EU sharps Directive aims to improve healthcare safety

Healthcare workers could be realising major safety improvements following the introduction of legislation covering sharps injuries, says Johnny Lundgren.

A recently published EU Directive will require all healthcare organisations to implement mandatory healthcare worker safety standards. Adopted by EU employment and social affairs ministers, the Directive (Council of the European Union, 2010) seeks to prevent injuries and infections to healthcare workers from sharp objects such as needles, along with the risk of subsequent infection from blood-borne pathogens such as hepatitis or HIV. The EU describes needlestick injuries as “one of the most serious health and safety threats in European workplaces and estimated to cause one million injuries each year” (EU Commission for Employment, 2010).

The new law will oblige healthcare organisations to take measures to prevent needlestick injuries to their staff, making the use of safety-engineered devices, both needles and intravenous catheters, much more widespread. The specific clause in the Directive refers to “providing medical devices incorporating safety-engineered protection mechanisms”.

Safety first

A number of public and private healthcare organisations across Europe, which recognise the need to improve healthcare worker safety, reduce the cost of treating injured workers and avoid expensive legal actions, have already converted to the use of safety-engineered devices well in advance of the impending legislation. However, many others have not yet done so.

This article provides healthcare executives, occupational health managers and health and safety heads with a brief factual summary of the new legislation, followed by a short description of the primary reasons why some healthcare organisations have decided to adopt a “safety-engineered-devices-only” policy in advance of the forthcoming legislation.

The magnitude of the problem is distorted by significant under-reporting. EU legislators estimate that European healthcare workers suffer one million needlestick injuries per year. However, this figure factors in a substantial level of under-reporting, and locally reported needlestick incidence statistics may significantly underestimate the problem (Robillard et al, 1995; Cato et al, 1994).

Misleading figures

Various studies have revealed that needlestick injuries are under-reported across Europe, and that a culture of silence still persists, even though healthcare professionals are aware of the benefits of early reporting (Doebbeling et al, 2003).

quotemarksEU legislators estimate that European healthcare workers suffer one million needlestick injuries per year.”

Looking across more recent studies into the issue, there is evidence of 75% under-reporting in Germany (Wicker et al, 2008), with figures approaching 60% in Spain (Parra-Ruiz et al, 2004). In the UK, under-reporting rates vary between 10% (Royal College of Nursing, 2008) and 90% (Au E et al, 2008; Thomas et al, 2009), depending on the role of the healthcare worker.

For France, the Netherlands and the rest of Europe, commentators put the range of under-reporting at between 40% and 75% (Wilburn et al, 2005).

Exact reasons for under-reporting are still unclear (Stringer et al, 2002), but may be due to reporting being considered too time-consuming, staff members being too busy and underestimation of the risks associated with such an exposure.

Certain expert commentators feel that current sharps policies (the procedure for dealing with post-injury reporting, diagnosis and prophylaxis) are in need of review in many healthcare organisations, regardless of the introduction of new EU legislation. One study on needlestick injury in the surgical environment (Parra-Ruiz et al, 2004) comments: “Needlestick injury is still a common problem, particularly in the surgical cohort, and remains significantly under-reported. The disparity between hospital sharps policy and actual surgical practice is considered and an explanation for the difference sought. Without this awareness of ‘real-life’ surgical practice, the occupational health figures for sharps injury will always tell a rosy story.”

Rules and regulations

During the 1990s, engineering controls, also known as safer needle devices, became available. These are now required in healthcare settings throughout the US since the passage of the Needlestick Safety and Prevention Act 2000.

Five of Spain’s autonomous regions have instituted, by law, the mandatory use of safety-engineered devices and achieved excellent results regarding the reduction of needlestick injuries (De Raeve, 2009). The president of the Consejo General de Enfermeria of Spain (Spanish Nurses Association), Maximo Gonzalez, estimates that there has been a reduction of 80% in needlestick injuries, and a cost saving of 70% as a result of this law.

Safety-engineered devices are in wide use in Europe, especially in France, where it is reported that they have proven effective in reducing up to 90% of sharps injuries (International Council of Nurses, 2004).

The use of safety-engineered devices is now specified in EU law. After several years of discussion between healthcare worker associations, healthcare employer organisations and EU Parliamentarians, in March 2010 European Union mi­nisters adopted an EU Directive aimed at preventing injuries and infections to healthcare workers from sharp objects such as needles.

quotemarksIn the UK, the annual cost of dealing with needlestick injuries is estimated at £500,000 per NHS trust.”

This Directive was published in the EU’s official journal in June 2010, and is required to be implemented as national law in all EU countries by May 2013 at the latest. Interestingly, the legislation has ended up being the result of a coordinated and cooperative joint request from employer and employee organisations in the sector.

Both the public and private healthcare sectors are affected by the legislation, which is designed to “ensure the highest possible level of safety in the working environment in hospitals and wherever healthcare activities are undertaken”. The Directive declaration specifically mandates better training, better working conditions and the use of safer medical instruments incorporating sharps protection mechanisms.

Cutting-edge benefits

For most healthcare organisations that have chosen to convert to safety-engineered devices, the case for such a conversion has been based on a number of factors. First, the avoidance of expensive lawsuits from injured parties is a motivating factor common to hospitals, general practices and medical laboratories alike. The awards to injured parties can be very large.

Avoiding the cost of treating injured and potentially infected healthcare workers is also a key financial management factor. The cost associated with each inoculation injury has been estimated to range between £13,000 and £880,000 for an injury resulting in the transfer of a blood-borne virus (National Health Services for Scotland, 2001).

In the UK, the annual cost of dealing with needlestick injuries is estimated at £500,000 per NHS trust, whereas the total cost of introducing safety-engineered devices to prevent needlestick injuries is estimated at £136,000 per NHS trust per year – roughly a quarter of the cost of treating injuries (according to a Memorandum submitted by the Safer Needle Network to Select Committee on Public Accounts, 2 May 2003).

Most organisations, private and public, however, will also be motivated by the ethical duty to provide staff with a safer working environment, something that often improves staff loyalty, motivation, productivity and recruitment.

Quick on the uptake

There is a growing body of evidence in the UK that what is good for staff is good for patients, with a recent report on NHS health and wellbeing stating that “organisations that prioritised staff health and wellbeing performed better, with improved patient satisfaction, stronger quality scores, better outcomes, higher levels of staff retention and lower rates of sickness absence” (Boorman, 2009).

For private medical laboratories in particular, the whole brand image of a safe environment also plays a major role in attracting patients.

Now that the use of safety-engineered devices is becoming specifically cited in European law, the number of early adopters (those who are moving ahead of the mandatory deadline) is growing steadily.

quotemarksNow that the use of safety-engineered devices is becoming specifically cited in European law, the number of early adopters is growing steadily.”

These organisations have managed to put a convincing business case together – usually combining ethical, financial and risk mitigation factors. As the practical, legal and reputational downside of non-conversion becomes increasingly publicised through the passage of the new law, the early adopter community should grow at an accelerating pace.

Johnny Lundgren is vice-president and general manager, north-west Europe, for medical technology firm Becton, Dickinson and Company.


6635/10 ADD 1 MH/vk 1 DG G 2B Council of the European Union.

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XpertHR takes a look at the reasoning behind the introduction of the EU Directive to prevent injuries caused by medical sharps.

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