Preventing sharps injuries – European Biosafety Network publishes new guidance

More sharps injuries due to COVID-19 

Healthcare workers face numerous risks to their health and well-being at work. Due to the COVID-19 pandemic, doctors and nurses working with patients have been facing an increased risk of infection. In addition, exposure to other diseases has also increased because of a sharp rise in needlestick injuries due to the pandemic. A survey conducted by IPSOS MORI, commissioned by the European Biosafety Network (EBN), has revealed that COVID-19 has caused an estimated increase in the number of sharps injuries to healthcare workers by 276,000 in the year 2020. 1  An overwhelming majority (98%) of the respondents also said that the rise in the number of sharps injuries was because of increased pressure and stress due to COVID-19.1  

Sharps injuries are accidents caused when needles or other medical/surgical instruments penetrate the skin. Such injuries can cause the transfer of blood-borne pathogens, like HIV and hepatitis B or C viruses, from the patient to the healthcare worker. Sharps injuries can also have a major psychological impact on healthcare workers, for whom ensuring the safety of patients is a great priority. 

The EU Medical Devices Regulation (MDR), Annex 1, Chapter II, GSPR 11.1 and 22.2 

In 2017, the EU Medical Devices Regulation (EU) 2017/745 (MDR) was published. It includes two General Safety and Performance Requirements (GSPR), Annex 1, Chapter II, GSPR 11.1 and 22,2, which require medical devices to be designed to reduce the risk of sharps injuries as far as possible. The Regulation sets out a goal that all EU countries must achieve and that the individual states decide the way to implement it.  

Guidance by EBN and the Spanish General Nursing Council 

It is important to avoid gaps in the interpretation of the MDR and in particular, of the GSPRs. Towards this end, the EBN and the Spanish General Nursing Council have published a guide to enable the consistent interpretation and implementation of Annex 1 Chapter II, GSPR 11.1 and 22.2.2 According to the guidance, the only way to ensure a homogeneous interpretation of Annex 1, Chapter II, GSPR 11.1 and 22.2 of the MDR is the inclusion of the concept of ‘medical devices incorporating safety-engineered protection mechanisms’.  The guidance also describes five key factors and three requirements to consider in the interpretation of the GSPRs. 2

 The ultimate aim is to eliminate sharps injuries and protect patients and healthcare workers through: 

  • The consistent interpretation and universal implementation of the MDR 
  • The EU-wide surveillance and the development of a permanent observatory to deliver detailed information and data on sharps injuries 
  • The comprehensive use of safety-engineered devices designed to prevent sharps injuries. 






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