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 SectorEach 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.
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’ preventableCullen 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 Hierarchy1. 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 FeaturesDevices 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
InterventionIntervention Review“Blunt versus sharp suture needles for preventing percutaneous exposureincidents in surgical staff”Annika Parantainen1,*,Jos H Verbeek2,Marie-Claude Lavoie3,Manisha Pahwa4Editorial Group: Cochrane Occupational Safety and Health GroupPublished Online: 9 NOV 2011Assessed as up-to-date: 30 APR 2011DOI: 10.1002/14651858.CD009170.pub2 http://onlinelibrary.wiley.com/doi/10.1002/1 4651858.CD009170.pub2/pdf/abstract
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)
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
SummaryNew 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