Appalled by the failure of previous legislation to prevent the one million needlestick injuries each year in Europe, the health unions last year demanded EU action.
The EU Directive of 2010 gave legal effect to an agreement between the unions and employers and is set to become national law by the member states. The rules come into play in the UK on 11 May.
The transposition is solely the responsibility of the HSE, who is charged with writing the regulations, administrating the statutory consultation and finally enforcement.
The HSE makes it clear in the report on the consultative document that healthcare workers ‘already have a legal duty under existing legislation to carry out a suitable and sufficient assessment of the risks posed by sharps’.
The duty is now risk control.
What are the current risks?
Dental syringes and needles are different to the medical equivalents – the syringes are re-usable and the needles have two points. All dental cartridge syringes on sale in the UK fail risk assessment: ‘If a risk assessment reveals a risk of injury, the worker’s exposure must be eliminated.’ The most vital of these dental risk assessments causing the failure are:
Contaminated biofilm – This has already been identified in DH sterilisation protocols. Here, the needle perforator scrapes the biofilm in the syringe cannula and then infects the anaesthetic solution producing an automatically contaminated injection – in effect, an unrecorded needlestick
80% of dental needlestick injuries are due to the recapping process and the requirement to remove the contaminated needle from the reusable syringe
Requirement of two-handed operation in operating dental safety shields
Unlike medical shields, the dental one has an open end that can allow a small finger to access the needle point. See ISO/WD 23908-1 (N 84)
Dental shields do not give the required strong visual warning, as such warnings can obscure the aspirant
Other risk factors apply..
Under regulation 5(1) (b), an employer must substitute unprotected sharps with those that incorporate features or mechanisms that reduce or eliminate the risk of accidental injury. There are already syringes/needles that integrate a slide or cover that protects the user.
Safer sharps do not remove all risk as injury can occur accidentally during a procedure. The regulations suggest that end users (the operatives) should be involved during the selection of safer sharps to ensure that risk of injury is reduced. Some of the dental syringes can be modified to conform, although the metal syringe cannot. Alternatively, some major manufacturers and suppliers have new single-use cartridge syringes specifically designed to overcome the risk factors listed above.
However, during the consultation period, the HSE was made newly aware of certain uses of sharps that would require clarification of the proposed regulations, in particular ‘parking’ of dental syringes (for top-up injections), tied closely with the requirement for a ‘secure container’ and strip-down of syringes.
The high cost of injection moulds will mean that no manufacturer or supplier will sign off their final requirements until the regulations are passed in parliament and all new risk assessments have been completed.
What must you do?
Firstly, you must ensure that you have fulfilled your legal obligations of risk assessment, which will confirm that all present syringes do not conform. Then, when the regulations are passed by parliament update, your risk assessments are necessary.
It might help with your assessments if you use the dental sharps assessment questionnaire that will be available on the Hambley Limited website, www.hambleylimited.com, or visit the TDICT Project website, www.tdict.org.
As modified or new syringes capable of compliant risk control become available, you will be in a position to choose. The following should be considered when changing to safer sharps:
The new device must not compromise patient care
The reliability of the device
The operator can retain appropriate control over the procedure
Ease of use
Is the safety mechanism design suitable for the application?
It is important for both employers and employees to understand the changes that are needed to ensure compliance under these regulations. If in any doubt, further advice could be sought from your local HSE.