Page updated 9 October 2006
CE Marking of Medical Equipment
- Does the instrument have lumens/ channels and how are these to be cleaned
- Does the instrument need dismantling before cleaning
- Does the instrument have electrical components and do you have the capacity to clean and sterilize them in the manner described by the manufacturer
- Is the method of cleaning recommended by the manufacturer available in your practice, or would replacement with a single use disposable item be a valid alternative
- Which cleaning agents are recommended and do you have COSHH assessments prepared on these.
- Does the instrument have a limited life span and is it still within date
- Owners of pressure systems are required to demonstrate that they know the safety operating limits, principally pressure and temperature of their pressure systems and that they are safe under those conditions. Fit suitable protective devices and ensure they are functioning properly
- Owners need to ensure that a suitable written scheme of examination is in place before the system is operated
- They need to ensure that the pressure system is actually examined by a "Competent Person" in accordance with the written scheme of examination. The written scheme needs to be reviewed regularly to establish that it is still appropriate especially as the system ages when more frequent examinations may be required
- Carry out suitable maintenance
- Ensure that there is a set of operating instructions for the sterilizer, safety devices and pipe work including instructions for emergencies
- Ensure that staff are fully trained in the operation and use of the equipment and the management of steam related injuries (scalds/burns).
- An operator or owner acting negligently in circumventing safety features might incur legal liability for injury or damage to people or property or be committing a criminal offence.
Since 1998, manufacturers of medical devices must by law, provide instructions on decontamination of their equipment including methods for cleaning, disinfection, sterilisation, packaging and state any limit to the number of times an item can be sterilized. All medical devices (such as benchtop sterilizers) marketed in the European Union carry a "CE" mark, which indicates that the equipment satisfies the requirements of the directive and that it is "fit for the intended purpose".
Failure by the dentist to adhere to these guidelines may damage the equipment (e.g. steam sterilizing plastics with low melting points). Importantly, it may also invalidate any warranties and transfer liability from the manufacturer to the re-processor/ or person who authorised the re-processing namely the dentist. Failure to comply with manufacturer's decontamination instructions may put patients and staff at risk.
Dentists are advised to carry out an assessment of the decontamination procedures and systems employed for all types of reusable equipment to confirm that decontamination is being performed in compliance with manufacture's instructions.
Key points to check include:
Always seek further advice from the manufacturer if confirmation or clarification of decontamination instructions is needed. This information is normally posted on the manufacturer's website or from your local Community Infection Control Nurse or Dental Advisor.
A new sterilizer has to be installed, commissioned and validated before you use it. You should retain all records (for 11 years) of these activities in the sterilizer logbook for future reference. A Registered Authorised person (sterilizers) (AP)- registered with the Institute of Health Engineering and Estates Management will be able to provide advice about the validation of a new sterilizer and a qualified Competent person (pressure vessels) (TP) should carry out the validation tests for a vacuum autoclave.
Further information can be obtained from a n independent advisor (Authorised person-AP) who will be able to provide information on a range of sterilizers. Alternatively, a supplier can be contacted directly, they should be informed of the sterilizer's intended use and written assurance should be obtained from the supplier that the sterilizer is suitable for the intended purpose. The dentist should be aware that the sterilizer must be installed and commissioned by an accredited engineer.
Pressure vessel insurance, installation and validation
All steam sterilizers and associated pipe work are subject to the Pressure Systems Safety Regulations 2000. You must have pressure vessel insurance for both your sterilizer(s) and compressor(s) i.e. third party liability insurance to cover the particular risks associated with pressurized equipment and steam. Your practice insurance may not cover sterilizers unless it is specifically listed on the policy, so check with your insurance broker.
Please consult the HSE booklet ("Pressure systems and you" available from www.hse.gov.uk or www.hsebooks .co.uk ) for further details of periodic pressure system regulations or contact your local Health and Safety executive office for advice.
The Regulations state that:
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