eu needlestick directive

Safer Needles Directive-

Occupational Blood Exposure

27th November 2012 Dr Peter Noone

Consultant in Occupational Medicine.

European Directives 89/391 and 2000/54

on the Prevention of Sharps Injuries in

the Healthcare Sector Each MS has until May 2013 to comply,

Implementing measures to prevent potentially fatal injuries including:

• Medical devices incorporating safety engineered mechanisms,

• Effective training,

• Effective working procedures, including disposal of used sharps,

• Well resourced and organised workforce,

• Local, National and Europe wide reporting mechanisms,

• A ban on recapping.

EU Sharps Directive

March 2010, EU Employment & Social Affairs Ministers adopted a Directive to prevent injuries and blood borne infections to hospital and healthcare workers from sharp objects, such as needle sticks.

Council Directive 2010/32/EU of 10th May 2010 was published in the Official Journal of the European Union, No. L134 of 1 June 2010, p66-72. Member States, including Ireland have 3 years to transpose it into national legislation (by May 2013).

The aim of the Directive is to:

Achieve the safest possible working

environment;

Prevent workers' injuries caused by medical

sharps (including needle sticks);

Protect workers at risk;

Set up an integrated approach establishing

policies in risk assessment, risk prevention,

training, information, awareness raising and

monitoring;

Put in place response and follow up procedures;

Under-reporting

NSI under-reported across Europe, (Doebbeling et al, 2003).

EU legislators estimate one million needlestick injuries per

year to HCWs.

75% under-reporting in Germany (Wicker et al, 2008),

60% in Spain (Parra-Ruiz et al, 2004).

UK between 10% (RCN, 2008) and 90% (Au E et al, 2008;

Thomas et al, 2009), depending on the role of the HCW.

France, Netherlands and rest of EU the range of under-reporting

at between 40% and 75% (Wilburn et al, 2005).

UK, Estimated under-reporting of between 29-61%, Roy E, Robillard P.

Underreporting of accidental exposures to blood and other body fluids in healthcare settings: an alarming situation. Adv Expo Prev 1995;1:11.

Hierarchy of controls applied to

sharps injury prevention

Pattern of NSI/OBEs

“I keep six honest serving-men

(They taught me all I knew);

Their names are What and Why and When

And How and Where and Who”.

Rudyard Kipling, the Elephant’s child 1902

When ?

According to data from the Health Protection Agency

(HPA, 2008) and from the USA (Centers for Disease

Control and Prevention, 2010), sharps injuries occur:

during use

after use, before disposal

between steps in procedures

during disposal

while re-sheathing or recapping a needle.

What with ?

Who ?

Where?

How?

Relative risk of BBV Exposure

Estimated risk of transmission

HCV transmissions to HCWs

HIV exposures UK

Preventable injuries GAO U.S.(1)

S. Campbell, L. Chiarello, P. Srivastava, D. Cardo, and The NaSH Surveillance Group, “Preventability of Needlestick Injuries to HCWs

in the National Surveillance System for Healthcare Workers,” Abstracts--4th Decennial International Conference on Nosocomial &

Healthcare-Associated Infections (Atlanta, Ga.: Centers for Disease Control and Prevention, July 2000),

http://www.cdc.gov/ncidod/hip/NASH/4thabstracts.htm - 7

Preventable of NSI by safety devices,

Germany (2)

Preventable injuries (3)

A Scottish study concluded 61% of venepuncture-

related injuries were ‘probably’ preventable by

safety device use and 21% were ‘definitely’

preventable Cullen BL, Genasi F, Symington I et al. Potential for reported NSI prevention among HCWs through safety

device usage and improvement of guideline adherence: expert panel assessment. J Hosp Infect

2006;63:445–451.

Sample sizes for a device with an injury rate of

5/100 000 usages (e.g. syringe devices) to achieve

80% power at 5% significance level is one million

devices to show a 50% reduction in injuries

Cost

PCE estimated to cost between £13k- £880k for

an injury resulting in seroconversion of a BBV (National Health Services for Scotland, 2001).

Annual cost for NSI management is estimated

at £500k per UK NHS trust,

C.f. cost of preventive safety-engineered

devices estimated at £136k per NHS trust per

year - ~ quarter the cost of treating injuries. (Memorandum submitted by the Safer Needle Network to Select Committee on Public

Accounts, 2 May 2003).

The risk of infection depends on a

number of factors.

They include:

the depth of the injury

the type of sharp used (hollow bore needles

are higher risk although subcutaneous

needles also present a risk)

whether the device was previously in the

patient’s vein or artery

how infectious the source patient is at the

time of the injury.

Risk in relation to Exposure

The risk of infection by a contaminated

needle is estimated as follows (HPA,

2008):

one in three for hepatitis B (6-30%)

one in 30 for hepatitis C (0.5-2%)

one in 300 for HIV (0.3%)

NSI among Surgeons in Training

NEJM 2007/17 USA Centres

582/699 respondents had had needle-stick injuries,

After 5yrs 99% had had NSI (53% high risk),

51% not reported (16% high risk),

72% in OT, most self inflicted with solid needle

during suturing.

Risk of HIV or HCW seroconversion 1.43/yr in UK,

or 0.0086/1000 beds/yr. (Elder A et al, Occ Med 2006;56:566-574),

For acute health organisation of 1500 beds, this = 1

seroconversion /78 years.

NI surgeons

52/70 (75%) surgeons and trainees replied.

42/52 (81%) suffered at least 1 NSI,

4/52 (8%) reporting > 20 NSIs.

8/52 (19%) reported all NSI to OHS with no significant difference between consultants and trainees (P = 0.2).

12 (23%) felt that reporting of injuries helped to reduce transmission rates.

18 (35%) said NSI caused them moderate-significant anxiety.

Top reasons for not reporting were (0–4). (a) Process too time consuming (2.7),

(b) transmission risk very low (2.6),

(c) do not want to disrupt operating list (2.0),

(d) post exposure prophylaxis ineffective (1.3)

Kennedy R et al, Irish Journal of Medical Science September 2009, Volume 178, Issue 3, pp 297-299

Risk Control Hierarchy

1. Elimination – eliminating unnecessary sharps use with

changes in practice;

2. Engineering Controls - medical devices incorporating safety-

engineered mechanisms;

3. Safe Systems of Work – specifying safe procedures for using

and disposing of sharp instruments and contaminated waste,

Recapping banned, information, instruction and training.

4. PPE - the use of Personal Protective Equipment (gloves,

masks, gowns, etc);

5. Vaccination – for hepatitis B, in accordance with national law

and/or practice of the Member State.

6. Reporting & Surveillance systems standardised.

Injury Prevention Safer Devices

By definition a safer device incorporates

engineering controls to prevent OBE, before,

during, or after use through built in safety

features. The term ‘safer device’ is broad and

includes many different type of instrument.

Think unguarded piece of machinery!

Conventional needles are inherently unsafe by

design and should be eliminated where possible.

(Unison 2002)

Safety Features

Devices may be …

Active;

Passive;

Passive features enhance safety design and are more likely to have a greater impact on prevention. Further benefits include reduction in ‘down-stream injury.

Characteristics; Safety Features

Provide a barrier between hands and Sharp

Allow/require the workers hand to remain behind

the sharp at all times

Be integral to the device, not an accessory

Be in effect before disassembly, and remain in

effect after disposal

Be simple and self evident to operate, and

require little training.

(US FDA)

Percutaneous Injuries before and after the

Needle-stick Safety and Prevention Act

Intervention

Intervention Review

“Blunt versus sharp suture needles for preventing percutaneous exposure

incidents in surgical staff”

Annika Parantainen1,*,

Jos H Verbeek2,

Marie-Claude Lavoie3,

Manisha Pahwa4

Editorial Group: Cochrane Occupational Safety and Health Group

Published Online: 9 NOV 2011

Assessed as up-to-date: 30 APR 2011

DOI: 10.1002/14651858.CD009170.pub2

http://onlinelibrary.wiley.com/doi/10.1002/1

4651858.CD009170.pub2/pdf/abstract

HSE North East.

EPINet Since 2002.

867 Incidents Recorded.

Blood Exp Sharps Total

Cavan 22 165 187

Drogheda 59 280 339

Dundalk 10 95 105

Monaghan 6 47 53

Navan 19 164 183

187

339

105

53

183

0

50

100

150

200

250

300

350

400

Cavan Drogheda Dundalk Monaghan Navan

Interventions HSE DNE

A safer lancet was introduced January 2001, The proportion of injuries relating to lancets reduced

from 33% to 3-4%.

Reduction is sustained (4% 2011). Noone P, Carroll A, Safer devices preventing occupational blood and body fluid exposures Occup Med (Lond). 2005 Aug;55(5):404-5.

Single use, safety shielded phlebotomy system introduced in March 2006. The proportion of injuries from venesection reduced from

an average of 12.5% in previous 4 years to 6-7%.

Reduction is sustained (7% 2011)

Annual Reports, All Sites. 2005 2006 2007 2008 2009 2010 2011

PCE 83 81 66 58 71 67 72

MCE. 13 10 7 10 12 19 10

Total 96 91 73 68 83 82 82

Total

9691

7368

83 82 82

0

20

40

60

80

100

120

2005 2006 2007 2008 2009 2010 2011

Butterfly

Injury rates: 8% of injuries sustained from winged steel needles used for sub-cut infusion, and venous access.

Audit: In Cavan the general ward areas report use of non safety engineered winged steel needles (Butterfly). Monaghan had a safety system in use in Endoscopy.

.

KPI: Introduction of appropriate safety devices to eliminate associated injuries.

Mary Hotaling, Joint Commission on Accreditation of Healthcare Organizations February 2009 Volume 35 Number 2 101

Other opportunity areas..

Blood culture: Safety vacuum set.

Blood Gas

Prefilled injectables

IM injection.

Specialist areas

OR

Maternity

Dialysis

Summary

New Legislative requirements:

Medical devices incorporating safety engineered mechanisms

• Effective training

• Effective working procedures, including disposal of used sharps

• Well resourced and organised workforce

• Local, National and Europe wide reporting mechanisms

• A ban on recapping

Thank-you