Requirements of the Manufacturer

Dental practices use a large amount of specialist equipment which represents a significant financial investment. It makes sense to ensure that this equipment is working optimally and maximise its useful life.

Requirements of the Manufacturer

The MDD/MDR require of the manufacturer of a medical device/surgical instrument that 'Instructions for use must be included in the packaging for every device'.

These instructions must include the appropriate decontamination instructions, and any limitations on the process such as detergent type, maximum temperatures, and storage requirements.

If the instructions are not included, or if they have been lost, the manufacturer should be approached for replacements. These instructions must be retained in the practice for ease of referral, and their content included in the protocols for decontamination.

Dental practices use a large amount of specialist equipment which represents a significant financial investment. It makes sense to ensure that this equipment is working optimally and maximise its useful life.

The manufacturer's instructions should be studied and retained. The content should be in terms of:

  • Operation
  • Cleaning
  • Routine checks and maintenance
  • Servicing and repair

These should be incorporated into the practice schedules to ensure that all necessary actions are carried out without fail.

As well as the manufacturers requirements there may be statutory requirements applicable to the equipment. The provisions of relevant legislation such as The Electricity at Work Regulations 1989 should be taken into account for all electrical appliance, clinical or otherwise. Routine formal visual safety checks should be performed annually with a periodic inspection for equipment which requires an ‘earth’ connection for safety, such as decontamination equipment. The maximum period between inspections and testing is 5 years.

Compressors, autoclaves, and potentially washer disinfectors, are classified as Pressure Vessels and the requirements of The Pressure Systems Safety Regulations 2000 will also apply. The need for pressure vessel insurance and a Written Scheme of Examination is a legal liability and can be provided by the Competent Person (Pressure Vessels). This may be provided by an insurance company.