hoˆpital C. Gue´ rin, Chateller-
ault; CH L. Pasteur, Cherbour; HIA Percy, Clamart; Hoˆpital
G. Montpied, Clermont Ferrand; Hoˆ pitaux Civils de Colmar;
CH de Cosne sur Loire; CH L. Pasteur, Dole; Hoˆ pital V.
Jousselin, Dreux; CH d’Etampes; Centre Me´dical de Forcilles,
Ferolles Attilly; CH de Gap; CH de Gray; Hoˆpital Marin de
la Ville de Paris, Hendaye; EPSM G. Mazurelle, La Roche sur
Yon; Hoˆ pital d’Arcachon, La Teste de Buch; CH de Le Blanc;
CH du Havre; CH du Mans; CH de Lons Le Saunier; Hoˆp-
itaux de La Timone, Marseille, CHIC de Moissac; CH du
Belve´de`re, Mont St Aignan; CH A. Boulloche, Montbe´liard;
CHI Eaubonne-Montmorency; CH Moulins-Yzeure; CHU de
Nantes; CHG de Neufchaˆteau; CH de Niort; CH d’Obernai;
CHR d’Orle´ans; CHU Bichat-Claude Bernard, Paris; Institut
Mutualiste Montsouris, Paris; Hoˆpital Europe´en G. Pompi-
dou, Paris; CHG de Pau; CH du Centre Bretagne, Pontivy;
CH de Pontorson; CH de Gourmelen, Quimper; GH Sud
Ardennes, Rethel; CH de Rochefort; Hoˆpitaux Drome Nord,
Romans; CH F. Tosquelles, Saint Alban sur Limagnole; CHR
de Saint Amand Monrond; CH de Saint Dizier; Hoˆpital La
needlestick injury rates and safety-engineered devices 407
Musse, Saint Se´bastien de Morsent; CH de Saint Denis Hoˆp-
itaux du Le´man- HG Pianta, Thonon les Bains; CH Le Mas
Careiron, Uzes; and CHI de Wasquehal.
acknowledgments
We thank all the participants in the study and David Young for his critical
review of the manuscript.
Financial support. French Ministry of Health; Agence Franc¸aise de Se´-
curite´ Sanitaire des Produits de Sante´.
Potential conflicts of interest. All authors report no conflicts of interest
relevant to this article.
Address reprint requests to Gerard Pellissier, PhD, UFR de Me´decine Bi-
chat, GERES, 16 rue Henri Huchard, F-75018 Paris, France.
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... Diversos estudos apontam para uma redução das taxas de acidente por picada durante o cateterismo venoso periférico após a introdução de dispositivos com mecanismo de segurança nos contextos clínicos. Interessantemente, vários estudos indicam que os CVPs com sistema de segurança passivo tem demonstrado ser mais eficazes na redução de acidentes por picada entre profissionais de saúde (Hoffmann, Buchholz e Schnitzler, 2013;Tosini et al., 2010). Por outro lado, na sua revisão, Reddy e colaboradores (2017) identificaram que o uso de CVPs com sistema ativo de segurança, dada a necessidade de manipulações adicionais pelo profissional, aumentam o risco de contacto com salpicos sangue da pessoa (risco relativo de 1,6; 1,08-2,36; CI 95%). ...
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Despite its ubiquitous nature, peripheral venous ca-theterization is frequently associated in the literature with needlestick injuries by health professionals, with repercussions at the individual and organizational level. Internationally, there have been several efforts in the political, industrial, and clinical sectors to mitigate this problem, particularly through the implementation of safety-engineered peripheral intravenous catheters (PIVCs). In this article, we identify the characteristics of innovative devices available on the market and establish recommendations for their acquisition/imple-mentation in clinical settings.
... This study found that sharp device injuries occurred most frequently in the wards, followed by emergency rooms (ER), then operating rooms (OR). This result is similar to other studies [19,20], that show the wards are the most common place of NSIs occurrence (65.6%). Among nurses, most NSIs occur in the wards followed by ER, while among physicians most of the NSIs occur in the ER, followed by OR. ...
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Background Our study sought to determine the frequency of Needlestick injuries (NSIs) among Healthcare Workers (HCWs) working at governmental hospital and to study the factors that associated with occurrence of NSIs, and to develop recommendations for a comprehensive program for prevention. Methods Retrospective study of all reported cases of NSIs in the period from April 2016 to May 2018 among healthcare workers at a governmental hospital. Results Incidence of NSIs over 26 months was 8.4% among all participants. Nurses were the most affected staff (52.5%) resulted commonly from disposing syringes (58.9%). In contrast, the incidence of NSIs among physicians was 24.9% where surgical devices were the primary source of NSIs among them (40%). Failure to complete all required hepatitis B vaccination was common among expatriates of the participants of this study. Conclusions NSIs was common among HCWs participated in this study. Preventive measures should be implemented including adequate hepatitis B immunization.
... Spillage or leakage was assumed to be slightly higher for the HV-R due to the reconstitution step. Probability of (non-)contaminated NSI error was based on the study by Tosini et al [23]. Duration of vaccination visit for both vaccines was assumed to be approximately one hour. ...
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Objectives: Non-reconstituted, hexavalent vaccines (HV-NRs) can facilitate clinical practice by shortening vaccine preparation and administration time and by reducing the risk of vaccination errors compared to combination vaccines requiring reconstitution. The aim of this study was to determine the budget impact of introducing an HV-NR into the United Kingdom’s (UK) pediatric immunization program, which currently uses a hexavalent vaccine requiring reconstitution (HV-R). Methods: To evaluate this scenario, a budget impact model covering a 10-year time horizon was developed. The target population constituted closed UK birth cohorts from 2020 to 2029. Total direct costs from the payer’s perspective consisted of four main categories: vaccine acquisition and management, healthcare provider’s service provision, (non-)contaminated needle-stick and sharps injury (NSI), and non-NSI vaccination error costs. The net budget impact was calculated by comparing the costs in two different market share scenarios. Results: The use of HV-NR instead of HV-R was estimated to save £9,079,927 over a 10-year time horizon (i.e. £907,993 per year). Assuming all other vaccine criteria are equivalent the budget impact was most sensitive to changes in time spent by the healthcare provider and management costs. Conclusion: Results suggest that introducing an HV-NR into the UK’s pediatric immunization program is potentially cost saving for the healthcare system.
... A study performed in the Netherlands reported that the introduction of SEDs did not result in a decrease in the overall number of NSIs, but in a reduction in NSIs after the use of blood sugar needles with a passive system [23]. Other authors have also reported that the number of NSIs is reduced when passive SEDs are used [24]. Thus, the effect of passive SEDs has not yet been fully clarified [14]. ...
Article
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Safety-engineered devices (SEDs) have been developed to protect healthcare personnel (HCP) from needlestick and sharps injuries (NSIs). The aim of this study was to analyze NSIs associated with SEDs and non-SEDs among HCP in hospitals, medical offices and care facilities. Records from online questionnaires on NSIs were used. Causes of NSIs were compared for SED use and healthcare setting. A sample of 835 files was included. Injuries with SEDs accounted for 35.0% of all NSIs, whereas the proportions were higher in medical offices and lower in care facilities. NSIs in nurses were more often associated with SEDs than NSIs in physicians. NSIs from intravenous needles were associated with SEDs in more than 60% of cases in hospitals and medical offices and in about 30.0% of cases in care facilities. In contrast, suturing was associated with every fourth NSI in hospitals, of which fewer than 10.0% were associated with SEDs. In care facilities, SEDs were involved in 36.1% of NSIs during subcutaneous injections. NSIs during disposal accounted for 29.2% of total NSIs, of which 36.1% were associated with SEDs. Frequent reasons for SED-associated NSIs were technical problems, unexpected patient movement and problems during disposal. Our analysis shows that many NSIs are associated with SEDs. Continuous training is necessary in the handling and disposal of SEDs.
... Studies on prevalence of occupational exposure to BBF among health care workers and students in both developed [12,13] and developing countries [14,15] have been published. A study carried out among HCW in Serbia revealed that 29.6% of participants experienced at least one incidence that exposed them to BBF within the previous year [16]. ...
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... On the other hand, there are European studies that report positive results regarding the ability of SEDs to reduce the number of percutaneous accidents. 12 Some authors reported a reduction in the number of exposures by 74% and identified the most important preventive factor in the use of SEDs. 13 Similarly, in Great Britain, the use of SEDs was found to lead to a reduction in the total number of accidental punctures by 56% and 80%, depending on the device analysed. ...
Article
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Objective Needlestick and sharps injuries (NSIs) involving healthcare workers (HCWs) are worldwide under surveillance since long time; the implementation of the European Directive 32/2010 regarding the mandatory use of safety-engineered devices (SEDs) seems to have reduced the number of these accidents. Our surveillance investigated the frequency and the modality of SED-related NSIs in the Piedmont region to verify changes in the epidemiology of these events. Methods We analysed the exposure records of NSIs, device usage data and structural data of 42 acute care hospitals and compared conventional and safety devices. We calculated the accident rates per 100 000 needles and, as a measure of SED efficacy, the relative risk between the use of safety and non-safety devices with a 95% CI. We also described the dynamics of the NSIs and the most involved professional groups of HCWs, procedures and devices. Results Total and specific device accident rates for 100 000 needles were lower with the use of SEDs. In 2015–2016, there were 1640 NSIs, with a decreasing absolute number during the observation period; 18% were SEDs related. Half of the total accidents with SEDs occurred in the patient’s room, and nurses were involved in 78% of the cases. The most involved devices were the butterfly needles and peripheral venous catheters, and the most involved procedures were venous sampling (40%) and phlebotherapy (16%). The exposures occurred mostly during the procedure, and 45% of the SED-related injuries occurred during the disposal of the device; 92% of the SEDs involved had a manual activation mechanism. Conclusion In agreement with the results of other European studies, our results show that SEDs reduce the risk of percutaneous exposure of HCWs, but in introducing SEDs, we must select those with a higher level of safety (with a passive activation mechanism) and improve the healthcare staff training programmes.
Article
Objective: to analyze the handling of the safety device with engineering control in peripheral venous catheter and the adherence to Standard Precautions by nursing professionals during peripheral venous puncture in adults. Method: observational, descriptive study, with quantitative approach, performed in a surgical clinical hospitalization unit. Data collected through a semi-structured instrument, containing variables related to the catheter and the observation of the procedure. The data were analyzed using descriptive statistics. Results: the study sample consisted of 28 professionals, and 235 procedures were observed. Hand hygiene with antiseptic was performed in 23% (54); alcohol solution in 10.6% (25). Procedure gloves and goggles were used in 56.6% (133) and 2.1% (5), respectively. The catheter with retractable device was incorrectly activated in 45.1% (106). Conclusion: most professionals used the peripheral venous catheter with inadequate engineering control and the standard precautions were low.
Article
The first documented mention of a needlestick injury (NSI) in the medical literature appeared in 1906. Despite growth in academic and clinical interest for NSI prevention, a global report identified that approximately 3 million healthcare workers have suffered percutaneous exposure to blood-borne pathogens. Legislation is an important component of NSI prevention. Unfortunately, the impact of legislation may not always reduce the incidence of NSI as much as expected. Safety-engineered device (SED) implementation has demonstrated a substantial reduction in NSI rates compared with non-SEDs. More importantly, passive SEDs are 10 times less likely to be connected with an NSI incident.
Article
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Background: The 2013 UK sharps safety regulations require healthcare facilities to use safety-engineered devices (SEDs) to protect staff. The recent increase in UK-reported occupational exposures could indicate increased reporting or increased exposures from suboptimal SED use. Aim: To ascertain SED use through examination of sharps container contents in a sample of UK hospitals. Methods: Reusable sharps containers (RSCs) were selected from seven UK hospitals in 2013 and seven different hospitals in 2016. At licensed processing facilities, the operator, wearing protective apparel, decanted RSCs, separated hollow-bore needles (HBNs) from other sharps and enumerated HBNs into capped/uncapped non-SEDs, activated/non-activated/tampered SEDs, and blunt draw-up SEDs. Probability, risk ratios (RRs) and 95% confidence limits (95% CLs) were calculated using WinPepi v2.78. Results: In 2013 and 2016, respectively, 2545 HBNs were categorized from 22 RSCs versus 2959 HBNs from 33 RSCs; 70% of HBNs were SEDs versus 93% (P < 0.001; RR 1.33; CL 1.30-1.37); 32% of activatable HBNs were not activated versus 22% (<0.001; 0.67; 0.60-0.76); 41% of HBNs were discarded 'sharp' versus 20% (<0.001; 0.48; 0.44-0.52); 25% of HBNs were uncapped needles versus 6% (<0.001; 0.22; 0.19-0.26); 5% of HBNs were capped needles versus 1% (P > 0.05); and 1% of SEDs were tampered with in both years (P > 0.05). Hospital practices varied widely. Conclusions: SED use and activation have increased significantly since 2013. Of concern is that in 2016, 22% of SEDs were non-activated and 20% of sharps were discarded 'sharp'. Increased training in SED handling, assiduous adherence to safe sharps work practices and a higher level of individual safety-ownership are indicated.
Article
Objectives. —To identify the types of medical devices causing needlestick injuries among Italian health care workers, to document the device-specific injury rates and time trends for different hollow-bore needles, and to compare injury rates from these devices with those reported in the United States.Design. —Longitudinal survey.Settings. —Twelve Italian acute care public hospitals.Methods. —Data were obtained from a multihospital surveillance database on the number of total injuries reported in each device category. Hospitals provided the corresponding number of devices used annually for each needle type.Main Outcome Measure. —Number of needlestick injuries by type of hollow-bore needle per 100000 devices used per year.Results. —A total of 2524 injuries from hollow-bore needles were reported. Disposable syringes/hypodermic needles accounted for 59.3% of injuries, followed by winged steel needles (33.1%), intravenous catheter stylets (5.4%), and vacuum-tube phlebotomy needles (2.2%). Intravenous catheter stylets had the highest needlestick injury rate (15.7/100 000 devices used), and disposable syringes had the lowest needlestick injury rate (3.8/100 000). In contrast to the other devices, the injury rate from winged steel needles increased from 6.2 per 100 000 in 1990 to 13.9 per 100000 in 1992.Conclusions. —The device-specific needlestick injury rates in Italy are similar to those reported in the United States, suggesting similar exposure experience in two countries. However, in contrast to the United States, needleless intravenous access is standard practice in Italy and thus eliminates one potential risk to Italian health workers. Implementation of safer equipment, such as shielded or retracting needles, and continuing training programs are needed to further reduce the hazards that health care workers face.(JAMA. 1994;272:607-610)
Article
The risk of accidental blood and body fluid (BBF) exposure is a daily concern for health care workers throughout the world, and various strategies have been introduced during the past decade to help reduce that risk. To assess the impact of multifocal reduction strategies introduced in hospitals affiliated with the Northern France network, we recently examined data from 4 years of BBF-exposure reports filed by network employees. A total of 7649 BBF exposures were reported by health care workers to occupational medicine departments in 61 hospitals. Nurses and nursing students accounted for 4587 (60%) of exposures, followed by nurses' aides and clinicians. Most (77.6%) of the reports were related to needlestick injury (NSI).In addition, we examined BBF exposure trends over time by analyzing data from 18 hospitals (29.5%) with data available for the time period of 1995 to 1998. These were assessed in nurses, who have the highest and most consistent reporting rate. We noted that the BBF-exposure incidence rate for all BBF exposures in nurses decreased from 10.8 to 7.7 per 100 nurses per year between 1995 and 1998 (P < .001), whereas the NSI rate decreased 8.9 per 100 nurses per year in 1995 to 6.3 in 1998 (P < .001). The percentage of NSIs that resulted from noncompliance with universal precautions also decreased significantly (P = .04).Widespread improvements in procedures and engineering controls were implemented in the Northern France network before and during the study period. Significant reductions were observed in reports of BBF exposures and NSIs, particularly in nurses. These findings are similar to those in other countries and reflect the overall improvement in the management of occupational risk of BBF in health care workers.
Article
The Occupational Safety and Health Administration (OSHA) revised the Bloodborne Pathogen Standard and, on July 17, 2001, began enforcing the use of appropriate and effective sharps devices with engineered sharps-injury protection. OSHA requires employers to maintain a sharps-injury log that records, among other items, the type and brand of contaminated sharps device involved in each injury. Federal OSHA does not require needlestick injury rates to be calculated by brand or type of device. A sufficient sample size to show a valid comparison of safety devices, based on injury rates, is rarely feasible in a single facility outside of a formal research trial. Thus, calculations of injury rates should not be used by employers for product evaluations to compare the effectiveness of safety devices. This article provides examples of sample-size requirements for statistically valid comparisons, ranging from 100,000 to 4.5 million of each device, depending on study design, and expected reductions in needlestick injury rates.
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While bupivacaine is more cardiotoxic than other local anesthetics, the mechanistic background for different toxic effects remains unclear. Several cardiotoxic compounds act on lipid bilayers to change the physicochemical properties of membranes. We comparatively studied the interaction of local anesthetics with lipid membranous systems which might be related to their structure-selective cardiotoxicity. Amide local anesthetics (10–300 μM) were reacted with unilamellar vesicles which were prepared with different phospholipids and cholesterol of varying lipid compositions. They were compared on the potencies to modify membrane fluidity by measuring fluorescence polarization. Local anesthetics interacted with liposomal membranes to increase the fluidity. Increasing anionic phospholipids in membranes enhanced the membrane-fluidizing effects of local anesthetics with the potency being cardiolipin ≫ phosphatidic acid > phosphatidylglycerol > phosphatidylserine. Cardiolipin was most effective on bupivacaine, followed by ropivacaine. Local anesthetics interacted differently with biomimetic membranes consisting of 10 mol% cardiolipin, 50 mol% other phospholipids and 40 mol% cholesterol with the potency being bupivacaine ≫ ropivacaine > lidocaine > prilocaine, which agreed with the rank order of cardiotoxicity. Bupivacaine significantly fluidized 2.5–12.5 mol% cardiolipin-containing membranes at cardiotoxicologically relevant concentrations. Bupivacaine is considered to affect lipid bilayers by interacting electrostatically with negatively charged cardiolipin head groups and hydrophobically with phospholipid acyl chains. The structure-dependent interaction with lipid membranes containing cardiolipin, which is preferentially localized in cardiomyocyte mitochondrial membranes, may be a mechanistic clue to explain the structure-selective cardiotoxicity of local anesthetics.
Article
The risk of accidental blood and body fluid (BBF) exposure is a daily concern for health care workers throughout the world, and various strategies have been introduced during the past decade to help reduce that risk. To assess the impact of multifocal reduction strategies introduced in hospitals affiliated with the Northern France network, we recently examined data from 4 years of BBF-exposure reports filed by network employees. A total of 7,649 BBF exposures were reported by health care workers to occupational medicine departments in 61 hospitals. Nurses and nursing students accounted for 4,587 (60%) of exposures, followed by nurses' aides and clinicians. Most (77.6%) of the reports were related to needlestick injury (NSI). In addition, we examined BBF exposure trends over time by analyzing data from 18 hospitals (29.5%) with data available for the time period of 1995 to 1998. These were assessed in nurses, who have the highest and most consistent reporting rate. We noted that the BBF-exposure incidence rate for all BBF exposures in nurses decreased from 10.8 to 7.7 per 100 nurses per year between 1995 and 1998 (P <.001), whereas the NSI rate decreased 8.9 per 100 nurses per year in 1995 to 6.3 in 1998 (P <.001). The percentage of NSIs that resulted from noncompliance with universal precautions also decreased significantly (P =.04). Widespread improvements in procedures and engineering controls were implemented in the Northern France network before and during the study period. Significant reductions were observed in reports of BBF exposures and NSIs, particularly in nurses. These findings are similar to those in other countries and reflect the overall improvement in the management of occupational risk of BBF in health care workers.
Article
To reduce the risk of accidental needlestick injuries, first active then passive safety devices were developed on IV catheters. However, whether these catheters are easy to implement and really protect personnel from accidental needlestick is untested. In this prospective randomized survey, we compared a passive safety catheter with an active safety catheter and a nonsafety classic catheter. The main objective was to evaluate the difficulty of inserting the catheters in terms of the number of insertion failures, difficulties introducing the catheter and withdrawing the needle, and the normality of the blood reflux in the delivery system. The second objective was to determine the degree of exposure to patients' blood evaluated as the number of exposures of the staff and blood splashes of the environment, and the staff's sense of protection. Seven hundred fifty-nine assessment cards were collected. The number of failures for the three catheter groups was similar and not statistically different. Introduction of the catheter was more difficult with the active safety catheter. Needle withdrawal was more difficult with the passive safety catheter. The blood reflux was abnormal more often with the safety catheters. The staff's exposure was more frequent with the active safety catheter. The number of blood splashes was more common with the safety catheters. Safety catheters are not superior with regard to failure rate in the catheter's placement. Users feel better protected, but find the use of safety catheters more difficult, and their handling generates more splashing of blood into the environment. The passive safety catheter is more efficient than the active safety catheter with regard to ease of introduction of the catheter into the vein and the staff's exposure to the patient's blood.
Article
Local anesthesia forms the foundation of pain control techniques in clinical dentistry. Within the rich local anesthetic drugs available in dentistry for the prevention and management of pain 4% articaine solutions achieve highest level of anesthetic potency and lowest systemic toxicity in all clinical situations, prior to its superlative physicochemical characteristics and the pharmacological profile. These are - low lipid solubility, high plasma protein binding rate, fast metabolization, fast elimination half time; low blood level. Articaine inactivates in both ways: in the liver and the blood serum. It has good spreading through tissues. Thus, articaine seems to be the local anesthetic of first choice in tissues with suppurative inflammation, for adults, children (over 4), elderly, pregnant women, breastfeeding women, patients suffering from hepatic disorders and renal function impairment. In Articaine solutions (1: 200,000) epinephrine is in low concentration, thus in patients at high risk adverse responses are maximally decreased. In these patients articaine should be used with careful consideration of risk/benefit ratio. Articaine solutions must not be used in persons who are allergic or hypersensitive to sulphite, due to content of Sodium metabisulfite as vasoconstrictor's antioxidant in it. Incidence of serious adverse effects related to dental anesthesia with articaine is very low. Toxic reactions are usually due to an inadvertent intravascular injection or use of excessive dose. To avoid overdoses maximum recommendation dose (MRD) must not be exceeded and aspiration test always performed prior all LA injections. In these article we introduce new graphs providing a quick and effect way to determine maximum LA dose. If the overdose reactions develop, adherence to the basic step of emergency management with end to a successful outcome in virtually all cases.