This website is intended for healthcare professionals only.

Hospital Healthcare Europe
Hospital Pharmacy Europe     Newsletter    Login            

Sharps injury legislation: lessons for the EU from the US experience

Lessons that can be learnt from the US Needlestick Safety and Prevention Act following implementation of the 2011 Directive on sharps injury prevention in the EU are discussed
Kenneth Strauss MD
Endocrinologist and Director of Safety in Medicine,
European Medical Association and Global Medical Director, BD
A decade after the US passed the Needlestick Safety and Prevention Act (NSPA),(1) the European Council issued a Directive on sharps injury prevention (Council Directive 2010/32/EU).(2) The 2010 Directive was initiated as a means of combating the estimated one million sharps injuries occurring in the EU each year.(3) All EU Member States were mandated to incorporate the Directive into National law by 11 May 2013.
The application of the EU Directive was arguably a milestone moment in ensuring healthcare worker safety in Europe. Its level of implementation, however, has varied across Europe, with some Member States failing to meet the initial deadline and some struggling to strictly enforce new legislation. To ensure the success of the Directive, it is important that all medical and surgical personnel be aware of, and comply with, the legislation that has come into force as a result.
As more than ten years have passed since the introduction of the NSPA, Europe can benefit from looking to the US and acknowledging the impact of the Act. Such activity will help to manage expectations of the outcomes of the EU Directive, and aid the avoidance of any foreseeable issues where possible. 
The NSPA required the Occupational Safety and Health Administration (OSHA) to adapt the Bloodborne Pathogens Standard to incorporate the law’s requirements. A recent study1 published within Infection Control and Hospital Epidemiology has attempted to measure the effect of the NSPA. Having analysed injury data from 85 hospitals, it revealed a swift reduction in injury rates. There was a drop of greater than one-third in 2001, and the decrease was sustained through to 2005.(4) Prior to the passing of the NSPA, during the period 1995-2000, 13,377 percutaneous injuries were recorded as opposed to 5379 during the post-NSPA period, 2001-2005.(4) 
It may be suggested that the adoption of safety-engineered medical devices (SEMDs) contributed to the drop in percutaneous injuries. The term ‘safer sharp’ can be defined as “medical sharps that incorporate features or mechanisms to prevent or minimise the risk of accidental injury.”(5)
Safety-engineered medical devices for the prevention of sharps injuries include, but are not limited to: 
“Syringes with guards or sliding sheaths that shield the attached needle after use; needles that retract into a syringe after use; shielded or retracting catheters used to access the bloodstream for intravenous administration of medication or fluids; intravenous medication delivery systems that administer medication or fluids through a catheter port or connector site using a needle that is housed in a protective covering, blunt suture needles; and plastic (instead of glass) capillary tubes;(6) as well as safety insulin pen needles and retractable lancets for blood testing.”
In the US, the uptake of SEMDs was low prior the NSPA, and injury rates changed little in the years prior to the legislation.(4) An increase in uptake followed the NSPA, as did a reduction in injuries.(4) Nevertheless, the number of injuries attributable to SEMDs increased from 10% during 2001–5 to 20% in 2001 and up to 45% by 2005.(4) One should note, however, that this increase does not necessarily represent a contradiction, due to the fact that, any time a medical sharp is used, a risk of injury exists. If all medical sharps were safety engineered, SEMDs would account for 100% of sharps injuries. A complete uptake of SEMDs would not necessarily eliminate sharps injuries, although it seems they would be significantly minimised.
This also serves to highlight that appropriate education, training and communication of the reasons for the change appear to be vital to ensuring the effectiveness of introducing SEMDs, especially as some devices require manual activation in order for their safety mechanisms to work. The EU Directive states that employers and workers’ representatives should be included in consultation on the choice and use of safe equipment, and identify together how best to carry out training, information and awareness-raising processes.(7) Europe should pay close attention to this aspect of the Directive, as it appears evident from the US experience that sharps safety messaging needs constant reinforcement. 
For example, in 2010, the American Nurses Association (ANA) re-launched its safety campaign “because even 10 years after the legislation passed, there are still many nurses around the country who don’t realise they have rights and that there are tools available that prevent these injuries.”(7)
Healthcare employers now have a duty to ensure that staff have access to up-to-date and innovative technology that fully supports their right to safety. It has also been argued that “There is stagnation out there, in that new sharps-safety devices aren’t embraced enthusiastically because busy, overworked staff can’t cope with anything new, even if they would be safer for doing so.”(8) All education and training should be made easily available, clear, and be regularly reinforced.  
It is unlikely that SEMDs alone contributed to the fall in percutaneous injuries following the NSPA. Strong enforcement by the OHSA is also deemed to have had an effect. The number of OSHA citations for violations of the Bloodborne Pathogens Standard more than doubled in the years following passage of the NSPA.(4) Similarly, the dollar amount of related penalties increased, from a total of $21,000 in 2001 to $108,200 in 2005.(4)
It may be that the threat of citations and monetary penalties have accelerated hospital compliance, resulting in a reduction in injuries. Should EU Member States strictly hold non-compliant healthcare organisations to account, they may also hope to see a significant reduction in injuries. Depending on the legislation of each Member State, enforceable violations could include, for example, failing to introduce SEMDs where reasonably practicable to do so, and failing to include procedures for documenting and reporting incidents. The enforcement of consequences seems an effective way of asserting the importance of compliance in the minds of Directors. It must be remembered that the Directive applies to all environments in which medical sharps are in use, including nursing and care homes, and general practice surgeries. 
The experience of implementing increased sharps safety legislation in the US provides valuable insight into what Europe can expect to see as a result of the EU Directive on sharps injury safety. A significant reduction in injuries could be achieved should SEMDs be appropriately employed, and if regulations and penalties are enforced. Each healthcare organisation should fully immerse itself in its country’s sharps injury legislation to ensure compliance. Sharps injuries can have an extremely damaging effect on those injured, which can include healthcare workers and patients. Proper education, training and enforcement should be undertaken regularly and the consequences of sharps injuries made clear to all those at risk of injury. 
On 2 December 2013, the European Biosafety Network held its 4th Summit at the Polish Parliament in Warsaw. Members of the European Biosafety Network and attendees at the Summit have worked for many years to help achieve legislative requirements, and their goal now is to ensure that the EU Directive is effectively applied so that all workers in Europe finally receive the protection that they deserve.  
One of the overarching messages from the event is that there is a need for consistency of practices and messaging throughout all healthcare organisations in all Member States.  Introducing protection measures, risk assessment policies, training information, awareness raising and communication, monitoring response and follow-up are all important elements to be implemented in order to effectively ensure safety. 
Results from a recent survey of European nurses9 conducted by the European Federation of Nurses Associations (EFN) show that, although the EU Directive has improved practice in the workplace, in reality, a lack of an explicit ban on recapping, risk assessment policies, access to safety devices and of education and awareness raising are still major problems that need to be addressed.
Europe’s medical community needs to learn from the US’s experience, and ensure that it does not fall into complacency now that legislation has been introduced. With the continued collaboration of all European safety, medical and nursing organisations, the current problems can be addressed and the issue of biosafety can in the future hopefully cease to exist.
  1. The Senate and House of Representatives of the United States of America in Congress, Needlestick Safety and Prevention Act, 24th January 2000,….
  2. EU Council, EU Council Directive 2010/32/EU,2 May 2010,
  3. EU Commission for Employment, Social Affairs and Inclusion, New legislation to reduce injuries for 3.5 million healthcare workers in Europe, 8th March 2010.
  4. Kornblatt Phillips E et al. Issues in Understanding the Impact of the Needlestick Safety and Prevention Act on Hospital Sharps Injuries. Infect Cont Hosp Epidemiol 2013;34(9):935–9.
  5. Health and Safety Executive, Health and Safety (Sharps Instruments in Healthcare) Regulations 2013 – Guidance for employers and employees, p2 .
  6. Occupational Safety and Health Administration, Enforcement Procedures for the Occupational Exposure to Bloodborne Pathogens, November 27, 2001,….
  7. Chwedyk P. Sticking to the Law: The Needlestick Safety and Prevention Act of 2000 has reduced preventable sharps injuries among nurses. But is it enough? Advance Healthcare Network for Nurses, 6th December 2011,….
  8. Pyrek KM. Needlestick Safety and Prevention Act 10-Year Anniversary. Infect Cont Today  2nd November 2010,….
  9. Gomez S, De Raeve P. EFN Report on the Implementation of Directive 2010/32/EU on the prevention of sharps injuries in the healthcare sector – Descriptive and Explorative Cluster Analysis of Directive 2010/32/EU Implementation into Clinical Practice Data, Biosafety Summit December 2013.