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

Viraj K Reddy; Marie‐Claude Lavoie; Jos H Verbeek; Manisha Pahwa

doi:10.1002/14651858.CD009740.pub3

. 2017 Nov 14;2017(11):CD009740. doi: 10.1002/14651858.CD009740.pub3

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

Viraj K Reddy ¹, Marie‐Claude Lavoie ², Jos H Verbeek ^1,^✉, Manisha Pahwa ³

Editor: Cochrane Work Group

PMCID: PMC6491125 PMID: 29190036

Abstract

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 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.

Plain language summary

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 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.

Summary of findings

Summary of findings for the main comparison. (RCT) Safe blood collection systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Safe blood collection systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel (RCTs)
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel (RCTs)  Setting: emergency care department of hospital  Intervention: Safe blood collection systems  Comparison: regular systems
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Risk with regular systems	Risk with Safe blood collection systems
Needlestick injuries immediate follow up	Study population		RR 0.20  (0.01 to 4.15)	550  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 2}
	7 per 1 000	1 per 1 000  (0 to 30)
Blood splashes	Study population		RR 0.14  (0.02 to 1.15)	550  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 3 4}
	25 per 1 000	4 per 1 000  (1 to 29)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Safe intravenous systems compared to regular systems RCT for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: hospital (general, medical, surgical and intensive care units)  Intervention: Safe intravenous systems  Comparison: regular systems RCT
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Risk with regular systems RCT	Risk with Safe intravenous systems
Needlestick injuries	Study population		Rate ratio 0.62  (0.27 to 1.41)	(1 RCT, three arms)	⊕⊝⊝⊝  VERY LOW ^{1 2}	Calculated based on 1000 patient days
	0.71 per 1 000	0.44 per 1 000  (0.19 to 1.00)
Incidences of blood contamination ‐ Active systems	Study population		RR 1.60  (1.08 to 2.36)	961  (4 RCTs)	⊕⊕⊝⊝  LOW ^{3 4}
	92 per 1 000	148 per 1 000  (100 to 218)
Incidences of blood contamination ‐ Passive systems	Study population		RR 0.94  (0.50 to 1.75)	528  (2 RCTs)	⊕⊕⊝⊝  LOW ^{3 4}
	79 per 1 000	74 per 1 000  (40 to 138)
Incidence of blood leakage ‐ Active systems	Study population		RR 0.21  (0.11 to 0.37)	147  (1 RCT)	⊕⊕⊝⊝  LOW ⁵
	684 per 1 000	144 per 1 000  (75 to 253)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Safe injection systems compared to regular systems RCT for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: hospital  Intervention: Safe injection systems  Comparison: regular systems RCT
Outcomes	*Anticipated absolute effects^ (95% CI)**		Relative effect  (95% CI)	№ of participants  (studies)	Quality of the evidence  (GRADE)	Comments
	Risk with regular systems RCT	Risk with Safe injection systems
Questionnaire reported Needlestick injuries 6 mo follow up	Study population		RR 0.42  (0.14 to 1.25)	154  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 2}
	140 per 1 000	59 per 1 000  (20 to 174)
Questionnaire reported Needlestick injuries 12 mo follow up	Study population		OR 0.20  (0.04 to 0.96)	144  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 2}
	119 per 1 000	26 per 1 000  (5 to 115)
Hospital reported Needlestick injuries 6 mo follow up	Study population		OR 1.20  (0.51 to 2.84)	533  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 2}
	38 per 1 000	45 per 1 000  (20 to 100)
Hospital reported Needlestick injuries 12 mo follow up	Study population		OR 0.72  (0.28 to 1.81)	533  (1 RCT)	⊕⊝⊝⊝  VERY LOW ^{1 2}
	41 per 1 000	30 per 1 000  (12 to 72)
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).    CI: Confidence interval; RR: Risk ratio; OR: Odds ratio;
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Safe passive injection systems compared to safe active injection systems ITS for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: hospital  Intervention: Safe passive injection systems  Comparison: safe active injection systems ITS
Outcomes	Impact	№ of participants  (studies)	Quality of the evidence  (GRADE)
Change in level of needlestick injuries	Effect size 0.23; confidence interval ‐1.89 to 2.35.	(1 observational study)	⊕⊝⊝⊝  VERY LOW ¹
Change in slope of needlestick injuries	Effect size ‐0.74; confidence interval ‐1.66 to 0.18.	(1 observational study)	⊕⊕⊝⊝  LOW ¹
Interpretation of effect size: small (0‐0.2) medium (0.2‐0.5) large (0.6 and above), a effect size with negative sign implies decrease and positive sign implies increase of effect.
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Multiple safe devices compared to regular devices ITS for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: healthcare  Intervention: Multiple safe devices  Comparison: regular devices ITS
Outcomes	Impact	№ of participants  (studies)	Quality of the evidence  (GRADE)
Number of reported sharps injuries, level	Study 1: effect size ‐1.04; confidence interval ‐2.20 to 0.12. Study 2: effect size 0.43; confidence interval ‐0.30 to 1.16.	(2 observational studies)	⊕⊝⊝⊝  VERY LOW ^{1 2 3}
Number of reported sharps injuries, slope	Study 1: effect size ‐0.01; confidence interval ‐0.15 to 0.13. Study 2: effect size 0.56; confidence interval 0.23 to 0.89.	(2 observational studies)	⊕⊝⊝⊝  VERY LOW ^{1 4}
Interpretation of effect size: small (0‐0.2) medium (0.2‐0.5) large (0.6 and above), a effect size with negative sign implies decrease and positive sign implies increase of effect.
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Sharps containers compared to no containers ITS for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: hospital  Intervention: Sharps containers  Comparison: no containers ITS
Outcomes	Impact	№ of participants  (studies)	Quality of the evidence  (GRADE)
Number of reported sharps injuries, level	Study 1: effect size 3.29; confidence interval 0.68 to 5.90. Study 2: effect size 1.35; confidence interval ‐1.75 to 4.45.	(2 observational studies)	⊕⊝⊝⊝  VERY LOW ^{1 2}
Number of reported sharps injuries, slope	Study 1: effect size 0.02; confidence interval ‐1.06 to 1.10. Study 2: effect size 2.55; confidence interval 1.20 to 3.90.	(2 observational studies)	⊕⊝⊝⊝  VERY LOW ^{1 2 3}
Interpretation of effect size: small (0‐0.2) medium (0.2‐0.5) large (0.6 and above), a effect size with negative sign implies decrease and positive sign implies increase of effect.
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Legislation compared to no legislation ITS for preventing percutaneous exposure injuries caused by needles in healthcare personnel
Patient or population: preventing percutaneous exposure injuries caused by needles in healthcare personnel  Setting: healthcare  Intervention: Legislation  Comparison: no legislation ITS
Outcomes	Impact	№ of participants  (studies)	Quality of the evidence  (GRADE)
NSI‐ change in level ‐ Interruption	Effect size ‐6.15; confidence interval ‐7.76 to ‐4.54.	(2 observational studies)	⊕⊕⊕⊝  MODERATE ¹
NSI‐ change in level ‐ Gradual introduction	Effect size 0.80; confidence interval 0.41 to 1.19.	(1 observational study)	⊕⊕⊝⊝  LOW ¹
NSI‐ Change in slope ‐ Interruption	Effect size ‐0.94; confidence interval ‐1.97 to 0.09	(2 observational studies)	⊕⊝⊝⊝  VERY LOW ^{1 2}
NSI‐ Change in slope ‐ Gradual introduction	Effect size 0.50; confidence interval 0.36 to 0.64	(1 observational study)	⊕⊕⊝⊝  LOW ¹
Interpretation of effect size: small (0‐0.2) medium (0.2‐0.5) large (0.6 and above), a effect size with negative sign implies decrease and positive sign implies increase of effect.
GRADE Working Group grades of evidence   High quality: We are very confident that the true effect lies close to that of the estimate of the effect  Moderate quality: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different  Low quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect  Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect

Study name	Device Commercial Names	Device Category	Safety Device type	passive/ active	For sale?
Asai 1999 active	Insyte AutoGuard intravenous cannula	Safe IV system (insertion)	button for actively retracting the needle	active	Yes
Asai 2002 active	Insyte Autoguard intravenous cannula	Safe IV system (insertion)	button for actively retracting the needle	active	Yes
Asai 2002 passive	Protective Acuvance	Safe IV system (insertion)	automated retraction of needle	passive	Yes
Azar‐Cavanagh 2007	Unnamed intravenous catheter stylet	Safe IV system (insertion)	retractable protection shield	active?	?
Baskin 2014	BD Eclipse injector 3‐mL, BD preset syringe with BD Luer‐Lok tip 25G×1	Blood collection	cannula protection shield is activated with one hand after puncture and clicks irreversibly over the cannula	active	Yes
Chambers 2015 hospitals	not reported	Multiple safe devices	safety engineered needles and needleless devices	passive or semi‐automatic	?
Chambers 2015 long‐term nursing care	nor reported	Multiple safe devices	safety engineered needles and needleless devices	passive or semi‐automatic	?
Cote 2003	Angiocath Autoguard IV catheters	Safe IV system (insertion)	button for actively retracting the needle	active	Yes
Edmond 1988	Winfield sharpsguard	Sharps container	bedside sharps container	n.a.	No
Gaballah 2010	Unnamed safety dental syringes	Injection system	does not require re‐sheating or removal of the needle from its syringe	passive?	?
Goldwater 1989	Needle guard Biosafe New Zealand	Blood collection	shield on cap prevents injury while recapping	n.a.	No
Goris 2015	Unnamed safety engineered passive retractable syringes	Injection system	automatically and instantly retracts the needle from the patient into the barrel of the syringe	passive	?
Grimmond 2010	Daniels sharpsmart	Sharps container	bedside sharps container	n.a.	Yes
L'Ecuyer 1996 2wva	2‐way valve Safsite Braun medical	Safe IV system (insertion and needleless)	two valve system with plastic sharp that remains in the device	passive	Yes
L'Ecuyer 1996 mbc	Lifeshield metal blunt cannula	Safe IV system (needleless iv system)	metal blunt cannula	passive	Yes
L'Ecuyer 1996 pbc	Interlink PBC plastic cannula	Safe IV system (insertion and needleless)	plastic sharp covered by blunt plastic cannula	passive	Yes
Mendelson 1998	1‐valve Safsite Braun medical	Safe IV system (needleless)	valve of IV system incompatible with needle	passive	Yes
Phillips 2013	safety engineered sharps	Multiple safe devices	not explained	?	?
Prunet 2008 active	Insyte Autoguard intravenous cannula	Safe IV system (insertion)	button for actively retracting the needle	active	Yes
Prunet 2008 passive	Introcan Safety IV system (Braun)	Safe IV system (insertion)	automatic shield on needle tip at withdrawing	passive	Yes
Reddy 2001	'safety syringes and needleless IV'	Multiple safe devices	not explained	?	?
Richard 2001	'sharps containers'	Sharps container	first in treatment rooms later bedside placements	?	?
Rogues 2004	SafetyLock BD, resheathable winged steel needle	Blood collection	after pushing (two handed) needle retracts into sheath	active	Yes
Seiberlich 2016	ViaValve safety I.V. catheter	Safe IV system (insertion)	contains a valve that is designed to restrict blood flow back out of the catheter hub upon initial venipuncture	active	Yes
Sossai 2010	Introcan safety IV system (Braun)	Safe IV system (insertion)	automatic shield on needle tip at withdrawing	passive	Yes
Valls 2007	Eclipse BD; Saf‐T‐ E‐Z Set, BD; Surshield, Terumo; Preserts BD; Provent plus, Smiths; Genie BD; Surgilance Terumo; Blunt administration needles BD	Multiple systems	n.a.	active and passive	Yes
van der Molen 2011	Eclipse BD	Injection system	after injection needle covered with shield	active	Yes
Whitby 2008	VanishPoint; VanishPoint blood tube holders; BD Safety‐Lok; SmartSite needle‐free system; Smartsite Plus	Multiple systems	retractable syringes, needle‐free IV systems and safety winged butterfly needles.	passive	Yes
Zakrzweska 2001	Safety Plus Septodont (Dental injections)	Injection system	Protective sheaths can be temporarily or definitely protect the needle	active	Yes

Study	Intervention independent of other changes	Sufficient data points	Test for trend	Intervention did not affect data collection	Blinded outcome assessment	Complete data set	Reliable outcome measure	Total score
Goldwater 1989	Not done (0) Comment: staff turnover during study period. Staff preference for the use of the intervention devices varied across study periods.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Data collection seems to remained the same pre and post‐intervention.	Not clear (0) Authors do not provide information on blinding.	Done (1)	Not clear (0): Comment: no system for NSI seems to have been in placed during the study period. Uncertain about the consistency of the reporting during the study period.	4
Rogues 2004	Done (1) Quote: "Conventional phlebotomy non‐safety devices were removed from all departments, and the new products were in place on implementation" Comment: only one device seems to have been introduced during intervention but authors do not specify if additional changes occurred during the study.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.	Not clear (0) Comment No information is available on blinding.	Not done (0) Comment: data not available for the estimated number of phlebotomies performed for 1993 and 1994.	Done (1) Comment: hospital has a sharp injury surveillance system prior and after intervention. Althought not ideal as possibility of underreporting but appropriate for the study outcome.	5
Reddy 2001	Not done (0) Quote: one of the confounder present throughout the post intervention phase was the availability of traditional needles devices. Comment: intervention occurs simultaneously with the availability of non‐safety device.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.	Not clear (0) Comment: no information available on blinding	Not done (0) Comment: physicians were excluded from analysis as no information on FTE.	Done (1) Comment: hospital had a sharp injury surveillance system prior and after intervention. Althought no ideal as possibility of underreporting but appropriate for the study outcome.	4
Azar‐Cavanagh 2007	Done (1) Comment: safety devices seem to have systematically replaced the conventional devices. Authors do not specify if additional changes occurred during the study.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Comment: the method of data collection remains the same throughout the study. It does not appears to be influenced by the intervention.	Not clear (0) Comment: authors do not specify if data analysts were blinded to the study. Healthcare workers could not have been blinded to the introduction of the new devices.	Done (1) Comment: data is available for all health workers.	Done (1) Coment:	6
Sosai 2010	Not done (0) Comment: authors indicated that some conventional devices were still used during the intervention period despite study which aimed to replace all conventional devices by new safety devices.	Done (1) comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not done (0) Quote: "after launching the sharps awareness campaign in 2003, # of injuries increased possibility because of sharps awareness campaign" Comment: intervention seems to have affected reporting of NSI.	Not clear (0) Comment: information on blinding is not reported.	Done (1) Comment: all hospital employees were included in the study.	Done (1) Comment: used the incident reporting system throughout the study which appears to be adequate measure for NSI.	4
Edmond 1988	Not clear (0) Comment: no information if additional changes were introduced during the same period at the hospital.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Comment: intervention does not appears to have affected method of data collection.	Not clear (0) Quote: "the subjects were unaware of the nature of the study". Comment: the reporting of the NSI was not likely to be affected by the staff knowing of the study. However, health workers would be aware of the change in the type of devices used.	Not clear (0) Comment: information about the number of nurses for pre‐intervention but not for post‐intervention. For NSI, the number of staff per year is not available.	Done (1) Comment: authors used employee health records for pre and post intervention. For NSI, this system appears reliable for the outcome of interest.	4
Richard 2001	Not clear (0) Comment: no information if additional changes were introduced during the same period at the hospital.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not done (0) Quote: the increase in total injuries reported in 1998 followed a better reporting stimulated by the second educational program. Comment: the reporting system started in 1993, it is possible that as more people became aware of the surveillance system, there was an increase in reporting.	Not clear (0) Comment: No information is available on blinding	Not clear (0) Comment: no information on the actual number of healthcare workers included during pre and post intervention.	Not clear (0) Comment: it is unclear if the reporting system was used consistently throughout the years especially as it was launched during the early phase of the study.	2
Chambers 2015 hospitals	Done (1) Comment: safety devices seem to have replaced the conventional devices due to legislation.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not clear (0) Comment: Increased attention to needle stick injury prevention during the period of regulatory change may have resulted in increased reporting.	Done (1) Comment: data was obtained from an administrative source.	Not done (0) Comment: the data set represented 63 percent of all needlestick injury claims.	Done (1) Comment: authors used work place safety and insurance board data for compensation claims. For NSI, this system appears reliable for the outcome of interest.	5
Chambers 2015 long‐term nursing care	Done (1) Comment: safety devices seem to have replaced the conventional devices due to legislation.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not clear (0) Comment: Increased attention to needle stick injury prevention during the period of regulatory change may have resulted in increased reporting.	Done (1) Comment: data was obtained from an administrative source.	Not done (0) Comment: the data set represented 63 percent of all needlestick injury claims.	Done (1) Comment: authors used work place safety and insurance board data for compensation claims. For NSI, this system appears reliable for the outcome of interest.	5
Goris 2015	Done (1) Quote: "The existing inventories of subcutaneous active safety‐engineered devices were removed and replaced with subcutaneous passive safety‐engineered devices" Comment: All conventional devices were replaced by safety‐engineered devices at the start of the intervention.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not clear (0) Comment: the reporting might have increased after inrodcution of the passive safety‐engineered device due to heightened awareness.	Done (1) Comment: data was obtained from an administrative source.	Done (1) Comment: data for all the healthcare workers was provided in the form of employee productive hours in the pre and post intervention phase.	Done(1) Comment: authors used BJC occupational health database records for pre and post intervention. This being administrative data appears to be reliable for the outcome of interest.	6
Phillips 2013	Done (1) Comment: safety devices seem to have replaced the conventional devices due to legislation.	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Not clear (0)	Done (1) Comment: data was obtained from an administrative source.	Not done (0) Comment: Data set represented only 73% of the total sample.	Done (1) Comment: Data was obtained from the US Exposure Prevention Information Network (EPINet) sharps injury surveillance database. This appears to be adequate measure for NSIs.	5
Whitby 2008	Not clear (0)	Done (1) Comment: inlcusion of 3 data points before and after, the study was reanalysed using ARIMA model.	Done (1) Comment: we reanalysed the study for trend.	Done (1) Comment: the constant and unchanging rate of NSI with solid suture needles implies that reduction of NSI relates neither to the education program associated or increased reporting rates.	Not done (0) Comment: health workers were aware of the change in the type of devices used.	Done (1) Comment: data is available for all health workers.	Done (1) Comment: used the same system of reporting of NSI in pre and post intervention period to the infectious diseases department which has been in place since 1996.	5

Comparison and outcome	Starting level	Risk of bias	Consistency	Directness	Precision	Publication bias	Quality of evidence
Safe versus traditional blood collection systems RCT ‐ all outcomes	high	1 RCT high RoB	consistent	direct	wide CI	impossible to determine	very low
Safe versus traditional blood collection systems ITS	low	2 ITS high RoB	consistent	direct	wide CI	impossible to determine	very low
Safe versus traditional IV systems RCT ‐ all outcomes	high	5 RCT high RoB, 1 RCT low RoB	consistent	direct	wide CI	impossible to determine	very low
Safe versus traditional IV systems CBA	low	1 CBA high RoB	consistent	direct	wide CI	impossible to determine	very low
Safe versus traditional IV systems ITS	low	1 ITS low RoB, 1 ITS high RoB	consistent	direct	wide CI	impossible to determine	very low
Safe versus traditional injection systems RCT	high	1 RCT high RoB	consistent	indirect; hospital	wide CI	impossible to determine	very low
Safe versus traditional injection systems CBA	low	1 CBA high RoB	consistent	indirect; dentists	wdie CI	impossible to determine	very low
Safe pasive injection systems versus safe active injection systems ITS	low	1 ITS low RoB	consistent	direct	wide CI	impossible to determine	very low
Multiple safe versus traditional devices ITS	low	2 ITS high RoB	inconsistent	direct	wide CI	impossible to determine	very low
Multiple safe versus traditional devices CBA	low	1 CBA high RoB	consistent	direct	wide CI	impossible to determine	very low
Sharps containers versus no containers ITS	low	1 ITS low RoB, 1 ITS high RoB	inconsistent	direct	wide CI	impossible to determine	very low
Sharps containers versus no containers CBA ‐ all outcomes	low	1 CBA high RoB	consistent	direct	wide CI	impossible to determine	very low
Legislation versus no legislation ITS	low	2 ITS high RoB	consistent	direct	wide CI	impossible to determine	low

Date	Event	Description
8 November 2017	New citation required but conclusions have not changed	We updated the review with seven new studies which left the conclusions largely unchanged.
11 August 2017	New search has been performed	We updated the systematic searches and incorporated their results in the review. We also added a new comparison about the introduction of legislation.
7 February 2012	Amended	The original version of this protocol was published with the title: "Prevention of percutaneous injuries with risk of hepatitis B, hepatitis C, or other viral infections for health‐care workers". However, it turned out that the scope was far too wide and would result in an unmanageable number of studies for one review. Therefore the decision was taken to split the protocol into four new ones. The other three new titles are: "Blunt versus sharp suture needles for preventing percutaneous exposure incidents in surgical staff", "Education and training for preventing percutaneous exposure injuries in health care personnel" and "Extra gloves or special types of gloves versus a single pair of gloves for preventing percutaneous exposure injuries in healthcare personnel".

Database	Period of search	Search strategy
The Cochrane Hepato‐Biliary Group Controlled Trials Register	1996 to 7 Oct 2010	('health care worker' or 'health personnel' or 'HCWs' ) and ( 'virus disease' or 'virus' or 'viral infect')
EMBASE	1974 to 17 Sept 2010	#6 #5 AND [humans]/lim AND [embase]/lim #5 #3 AND #4 #4 [randomized controlled trial]/lim OR [controlled clinical trial]/lim OR random* OR 'double blind' OR 'single blind' OR (singl* OR doubl* OR trebl* OR tripl* AND (blind* OR mask)) OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'triple blind procedure'/exp OR placebo OR 'controlled study'/exp OR 'cross sectional study'/exp OR 'crossover procedure'/exp OR 'latin square design'/exp OR 'follow up'/exp OR 'comparative study'/exp OR 'evaluation studies'/exp OR 'evaluation study' OR prospectiv* OR volunteer* #3 #1 AND #2 #2 'health care personnel'/exp OR 'health care personnel' OR 'health care worker'/exp OR 'health care worker' OR 'health care workers' OR 'health care facilities and services'/exp OR 'medical profession'/exp OR 'nursing as a profession'/exp OR ('virus transmission'/exp AND 'patient'/exp AND professional) #1 'needlestick injury'/exp OR needlestick* OR 'needle stick'/exp OR 'sharp injury' OR 'sharp injuries' OR 'sharp medical' OR 'sharp instrument' OR 'sharp needle' OR 'sharp needles' OR sharps OR 'percutaneous exposure' OR 'percutaneous injury' OR 'percutaneous injuries' OR 'percutaneous trauma' OR 'stick injury' OR 'stick injuries' OR 'stab wound'/exp OR 'face injury'/de OR 'eye injury'/de OR 'arm injury'/de OR 'hand injury'/de OR 'needle'/exp OR (splash* AND ('blood'/exp OR blood OR secretion* OR fluid* OR 'body fluid'/exp OR 'body fluids'/exp))
Wiley InterScience  Cochrane Library Databases:  CENTRAL and NHSEED	1993 to 7 Oct 2010	#3 #1 AND #2 #2 EXP Needlestick Injuries (MeSH) OR needlestick* OR "needle stick OR "needle sticks" OR "percutaneous exposure" OR "percutaneous exposures" OR "percutaneous injury" OR "percutaneous injuries2 OR "stick injury" OR "stick injuries" OR Wounds, Stab (MeSH) OR Wounds, Penetrating (MeSH) OR Facial injuries (MeSH) OR EXP Eye Injuries, Penetrating (MeSH) OR Forearm Injuries (MeSH) OR EXP Hand Injuries (MeSH) OR [splash* AND blood OR secretion* OR fluid* OR EXP Body Fluids (MeSH) OR EXP Bodily Secretions (MeSH)] #1 EXP Health Occupations (MeSH) OR EXP Health Personnel (MeSH) OR EXP Health Facilities (MeSH) OR "health care worker" OR "health care workers" OR Disease Transmission, patient‐to‐Professional (MeSH)
Science Citation Index Expanded	1986 to 5 October 2010	#4 #1 AND #2 AND #3 #3 TS=(random* OR control* OR trial OR trials OR "single blind" OR "double blind" OR "triple blind" OR "latin square" OR placebo* OR comparative OR "follow up" OR prospectiv* OR "cross over" OR volunteer) #2 TS=(needlestick OR "needle stick" OR "needle sticks" OR "stick injury" OR "stick injuries" OR "wound stab" OR "stab wound" OR "penetrating wound" OR "penetrating wounds") OR TS=(sharp* AND ( injury OR injuries OR medical OR instrument)) OR TS=(percutaneous AND (exposure OR exposures OR injury OR injuries)) OR TS=(injur AND (facial OR eye OR eyes OR arm OR hand OR finger OR fingers)) OR TS=(splash* AND (blood OR secretion* OR fluid OR fluids)) OR TS="blood borne infection" #1 TS=("health care worker" OR "health care workers" OR "health occupations" OR "health personnel" OR physician* OR nurse* OR hospital* OR clinic OR clinics)
CINAHL	1982 to 30 Sept 2010	#5 #3 AND #4 #4 "randomized controlled trial" or "clinical trials" or "clinical trial" or "random allocation" or "double blind". or "single blind" or ((singl* or doubl* or trebl* or tripl) and (blind or mask)) or "latin square" or placebo# or random or "research design" or "comparative study" or "comparative studies" or "evaluation study" or "evaluation studies" or "follow up study" or "follow up studies" or "prospective study" or "prospective studies" or "cross over study" or "cross over studies" or control* or prospective* or volunteer or (MH "Clinical Trials+") or (MH "Nonrandomized Trials") or (MH "Crossover Design") #3 #1 AND #2 #2 TX "needlestick injury" or needlestick# or "needle stick" or "needle sticks" or "sharp injury" or "sharp injuries" or "sharp medical device" or "sharp medical devices" or "sharp instrument" or "sharp instruments" or "sharp needle" or "sharp needles" or "percutaneous exposure" or "percutaneous exposures" or "percutaneous injury" or "percutaneous injuries" or "stick injury" or "stick injuries" or "wounds, stab" or "wounds, penetrating" or "facial injuries" or "eye injuries, penetrating" or "arm injuries" or "forearm injuries" or "hand injuries" or "finger injuries" or (splash# and (blood or secretion# or fluid#)) or ("occupational exposure" and ("body fluid" or "body fluids" or blood)) #1 (MH "Health Occupations") OR health occupations or (MH "Health Personnel+") or (MH "Health Facilities+") OR health facilities or TX "health care worker" or TX "health care workers" or (MH "Personnel, Health Facility+") or (MH "Occupational Health Services+") or (MH "Occupational Hazards+") or (MH "Occupational Exposure") or TX "health care personnel" or (MH "Health Personnel+") or (MH "HIV Infections+")
OSH UPDATE (NIOSHTIC‐2 and CISDOC)	NIOSHTIC‐2: 1900 to 7 Oct 2010  CISDOC: 1987 to 7 Oct 2010	#15 #13 AND #14 #14 PY{2007} OR PY{2008} OR PY{2009} #13 #7 AND #12 #12 #8 OR #11 #11 #9 AND #10 #10 GW{blind* OR mask} #9 GW{singl OR doubl* OR tripl* OR trebl} #8 GW{random OR control* OR trial OR trials OR comparativ* OR evaluation* OR "latin square" OR placebo OR "follow up" OR prospectiv* OR "cross over" OR volunteer} #7 #1 AND #6 #6 #2 OR #5 #5 #3 AND #4 #4 GW{splash} #3 GW{blood OR fluid* OR secretion} #2 GW{"sharp medical" OR "sharp instrument" OR "sharp instruments" OR needlestick OR "needle stick" OR "needle sticks" OR "sharp injury" OR "sharp injuries" OR "stab wound" OR "stab wounds" OR "wound penetrating" OR "stick injury" OR "stick injuries" OR "percutaneous injury" OR "percutaneous injuries" OR "percutaneous exposure" OR "percutaneous exposures" OR "sharp needle" OR "sharp needles"} #1 GW{nurse OR nurses OR physician OR physicians OR hospital* OR "health occupation" OR "health occupations" OR "health personnel" OR "health care personnel" OR "health care worker" OR "health care workers" OR "health worker" OR "health workers"}
MEDLINE in PubMed	from 1950 to 17 Sept 2010	#5 Search #1 AND #2 AND (#3 OR #4) #4 Search effect[tw] OR control[tw] OR controls[tw] OR controla[tw] OR controle[tw] OR controli[tw] OR controll[tw] OR control'[tw] OR evaluation[tw] OR program[tw] #3 ("Randomized Controlled Trial"[pt] OR "Controlled Clinical Trial"[pt] OR "Randomized Controlled Trials as Topic"[mh] OR "Random Allocation"[mh] OR "Double‐Blind Method"[mh] OR "Single‐Blind Method"[mh] OR "Clinical Trial"[pt] OR "Clinical Trials as Topic"[mh] OR "clinical trial"[tw] OR ((singl[tw] OR doubl[tw] OR trebl[tw] OR tripl[tw]) AND (mask[tw] OR blind[tw])) OR "latin square"[tw] OR Placebos[mh] OR placebo[tw] OR random[tw] OR "Research Design"[mh:noexp] OR "Comparative Study"[pt] OR "Evaluation Studies as Topic"[mh] OR "Follow‐up Studies"[mh] OR "Prospective Studies"[mh] OR "Cross‐over Studies"[mh] OR control[tw] OR controls[tw] OR controla[tw] OR controle[tw] OR controli[tw] OR controll[tw] OR control'[tw] OR prospectiv[tw] OR volunteer[tw]) NOT (Animals[mh] NOT Humans[mh) #2 "Needlestick injuries"[mh] OR needlestick[tw] OR "needle stick"[tw] or "needle sticks"[tw] OR "sharp injury"[tw] OR "sharp injuries"[tw] OR sharps[tw] OR "sharp medical device"[tw] OR "sharp medical devices"[tw] OR "sharp instrument"[tw] OR "sharp instruments"[tw] OR "sharp medical instrument"[tw] OR "sharp medical instruments"[tw] OR "sharp needle"[tw] OR "sharp needles"[tw] OR "percutaneous exposure"[tw] OR "percutaneous exposures"[tw] OR "percutaneous injury"[tw] OR "percutaneous injuries"[tw] OR "stick injury"[tw] OR "stick injuries"[tw] OR "Wounds, Stab"[mh:noexp] OR "Wounds, Penetrating"[mh:noexp] OR "Facial injuries"[mh:noexp] OR "Eye Injuries, Penetrating"[mh] OR "Arm Injuries"[mh:noexp] OR "Forearm Injuries"[mh:noexp] OR "Hand Injuries"[mh] OR (splash* AND (blood[tw] or secretion[tw] OR fluid[tw] OR "Body Fluids"[mh])) #1 "Health Occupations"[mh] OR "Health Personnel"[mh] OR "Health Facilities"[mh] OR "health care worker"[tw] OR "health care workers"[tw] OR "Infectious Disease Transmission, Patient‐to‐Professional"[mh]
PsycINFO (OvidSP)	1967 to 6 Oct 2010	#5 limit 4 to all journals #4 #1 AND #2 AND #3 #3 random* OR control* OR trial OR trials OR comparativ* OR evaluation* OR ((singl* OR doubl* OR tripl* OR trebl) AND (blind OR mask)) OR "latin square" OR placebo OR "follow up" OR prospectiv* OR "cross over" OR volunteer* #2 (splash* AND (blood OR secretion* OR fluid OR fluids)) OR ("eye injuries" AND penetrating) OR (wound* AND (stab OR penetrating)) OR "percutaneous exposure" OR "percutaneous exposures" OR "percutaneous injury" OR "percutaneous injuries" OR "stick injury" OR "stick injuries" OR "sharp injury" OR "sharp injuries" OR "sharp medical" OR "sharp instrument" OR "sharp instruments" OR "sharp needle" OR "sharp needles" OR needlestick* OR "needle stick" OR "needle sticks" #1 (nursing or nurse or nurses or physician or physicians or "health care personnel" or "health personnel" or "health care worker" or "health care workers" or "Clinicians" or "Dentist" or "Health‐Personnel" or "Medical Personnel" or "Military‐Medical‐Personnel" or "Nurses" or "Physician" or "Psychiatric‐Hospital‐Staff*" or "medical students" or "hospitals" or "occupational exposure" or "occupational exposures").mp. [mp=title, abstract, heading word, table of contents, key concepts]
LILACS		"Health Occupations" or "Health Personnel" OR "Health Facilities" OR "health care worker" OR "health care workers" OR "Disease Transmission, Patient‐to‐Professional" OR "INJURIES" or "WOUNDS AND INJURIES/PC" or "accidents, OCCUPATIONAL" or "injuries, poisonings, and OCCUPATIONAL diseases" or "OCCUPATIONAL exposure" or "OCCUPATIONAL health policy" or "OCCUPATIONAL risks" OR "INJURIES" or "WOUNDS AND INJURIES/PC" or "accidents, OCCUPATIONAL" or "injuries, poisonings, and OCCUPATIONAL diseases" or "OCCUPATIONAL exposure" or "OCCUPATIONAL health policy" or "OCCUPATIONAL risks" [Descritor de assunto] and "CLINICAL TRIAL" OR "CLINICAL TRIAL, PHASE I" OR "CLINICAL TRIAL, PHASE II" OR "CLINICAL TRIAL, PHASE III" OR "CLINICAL TRIAL, PHASE IV" OR "COMPARATIVE STUDY" OR "CONTROLLED CLINICAL TRIAL" OR "EVALUATION STUDIES" OR "META‐ANALYSIS" OR "MULTICENTER STUDY" OR "RANDOMIZED CONTROLLED TRIAL" OR "REVIEW" [Tipo de publicação] and not "ANIMALS" or "HUMANS" [Palavras]

Database	Period of search	Search strategy
EMBASE	1 Jan 2014 to 1 November 2016	#6 #5 AND [humans]/lim AND [embase]/lim    #5 #1 AND #2 AND #3 AND #4    #4 [randomized controlled trial]/lim OR [controlled clinical trial]/lim OR random* OR 'double blind' OR 'single blind' OR (singl* OR doubl* OR trebl* OR tripl* NEAR1 (blind* OR mask)) OR 'single blind procedure'/exp OR 'double blind procedure'/exp OR 'triple blind procedure'/exp OR placebo OR 'controlled study'/exp OR 'cross sectional study'/exp OR 'crossover procedure'/exp OR 'latin square design'/exp OR 'follow up'/exp OR 'comparative study'/exp OR 'evaluation studies'/exp OR 'evaluation study' OR prospectiv* OR cohort OR (comparative NEAR/1 study) OR ‘time series’/exp    #3 'health care personnel'/exp OR 'health care personnel' OR 'health care worker'/exp OR 'health care worker’ OR ‘health workers’ OR ‘health professional’ OR ‘health care professionals’ OR ‘medical care professionals’ OR dentist* OR anesth* OR anaesth* OR phlebotomist OR surgeon* OR physician* OR doctor* OR nurse* OR 'health care workers' OR 'medical profession'/exp OR 'nursing as a profession'/exp OR hospital/exp OR 'health care facilities and services’/exp    #2 (sharp NEAR/2 (instrument* OR needle)) OR recap OR ((medical OR safe) NEAR/1 device) OR 'safety engineered' OR syringe OR (iv NEAR/1 system) OR (sharps NEAR/1 container)    #1 'needle stick injury'/exp OR (needle NEAR/1 stick) OR 'sharps injury' OR 'sharps injuries' OR 'percutaneous exposure' OR 'percutaneous injury' OR 'percutaneous injuries' OR 'percutaneous trauma' OR (splash NEAR/1 (blood OR secretion* OR fluid* OR 'body fluid' OR 'body fluids'))
Science Citation Index Expanded	1 Jan 2014 to 1 November 2016	#5 #1 AND #2 AND #3 AND #4    #4 TS=(random* OR control* OR trial OR trials OR "single blind" OR "double blind" OR "triple blind" OR "latin square" OR placebo* OR comparative OR "follow up" OR prospectiv* OR "cross over" OR volunteer)    #3 TS=(“sharps” OR “sharp medical device” OR “sharp medical devices” OR “sharp instrument” OR “sharp instruments” OR “sharp needle” OR “sharp needles” OR syringe OR “IV‐system” OR “sharps container” OR “safety engineered” OR recap* OR device)    #2 TS=(needlestick OR "needle stick" OR "needle sticks" OR "stick injury" OR "stick injuries" OR "wound stab" OR "stab wound" OR "penetrating wound" OR "penetrating wounds") OR TS=(sharp* AND ( injury OR injuries OR medical)) OR TS=(percutaneous AND (exposure OR exposures OR injury OR injuries)) OR TS=(injur* AND (facial OR eye OR eyes OR arm OR hand OR finger OR fingers)) OR TS=(splash* AND (blood OR secretion* OR fluid OR fluids)) OR TS="blood borne infection”    #1 TS=("health care worker" OR "health care workers" OR "health occupations" OR "health personnel" OR physician* OR nurse* OR hospital* OR clinic OR clinics OR “healthcare worker” OR “health worker” OR “health professional” OR “health professionals” OR “healthcare professional” OR “health care professional” OR “medical care personnel” OR dentist* OR doctor* OR anesth* OR anaesth* OR phlebotomist* OR surgeon* OR veterinarian*)
PsycINFO (OvidSP)	1 Jan 2014 to 1 November 2016	#6 limit #5 to all journals    #5 #1 AND #2 AND #3 AND #4    #4 random* OR control* OR trial OR trials OR comparativ* OR evaluation* OR ((singl* OR doubl* OR tripl* OR trebl) AND (blind OR mask)) OR "latin square" OR placebo OR "follow up" OR prospectiv* OR "cross over" OR volunteer*    #3 (“sharps" OR "sharp medical device” OR "sharp medical devices" OR "sharp instrument" OR "sharp instruments" OR "sharp medical instrument" OR "sharp medical instruments” OR “needlestick” OR “needle stick” OR “needle sticks” OR "sharp needle" OR "sharp needles" OR "syringe" OR "IV‐system" OR "sharps container" OR "safety engineered” OR “recap" OR “device”)    #2 (splash* AND (blood OR secretion* OR fluid OR fluids)) OR ("eye injuries" AND penetrating) OR (wound* AND (stab OR penetrating)) OR "percutaneous exposure" OR "percutaneous exposures" OR "percutaneous injury" OR "percutaneous injuries" OR "stick injury" OR "stick injuries" OR "sharp injury" OR "sharp injuries" needlestick* OR "needle stick" OR "needle sticks”    #1 (nursing or nurse or nurses or physician or physicians or "health care personnel" or "health personnel" or "health care worker" or "health care workers" or "Clinicians" or "Dentist” or “anesth” or “anaesth” or “phlebotomist” or “surgeon” or “veterinarian" or "Health‐Personnel" or "Medical Personnel" or "Military‐Medical‐Personnel" or "Nurses" or "Physician" or "Psychiatric‐Hospital‐Staff*" or "medical students" or "hospitals" or "occupational exposure" or "occupational exposures").mp. [mp=title, abstract, heading word, table of contents, key concepts]
Wiley InterScience  Cochrane Library Databases:  CENTRAL and NHSEED	1 Jan 2014 to 1 November 2016	#4 #1 AND #2 AND #3    #3 EXP Health Occupations (MeSH) OR EXP Health Personnel (MeSH) OR EXP Health Facilities (MeSH) OR "health care worker" OR "health care workers" OR Disease Transmission, patient‐to‐Professional (MeSH) OR “health workers” Or “health worker” OR “health professional” OR “health professionals” OR “healthcare professional” OR “healthcare professionals” OR “health care professional” OR “health care professionals” OR “medical care personnel” OR dentist* OR surgeon* OR physician* OR doctor* OR anesth* OR anaesth* OR phlebotomist* OR nurse* OR veterinarian*    #2 EXP Needlestick Injuries (MeSH) OR needlestick* OR “needle stick” OR “needle sticks” OR “percutaneous exposure” OR “percutaneous exposures” OR “percutaneous injury” OR “percutaneous injuries” OR “stick injury” OR “stick injuries” OR Wounds, Stab (MeSH) OR Wounds, Penetrating (MeSH) OR Facial injuries (MeSH) OR EXP Eye injuries, penetrating (MeSH) OR Forearm Injuries (MeSH) OR EXP Hand Injuries (MeSH) OR splash* AND blood OR secretion* OR fluid* OR EXP Body Fluids (MeSH) OR EXP Bodily Secretions (MeSH)    #1 sharps OR "sharp medical device” OR “sharp medical devices” OR “sharp instrument” OR “sharp instruments” OR “sharp medical instrument” OR “sharp medical instruments” OR “sharp needle” OR “sharp needles” OR syringe* OR IV‐system* OR “sharps container” OR "safety engineered” OR “recap” OR “device"
CINAHL	1 Jan 2014 to 1 November 2016	S5 S1 AND S2 AND S3 AND S4    S4 "randomized controlled trial" or "clinical trials" or "clinical trial" or "random allocation" or "double blind". or "single blind" or ((singl* or doubl* or trebl* or tripl) and (blind or mask)) or "latin square" or placebo# or random or "research design" or "comparative study" or "comparative studies" or "evaluation study" or "evaluation studies" or "follow up study" or "follow up studies" or "prospective study" or "prospective studies" or "cross over study" or "cross over studies" or control* or prospective* or volunteer or (MH "Clinical Trials+") or (MH "Nonrandomized Trials") or (MH "Crossover Design”)    S3 TX "sharp medical device" or "sharp medical devices" or "sharp instrument" or "sharp instruments" or "sharp needle" or "sharp needles" or "sharps" or "sharp medical instrument" or "sharp medical instruments" or “syringe" or "IV‐system" or "sharps container" or "safety engineered" or “recap" or “device”    S2 TX "needlestick injury" or needlestick# or "needle stick" or "needle sticks" or "sharp injury" or "sharp injuries” or "percutaneous exposure" or "percutaneous exposures" or "percutaneous injury" or "percutaneous injuries" or "stick injury" or "stick injuries" or "wounds, stab" or "wounds, penetrating" or "facial injuries" or "eye injuries, penetrating" or "arm injuries" or "forearm injuries" or "hand injuries" or "finger injuries" or (splash# and (blood or secretion# or fluid#)) or ("occupational exposure" and ("body fluid" or "body fluids" or blood)    S1 (MH "Health Occupations") OR health occupations or (MH "Health Personnel+") or (MH "Health Facilities+") OR health facilities or TX "health care worker" or TX "health care workers" or (MH "Personnel, Health Facility+") or (MH "Occupational Health Services+") or (MH "Occupational Hazards+") or (MH "Occupational Exposure") or TX "health care personnel" or (MH "Health Personnel+") or (MH "HIV Infections+") or TX "medical care professionals" or (MH "Infectious Disease Transmission, Patient‐to‐Professional+") or TX “dentist" or TX “anesth" or TX “anaesth" or TX “phlebotomist" or TX “surgeon" or TX “physician" or TX “doctor" or TX “nurse" or TX “veterinarian”
OSH UPDATE	1 Jan 2014 to 1 November 2016	#3 needlestick* OR "needle stick" OR "needle sticks" OR "sharps injury" OR "sharps injuries" OR "percutaneous injury" OR "percutaneous injuries" OR "percutaneous exposure" OR "percutaneous exposures" OR “blood splash” OR “blood splashes” #2 "sharp instrument" OR "sharp instruments" OR "sharp needle" OR "sharp needles" OR recap* OR “safe device” OR “safety engineered” OR “sharps containers” OR “IV system” OR device* #1 'health care personnel' OR 'health care worker’ OR ‘health care workers’ OR ‘health professional’ OR ‘health care professionals’ OR dentist* OR anesth* OR anaesth* OR phlebotomist OR surgeon* OR physician* OR doctor* OR nurse* OR hospital
MEDLINE in PubMed	1 Jan 2014 to 1 November 2016	#6 (#1 AND #2 AND #3 AND (#4 OR #5))    #5 (effect[tw] OR control[tw] OR controls[tw] OR controla[tw] OR controle[tw] OR controli[tw] OR controll[tw] OR control'[tw] OR evaluation[tw] OR program[tw])    #4 (("Randomized Controlled Trial"[pt] OR "Controlled Clinical Trial"[pt] OR "Randomized Controlled Trials as Topic"[mh] OR "Random Allocation"[mh] OR "Double‐Blind Method"[mh] OR "Single‐Blind Method"[mh] OR "Clinical Trial"[pt] OR "Clinical Trials as Topic"[mh] OR "clinical trial"[tw] OR ((singl[tw] OR doubl[tw] OR trebl[tw] OR tripl[tw]) AND (mask[tw] OR blind[tw])) OR "latin square"[tw] OR Placebos[mh] OR placebo[tw] OR random[tw] OR "Research Design"[mh:noexp] OR "Comparative Study"[pt] OR "Evaluation Studies as Topic"[mh] OR "Follow‐up Studies"[mh] OR "Prospective Studies"[mh] OR "Cross‐over Studies"[mh] OR control[tw] OR controls[tw] OR controla[tw] OR controle[tw] OR controli[tw] OR controll[tw] OR control'[tw] OR prospectiv[tw] OR volunteer[tw]) NOT (Animals[mh] NOT Humans[mh))    #3 ("sharps"[tw] OR "sharp medical device"[tw] OR "sharp medical devices"[tw] OR "sharp instrument"[tw] OR "sharp instruments"[tw] OR "sharp medical instrument"[tw] OR "sharp medical instruments"[tw] OR "sharp needle"[tw] OR "sharp needles"[tw] OR "syringe"[tw] OR "IV‐system"[tw] OR "sharps container"[tw] OR "safety engineered"[tw] OR “recap"[tw] OR “device"[tw])    #2 ("Needlestick injuries"[mh] OR needlestick[tw] OR "needle stick"[tw] or "needle sticks"[tw] OR "sharp injury"[tw] OR "sharp injuries"[tw] OR "percutaneous exposure"[tw] OR "percutaneous exposures"[tw] OR "percutaneous injury"[tw] OR "percutaneous injuries"[tw] OR "stick injury"[tw] OR "stick injuries"[tw] OR "Wounds, Stab"[mh:noexp] OR "Wounds, Penetrating"[mh:noexp] OR "Facial injuries"[mh:noexp] OR "Eye Injuries, Penetrating"[mh] OR "Arm Injuries"[mh:noexp] OR "Forearm Injuries"[mh:noexp] OR "Hand Injuries"[mh] OR (splash AND (blood[tw] or secretion[tw] OR fluid[tw] OR "Body Fluids"[mh])))    #1 (("Health Personnel"[Majr] OR "health personnel"[tiab] OR "health care personnel"[tw] OR "healthcare personnel"[tw] OR "health care worker"[tw] OR "health care workers"[tw] OR "healthcare worker"[tw] OR "healthcare workers"[tw] OR "health worker"[tw] OR "health workers"[tw] OR "health professional"[tw] OR "health professionals"[tw] OR "health care professional"[tw] OR "health care professionals"[tw] OR "healthcare professional"[tw] OR "healthcare professionals"[tw] OR "medical care personnel"[tw] OR "Health Occupations"[mh] OR "Health Personnel"[mh] OR "Health Facilities”[mh] OR "Infectious Disease Transmission, Patient‐to‐Professional"[mh] OR "dentist"[tw] OR “anesth”[tw] OR “anaesth”[tw] OR “phlebotomist”[tw] OR “surgeon”[tw] OR “physician”[tw] OR "doctor"[tw] OR "nurse"[tw] OR “veterinarian*"[tw]))

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 Number of reported sharps injuries, level	2	Effect Size (Random, 95% CI)	‐3.84 [‐9.56, 1.88]
1.1 Cap shield	1	Effect Size (Random, 95% CI)	‐1.04 [‐2.27, 0.19]
1.2 Needle sheath	1	Effect Size (Random, 95% CI)	‐6.88 [‐9.53, ‐4.23]
2 Number of reported sharps injuries, slope	2	Effect Size (Fixed, 95% CI)	Totals not selected
2.1 Cap shield	1	Effect Size (Fixed, 95% CI)	0.0 [0.0, 0.0]
2.2 Needle sheath	1	Effect Size (Fixed, 95% CI)	0.0 [0.0, 0.0]

Methods	Study design: Randomised Controlled Trial with two intervention arms and one control arm. Object of randomisation: patients.
Participants	Japan. Researchers and assistants performing intravenous (n = 150) and intra‐arterial cannulations (n = 150) in elective surgery. Number studied: 300 patients. Intervention group one n = 100 (Insyte Autoguard cannula with a button for actively retracting the needle. Control group n = 100 (divided over the two intervention arms).
Interventions	Arm one: Use of safeguarded needles (Insyte Autoguard) in intravenous cannulations. The control group used conventional Insyte catheter needles.
Outcomes	Needlestick injuries (none detected), median number of blood contamination from inserted catheter or needles on staff, patients, equipment or tray.
Notes	We combined the results of the intravenous and intra‐arterial cannulation when the same devices were used.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"In each part of the study, patients were randomly allocated intro three groups. Block randomisation (in blocks of 15) was used for the allocation. No additional information available on randomisation process.
Allocation concealment (selection bias)	Low risk	"cards indicating allocations were placed in a serially numbered, sealed opaque envelope?" Adequate allocation concealment.
Blinding (performance bias and detection bias)   All outcomes	Low risk	"The presence or absence of blood on a tray was assessed by a researcher who was blinded to the allocation" Healthcare workers could not have been blinded as they were using the devices but bias seems unlikely here.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	No missing outcome data.
Selective reporting (reporting bias)	Low risk	Authors reported the outcomes mentioned in the method section: information is available for the three groups for the ease of insertion, information on the backflow, ease of handling needle, blood contamination, needlestick injuries and problems at insertion.
Similar recruitment of groups	Unclear risk	Patients characteristics were similar in terms of the age, weight and height. There were differences between groups for sex. No information available on the characteristics of the researchers and assistants such as years of experience, professions, difference between the intervention and control groups in terms of the staff.
Adjustment for baseline differences	Unclear risk	No information related to adjustment for baseline differences is reported.
Other bias	High risk	"We thank Japan Becton for supplying Insyte and Insyte Autoguards and Johnson & Johnson Medical for supplying protective acuvance needles." The involvement of a medical devices manufacturing company may have potentially introduced information bias.

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Needlestick injuries immediate follow up	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected
2 Blood splashes	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Needlestick injuries	3		Rate Ratio (Fixed, 95% CI)	0.62 [0.27, 1.41]
2 Incidences of blood contamination	6	1489	Risk Ratio (M‐H, Fixed, 95% CI)	1.38 [1.00, 1.92]
2.1 Active systems	4	961	Risk Ratio (M‐H, Fixed, 95% CI)	1.60 [1.08, 2.36]
2.2 Passive systems	2	528	Risk Ratio (M‐H, Fixed, 95% CI)	0.94 [0.50, 1.75]
3 Incidence of blood leakage	1		Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3.1 Active systems	1		Risk Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 Questionnaire reported Needlestick injuries 6 mo follow up	1	Risk Ratio (M‐H, Fixed, 95% CI)	Totals not selected
2 Hospital reported Needlestick injuries 6 mo follow up	1	Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
3 Questionnaire reported Needlestick injuries 12 mo follow up	1	Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected
4 Hospital reported Needlestick injuries 12 mo follow up	1	Odds Ratio (M‐H, Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 change in level of needlestick injuries	1		Effect size (Random, 95% CI)	Totals not selected
2 Change in slope of needlestick injuries	1		Effect Size (Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of reported sharps injuries, level	2		Effect Size (Random, 95% CI)	2.49 [0.49, 4.48]
2 Number of reported sharps injuries, slope	2		Effect Size (Random, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Number of needlestick injuries	1		Rate Ratio (Fixed, 95% CI)	Totals not selected
2 Number of container related needlestick injuries	1		Rate Ratio (Fixed, 95% CI)	Totals not selected

Outcome or subgroup title	No. of studies	Statistical method	Effect size
1 NSI‐ change in level	3	Effect Size (Random, 95% CI)	Subtotals only
1.1 Interruption	2	Effect Size (Random, 95% CI)	‐6.15 [‐7.76, ‐4.54]
1.2 Gradual introduction	1	Effect Size (Random, 95% CI)	0.80 [0.41, 1.19]
2 NSI‐ Change in slope	3	Effect Size (Random, 95% CI)	Subtotals only
2.1 Interruption	2	Effect Size (Random, 95% CI)	‐0.94 [‐1.97, 0.09]
2.2 Gradual introduction	1	Effect Size (Random, 95% CI)	0.5 [0.36, 0.64]

Methods	Study design: Interrupted Time‐Series Study
Participants	USA. Healthcare workers handling needles and thus with potential exposure to blood borne pathogens. Number studied: 11,161 healthcare workers for the pre‐intervention period (18 months) and 12,851 healthcare workers for the post‐intervention period (18 months).
Interventions	Introduction of an intravenous catheter stylet with a safety engineered feature (a retractable protection shield). The mechanism has to be activated by the worker. Suture needles were not replaced by safety engineered needles and were thus used as control group.
Outcomes	Number of percutaneous injuries per 1000 healthcare workers.
Notes	Pre‐intervention rate (PI per 1000 health workers) IV catheter needle (2.5; 2.3, 2.5 for each six‐month period respectively). Total data points (n = 6).

Methods	Study design: Controlled Before and After Study
Participants	UK (London). Bachelor of dental surgery students (3rd, 4th, 5th year) and dental nursing students from three hospitals in London.
Interventions	Use of dental syringe that does not require re‐sheathing or removal of needle from the syringe. Control group used conventional metallic dental syringe.
Outcomes	Outcome: incident reports of NSI sustained by dental students and nurse students over the period 1.2007 to 12.2008. The type of syringe system causing NSIs was not reported for the departments in the intervention and control groups. Unit: not specified.
Notes	We contacted the authors but they did not respond.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	Not an RCT.
Allocation concealment (selection bias)	High risk	Not an RCT.
Blinding (performance bias and detection bias)   All outcomes	Unclear risk	Not reported.
Incomplete outcome data (attrition bias)   All outcomes	Unclear risk	Not reported.
Selective reporting (reporting bias)	High risk	Type of syringe system causing NSIs among various departments was not mentioned in the outcome.
Similar recruitment of groups	High risk	Same time period of recruitment but different groups recruited from different hospitals.
Adjustment for baseline differences	Unclear risk	No information regarding adjustment for baseline differences.
Other bias	Unclear risk	The study appears to be free of other types of bias.

Methods	Study design: Cluster Randomised Controlled Trial. Object of randomisation: nursing divisions. Three‐armed trial with separate control groups
Participants	USA. Nursing personnel from general, medical, surgical and intensive‐care units performing intravenous therapy. Number studied: 73,454 patient days (980,392 productive hours worked). Intervention three n = 19,436. Control n = 19,550.
Interventions	Use of needleless intravenous device 2‐way valve. Passive system no need for activation. Control groups used standard IV needle systems.
Outcomes	Reported needlestick injures per 1000 patient‐days and 1000 productive hours worked.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"Four groups of nursing divisions were prospectively randomised to use one of the two safety devices"
Allocation concealment (selection bias)	Unclear risk	No information about allocation concealment is available.
Blinding (performance bias and detection bias)   All outcomes	Unclear risk	No information available on blinding.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Selected nursing division were assigned to either the intervention (MBC then replaced by PBC, and 2‐way). The MBC was replaced after four months due to staff dissatisfaction. Authors reported all outcomes data for the intervention and control group.
Selective reporting (reporting bias)	Unclear risk	"Intravenenous‐therapy related injuries were categorized further as follows: low‐risk injuries involved needles without direct blood contact; intermediate risk injuries involved needles likely to have occult blood present and high risk injuries involved needles in direct contact with blood." However, there is no information available based on this categorization stipulated in the method section.
Similar recruitment of groups	High risk	The nursing divisions selected to participate to the study were from the same hospital. The recruitment time period of 2‐way device differed from the PBC. The PBC was selected to replace the MBC (after four months) due to staff dissatisfaction.
Adjustment for baseline differences	Unclear risk	The demographics of the workers (age, sex, years of experience) are not reported. The adjustment for baseline differences is not reported in the analysis.
Other bias	High risk	"Study participants generally have ready access to the traditional devices, which may contaminate the evaluation, so much attention must be focused on appropriate experimental device distributions and traditional device removal prior to study initiation." NSI reported in the study group may have been caused by the use of the traditional device. Based on the information available, it is not possible to separate NSI caused by the new devices or traditional ones.

PERMALINK

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

Viraj K Reddy

Marie‐Claude Lavoie

Jos H Verbeek

Manisha Pahwa

Abstract

Background

Objectives

Search methods

Selection criteria

Data collection and analysis

Main results

Authors' conclusions

Plain language summary

Summary of findings

Summary of findings for the main comparison. (RCT) Safe blood collection systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 2. (ITS) Safe blood collection systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 3. (RCT) Safe intravenous systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 4. (CBA) Safe intravenous systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 5. (ITS) Safe intravenous systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 6. (RCT) Safe injection systems compared to regular systems RCT for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 7. (CBA) Safe injection systems compared to regular systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 8. (ITS) Safe passive injection systems compared to safe active injection systems for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 9. (ITS) Multiple safe devices compared to regular devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 10. (CBA) Multiple safe devices compared to regular devices for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 11. (ITS) Sharps containers compared to no containers for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 12. (CBA) Sharps containers compared to no containers for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Summary of findings 13. (ITS) Legislation compared to no legislation for preventing percutaneous exposure injuries caused by needles in healthcare personnel.

Background

Description of the condition

Description of the intervention

How the intervention might work

Why it is important to do this review

Objectives

Methods

Criteria for considering studies for this review

Types of studies

Types of participants

Types of interventions

Inclusion criteria

Exclusion criteria

Types of outcome measures

Primary outcomes

Secondary outcomes

Search methods for identification of studies

Electronic searches

Searching other resources

Data collection and analysis

Selection of studies

Data extraction and management

Assessment of risk of bias in included studies

Overall judgement of risk of bias at study level

Measures of treatment effect

Unit of analysis issues

Dealing with missing data

Assessment of heterogeneity

Assessment of reporting biases

Data synthesis

Subgroup analysis and investigation of heterogeneity

Sensitivity analysis

Results

Description of studies

Results of the search

1.

Included studies

Interventions

1. Content of the interventions.

Types of study designs

Participants

Outcomes

Geographical location

Year of study

Excluded studies

Risk of bias in included studies

2.

3.

Allocation

Adequate sequence generation

Allocation concealment

Methods	Study design: Controlled Before‐After Study with Cross‐Over
Participants	USA. Health care workers in sixteen nursing units excluding pediatrics, obstetrics‐gynaecology and intensive care, performing procedures which required the use of IV systems. We estimated that the number of workers in each groups was around 220. All IV insertions in the selected units during a period of six months. Eight units belonged to the intervention group and eight units to the control group, and the roles were switched in the middle of the study period.
Interventions	Use of a needleless intermittent intravenous access system with a reflux valve. Control group used a conventional heparin lock.
Outcomes	Number of reported percutaneous injuries per study week. Secondary outcomes: Local complications at insertion site, bacteraemia of patients, device‐related complications, staff satisfaction and cost analysis.
Notes	Study includes information about costs; We calculated the RR (SE) for needlestick injuries of the intervention and the control group based on our estimates of the number of persons and the number of needlestick injuries reported by the authors. We added 0.5 to fill empty cells.
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	High risk	No randomisation.
Allocation concealment (selection bias)	High risk	No randomisation.
Blinding (performance bias and detection bias)   All outcomes	Unclear risk	No information about blinding.
Incomplete outcome data (attrition bias)   All outcomes	Low risk	Authors indicated that study was completed in 16 medical and surgical units. The outcome data appears to be reported for the 16 units. No outcome data at the unit level.
Selective reporting (reporting bias)	Low risk	All expected outcomes are reported and correspond to the ones mentioned in the method section.
Similar recruitment of groups	Low risk	The intervention and control groups were from the same hospital. There is no information about the FTE change during study period. The study was completed within a short period of time (25 weeks), staff difference between before and after intervention is unlikely to be different.
Adjustment for baseline differences	Unclear risk	Authors specified that the wards for the control and intervention were similar in terms of staff‐to‐patient ratio and the type of illness of the patients. The units were different in terms of speciality for the control and intervention group. No information is available to compare the control and intervention groups for the number of staff, working experience, age and sex. Adjustment for baseline differences is not reported in the analysis.
Other bias	High risk	The outcome, NSI, is reported by study weeks. There is no information about number of FTE or number of devices used. Although the staff‐to‐patient ratios were similar, we do not know if the number or type of procedures were similar in both groups.

Methods	Study design: Interrupted Time‐Series
Participants	France. 3600 bed university hospital, sharp injuries reported on an annual of 8500 FTE (2900 nurses). Number of phlebotomist nurses, not reported.
Interventions	1. re‐sheathable winged steel needles and Vacutainer blood collecting tube and 2. vacutainer blood collecting tubes with recapping sheaths. Each product required the healthcare worker to activate the safety feature immediately after phlebotomy. We regarded both devices as one intervention. The two safety mechanisms required two‐handed activation and were thus active. Pre‐intervention period (four years) and post‐intervention period (three years)
Outcomes	Phlebotomy‐related PIs (vacuum‐tube + winged steel needle) per 100 devices purchased.
Notes	Baseline rate: Number of phlebotomy PI reported for first two years but no denominator available. For third year of baseline, rate was 18.8 phlebotomy PI related per 100,000 purchased devices. Total number of data points (n = 7).

Methods	Study design: Cluster‐RCT
Participants	Netherlands. Workers of voluntarily participating hospital wards (academic hospital). Demographics and working experience of staff included. Number studied: 796 participants. Intervention one (safety device + workshop) = 267 participants (seven wards), intervention two (workshop only) = 263 (eight wards), control group = 266 (eight wards)
Interventions	1. (NW): one‐hour PowerPoint workshop about NSIs, introduction/demonstration by supplier of new device, plus replacement of existing injection needles on the ward with injection needle with safety device. The safety device had to be activated by the workers. 2. (W) only received workshop, no new needle device)
Outcomes	Self‐reported number of NSIs within six‐month period and official hospital database registered NSIs.
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	No information on randomisation process.
Allocation concealment (selection bias)	Unclear risk	No information on allocation concealment.
Blinding (performance bias and detection bias)   All outcomes	Unclear risk	No information available on blinding.
Incomplete outcome data (attrition bias)   All outcomes	High risk	A. Questionnaire‐based NSI 1. Baseline: Workshop + device group: Data missing on 99/267 (37%) Workshop group: Data missing on 102/263 (39%) Control group: Data missing on 100/266 (38%) 2. At six months: Workshop + device group: Data missing on 197/267 (74%) Workshop group: Data missing on 179/263 (68%) Control group: Data missing on 180/266 (68%) 3. 12 months: Workshop + device group: Data missing on 187/267 (70%) Workshop group: Data missing on 160/263 (60%) Control group: Data missing on 192/266 (74%) B. Hospital registry NSI No missing outcome data
Selective reporting (reporting bias)	Low risk	All outcomes stated in the methods section reported.
Similar recruitment of groups	Low risk	Participants were randomised within the same hospital.
Adjustment for baseline differences	Low risk	There is difference among the groups in regards to sex and working experience. These differences may have influenced the results. For example, there are 17% apprentice nurse in the intervention group compared to 7% in the control group. "the differences in individual and job characteristics between the intervention groups and the control group at baseline were examined using generalized estimated equations (GEE) correcting for wards."
Other bias	Low risk	The study appears to be free of other types of bias.

Study	Reason for exclusion
Beynon 2015	The study was an ITS design but had insufficient data points.
Bowden 1993	The study design did not match our inclusion criteria (not an intervention study).
Buswell 2014	The study design did not match our inclusion criteria (not an intervention study), The study group did not match our inclusion criteria (livestock workers).
Carvalho 2016	The study was an ITS design but had insufficient data points.
Chaillol 2010	The study design did not match our inclusion criteria (surveillance data).
Chakravarthy 2014	The study was an ITS design but had insufficient data points.
Cleveland 2007	The study design did not match our inclusion criteria (surveillance data).
Cullen 2006	The study design did not match our inclusion criteria (surveillance study follow up by expert analysis stating which NSI could have been prevented).
Di Bari 2015	The study design did not match our inclusion criteria (assesment study).
Floret 2015	The study design did not match our inclusion criteria (surveillance data).
Ford 2011	The main outcome of the study does not include NSI. “The aim of the evaluation was to assess the range of sharp safety hypodermic needle devices available in the UK, in terms of device performance and user acceptability. The evaluation was not designed to assess reductions in needlestick injury rates.”
Fukuda 2016	The study design was a CBA but the before data was missing.
Goossens 2011	The study design did not match our inclusion criteria (no comparison group).
Gramling 2013	The study design did not match our inclusion criteria (descriptive study).
Grimmond 2014	The study design did not match our inclusion criteria (not an intervention study).
Guerlain 2010	The study design did not match our inclusion criteria (no comparison group).
Hotaling 2009	The study was an ITS design but had insufficient data points.
Iinuma 2005	The study design did not match our inclusion criteria (surveillance data).
Jagger 2010	The study was an ITS design but had insufficient data points.
Kanamori 2016	The study was an ITS design but had insufficient data points.
Kim 2015	The study design did not match our inclusion criteria (compliance study).
Lamontagne 2007	The study design did not match our inclusion criteria (surveillance data).
Laramie 2011	The study design did not match our inclusion criteria (surveillance data).
Lauer 2014	The study was an ITS design but had insufficient data points.
Lipscomb 2010	The study design did not match our inclusion criteria (descriptive study).
Lu 2015	The study was an ITS design but had insufficient data points.
Markkanen 2015	The study design did not match our inclusion criteria (qualitative study).
Massachusetts 2011	The study design did not match our inclusion criteria (surveillance study).
McAllister 2014	The main outcome of the study does not include NSI (study evaluvated patient safety).
Menezes 2014	The study was an ITS design but had insufficient data points.
Montella 2014	The study design did not match our inclusion criteria.
Neo 2016	The study design did not match our inclusion criteria (not about safety‐engineered devices).
Perry 2012a	The study was an ITS design but had insufficient data points.
Pigman 1993	The study was not a field study.
Rajkumari 2015	The study intervention does not match our inclusion criteria (the paper describes effectiveness of interactive classes).
Roff 2014	The paper describes spatter contamintaion by active SED but it is not a controlled study.
Shimatani 2011	The study design did not match our inclusion criteria (CBA but no comparison group).
Sibbitt 2011	The study design did not match our inclusion criteria (no comparison group).
Skolnick 1993	The study was an ITS design but had insufficient data points.
Smith 2013	The main outcome of the study does not include NSI.
Sossai 2016	The study design did not match our inclusion criteria.
Steuten 2010	The study design did not match our inclusion criteria (literature review ‐ not original research).
Tosini 2010	The study design did not match our inclusion criteria (surveillance data).
Unahalekhaka 2015	The study design did not match our inclusion criteria (descriptive study).

Methods	Time‐series
Participants	Healthcare workers
Interventions	Devices ?
Outcomes	Needlestick injuries ?
Notes