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Sharps Directive: influencing pharmacy and procurement


Pharmacists are well placed to offer input into risk assessment processes required to implement the Sharps Directive but knowledge of the various safety devices available and how to influence the procurement decisions for these products is necessary
Mark Santillo MRPharmS
Regional Quality Assurance Officer
South Devon Healthcare
NHS Foundation Trust, Torquay, UK
A sharps injury is defined as an incident that causes a needle or sharp object to penetrate the skin.(1) Needlestick injuries are the most common cause of sharps injuries and pose a serious risk to health care workers. Current numbers of needlestick injury, estimated at one million in the European Union each year, are likely to be a gross underestimate because of under-reporting and a lack of coordinated national surveillance programmes.(2,3)
In the UK, the Royal College of Nursing reported that 48% of nurses polled (n=4407) had experienced a needlestick injury during their career.(4)
Injuries from contaminated needles carry a risk of infection from more than 20 blood-borne pathogens, including hepatitis B and C and HIV. The risk of transmission of infection from an individual needlestick injury is small but, because instances are so common, the potential for infections is great.
EU Directive 2010/32/EU
The introduction of EU Directive 2010/32/EU in 2010 was aimed at preventing injuries and reducing blood-borne infections to healthcare workers from sharp instruments, including needles.(5) The EU Directive was first published in June 2010, and is required to be implemented as national law in all EU countries by May 2013. The main principles of the directive include:
  • A well-trained and adequately resourced workforce
  • The need for effective working procedures and safe disposal processes, thereby minimising risk
  • Using the hierarchy of controls to eliminate sharps injuries
  • Use of devices with safety-engineered features
  • Promotion of a ‘no-blame’ culture; focusing on systemic factors rather than individual errors, together with suitable reporting mechanisms
  • A ban on recapping where there is risk of infection or injury.
Once the Directive is put into law in the various Member States, there will many implications for hospital pharmacists and support staff as well as other healthcare professionals. The ban on recapping will be difficult to address in pharmacy technical services units and radiopharmacies. Within the UK, these issues have been raised with regulators and we await the wording in the final legislation. The latest indication following the consultation is that a change in current resheathing practice will be expected by the legislation.
In the more clinical setting, with a potential risk of needlestick injuries causing blood-borne infections, including HIV and hepatitis, the issues are more clear cut; any measures taken to reduce these risks need to be encouraged. This has implications for the procurement of injectable products, which are supplied in ready-to-use forms such as prefilled syringes and pen-type injection devices.
Many of these presentations are administered by subcutaneous injection and are subject to a lower risk than injections given by other routes; however, their frequency of use means that the overall risk is still significant. Furthermore, because of the subcutaneous route, it is likely that they will always need to be administered using a needle, or possibly micro-needle, technology.
Safer needle devices
Safer needle devices can be categorised according to their passive or active nature. Passive safety features are preferable because they do not require intervention by the operator. The safety features remain in effect before, during and after use, meaning healthcare workers do not have to activate them. Examples include retractable needles and protective sleeves that cover the needle automatically after use.
Active safety features require the healthcare worker to manually activate the safety feature (for example, a needle with a sheath and needle retraction). Needle shielding describes when a hinged needle shield is attached to the hypodermic syringe and, following use, the needle is placed in the shield and contained therein.
Safer needle devices:
  • Provide a barrier between the hands and needle after use
  • Allow or require the worker’s hands to remain behind the needle at all times
  • Are an integral part of the device and not an accessory
  • Are in effect before disassembly and remain in effect after disposal to protect downstream workers
  • Are simple and self-evident to operate, and require little or no training to use effectively.
All healthcare employers should conduct their own evaluations on the safety products available. However, there is potential to produce generic assessments for use in the procurement process. In the UK, Unison has produced guidance on evaluating safer needle devices that can be used as a format for the assessment of the various systems.(6)
Safer devices are likely to be more expensive; however, costs associated with needlestick injuries, including litigation, staff sickness and loss of professional reputation, can be significant.
Procurement decisions should therefore not be made on the basis of cost alone. There is a further need for pharmacists to liaise with the pharmaceutical industry in order to ensure that the products of the future offer a safe and affordable solution to minimise the risk of needlestick injuries.
The use of resheathing blocks within aseptic services has been evaluated in a project carried out at Newcastle-upon-Tyne Hospitals NHS Foundation Trust, neither of the two available devices evaluated was found to be ideal for purpose.(7) The use of resheathing blocks will increase preparation times and may impact on product contamination and cross-contamination risk, so these do not offer the ideal solution to aseptic services units.
Hospital pharmacists are well placed to offer input into risk assessment processes required to implement the Directive in the EU member states; however, they will need to familiarise themselves with the various products and devices available and influence the procurement decisions for these products. Products with a variety of safer needle devices are available on the market; some are fully compliant passive devices, whereas others need activation by the healthcare worker.
If the ban on recapping needles within aseptic services is confirmed, then a solution that does not increase overall risk of aseptic processing will be required; time is short in order to achieve this.
Key points
  • The EU Directive on prevention of sharps injuries is required to be implemented in Member States in May 2013.
  • The Directive is aimed at significantly reducing the number of sharps injuries within healthcare providers throughout the EU.
  • The Directive includes a ban on recapping needles if there is risk of infection or injury. This could have a significant effect within aseptic services units where recapping is currently a necessary part of the preparation process.
  • There are already injectable medicines on the market with both passive and active safer needle devices. Passive devices are preferable as they work automatically and cannot be bypassed.
  • Pharmacists are well placed to influence procurement decisions of ready-to-administer injections and to contribute to risk assessment processes.
  1. Health and Safety Executive. Sharps injuries.
  2. Adams D. To the point, needlestick injuries, risks, prevention and the law. Br J Nurs 2011;20(8):S4–S11.
  3. Prevention of sharps injuries framework agreement (accessed 18 February 2013).
  4. Royal College of Nursing, Needlestick injuries, The point of prevention. 2009. (accessed 18 February 2013).
  5. Council Directive 2010/32/EU. 10 May 2010. Implementing the Framework Agreement on prevention from sharp injuries in the hospital and healthcare sector concluded by HOSPEEM and EPSU.
  6. Unison. Evaluating safer needles. A Unison guide: needle safety at work. Number 2. (accessed 18 February 2013).
  7. O’Mahony M, Beaney A. Implications of the European Council Directive 2010/32/EU on aseptic practices in the UK.

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