ArticlePDF AvailableLiterature Review

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel

November 2017
Cochrane Database of Systematic Reviews 11(3)

DOI:10.1002/14651858.cd009740.pub3

Authors:

Viraj K Reddy

George & Fay Yee Centre for Healthcare Innovation, University of Manitoba, Winnipeg, Manitoba, Canada

Jos H Verbeek

Amsterdam University Medical Center

Background: Percutaneous exposure injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood borne infections such as hepatitis B and C, and human immunodeficiency virus (HIV). Safety features such as shields or retractable needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness. Objectives: To determine the benefits and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in healthcare personnel versus no intervention or alternative interventions. Search methods: We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and PsycINFO (until 11 November 2016). Selection criteria: We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs of the effect of safety engineered medical devices on percutaneous exposure injuries in healthcare staff. Data collection and analysis: Two of the authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a fixed-effect or random-effects model meta-analysis where appropriate. Main results: We included six RCTs with 1838 participants, two cluster-RCTs with 795 participants and 73,454 patient days, five CBAs with approximately 22,000 participants and eleven ITS with an average of 13.8 data points. These studies evaluated safe modifications of blood collection systems, intravenous (IV) systems, injection systems, multiple devices, sharps containers and legislation on the implementation of safe devices. We estimated the needlestick injury (NSI) rate in the control groups to be about one to five NSIs per 1000 person-years. There were only two studies from low- or middle-income countries. The risk of bias was high in 20 of 24 studies. Safe blood collection systems:We found one RCT that found a safety engineered blood gas syringe having no considerable effect on NSIs (Relative Risk (RR) 0.2, 95% Confidence Interval (95% CI) 0.01 to 4.14, 550 patients, very low quality evidence). In one ITS study, safe blood collection systems decreased NSIs immediately after the introduction (effect size (ES) -6.9, 95% CI -9.5 to -4.2) but there was no further decrease over time (ES -1.2, 95% CI -2.5 to 0.1, very low quality evidence). Another ITS study evaluated an outdated recapping shield, which we did not consider further. Safe Intravenous systemsThere was very low quality evidence in two ITS studies that NSIs were reduced with the introduction of safe IV devices, whereas one RCT and one CBA study provided very low quality evidence of no effect. However, there was moderate quality evidence produced by four other RCT studies that these devices increased the number of blood splashes when the safety system had to be engaged actively (relative risk (RR) 1.6, 95% CI 1.08 to 2.36). In contrast there was low quality evidence produced by two RCTs of passive systems that showed no effect on blood splashes. Yet another RCT produced low quality evidence that a different safe active IV system also decreased the incidence of blood leakages. Safe injection devicesThere was very low quality evidence provided by one RCT and one CBA study showing that introduction of safe injection devices did not considerably change the NSI rate. One ITS study produced low quality evidence showing that the introduction of safe passive injection systems had no effect on NSI rate when compared to safe active injection systems. Multiple safe devicesThere was very low quality evidence from one CBA study and two ITS studies. According to the CBA study, the introduction of multiple safe devices resulted in a decrease in NSI,whereas the two ITS studies found no change. Safety containersOne CBA study produced very low quality evidence showing that the introduction of safety containers decreased NSI. However, two ITS studies evaluating the same intervention found inconsistent results. LegislationThere was low to moderate quality evidence in two ITS studies that introduction of legislation on the use of safety-engineered devices reduced the rate of NSIs among healthcare workers. There was also low quality evidence which showed a decrease in the trend over time for NSI rates.Twenty out of 24 studies had a high risk of bias and the lack of evidence of a beneficial effect could be due to both confounding and bias. This does not mean that these devices are not effective. Authors' conclusions: For safe blood collection systems, we found very low quality evidence of inconsistent effects on NSIs. For safe passive intravenous systems, we found very low quality evidence of a decrease in NSI and a reduction in the incidence of blood leakage events but moderate quality evidence that active systems may increase exposure to blood. For safe injection needles, the introduction of multiple safety devices or the introduction of sharps containers the evidence was inconsistent or there was no clear evidence of a benefit. There was low to moderate quality evidence that introduction of legislation probably reduces NSI rates.More high-quality cluster-randomised controlled studies that include cost-effectiveness measures are needed, especially in countries where both NSIs and blood-borne infections are highly prevalent.

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Cochrane Database of Systematic Reviews

Devices for preventing percutaneous exposure injuries caused

by needles in healthcare personnel (Review)

Reddy VK, Lavoie MC, Verbeek JH, Pahwa M

Reddy VK, Lavoie MC, Verbeek JH, Pahwa M.

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Cochrane Database of Syst ematic Reviews 2017, Issue 11. Art. No.: CD009740.

DOI: 10.1002/14651858.CD009740.pub3.

www.cochranelibrary.com

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

T A B L E O F C O N T E N T S

1HEADER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1ABSTRACT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2PLAIN LANGUAGE SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . . . . . . . . . . . . . . . . . . .

6BACKGROUND . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7OBJECTIVES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

7METHODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10RESULTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure 1. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Figure 2. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

Figure 3. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

22ADDITIONAL SUMMARY OF FINDINGS . . . . . . . . . . . . . . . . . . . . . . . . . .

38DISCUSSION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

39AUTHORS’ CONCLUSIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40ACKNOWLEDGEMENTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

40REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

47CHARACTERISTICS OF STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

79DATA AND ANALYSES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

iDevices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

[Intervention Review]

Devices for preventing percutaneous exposure injuries caused

by needles in healthcare personnel

Viraj K Reddy1, Marie-Claude Lavoie2, Jos H Verbeek1, Manisha Pahwa3

1Cochrane Work Review Group, Finnish Institute of Occupational Health, Kuopio, Finland. 2University of Maryland Baltimore,

Baltimore, Maryland, USA. 3Dalla Lana School of Public Health, University of Toronto, Toronto, Canada

Contact address: Jos H Verbeek, Cochrane Work Review Group, Finnish Institute of Occupational Health, Neulaniementie 4, Kuopio,

70101, Finland. jos.verbeek@ttl.ﬁ.

Editorial group: Cochrane Work Group.

Publication status and date: New search for studies and content updated (no change to conclusions), published in Issue 11, 2017.

Citation: Reddy VK, Lavoie MC, Verbeek JH, Pahwa M. Devices for preventing percutaneous exposure injuries caused

by needles in healthcare personnel. Cochrane Database of Systematic Reviews 2017, Issue 11. Art. No.: CD009740. DOI:

10.1002/14651858.CD009740.pub3.

A B S T R A C T

Background

Percutaneous exposure injuries from devices used for blood collection or for injections expose healthcare workers to the risk of blood

borne infections such as hepatitis B and C, and human immunodeﬁciency virus (HIV). Safety features such as shields or retractable

needles can possibly contribute to the prevention of these injuries and it is important to evaluate their effectiveness.

Objectives

To determine the beneﬁts and harms of safety medical devices aiming to prevent percutaneous exposure injuries caused by needles in

healthcare personnel versus no intervention or alternative interventions.

Search methods

We searched CENTRAL, MEDLINE, EMBASE, NHSEED, Science Citation Index Expanded, CINAHL, Nioshtic, CISdoc and

PsycINFO (until 11 November 2016).

Selection criteria

We included randomised controlled trials (RCT), controlled before and after studies (CBA) and interrupted time-series (ITS) designs

of the effect of safety engineered medical devices on percutaneous exposure injuries in healthcare staff.

Data collection and analysis

Two of the authors independently assessed study eligibility and risk of bias and extracted data. We synthesized study results with a

ﬁxed-effect or random-effects model meta-analysis where appropriate.

Main results

We included six RCTs with 1838 participants, two cluster-RCTs with 795 participants and 73,454 patient days, ﬁve CBAs with

approximately 22,000 participants and eleven ITS with an average of 13.8 data points. These studies evaluated safe modiﬁcations

of blood collection systems, intravenous (IV) systems, injection systems, multiple devices, sharps containers and legislation on the

implementation of safe devices. We estimated the needlestick injury (NSI) rate in the control groups to be about one to ﬁve NSIs per

1000 person-years. There were only two studies from low- or middle-income countries. The risk of bias was high in 20 of 24 studies.

1Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

Safe blood collection systems:

We found one RCT that found a safety engineered blood gas syringe having no considerable effect on NSIs (Relative Risk (RR) 0.2,

95% Conﬁdence Interval (95% CI) 0.01 to 4.14, 550 patients, very low quality evidence). In one ITS study, safe blood collection

systems decreased NSIs immediately after the introduction (effect size (ES) -6.9, 95% CI -9.5 to -4.2) but there was no further decrease

over time (ES -1.2, 95% CI -2.5 to 0.1, very low quality evidence). Another ITS study evaluated an outdated recapping shield, which

we did not consider further.

Safe Intravenous systems

There was very low quality evidence in two ITS studies that NSIs were reduced with the introduction of safe IV devices, whereas one

RCT and one CBA study provided very low quality evidence of no effect. However, there was moderate quality evidence produced by

four other RCT studies that these devices increased the number of blood splashes when the safety system had to be engaged actively

(relative risk (RR) 1.6, 95% CI 1.08 to 2.36). In contrast there was low quality evidence produced by two RCTs of passive systems

that showed no effect on blood splashes. Yet another RCT produced low quality evidence that a different safe active IV system also

decreased the incidence of blood leakages.

Safe injection devices

There was very low quality evidence provided by one RCT and one CBA study showing that introduction of safe injection devices

did not considerably change the NSI rate. One ITS study produced low quality evidence showing that the introduction of safe passive

injection systems had no effect on NSI rate when compared to safe active injection systems.

Multiple safe devices

There was very low quality evidence from one CBA study and two ITS studies. According to the CBA study, the introduction of

multiple safe devices resulted in a decrease in NSI,whereas the two ITS studies found no change.

Safety containers

One CBA study produced very low quality evidence showing that the introduction of safety containers decreased NSI. However, two

ITS studies evaluating the same intervention found inconsistent results.

Legislation

There was low to moderate quality evidence in two ITS studies that introduction of legislation on the use of safety-engineered devices

reduced the rate of NSIs among healthcare workers. There was also low quality evidence which showed a decrease in the trend over

time for NSI rates.

Twenty out of 24 studies had a high risk of bias and the lack of evidence of a beneﬁcial effect could be due to both confounding and

bias. This does not mean that these devices are not effective.

Authors’ conclusions

For safe blood collection systems, we found very low quality evidence of inconsistent effects on NSIs. For safe passive intravenous

systems, we found very low quality evidence of a decrease in NSI and a reduction in the incidence of blood leakage events but moderate

quality evidence that active systems may increase exposure to blood. For safe injection needles, the introduction of multiple safety

devices or the introduction of sharps containers the evidence was inconsistent or there was no clear evidence of a beneﬁt. There was

low to moderate quality evidence that introduction of legislation probably reduces NSI rates.

More high-quality cluster-randomised controlled studies that include cost-effectiveness measures are needed, especially in countries

where both NSIs and blood-borne infections are highly prevalent.

P L A I N L A N G U A G E S U M M A R Y

Devices with safety features for preventing percutaneous exposure injuries in healthcare staff

What is the aim of this review?

Healthcare workers use needles, syringes and other devices for collecting patients’ bood and to inject drugs that are in liquid form.

Sometimes healthcare workers come into contact with the sharp end of these devices by accident. Such instances are called needlestick

2Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

injuries (NSI) and they may expose healthcare workers to the risk of serious infections such as hepatitis or human immunodeﬁciency

virus (HIV). Safety features such as shields or retractable needles can help prevent these injuries. We searched in multiple databases for

randomised (RCTs) and non-randomised studies (NRS) that had evaluated these features.

Key messages

The evidence on safety devices preventing NSI is of low quality and inconsistent. The lack of a strong and consistent helpful effect

could be due to bias. This does not mean that these devices are not effective. The risk of blood contamination may be greater.

More high-quality experimental studies with groups of healthcare workers are needed to compare the effects and cost-effectiveness of

various types of safety devices on NSIs, especially in countries where both NSIs and blood-borne infections are common.

What was studied in the review?

We included eight RCTs and 16 NRS. These studies evaluated the safety of blood collection systems, intravenous (IV) systems, injection

systems, multiple devices, sharps containers and legislation. We estimated that one to ﬁve NSIs occur per 1000 workers every year

without intervention. The risk of bias was high in 20 out of 24 studies.

What are the main results of the review?

For safe blood collection systems, one RCT found very low quality evidence showing no considerable effect and one NRS produced

very low quality evidence showing a large reduction in NSI. Another NRS used an outdated cap shield.

For safe IV devices, there was very low-quality evidence that NSIs decreased in two NRS but not in one RCT and one other NRS.

However, four other RCT studies produced moderate quality evidence that the devices which had to be switched on increased the

number of blood splashes. In two RCT studies where the safety feature automatically switched on produced low quality evidence

showing no change in amount of blood splashes. Another RCT study found low quality evidence showing a decrease in the number of

blood leakage events with these devices.

For safe injection devices, there was very low quality evidence that these reduced the NSI rate in one RCT and in one NRS. However,

another NRS found low quality evidence no difference in NSI rate between active and passive safe injection devices.

For the introduction of several safety devices at once, there was very low quality evidence of inconsistent effects from three NRS. .One

NRS showed a decrease in NSI rate but the other two studies showed no difference.

For the use of safety containers, there was very low quality evidence of inconsistent effects from three NRS. . One NRS showed a

decrease in NSI but the other two studies showed inconsistent results.

For the introduction of legislation on safety-engineered devices, there was low to moderate quality evidence produced by two NRS

studies showing a reduction in NSIs.

How up-to-date is this review?

We searched for studies up until 11 November 2016.

3Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

S U M M A R Y O F F I N D I N G S F O R T H E M A I N C O M P A R I S O N [Explanation]

Saf e blood collection systems compare d to regular syste ms for pre venti ng pe rcutaneous exposure injuries caused by needles in healt hcare personnel ( RCT s)

Patient or population: p reventing perc utaneo us expo s ure in juries caused b y needles in hea lthc are perso nnel (RCTs )

Set ting: em ergency ca re department of ho spit al

Intervention: Safe blo od c ollect i on s ys t em s

Comparison: r eg ula r sys tem s

Outcomes Anticipat ed absolut e effe cts∗(95% CI) Relati ve ef fect

(9 5% CI )

of participants

(studi es)

Quality of the evidence

(GRADE)

Comments

Risk with regular sys-

tems

Risk with Safe blood

coll ection systems

Needle stic k inj uries im -

mediat e f o llo w up

Stu dy p opu lat ion RR 0.20

(0 .01 t o 4.1 5)

55 0

(1 RCT)

⊕

VERY LOW 12

7 per 1 000 1 per 1 00 0

(0 t o 30)

Bloo d s plash es Stu dy p opu lat ion RR 0.14

(0 .02 t o 1.1 5)

55 0

(1 RCT)

⊕

VERY LOW 134

25 p er 1 000 4 per 1 00 0

(1 t o 29)

*The risk in the intervention group (and its 95% conf i dence in t er va l) is b ased on the assu m ed ri sk in the c om pariso n g ro up and the relative e ffect o f t he int er vent i on (an d i t s

95 % CI).

CI: Co nfi denc e interval; RR: Risk rat io; OR: Odds ratio ;

GRADE Working Group grades of evidence

High quality: We are very con f i dent t hat t he true ef f ect lies c los e t o t hat of the estim a t e of t he ef fect

Moderate quality: We are m odera tel y con f ident in the ef f ect estim a te: Th e t rue effec t i s l ikely to be clo se to t he estim ate of the ef fect, but t h ere is a pos s ibi lit y t hat it i s

su bst a nti all y dif ferent

Low quality: Our con f idence in the eff ec t est i m ate is lim i t ed : The t rue eff ec t m ay be subs t ant ial ly di f f e rent f r om t he estim a t e of t h e ef fect

Very low quality: We have ver y li t tle co nfid enc e in the ef f ect es t im ate: The true ef f ect is likely t o be su bsta ntiall y dif f erent f rom t he es timat e of eff ec t

1We dow ngrad ed the q uality o f evidenc e by one l ev el due to risk of bias ( sel ec t ion bias, perform ance bi as and detectio n bias ).

4Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

2We do w ngrad ed th e qu ali ty of evid enc e by two levels d ue to i m p recis ion (w i de conf idenc e int erval and very few ev en ts).

3We do w ngr aded t he quality o f evi dence by one l evel d ue to indi rectness (bl ood splas hes w er e ac t ual ly visi ble b loo d

leakag es) .

4We dow n graded t he quali t y of evidenc e by one l evel d ue to i m precis ion (conf idenc e i nterval crosse s 1 ).

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5Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

B A C K G R O U N D

Healthcare workers (HCWs) are exposed to several occupational

hazards, including biological agents. Percutaneous injury and oc-

cupational exposure to blood and body ﬂuids increase the risk of

exposure of HCWs to blood borne pathogens such as hepatitis B

(HBV), hepatitis C (HCV) and human immunodeﬁciency virus

(HIV). These infections can lead to chronic and fatal diseases. In

the United States (US), the annual number of percutaneous in-

juries among hospital-based HCWs was estimated to be 384,325

in 1997 to 1998 (Panlilio 2004). Percutaneous injury incidence

rates have decreased since then. However, recently it was estimated

that still 300,000 HCWs sustain percutaneous injuries annually

in the US (Grimmond 2017). The World Health Organization

(WHO) estimates that 16,000 HCV, 66,000 HBV and 1000 HIV

infections may have occurred worldwide among HCWs in the year

2000 due to their occupational exposure to blood and body ﬂuids

(Pruss-Ustun 2005). More recent information relating to recent

global trends of percutaneous exposure injuries is not available.

Nonetheless it is reasonable to assume that the trends are not con-

siderably different from the US.

Description of the condition

A HCW’s risk for acquiring infectious diseases at work is inﬂu-

enced by a variety of environmental and social factors. The popu-

lation prevalence of speciﬁc diseases, percentage HBV vaccination

coverage in the population, availability of medical supplies, adher-

ence to standard precautions, accessibility and availability of post-

exposure prophylaxis, among others are important components

inﬂuencing the risk of HCWs becoming infected by blood borne

diseases. For HBV, the risk varies greatly based on the immuniza-

tion coverage among health workers and the served population.

For example, in 1990 the HBV infection rate among unvacci-

nated US healthcare personnel was three to ﬁve times greater than

in the US general population (MacCannell 2010). This number

decreased signiﬁcantly due to the introduction of routine HBV

immunization and comprehensive occupational health and safety

policies. The prevalence of HBV among HCWs is now ﬁve times

less than in the US general population (MacCannell 2010).

Occupational transmission of infectious diseases has a signiﬁcant

impact on the health of the workers and also on the healthcare

system as a whole. The transmission of occupational blood borne

infectious diseases leads to increased absenteeism and morbidity,

and in some cases to higher mortality rates, among HCWs. These

outcomes affect the delivery, provision, quality and safety of care.

HCWs may suffer from psychological stress due to the risk of ac-

quiring an infectious disease, which affects both their work and

personal life (Fisman 2002;Sohn 2006). There is also the ﬁnancial

burden associated with occupational exposure to blood borne dis-

eases, which includes costs related to blood tests, treatment, out-

patient visits, and lost working hours (Jagger 1990;Leigh 2007).

Description of the intervention

Exposure to blood or body ﬂuids is also called percutaneous expo-

sure and happens most often when HCWs are injured with sharp

needles or instruments, or when blood or body ﬂuids are splashed

on mucous membranes or wounds during medical interventions

or accidents. These incidents are called percutaneous exposure in-

cidents. The majority of these incidents are percutaneous injuries

which include sharps injuries or needlestick injuries (NSIs). The

actual causes of a NSI are multifactorial and include elements such

as types of devices and procedures, lack of access to or availability

of personal protective equipment for the HCWs, suboptimal use

of personal protective equipment, lack of training and education

on infection control and occupational health principles, improper

management of needles, poor organisational climate, high work-

load and fatigue, working alternate shifts, high mental pressure

and subjective perception of risk (Akduman 1999;Ansa 2002;

Clarke 2002;Doebbeling 2003;Fisman 2007;Ilhan 2006;Ngatu

2011;Oh 2005;Orji 2002;Roberts 1999;Smith 2006;Smith

2006b;Wallis 2007). Most of these causes can be addressed by

speciﬁc interventions.

Several epidemiological studies have demonstrated that some

needlestick injuries are associated with speciﬁc actions and med-

ical equipment, such as recapping and sharp devices respectively

(De Carli 2003). The practice of recapping needles is a major fac-

tor contributing to needlestick injuries (Ngatu 2011) and speciﬁc

devices have also been associated with an increased risk of per-

cutaneous injuries. According to MacCannell 2010, needlestick

injuries occurred more frequently with hollow-bore needles com-

pared to solid sharps (54% versus 40%). It is estimated that up to

25% of reported hollow-bore needlestick injuries among nurses

and physicians could have been prevented by the use of safer de-

vices (MacCannell 2010). Almost two-thirds of all reported in-

juries occurred with devices without safety features (MacCannell

2010).

Engineered medical devices such as retractable needles can reduce

and eliminate the exposure to blood and body ﬂuids. Even though

sometime ago legislation has been introduced in the US and Eu-

rope that mandates that safety-engineered devices should be used,

there is no generally agreed deﬁnition of what constitutes a sa-

fety-engineered device (OSHA 2001). Here, we deﬁne a safety-

engineered device as any medical device that purportedly protects

against percutaneous injuries.

How the intervention might work

There are several possibilities to prevent infection from needlestick

injuries. For hepatitis B, vaccination has been successful (Chen

2005). Vaccination is not yet possible for HCV or HIV (Mast

2004). Therefore, exposure elimination and reduction remain the

main preventive strategies.

Many hospitals are now using safe medical devices as an inter-

6Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

vention to reduce the risk of percutaneous injuries. These devices

eliminate or encapsulate the needles. For example, needleless intra-

venous systems are deﬁned as systems that administer medications

through an intravenous access device without using needle con-

nections. Some studies have noted a decrease in the risk of needle-

stick injuries following the introduction of safety medical devices

such as a needle free system for intravenous therapy (Mendelson

1998), meanwhile other studies have found inconclusive ﬁndings

for such systems (L’Ecuyer 1996 2wva).

Why it is important to do this review

There are several strategies available to abate percutaneous expo-

sure injuries among HCWs workers, and these are widely used.

Therefore, it is important to know if these preventive interven-

tions are effective. Retrospective studies indicate that percutaneous

exposure incidents would be reduced by more than 50% by be-

havioural interventions, either through education or adoption of

new techniques (Bryce 1999;Castella 2003). The use of safety

devices would probably also have a signiﬁcant effect (Bryce 1999;

Castella 2003;Jagger 1988;Waclawski 2004). There have been

several reviews on the effectiveness of interventions (Hanrahan

1997;Hutin 2003;Rogers 2000;Trim 2004;Tuma 2006) but

none have used the systematic Cochrane methodology. This re-

view excluded studies where sharp suture needles were substituted

with blunted ones as another Cochrane review (Parantainen 2011)

has already addressed the effect of this intervention. Extra gloves

or special types of gloves could theoretically be considered a de-

vice to prevent needlestick injuries while handling needles, but we

excluded these studies because there is another Cochrane Review

that shows that extra gloves are effective to prevent needlestick

injuries (Mischke 2014).

Recently the WHO issued guidelines for the use of safety-engi-

neered devices in healthcare settings (WHO 2016). However, they

based their recommendations on a judgment of moderate quality

evidence which was different from the low quality evidence that

we found in the 2014 version of this review.

O B J E C T I V E S

To determine the beneﬁts and harms of safety medical devices

aiming to prevent percutaneous exposure injuries caused by nee-

dles in healthcare personnel versus no intervention or alternative

interventions.

M E T H O D S

Criteria for considering studies for this review

Types of studies

We included all randomised controlled trials (RCT), cluster-ran-

domised trials (cluster-RCT), interrupted time-series (ITS) and

controlled before and after studies (CBA) irrespective of language

of publication, publication status, or blinding.

We expected thatthe availability of RCTs would be limited for this

topic. Interventions for prevention are very different from clinical

interventions. Many of these interventions are not implemented

at the individual level. For example, new equipment is used by

a group of workers or safety engineering controls are applied to

the whole department simultaneously. This approach makes indi-

vidual randomisation impossible. In principle, this can be partly

overcome by randomisation at the department level as in a cluster-

RCT design. However, as the level of aggregation increases, the

more difﬁcult this is to perform due to the level of recruitment

required. Therefore, we included the following non-randomised

study designs in our review: CBA studies with a concurrent con-

trol group, and ITS. CBA studies are also called prospective cohort

studies. They are easier to perform, taking into account that the

intervention is assigned at the group level, and still have reasonable

validity.

ITS designs are often based on routinely collected administrative

data from insurance or governmental sources, collected for injury

outcomes. In many cases the data are collected independently from

interventions and over long periods of time, offering reasonable

validity. If there are at least three data points before and three data

points after the intervention, we included these study designs as

ITS (EPOC 2006). Both ITS with and without a control group

were eligible for inclusion.

Types of participants

We included studies where participants were HCWs, including

dentists, which means all persons that are professionally involved

in providing health care to patients. The majority of study partic-

ipants had to fulﬁl this criterion.

Types of interventions

Inclusion criteria

We included studies examining any medical devices that aim to

prevent percutaneous exposure incidents and thus could reduce

the risk of exposure to blood or bodily ﬂuids.

We categorised the interventions based on the type of device in

the following way.

- Safety engineered devices for blood collection.

- Safety engineered devices for Injecting ﬂuids.

- Containers for collecting sharps.

7Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

Because these categories did not cover all studies that we found,

we added two categories.

- The use of multiple safety devices in an intervention programme.

- Intravenous systems.

- The introduction of legislation

Exclusion criteria

We excluded studies where sharp suture needles were substituted

with blunted ones. Another Cochrane review (Parantainen 2011)

has addressed the effect of this intervention. We also excluded

studies on devices that eliminate the use of suture needles or that

encapsulate suture needles during surgery because the risk of a

NSI is different with suture needles in surgery. Extra gloves or

special types of gloves were also excluded because there is another

Cochrane review on the effect of gloves to prevent needlestick

injuries Mischke 2014.

Types of outcome measures

Primary outcomes

Our primary outcome measure was exposure of HCWs to poten-

tially contaminated blood or bodily ﬂuids. Exposure can be re-

ported as self-reported NS I, sharps injury, blood stains on the skin,

or glove perforations. We considered all reports of such exposure

as valid measures of the outcome, such as self-reports, reports by

the employer, or observations of blood stains.

Secondary outcomes

We considered ease of use of the devices (including user satisfac-

tion) and information related to the cost of the intervention as

secondary outcomes.

Search methods for identiﬁcation of studies

Electronic searches

First, we generated search terms for percutaneous exposure inci-

dents. We then combined these terms for percutaneous exposure

incidents with the recommended search strings for randomised tri-

als and for non-randomised studies. We used the Robinson 2002

search strategy for randomised clinical trials and controlled clini-

cal studies. For ﬁnding non-randomised studies, we used the sen-

sitive search strategy for occupational health intervention studies

(Verbeek 2005).

We used the strategy to search CENTRAL, MEDLINE, EM-

BASE, NHSEED, Science Citation Index Expanded, CINAHL,

OSH-update, and PsycINFO from the earliest record to 1 Novem-

ber 2016. We also searched LILACS but only until 2012.

We felt that the yield did not outweigh the efforts and de-

cided to stop searching LILACS. In addition, we searched the

databases of WHO, the UK National Health Service (NHS) and

www.med.virginia.edu/epinet (Royle 2003).

We present the original search strategies for the databases listed

above in Appendix 1.

In the ﬁrst update of the original search that is common with

Parantainen 2011, we used recap* and device* as additional search

terms combined by OR and with the other terms as explained in

Appendix 2.

We present the most recent updated search strategies for the

databases listed above in Appendix 3.

Searching other resources

We screened the reference lists of all relevant studies for additional

studies.

Data collection and analysis

Selection of studies

Using the inclusion and exclusion criteria, the authors (M-CL, JV,

VR, MP) worked individually and independently to screen the

titles and abstracts of the references that were identiﬁed by the

search strategy as potential studies. Pairs of authors went through

the same references to increase the reliability of the results. We

obtained the full texts of those references that appeared to meet the

inclusion criteria. We did not blind ourselves regarding the trial

author details because we felt that it would notincrease validity. We

solved disagreements between pairs by discussion. A pair consulted

a third author if disagreement persisted.

Data extraction and management

Review authors worked in pairs (VR and JV, M-CL and MP) but

independently to extract the data onto a form. The form included

the essential study characteristics about the participants, interven-

tions, outcomes and results. We also noted any adverse events and

the sponsorship of the study. Two pairs of authors (VR and JV, M-

CL and MP) independently assessed the risk of bias of the studies.

The pairs used a consensus method if disagreements occurred. The

pairs consulted a third author if disagreement persisted. Again, we

did not mask trial names because we believed that it would not

increase validity.

Assessment of risk of bias in included studies

For the assessment of risk of bias in RCTs we used the risk of

bias tool in RevMan 2014. For CBA studies, we used two items

additional to the Cochrane risk of bias tool from a validated in-

strument (Downs 1998): adjustment for baseline differences and

similar timing of recruitment of intervention group.

8Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

For ITS studies we used the risk of bias criteria as presented by

Ramsay 2003.

Overall judgement of risk of bias at study level

For RCT studies we judged a study to be at a low risk of bias if at

least two of the following domains (random sequence generation,

allocation concealment and blinding) had a low risk of bias and the

remaining third domain had unclear risk of bias and none of the

other domains (attrition bias, reporting bias, similar recruitment

of groups, adjustment for baseline differences and other bias) had

a high risk of bias.

For CBA and ITS studies, we judged a study to be at a low risk of

bias if none of the domains were rated as high risk.

Measures of treatment effect

For RCTs and CBA studies with dichotomous outcomes, we used

relative risks or risk ratios (RR) as the measure of the treatment

effect. We did not use odds ratios because the incidence of most

outcomes was higher than 10% and then odds ratios give an in-

ﬂated impression of the relative risk.

In studies where needlestick injuries or glove perforations were

reported more than once for an individual we used rates and rate

ratios as the treatment effect. We calculated the log rate ratio and

the standard error and used these data as the input for RevMan.

For ITS studies, we extracted and re-analysed the data from the

original papers according to the recommended methods for anal-

ysis of ITS designs for inclusion in systematic reviews (Ramsay

2003). These methods utilise a segmented time-series regression

analysis to estimate the effect of an intervention while taking into

account secular time trends and any autocorrelation between in-

dividual observations. For each study, we ﬁtted a ﬁrst order au-

toregressive time-series model to the data using a modiﬁcation of

the parameterization of Ramsay 2003. Details of the mode speci-

ﬁcation are as follows:

Y = ß0 + ß1 time + ß2 (time - p) I (time > p) + ß3 I (time > p) +

E, E ~ N (0, s²).

For time = 1,...,T, where p is the time of the start of the interven-

tion, I (time ≥p) is a function which takes the value 1 if time is

p or later and zero otherwise, and where the errors E are assumed

to follow a ﬁrst order autoregressive process (AR1) and the errors

E are normally distributed with mean zero and variance s². The ß

parameters have the following interpretation:

ß1 is the pre-intervention slope;

ß2 is the difference between post- and pre-intervention slopes;

ß3 is the change in level at the beginning of the intervention

period, meaning that it is the difference between the obser ved level

at the ﬁrst intervention time point and that predicted by the pre-

intervention time trend.

We used the change in slope and the change in level as two different

measures of treatment effect for ITS studies.

Unit of analysis issues

For studies that employed a cluster-randomised design but did not

make an allowance for the design effect, we intended to calculate

the design effect. If no intra-cluster coefﬁcients were reported, al-

though they are needed to calculate the design effect, we would

have assumed a fairly large intra-cluster coefﬁcient of 0.05 to en-

able the calculation of design effect. We intended to use the meth-

ods that are recommended in the Cochrane Handbook for System-

atic Reviews of Interventions (Higgins 2011) for the calculations.

However, the two studies that used a cluster-randomised design

either did not provide data on the size of the clusters (L’Ecuyer

1996 2wva) or had a loss to follow up of 50% (van der Molen

2011), which made the cluster calculations questionable. There-

fore, we did not perform these calculations.

For studies with multiple study arms that belonged to the same

comparison, we divided the number of events and participants in

the control group equally over the study arms to prevent double

counting of study participants in the meta-analysis (Asai 2002

active;Asai 2002 passive).

Dealing with missing data

We contacted the authors for additional information if the data

needed for meta-analysis were missing (Hotaling 2009;Sossai

2010). If data were presented in ﬁgures only and the authors could

not be reached, we extracted data from the ﬁgures presented in

the article (Chambers 2015 hospitals;Chambers 2015 long-term

nursing care;Goldwater 1989;Goris 2015;Phillips 2013;Whitby

2008). If data such as standard deviations had been missing and

they could be calculated from other data present in the article,

such as P values, we would have done so according to the recom-

mendations in the Cochrane Handbook for Systematic Reviews of

Interventions (Higgins 2011), but there were no studies where this

was necessary.

Assessment of heterogeneity

Clinical homogeneity among studies was deﬁned based on the

similarity of populations, interventions, and outcomes measured

at the same follow-up point. We regarded all healthcare profession-

als as sufﬁciently similar to assume a similar preventive effect from

the use of similar devices. We categorised safe devices as indicated

under types of interventions and assumed that different devices

would lead to different effects. We added three extra categories:

intravenous (IV) systems, the introduction of multiple safe devices

at the same time and legislation that mandates the use of safe de-

vices. We deemed the interventions contained within these cate-

gories to be conceptually similar and sufﬁciently homogeneous to

be combined in a meta-analysis.

We divided outcomes into a category of needlestick injuries and a

category of blood or bodily ﬂuid splashes. Thus, we had two dif-

ferent outcome measures: needlestick injuries and blood splashes.

9Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

Even though the denominator of the NSI rates differed from pa-

tients to devices to workers we felt that they were sufﬁciently sim-

ilar to be combined.

Wedid not combine various study designs as we assumed that there

were large differences in risk of bias between the different study

types. We have presented the results per comparison separately for

each design type.

We assessed statistical heterogeneity by means of the I² statistic.

We used the values of < 40%, between 30% and 60%, between

50% and 90%, and over 75% as indicating not important, mod-

erate, substantial, and considerable heterogeneity respectively, as

proposed in the Cochrane Handbook for Systematic Reviews of In-

terventions (Higgins 2011).

Assessment of reporting biases

We will assess for publication bias with a funnel plot in future

updates of this review if more than ﬁve studies are available in a

single comparison.

Data synthesis

We pooled studies that contained sufﬁcient data and that we

judged to be clinically and statistically homogeneous with RevMan

5 software (RevMan 2014).

When studies were statistically heterogeneous we used a random-

effects model or we refrained from meta-analysis; otherwise we

used a ﬁxed-effect model.

For ITS,we ﬁrst standardised the data by dividing the outcome and

standard error by the pre-intervention standard deviation resulting

in an effect size, as recommended by Ramsay 2001. Then, we

entered the results into RevMan as the change in level and in

slope as two different outcomes using the general inverse variance

method.

Finally, we used the GRADE approach to assess the quality of

the evidence per comparison and per outcome as described in the

Cochrane Handbook for Systematic Reviews of Interventions (Higgins

2011). For comparisons that only included RCTs, we started at

high quality evidence. Then, we reduced the quality of the evidence

by one or more levels if there were one or more limitations in

the following domains: risk of bias, consistency, directness of the

evidence, precision of the pooled estimate, and the possibility of

publication bias. When the comparison included non-randomised

studies we started at the low quality level and downgraded further

if there were limitations, or we would have upgraded the quality if

there were reasons to do so. We used the programme GRADEpro

2017 to generate summary of ﬁndings tables for the two most

important outcomes for all comparisons but separated by design.

Subgroup analysis and investigation of heterogeneity

We intended to re-analyse the results for studies with a high base-

line or control group exposure rate, and for studies from low- and

middle-income countries, but this was not possible due to the few

studies that we found per comparison and the lack of studies from

low- and middle-income countries.

Sensitivity analysis

We intended to re-analyse the results including only studies with

a low risk of bias in order to ﬁnd out if risk of bias led to changes

in the ﬁndings but this was only possible for one comparison as

there weren’t enough low risk of bias studies to do so.

R E S U L T S

Description of studies

Results of the search

With the original search strategy described in Appendix 1 and

after removal of duplicates we had a total of 11,239 references.

Based on titles and abstracts, we selected 322 references for full-

text reading. Of these, we excluded those that did not fulﬁl our in-

clusion criteria. In cases where the article did not provide enough

data we contacted the authors and asked them to send the missing

information. If we did not receive sufﬁcient information to judge

if the study should be included, we excluded the study. This re-

sulted in 84 full text articles on NSI prevention. Of these, 14 stud-

ies fulﬁlled the inclusion criteria for this review. We updated the

search by adding the strategy described in Appendix 2 in January

2012. This resulted in 167 additional references from which we

selected seven for full-text reading. Of these full-text studies, there

were three additional studies that fulﬁlled our inclusion criteria.

Another update of the whole search (Appendix 1 combined with

Appendix 2) in January 2014 yielded another 292 references of

which three could be potentially included but are awaiting classiﬁ-

cation. Six are pending more information from the authors (Perry

2012;Phillips 2010;Phillips 2011;Phillips 2012;Phillips 2012a;

Uyen 2014) and one is pending translation from Italian (Ferrario

2012). In November 2016 we updated and reran the search strat-

egy again and it yielded an additional 1194 references (Appendix

3) out of which we screened 60 for full-text reading (see Figure

1). Out of these studies 7 studies fulﬁlled the inclusion criteria.

Altogether, this process led to a total of 24 studies that fulﬁlled

our inclusion criteria.

10Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

Figure 1. Study ﬂow diagram for 2017 update

Included studies

Interventions

We included a total of 24 studies, which contain three stud-

ies with two intervention arms (Asai 2002 active;Asai 2002

passive;Prunet 2008 active;Prunet 2008 passive;Chambers 2015

hospitals;Chambers 2015 long-term nursing care) and one study

with three intervention arms (L’Ecuyer 1996 2wva;L’Ecuyer 1996

mbc;L’Ecuyer 1996 pbc), corresponding to 29 different compar-

isons of safety medical devices that we named as different studies

to increase transparency of the meta-analyses. We elaborated on

the details of the devices in Table 1. Based on the information in

the articles, we checked on the Internet if the devices were still

for sale and if they still resembled the original description given

in the article. Even though we could not be sure that the devices

currently sold were exactly similar to those in the articles, we are

conﬁdent that the main safety features are still the same.

The types of devices used in the various studies were:

•safe blood collection devices (n = 3) (Baskin 2014;

Goldwater 1989;Rogues 2004);

•safe IV systems (n = 9) (Asai 1999 active;Asai 2002 active;

Asai 2002 passive;Azar-Cavanagh 2007;Cote 2003;L’Ecuyer

1996 2wva;L’Ecuyer 1996 mbc;L’Ecuyer 1996 pbc;Mendelson

1998;Prunet 2008 active;Prunet 2008 passive;Seiberlich 2016;

Sossai 2010);

11Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

•safe injection device (n = 4) (Gaballah 2012;Goris 2015;

van der Molen 2011;Zakrzewska 2001);

•multiple safety devices interventions (n = 5) (Chambers

2015 hospitals;Chambers 2015 long-term nursing care;Phillips

2013;Reddy 2001;Valls 2007;Whitby 2008); and

•safe needle disposal boxes (n = 3) (Edmond 1988;

Grimmond 2010;Richard 2001).

Safety engineered devices can be divided into two broad categories,

passive and active devices. Passive devices have a safety function

that is automatically activated without the user’s interference. This

type of safety device is supposed to offer better protection because

the human factor is excluded. Active devices require one- or two-

handed activation by a health worker after use.

Four studies used a similar type of safe active IV system (Auto-

guard IV) (Asai 1999 active;Asai 2002 active;Cote 2003;Prunet

2008 active). The safety mechanism of this device is activated by

pushing a button which retracts the needle. Two studies evalu-

ated a passive and an active system (Asai 2002 active;Asai 2002

passive;Prunet 2008 active;Prunet 2008 passive). In addition to

the Autoguard IV, Asai 2002 passive and Prunet 2008 passive used

a passive device. Asai 2002 passive used the Protective Acuvance,

which consists of two needles (one inside the other) where the

tip of the needle is automatically changed to a blunt needle upon

withdrawing. Prunet 2008 passive used the Introcan safety, which

automatically shields the needle tip upon withdrawing. The In-

trocan safety IV system was also used by Sossai 2010. Whereas

Seiberlich 2016 used a safe active IV system (ViaValve), which

consisted of a valve to prevent blood ﬂow back out of the catheter

hub on initial venipuncture.

A needleless system refers to a device that does not use needles

for the collection of body ﬂuids or administration of medication

or ﬂuid after initial IV access is established (Mendelson 1998).

L’Ecuyer 1996 2wva;L’Ecuyer 1996 mbc;L’Ecuyer 1996 pbc used

three needleless IV systems. One, the safety needleless IV tubing

system (blunt metal cannula), was replaced after four months by a

blunt plastic cannula due to dissatisfaction of employees with the

device. Mendelson 1998 evaluated a needleless IV system which is

incompatible with a needle. All other studies had employed either

a combination of the needleless system and insertion or evaluated

the effects of safe insertion only.

In the ﬁve studies involving multiple safety devices, one study

included safety-engineered needles and needleless devices that

were either passive or semi-automatic (Chambers 2015 hospitals;

Chambers 2015 long-term nursing care). The study by Phillips

2013 used safety-engineered sharps. Reddy 2001 used safety sy-

ringes and needleless IV systems. Valls 2007 used safety vacuum

phlebotomy systems, blood-gas syringes with a needle sheath,

lancets with retractable single-use puncture sticks, safe IV catheters

(passive and active), and safe injection devices. Whitby 2008 used

multiple passive safety-engineered devices including retractable sy-

ringes, needle-free IV systems and safety winged butterﬂy needles.

In the studies on safe disposal boxes, Edmond 1988 evaluated a

bedside needle disposal; Grimmond 2010 assessed a sharps con-

tainer with enhanced safety features such as automatic lock-out

when full; and Richard 2001 introduced small containers in all

patient areas combined with an educational program.

In studies focusing on safe blood collection, Rogues 2004 intro-

duced two devices: re-sheathable winged steel needles and Vacu-

tainer blood-collecting tubes with recapping sheaths. Goldwater

1989 used a shield on the needle cap to prevent the needle from

injuring the worker. Baskin 2014 used a safety-engineered blood

gas syringe in which the cannula protection shield is activated with

one hand after puncture and clicks irreversibly over the cannula.

Representing safe injection devices, Gaballah 2012 used safety

dental syringes that did not require re-sheating or removal of the

needle from its syringe. Goris 2015 used passive subcutaneous re-

tractable syringes that automatically and instantly retract the nee-

dle from the patient into the barrel of the syringe. van der Molen

2011 evaluated an injection needle with a safety feature shielding

the needle after the injection, and Zakrzewska 2001 assessed one

type of safety syringe for dentistry. The injection devices had an

active safety mechanism that had to be activated by the workers.

A total of 17 studies reported introducing the safety devices

together with training sessions (Azar-Cavanagh 2007;Baskin

2014;Edmond 1988;Gaballah 2012;Goldwater 1989;Goris

2015;L’Ecuyer 1996 mbc;L’Ecuyer 1996 pbc;L’Ecuyer 1996

2wva;Mendelson 1998;Prunet 2008 active;Prunet 2008 passive;

Richard 2001;Rogues 2004;Seiberlich 2016;Sossai 2010;Valls

2007;van der Molen 2011;Whitby 2008;Zakrzewska 2001).

Goldwater 1989 brieﬂy stated that staff completed an educational

program. Two studies did not report on the integration of training

or education as part of the study (Grimmond 2010;Reddy 2001).

Types of study designs

Study designs used to assess the effect of the intervention were:

•six RCTs (Asai 1999 active;Asai 2002 active;Asai 2002

passive;Baskin 2014;Cote 2003;Prunet 2008 active;Prunet

2008 passive;Seiberlich 2016);

•two cluster-RCTs (L’Ecuyer 1996 2wva;L’Ecuyer 1996

mbc;L’Ecuyer 1996 pbc;van der Molen 2011);

•ﬁve CBAs (Gaballah 2012;Grimmond 2010;Mendelson

1998;Valls 2007;Zakrzewska 2001); and

•eleven ITS (Azar-Cavanagh 2007;Chambers 2015

hospitals;Chambers 2015 long-term nursing care;Edmond

1988;Goldwater 1989;Goris 2015;Phillips 2013;Reddy 2001;

Richard 2001;Rogues 2004;Sossai 2010;Whitby 2008).

Participants

There were slight differences across studies in terms of selected

participants for the study. In nine studies, researchers referred

to the broad term of healthcare personnel or hospital work-

ers as participants (Chambers 2015 hospitals;Chambers 2015

12Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

long-term nursing care;Edmond 1988;Goris 2015;Grimmond

2010;Phillips 2013;Richard 2001;Rogues 2004;Sossai 2010;van

der Molen 2011). Reddy 2001 included health personnel with the

exception of physicians. Three studies included healthcare work-

ers explicitly at risk of blood borne pathogen exposure from con-

taminated needles, referred to as house staff, physicians, medi-

cal students, nurses, nursing assistants, emergency medical tech-

nicians and environmental service workers (Azar-Cavanagh 2007;

Mendelson 1998;Whitby 2008). Three studies included nursing

personnel only as participants (L’Ecuyer 1996 2wva;Seiberlich

2016;Valls 2007;). Two studies included anaesthesiologists (Cote

2003;Prunet 2008 active;Prunet 2008 passive). In two studies re-

searchers and assistants were the persons handlingthe needl es(Asai

1999 active;Asai 1999 active;Asai 2002 active). Dental clinic staff

were the target group in one study (Zakrzewska 2001). One study

included dental and nursing students (Gaballah 2012). One study

included emergency department doctors (Baskin 2014). Another

study included only laboratory staff (Goldwater 1989)

In one RCT the number of participants were 50 each in the inter-

vention and control groups (Asai 1999 active;Asai 2002 active;

Asai 2002 passive). In another RCT there were 254 and 251 par-

ticipants in each of the intervention groups and 254 participants

in the control group (Prunet 2008 active;Prunet 2008 passive).

There were 119 participants inthe control group and 211 in the in-

tervention group in (Cote 2003) and 275 in each group in (Baskin

2014). In (Seiberlich 2016) there were 79 in the control group

and 73 in the intervention group.

In the cluster-RCTs, van der Molen 2011 reported on eight wards

in each of the two intervention groups and the control group,

representing approximately 265 workers in each of the these three

groups during the initial phase. The authors adjusted for the clus-

ter effect by means of a GEE-analysis. L’Ecuyer 1996 2wva re-

ported 19,436 patient-days for the plastic two-way valves, 3840

patient-days for the metal blunt cannula (L’Ecuyer 1996 mbc) and

15,737 patient-days for the plastic blunt needle (L’Ecuyer 1996

pbc). However, the study did not mention the number of wards

that were randomised.

In the CBA studies, Grimmond 2010 recruited 14 hospitals in

both the control and the intervention groups, approximating over-

all 19,880 full-time equivalents (FTE) during the two-year study

period. Vall s 2007 recruited seven wards for the intervention group

and ﬁve wards for the control group from a hospital with 1000

workers. Zakrzewska 2001 had approximately 300 workers in both

the intervention and control groups. Mendelson 1998 reported on

eight medical units in both the intervention and control groups,

corresponding to approximately 220 workers per group. Gaballah

2012 recruited three hospitals - one for the control group and two

for the intervention group. However, the authors did not report

data relating to the number of participants.

In the ITS studies, Azar-Cavanagh 2007 reported on 11,161

healthcare workers for the pre-intervention period (18 months)

and 12,851 healthcare workers for the post-intervention period

(18 months). Reddy 2001 reported on 3011 FTE for the pre-

intervention period (three years) and 3992 FTE for the post-in-

tervention period (three years). Rogues 2004 reported on 8500

FTE (2000 nurses) per year for the pre-intervention period (four

years) and post-intervention period (three years). Edmond 1988

followed 278 nurses for the pre-intervention period (eight months)

but provided no information to determine if this number remained

the same for the intervention period (four months). Richard 2001

did not report the number of participants in the one participating

hospital during the seven-year study period. Goldwater 1989 re-

ported 127,000 venipunctures for the pre-intervention period (six

months), and 483,000 venipunctures with the device and 232,348

without the device during the intervention period (33 months).

Sossai 2010 reported that the number of employees at the hospital

ﬂuctuated between 4447 and 4636 throughout the study period

(two years pre-intervention and three years post-intervention).

Chambers 2015 hospitals reported on an average of 325 000 FTE

per year and included nine data points. Chambers 2015 long-term

nursing care also reported on an average of 325000 FTE per year

and included nine data points. Goris 2015 reported on 857 895

employee productive hours for the pre-intervention period and

237 202 employee productive hours for the post-intervention pe-

riod. Phillips 2013 reported on 184 years of cumulative data col-

lected from 85 hospitals in the pre-intervention period (six years)

and 150 years of cumulative data collected from 85 hospitals in

the post-intervention period (ﬁve years). Whitby 2008 reported

on 3053 FTE for the pre-intervention period (12 months) and

6506 FTE for the post-intervention period (24 months).

The average number of data points in the eleven ITS studies was

13.8 and ranged from six to 39.

Outcomes

Twenty-one studies included self-reported percutaneous injuries

as their main outcome (Asai 1999 active;Asai 2002 active;Asai

2002 passive;Azar-Cavanagh 2007;Chambers 2015 hospitals;

Chambers 2015 long-term nursing care;Cote 2003;Edmond

1988;Gaballah 2012;Goldwater 1989;Goris 2015;Grimmond

2010;L’Ecuyer 1996 2wva;L’Ecuyer 1996 mbc;L’Ecuyer 1996

pbc;Mendelson 1998;Phillips 2013;Reddy 2001;Richard 2001;

Rogues 2004;Sossai 2010;Valls 2007;van der Molen 2011;

Whitby 2008;Zakrzewska 2001). Seiberlich 2016 reported on

incidence of blood leakage and blood exposure risk reduction.

In two studies (Baskin 2014;Prunet 2008 active;Prunet 2008

passive) the main outcomes were both blood splashes and NSIs.

In three studies researchers reported only blood splashes (Asai

1999 active;Asai 2002 passive;Cote 2003;Prunet 2008 active;

Prunet 2008 passive). Three studies did not report NSIs as their

main outcome as no injury was reported during the study (Asai

1999 active;Asai 2002 passive;Prunet 2008 active;Prunet 2008

passive). Cote 2003 reported that the study was underpowered to

assess the difference in needlestick injuries between the groups.

13Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel (Review)

The denominators for the self-reported NSIs included: the num-

ber of procedures (Baskin 2014;Goldwater 1989;Rogues 2004),

medical devices (Prunet 2008 active;Prunet 2008 passive;Sossai

2010), FTE (Chambers 2015 hospitals;Chambers 2015 long-

term nursing care;Grimmond 2010;Phillips 2013;Reddy 2001;

Whitby 2008), health workers (Azar-Cavanagh 2007;Edmond

1988;van der Molen 2011), patient-days and productive hours

worked (L’Ecuyer 1996 2wva;L’Ecuyer 1996 mbc;L’Ecuyer 1996

pbc), study weeks (Mendelson 1998), hours worked (Zakrzewska

2001), patients-days and patients (Valls 2007), employee produc-

tive hours (Goris 2015). Richard 2001 reported the number of

percutaneous injuries and the proportion of injuries due to im-

proper disposal of sharps, which was deﬁned by the authors as an

NSI to worker assisting with a procedure, or NSI located on the

non-dominant hand while removing the needle. The denomina-

tors for the blood splashes were patients (Asai 1999 active;Asai

2002 active;Asai 2002 passive;Prunet 2008 active;Prunet 2008

passive) and number of procedures (Baskin 2014;Cote 2003). In

one study the denominator for NSIs was not reported (Gaballah

2012).

Researchers reported the ease of use of the devices in six stud-

ies (Asai 1999 active;Asai 2002 active;Asai 2002 passive;Baskin

2014;Mendelson 1998;Prunet 2008 active;Prunet 2008 passive;

Seiberlich 2016). Five studies included a cost analysis of the inter-

vention (Goris 2015;Mendelson 1998;Valls 2007;Whitby 2008;

Zakrzewska 2001).

To be able to estimate the absolute effect of an intervention it

was important to know what the control group injury rate or

the baseline rate was. The NSI rate varied from 5.0 percutaneous

injuries (PIs) per 1000 person-years for Azar-Cavanagh 2007 to

1.03 per 1000 FTE-years for Reddy 2001.Rogues 2004 reported a

rate of 17.0 phlebotomy related PIs per 100,000 devices purchased.

Sossai 2010 had a baseline rate of 9.67 per 100,000 catheters used

per year. Goldwater 1989 reported a rate of about 49 per 100,000

venipuncture-years.

Geographical location

The included studies originated from nine different countries.

Nine studies were from the USA (Azar-Cavanagh 2007;Cote

2003;Edmond 1988;Goris 2015;Grimmond 2010;L’Ecuyer

1996 2wva;L’Ecuyer 1996 mbc

Devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel

Abstract