Implementing the Sharps Regulations in the NHS

The Health and Safety (Sharp Instruments in Healthcare) Regulations 2013(1) have been in place since 11 May 2013. The Regulations represent implementation of the European Council Directive 2010/32/EU (the Sharps Directive)(2) into UK legislation.

All employers are required under existing health and safety law to ensure that risks from sharps injuries are adequately assessed and appropriate control measures are in place. The Sharps Regulations build on the existing law and provide specific detail on requirements that must be taken by healthcare employers and their contractors.(3)

The Regulations and other Health and Safety law require the standard hierarchy of control to be followed when considering sharps. If sharps can be eliminated from any tasks, then this should be done. Clearly, for many tasks, healthcare sharps, such as needles and lancets, will still be necessary. The second stage in the hierarchy is to use safer sharps where these are available.

Regulation 5(1)(b) covers the use of safer sharps (incorporating protection mechanisms). The employer must substitute traditional, unprotected medical sharps with a ‘safer sharp’ where it reasonably practicable to do so. The term safer sharp means medical sharps that incorporate features or mechanisms to prevent or minimise the risk of accidental injury. For example, a range of syringes and needles are now available with a shield or cover that slides or pivots to cover the needle after use.(3)

Methods of assessment for these type of devices are outlined in the Regulations and more detailed advice is given in the Unison Guidelines.(4) In both cases, employers are advised to consult employees in the assessment of safer sharps: this will help ensure that they are comfortable with the choice selected and that they use the new equipment safely.

Following introduction of the Regulations we then carried out a Freedom of Information (FOI) request for information from NHS Trusts within the UK in order to gauge how well they were complying with the Regulations. The FOI request was sent out in September 2013 and responses received over the following three months. The information requested was general in nature but with some questions focused on the assessment of procured ready-to-administer products and specifically the range of low molecular weight heparin (LMWH) products. This was aimed at understanding the levels of risk assessments carried out and also whether the Regulations had had any impact on the selection of products used. The full list of questions used in the FOI request can be found in Table 1.

In total, 47 replies were received from NHS Trusts throughout England, Wales and Scotland: some Trusts were able to give a high degree of detail in their replies while others did not answer all of the questions or could not provide replies with the same level of detail. Trusts responding varied in size from 2000 to 24,000 staff members.

There are clear signs that some Trusts have understood and have implemented the Regulations much better than others. For example, to question 9 ‘Has your Trust undertaken a safety device risk assessment on procured ready to administer injection devices?’ the responses were split 50% yes and 50% no (40 replies). Of those saying yes, many had answered this but their response would then mention only general risk assessments carried out within the Trust, and it is suspected that the actual number specifically assessing these products is much lower.

Some of the misconceptions in the replies include the statements in answer to question 11: ‘As LMWH devices are already safety devices risk assessments are not necessary’ and ‘As per the EU Directive, the Trust has implemented safer sharps devices which negates the need for risk assessments to be undertaken’. For some Trusts there appears to be acceptance that as long as a device is called a safer sharp then it is satisfactory to use this without further assessment; the Regulations, however, do make it clear that risk assessment is required and the Unison guidelines(4) can be used successfully for carrying out such assessments.(5)

One further concern is the belief that the safety aspects of devices are included in the assessment for medicinal products assessed for regional and national pharmacy contracts. This is not currently the case; even if it were so, it would not negate the need to also carry out risk assessments locally. Other reasons given for not carrying out risk assessments include: well-established licensed product or no change to clinical practice, assessments undertaken when products were added to the formulary and also, in one case, the mistaken suggestion the pharmaceutical companies are obliged to be compliant with the legislation. Although many companies do now supply medicines with safer sharps, the legislation does not put any emphasis on them to comply with the regulations and the acceptability of the safer sharps devices included is highly variable.(5,6)

The replies to question 12 were examined in some detail and were assessed based on the most widely used LMWH used within the Trust. For all products then the main reason for selection was the licensed indications, however, the secondary reasons behind specific product selection were quite different.

For dalteparin (n=16) the reasons for selection mentioned were: licensed indications 56%, financial 44%, contract/formulary/long-standing use 25% and safer needle device 6%. For fondaparinux (n=3) the reasons for selection mentioned were: licensed indications 100% and safer needle device 33%. For tinzaparin (n=12) the reasons for selection mentioned were: licensed indications 50%, financial 42% and contract/formulary/long-standing use 17%. For enoxaparin (n=17) the reasons for selection mentioned were: licensed indications 47%, financial 12%, contract/formulary/long-standing use 47% and safer needle device 41%.

Hence there is a clear difference in that those that have selected the safer needle device as an assessment criterion are generally using enoxaparin and fondaparinux both of which have a self-sheathing type of device and these were the clearly favoured devices reported by Wright, Caughey and Antoniou in a recent article in the British Journal of Nursing.(6)

For those Trusts who have made changes to their usage of LMWHs in the past two years (10 of the 47 replies; 22.2%) the reasons given were temporary changes due to a supply issue with tinzaparin,(3) introduction of a new LMWH for specific indications (tinzaparin for haemodialysis patients,(1) fondaparinux for unstable coronary artery disease),(2) the other four declined to give a reason for change. This does show that none of the respondents have made the change for safety reasons following risk assessment of the various devices.

Overall rates of sharps injuries for the two-year period for which data was requested varied dramatically between Trusts. Taking into consideration the number of employees as a measure of the size of the Trust and calculation a sharps injury per employee rate for each Trust, there is a range from 0.7 to 8.5% sharps injuries per member of staff over the sample period (note that this has been extrapolated for those Trusts unable to supply data for the whole period). The Trust with the lowest rate was an outlier with the second lowest being 1.3% and the third lowest rate 2.3%. The overall average rate of sharps injuries was 4.6% per staff member giving an annual rate of sharps injuries of 2.3% of staff per annum. Considering the total number of staff employed within the NHS then this is still a highly significant number of sharps injuries on an annual basis. The headcount within the NHS in England was 1,197,733 in December 2013,(7) with the rest of the UK added then this figure is somewhere around 1.3 million. If the rate of sharps injuries is extrapolated to the entire workforce then there would be approximately 30,000 reported sharps injuries expected per annum within the NHS.

The figures found during this study would appear to be broadly in line with those of the Royal College of Nursing, which reported that 48% of nurses polled (n=4407) had experienced a needlestick injury during their career8 and also that more than 1 million needlestick injuries are estimated to occur in the European Union each year.(9)

The latest Eye of the Needle report, published in December 2012, shows that between 2002 and 2011, 4,381 significant occupational exposures were reported (increasing from 276 in 2002 to 541 in 2011). Between 2008 and 2011, there were five hepatitis C virus nosocomial transmissions from patients to healthcare workers following percutaneous exposure injuries. The report goes on to state that 72 significant occupational exposures reported in the sample period involved ancillary staff with no direct involvement in patient care; of these, 81% (58/72) were due to percutaneous exposures, with 62% (36/58) caused by hollow bore needles. The majority of these exposures were due to non-compliance with standard infection control precautions for the handling and safe disposal of clinical waste.(10)

Despite this, many of the Trusts that responded to the FOI request could not supply any specific information on the breakdown of sharps injuries by type of sharp. In fact, 33 of the 47 respondents (70%) could not do this and it is difficult to comprehend how these organisations could prioritise on areas to reduce sharps injuries without collating and trending the information to a higher level. For those Trusts that did report the breakdown by specific types of device, the overall figures are given in Table 2.

Hence more than a quarter of sharps injuries were due to needles, the highest individual category recorded. Since the introduction of the Sharps Regulations there appears to have been little impact on overall numbers of sharps injuries being reported. Within those Trusts that were able to report data by month, the total average per month was 411 in the 19 months leading up to the Regulations and 407 in the five months since the Regulations were due to be implemented. Clearly the fall of 1% is not statistically significant but it was still early days into the legislation and it would be worthwhile reviewing the situation in another year or so.

Unfortunately few Trusts were able to provide an answer to question 8 regarding needlestick injuries specific to each type of LMWH presentation, and so it is difficult to draw too many conclusions from these data. In the Trusts that could provide this information, there were a total of 17 sharps injuries with LMWH devices from a total of 1525 reports, which gives an average of 1.1% of sharps injuries across these Trusts. If this figure was extrapolated across the NHS, it would still be significant. Based on the 4.6% of staff suffering a sharps injury figure calculated above, this would mean that 0.05% of staff would have suffered a sharps injury caused by a LMWH device specifically over the two-year period. Based on the staffing figure given above, this would amount to 325 needlestick injuries per year from LMWH products.

Clearly there is still a significant workload for many NHS Trusts in fully implementing the Sharps Regulations and specifically in the risk assessment of the various safer sharps devices that are available. There is little evidence to date that these organisations have selected products based on their safety engineered safer sharps devices. Instead, familiarity with the products and their licensed indications continue to be the main selection criterion.