1. Safer Needles Directive-
Occupational Blood Exposure
27th November 2012
Dr Peter Noone
Consultant in Occupational Medicine.

4. 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.

5. 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).

6. 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;

7. 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.

8. Hierarchy of controls applied to
sharps injury prevention

9. 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

10. 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.

11. What with ?

12. Who ?

13. Where?

14. How?

15. Relative risk of BBV Exposure

17. Estimated risk of transmission

18. HCV transmissions to HCWs

19. HIV exposures UK

20. 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

21. Preventable of NSI by safety devices,
Germany (2)

22. 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

23. 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).

24. 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.

25. 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%)

26. 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.

27. 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

28. 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.

29. 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)

30. 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.

31. 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)

32. Percutaneous Injuries before and after the
Needle-stick Safety and Prevention Act

33. 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

34. HSE North East.
Blood Exp Sharps Total
 EPINet Since 2002. Cavan 22 165 187
Drogheda 59 280 339
 867 Incidents Recorded.
Dundalk 10 95 105
Monaghan 6 47 53
Navan 19 164 183
400
350 339
300
250
200 187 183
150
100 105
50 53
0
Cavan Drogheda Dundalk Monaghan Navan

35. 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)

36. 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
120
100 96
91
80 83 82 82
73
68
60
40
20
0
2005 2006 2007 2008 2009 2010 2011

37. 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

38. Other opportunity areas..
 Blood culture: Safety vacuum set.
 Blood Gas
 Prefilled injectables
 IM injection.
 Specialist areas
 OR
 Maternity
 Dialysis

39. 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

40. Thank-you