Helping healthcare employers to prepare for sharps Directive

With the EU preparing to introduce legislation that will cover sharps injuries in the healthcare sector, employers that are most at risk must take steps towards compliance with the new laws, says Graham Johnson, clinical lead – nursing, Bupa Health and Wellbeing.

The use of safer devices to manage the risk of exposure to blood and body fluids caused as the result of needlestick injuries has been considered by Lundgren (2011), and while this control measure will undoubtedly reduce the incidence of these occupational injuries, there are other measures that should be considered.

An environment where needlestick injuries can be prevented, but an area that is often missed or not considered, is the operating department. More than one-third of incidents occurring between 2000 and 2007 were on the ward or in accident and emergency (43% and 37% respectively), and around one in five in intensive care and in operating theatres (22% and 20% respectively), where they are preventable with proper adherence to universal precautions and safe disposal of clinical waste (HPA, 2008).

The UK Health Protection Agency Centre for Infections scheme reports 914 needlestick injuries, with hollow-bore needles being the greatest risk, accounting for 68% of all percutaneous exposures between 2000 and 2007 (HPA, 2008). In a study of 98 UK surgeons in a large district general hospital (Thomas, 2009), 44% anonymously admitted to having had a needlestick injury. The study concluded that the incidence of such injuries was likely to be under-reported, particularly in the surgical sector.

So, with less than 24 months before the UK Government is required to introduce the European Directive on the prevention of sharps injuries in the hospital and healthcare sector, what practical steps can employers begin to take to prepare for the introduction of this legislation?

Laying down the law

In preparation for the implementation of the Directive into legislation, it is thought that the Health and Safety Executive (HSE) will now embark upon a programme of consultation before deciding how the Directive should be implemented into health and safety legislation.

Objectives of the European Directive

  • To achieve the safest possible working environment.
  • To prevent workers’ injuries caused by all medical sharps.
  • To protect workers at risk.
  • To set up an integrated approach establishing policies in risk assessment, risk prevention, training, information, awareness-raising and monitoring.
  • To put in place response and follow-up procedures.
    • Of course, the HSE may decide that to reduce any further burden on employers it would be simpler to add the Directive to existing legislation with supporting information and guidance.

      As an example, the Control of Substances Hazardous to Health (COSHH) legislation requires employers to evaluate the risks and select reasonably practicable control measures by the adoption of the hierarchical approach.

      Due to the nature of exposures to blood-borne viruses (BBVs) in the healthcare environment, it may not be reasonably practicable to wholly prevent exposure to BBVs. As such, healthcare employers are required to control the risk by the application of protection measures that are relevant and appropriate to the occupational activity and risks.

      These could include consideration of the design and use of appropriate work processes, systems and engineering controls, together with the use of suitable work equipment and, where adequate control of exposure cannot be achieved by other means, the provision of suitable personal protective equipment (PPE) in addition to other risk-prevention measures.

      Should employers fail to adopt these principles, the situation may result in adverse effects for the healthcare employee and the employer. Any healthcare employer that needs reminding of the penalties of non-compliance with legislative control measures should consider the case of Alison Dugmore, where a breach of COSHH reg.7, which imposes an absolute duty on an employer to ensure that exposure of its employees to substances hazardous to health is either prevented or controlled, resulted in Dugmore being exposed to natural rubber latex. The resulting action by Dugmore and her legal team resulted in a successful damages claim in excess of £300,000.

      Focus points

      All healthcare employees are likely to support the notion that every effort should be made to avoid exposure to blood and body fluids by the use of safe systems of work.

      To prepare, employers should ask themselves the following questions:

      • Does the organisation have a policy and procedure for the management of sharps injuries that explains the roles, responsibilities and arrangements?
      • Has it completed suitable and sufficient risk assessments?
      • Has it provided suitable and sufficient instruction and training to staff, to minimise the risk of infection effectively?
      • Is the organisation undertaking active monitoring, for example, inspecting and checking that arrangements are being implemented and controls are working?
      • Is the organisation undertaking reactive monitoring, for example, investigating relevant sharps incidents?
      • Has the organisation audited implementation and compliance with policies and procedures?
      • Has the organisation an improvement plan in place informed by proactive monitoring, reactive investigation and auditing?

      Control measures

      The overarching objective of the EU sharps Directive is to protect healthcare workers from injuries caused by all medical sharps including needlesticks. To ensure employers are able to meet their statutory duty of care, the Directive will require them to introduce hierarchy of control measures such as:

      • Elimination – eliminating the unnecessary use of sharps by implementing changes in practice and on the basis of the results of the risk assessment.
      • Safe procedures – specifying and implementing safe procedures for using and disposing of sharp medical instruments and contaminated waste.
      • Engineering controls – providing medical devices incorporating safety-engineered protection mechanisms.
      • PPE – ensuring the efficient use of PPE such as protective gloves, masks and gowns, for example.

      Handy tip

      While waiting for the UK health and safety legislators to decide on their strategy for the management of this occupational hazard, there is much that employers could be doing to prevent accidental exposure to BBVs. Indeed, given the publicity that the EU Directive has received, HSE inspectors may take the view that employers should be taking action now to manage the risks and not waiting until May 2013.

      quotemarksThe overarching objective of the EU sharps Directive is to protect healthcare workers from injuries caused by all medical sharps including needlesticks.”

      The benefits of double-gloving were recognised by an HSE Advisory Committee on Dangerous Pathogens publication, which stated that the film of latex of a glove appears to provide a wiping effect (HSE, 1995).

      The wiping effect of double-gloving was also considered in a study by Lefebvre et al (2008), which found that double-gloving provides the practitioner with extra protection when a needlestick injury occurs. This is because the two layers of latex act to wipe off a substantial amount of blood or body fluid that may be on the sharp as it passes through the glove.

      Although a needle or sharp instrument can easily penetrate a glove, the risk of transmission of infection is significantly reduced. Double-gloving reduces risk of exposure to patient blood by as much as 87% when the outer glove is punctured. Volume of blood on a solid suture needle is reduced by as much as 95% when passing through two glove layers, thereby reducing viral load in the event of a contaminated needlestick or sharps injury (Marczan, 2007).

      Double-gloving, particularly during a sterile surgical procedure, is a practice that is becoming more prevalent among healthcare professionals in recognition of the reduced risk associated with contracting a BBV. Double-gloving with a coloured under-glove, typically a puncture indication system, allows the user to identify when a breach to the outer glove occurs.

      Effectiveness of double-gloving

      Many clinical papers have discussed the merits of double-gloving. The Cochrane Review published two articles, in 2003 and 2006, about double-gloving to reduce surgical cross-infection (Tanner et al, 2007) that supported double-gloving with a puncture indication system; this enables glove wearers to identify perforations more easily compared with single-gloving. It is also significantly more effective than single-gloving in reducing glove perforations.

      The review also commented on a perceived issue of dexterity loss associated when double-gloved. The review suggested that double-gloving did not result in a significant number of outer-glove perforations, suggesting minimal impact on user dexterity.

      A study by Mansouri et al (2010) considered the comparison of blood transmission through latex and nitrile glove materials. It concluded that single-layer nitrile gloves gave better protection than single-layer latex gloves, but double-gloving with latex gloves provides better protection than single-layer gloves of either material.

      The high exposure to blood that comes with invasive surgery means a high risk of blood-borne pathogen transmission between patients and surgical staff. Both patients and the surgical team need protection from this risk, which can be reduced by protective barriers such as surgical gloves.

      quotemarksThe financial cost of a needlestick injury to healthcare employees can be staggering.”

      However, gloves can become perforated and their protective function is then compromised. Glove puncture rates are as high as 78% in some types of surgery and even laparoscopy is associated with a 20% perforation rate (Florman et al, 2005). Also, glove punctures often go undetected – up to 92% of perforations pass undetected by surgeons and nurses, thus increasing the risk of cross-infection (Maffulli N et al, 1991).

      BBV exposure

      It may be perceived by many healthcare professionals that acquiring a BBV will “never happen to me”. In fact, it only has to happen once for the healthcare worker’s life to change in an instant.

      Many examples of exposure to BBVs have been documented in the past, both in reports, clinical studies and the media. However, the exposure is on the increase year on year. Examples have been provided below to highlight the variety of BBV exposures.

      Personal and financial risks of needlestick injuries

      The financial cost of a needlestick injury to healthcare employees can be staggering when taking into account tests taken, drugs used, counselling offered, cost of cover for the absent employee for an indeterminate time, overtime payments or agency fees, and any litigation costs, which could be immeasurable. If the injured person was a surgeon, then far greater costs could be incurred.

      In 1996, a “Communicable Diseases Review” article detailed two investigations conducted on patients operated upon by surgeons who were infected with hepatitis B. In the first review, 310 patients had to be screened, with 20 (6%) having acquired hepatitis B from the surgery carried out by Dr X (Mukerjee et al, 2000).

      In the second report, a total of 31 patients were tested. Dr A had 16 patients requiring testing and Dr B had 15. Two of Dr A’s patients tested positive and all of Dr B’s were found to be negative.

      Interestingly, Dr X and Dr A, according to the reports, did not practice the use of double-gloving. However, Dr B routinely wore two pairs of gloves for all of the surgical procedures (Mukerjee et al, 2000).

      These cases highlight the further costs that can occur from BBVs. Neither of the reports outlined the financial cost of screening all of the patients or any compensation that may have been paid. It is reasonable to assume that the organisation for which these doctors were employed would have incurred a heavy financial burden.

      Healthcare worker occupational exposure to hepatitis C

      In February 2007 a healthcare worker, who had been training in an NHS trust hospital for three weeks, was instructed to take blood from a patient known to be infected with the hepatitis C virus. After taking the sample, the worker had difficulty reaching the sharps bin to dispose of the needle because other equipment surrounding the patient prevented access for her trolley.

      The worker subsequently placed the used needle on a work surface while she attended to the wound, which continued to bleed, but as she reached for a tissue, she caught her wrist on the needle. The employee was subsequently diagnosed with symptoms of the virus.

      quotemarksConsideration should be given to the evidence-based benefits of double-gloving in those environments where the risk of occupational exposure to BBVs is apparent.”

      The HSE investigation found that the employee was not made aware of the patient’s infection status until after the injury occurred and was not supervised during the procedure.

      An examination of the trust’s systems found failures to carry out suitable risk assessments where there was a risk of exposure to BBVs. They also failed to implement adequate controls or provide training around them, and lacked suitable arrangements for effective monitoring and review of safe working practices. The HSE issued four improvement notices in May 2008, which the trust subsequently complied with (HSE, 2010).

      Going forward

      The need to prevent the personal risks of needlestick injuries and exposure to BBVs has led to the introduction of legislation to reduce the incidence and prevalence of occupational-acquired diseases in the healthcare environment. As healthcare employers consider their approach to meet the EU sharps Directive and the need to introduce suitable and sufficient control measures to meet the employer’s statutory duties, consideration should be given to the evidence-based benefits of double-gloving in those environments where the risk of occupational exposure to BBVs is apparent.


      Lundgren J. “Straight to the point”. Occupational Health, vol.63, no.5 (May 2011).

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

      EU Commission for Employment, Social Affairs and Inclusion. “New legislation to reduce injuries for 3.5 million healthcare workers in Europe”; 8 March 2010.

      “HIV and AIDS: information and guidance in the occupational setting”. Health Protection Agency (2008).

      Thomas WJ, Murray JR. “The incidence and reporting rates of needle-stick injury amongst UK surgeons”. Ann R Coll Surg Engl. 2009 Jan;91(1):12-7. Epub 4 Nov 2008 (abstract).

      Dugmore v Swansea NHS Trust and another, Court of Appeal (Civil Division) [2002] EWCA Civ 1689, reported at [2003] ICR 574 CA (also at [2003] IRLR 164).

      “Management and prevention of sharps injuries: inspection of NHS trusts 2010/2011 by occupational health inspectors”. SIM 07/2010/01.

      Thomas S et al. “Intraoperative glove perforation – single versus double gloving in protection against skin contamination”. Postgrad Med J 2001;77:458-460.

      NHS Employers (2005). “The management of health, safety and welfare issues for NHS staff.”

      Mukerjee AK, Westmoreland D, Rees HG. Communicable Diseases Review (2000). “Lessons from two linked clusters of acute hepatitis B in cardiothoracic surgery patients”.

      Mukerjee AK, Westmoreland D, Rees HG. Communicable Diseases Report (1996). “Response to the discovery of two practising surgeons infected with hepatitis B”.

      Lefebvre DR, Strande LF, Hewitt CW. “An enzyme-mediated assay to quantify inoculation volume delivered by suture needlestick injury: two gloves are better than one”. J Am Coll Surg 2008;206:113-122.

      Tanner J, Parkinson H. “Double gloving to reduce surgical cross-infection”. Cochrane Database Syst Rev. 2007:(2):CD003087. (accessed 3 July 2007).

      Mansouri et al. M Occup Med (Lond) (2010) doi: 10.1093.

      Florman et al. Surgical Infections (2005); 6: 385-394.

      Maffulli N et al. J Hand Surg. 1991; 1, 6A: 1,034-7.

      Marczan BL (2007). Gimbel Surgical Gloves.

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