eu needlestick directive
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TRANSCRIPT
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