Evaluation of safety-engineered hypodermic needles & syringes in the NHS in Wales

J Ford (R&D Officer, SMTL)  and P Phillips (Director, SMTL)

Introduction

Sharps injury and exposure to blood-borne viruses is an occupational hazard for healthcare professionals. 'Sharp safety -engineered' devices are available designed to protect the user from injury following use. This article describes an evaluation of three sharp safety hypodermic needle devices carried out in six hospitals in Wales which was completed in April 2007. User acceptability and performance was assessed.

The evaluation process

The aim of the evaluation was to assess sharp safety hypodermic needle devices available in the UK, in terms of device performance and user acceptability. It involved bench-top assessments, device functionality tests and work-place evaluations. The following section describes the process that was undertaken.

1. Requested samples of all 'safety' hypodermic syringes/needle devices available in the UK at time of evaluation

2. Bench-top assessment of devices carried out by a group of health care professionals. Six devices were assessed in total and three of them considered appropriate for All Wales evaluations.

3. Functionality tests were carried out at SMTL. These included the 'splatter test' where fluorescent liquid is drawn up into the syringe and the safety feature activated over paper to detect any splatter using UV light. Also, the 'shield orientation' test was carried out where devices with needle shields were prepared for use and the position of the shield in relation to the needle bevel was noted (i.e. some shield orientations make venipuncture difficult).

4. The list of devices to be evaluated in Trusts was then finalised. They were the BD Eclipse (with needle shield) Tyco Magellan (needle shield/sheath) and Nipro Securegard (with retractable needle).

5. All Welsh NHS Trusts were invited to participate in evaluations. One coordinator and approximately 5 users were recruited from each participating Trust. Six hospitals in Wales took part.

6. Device companies provided participants with devices and a short training session prior to evaluations.

7. Evaluations commenced. Users performed usual tasks using the 'safety' devices instead of conventional devices where appropriate. A minimum of 10 devices were assessed by each user. Each user assessed each model of device in turn (order randomised by SMTL). The user filled in a questionnaire after each model of device has been evaluated. Questionnaires were designed by SMTL using a scoring system to evaluate device reliability, ease of activation etc.

8. Once users evaluated all device models, they completed a questionnaire comparing the devices with each other

9. SMTL collated, analysed and presented data

10. Results were made available to provide advice and recommendations regarding future All Wales purchase contracts

Figure 1 : The Magellan safety syringe (B.Braun) with a needle shield. Images showing various stages of activation of the safety feature.

Figure 2 : Integra (Becton Dickinson) hypodermic syringe with retractable needle. Shown before (above) and after (below) the safety feature has been activated.

Results

Splatter tests were carried out to assess whether devices had the potential to produce fluid splatter and therefore cause a potential infection risk. 20 Magellan, 20 Eclipse and 20 Securegard were used during this test. The shields were engaged by the investigator 7 cm above a surface. In the case of the Securegard, the plunger was pressed forward and then retracted so that the needle pulled back into the syringe barrel and the plunger was snapped off. Results showed that none of the Magellan devices tested produced any visible fluid splatter when they were activated. However, 5 out of the 20 BD devices demonstrated fluid splatter upon activation. Of these, 4 shields produced 1 spot of liquid, whilst 1 device produced 2 drops of liquid. Two out of the twenty Securegard devices tested produced splatter when the plunger was snapped from the device. In addition, 4 of the Securegard devices failed to activate (i.e. when the plunger was pressed all the way forward, the needle did not subsequently retract into the barrel).

The results from the evaluations were recorded as a median score but in most cases, there was a variety of views on each device (see table 1). Users in 4 different hospitals made comments about problems they had experienced whilst trying to operate the Securegard device. In cases where devices were reported to have 'failed', user error rather than device failure may be the cause of the problem and may reflect the greater training requirements of a particular safety device. However, 4 out of 20 devices tested in the laboratory failed to activate (i.e. the plunger was pushed forward as far as possible but the needle would not subsequently retract) and these devices were packaged with the needle already attached so there was no chance of 'user error' when connecting the needle to the syringe. This may have been what some users experienced in the evaluations.

Table 1 : Results of evaluation questionnaire showing median responses for each statement

KEY: '1' = strongly agree··through to '5' = strongly disagree

The Magellan device has a hinged shield (sometimes described as a sheath) which is bent at the hinge in the middle during the procedure and is slid over the needle following use. In contrast, the Eclipse shield pivots down over the top of the needle and clicks on to the needle. No major safety issues were identified with the Eclipse or Magellan products. The SecureGard device is activated following use by pushing the plunger forward until it locks on to the hub of the needle with a click. The plunger should then be pulled back, which retracts the needle into the barrel of the syringe, and the plunger is then snapped off. A number of reliability issues were raised by different users regarding the SecureGard product including leakage and accidental activation.When users were asked to directly compare the three safety devices with each other the shielded products (Magellan and Eclipse) were preferred to the retractable design (SecureGard), and the Magellan was favoured overall by most users. All who compared the devices stated that they would be prepared to consider using the Magellan instead of a conventional device.

Issues encountered during evaluations

One of the major issues raised during the evaluations was the time it took for Trusts to complete evaluations. Firstly organising a meeting at which the Company representative, the Trust coordinator and all users could be present meant that it sometimes took months to arrange. In addition, a common issue appeared to be that users did not have much opportunity to use these devices and so individual evaluations took much longer than anticipated. They stated that various reasons for this included the increased use of pre-filled syringes (for vaccinations such as Hepatitis B) and the practice of injecting medication directly into the ports of IV lines with needle-free syringes. It does seem likely that these issues also affected the number of injections that users could perform. Personnel changes in some Trusts (users and coordinators) also prevented the evaluations from progressing in some cases.

Conclusion and recommendations

All 3 devices were acceptable to some degree but the Magellan  appeared to be the preferred device overall. The majority of users felt comfortable using the Magellan and thought that they should be considered for use in the Welsh NHS. Those who evaluated all 3 types of devices were unanimous in their opinion to consider using the Magellan instead of a conventional device. The Eclipse also received favourable scores (although not quite as favourable as the Magellan). However, when all 3 were compared, only a couple of users stated that they would consider using the Eclipse rather than a conventional device. The Magellan also demonstrated superior performance in the fluid splatter tests when compared to the Eclipse. Although not totally unfavourable, the Securegard received the least positive response and generally appeared to be the most complicated device to use out of the three.

As a result of this evaluation, SMTL would describe the Magellan as the 'preferred' device.

Review of similar safety syringe evaluations

University Hospital Birmingham conducted an evaluation of the BD Eclipse, BD SafetyGlide and BD SafetyGlide insulin syringes in an evaluation exercise similar to ours (SafetyGlide products are not currently available on the UK market) (Adams and Elliott 2003). Fifty nurses took part in the evaluation, the nurses adapted to using the devices quickly and felt that they were safe to use. However, 4% of the SafetyGlide product and 2% of the Eclipse needles were reported to detach from the syringe when activating (they felt that either luer lock connections or the push and twist method was necessary with these 2 products). 3% of the Safetyglide products produced liquid splatter when they were activated (no Eclipse needle produced fluid splatter).

The Scottish NHS funded a large project in 2005 evaluating safety devices throughout Scottish NHS Trusts (Elder and Patterson 2005). There have been changes in the devices available in UK since this study. They looked at 9 designs of safety needle/syringe (including the Magellan and the Securegard but not the Eclipse). Three groups of evaluators (from 3 Scottish NHS Trusts) evaluated 3 of the device models each. They experienced similar problems to the Welsh study in getting users to take part due to low usage. User acceptance was 'generally low'. However, 60% of the Securegard users (n=23) stated that they would prefer to use it to a conventional syringe. All 4 users of the Magellan product said they would prefer to use it to a conventional device. The authors concluded that the Magellan product was one of the 'preferred' products and that the NeedlePro and Securegard were 'acceptable' products although they reiterated that results should be regarded with caution because of the low number of users involved.

Acknowledgements

Our sincere thanks go to all Trust coordinators and users who took part in the evaluations. Without their efforts this project could not have taken place. We are also extremely grateful to all the companies for the provision of devices, in particular we would like to thank Becton Dickinson, Tyco Healthcare and Nipro for the provision of devices for evaluations and for the help and cooperation of their representatives who visited Trusts and trained users.

Bibliography

Adams A, Elliott T (2003)
A comparative user evaluation of three needle-protective devices. British Journal of Nursing Vol. 12, no. 8. pg 470-474

Elder A, Patterson C (2005) Safer sharps devices:an evaluation of utility in NHS Scotland.Report to Scottish Executive Health Department Occupational Health and Safety Strategy Implementation Group. Edinburgh: SEHD