On inspections we want to see reliable systems, processes and practices to keep people safe. This includes using and maintaining equipment and making sure equipment is not out-of-date.
Out-of-date equipment could include needles, syringes, and defibrillator pads. If these are out-of-date, they are unsafe. There is the potential they could be used to administer drugs to patients or used for venepuncture. Our inspectors regard out-of-date equipment with the same significance as out-of-date medicines.
GP practices are responsible for ensuring their medical devices are maintained. This includes repairing all medical devices correctly, reconditioning and refurbishment. Where equipment is shared between two or more providers, responsibility and accountability should be clearly defines as to who will maintain equipment.
Provision, maintenance and repair of medical devices is part of risk assessment activity. This comes under the Health and Safety at Work Regulations 1999 (management regulations). The Health and Safety Executive publish comprehensive guidance on risk assessment.
GP practices should ensure regular and appropriate:
- replacement of equipment.
- Regular cleaning and checking of equipment includes:
- checking for dirt, damage or contamination
- ensuring additional equipment is available. For example, sealed and in-date adult and paediatric defibrillator pads.
Manufacturer’s guidance should be followed about frequency of calibration and electrical testing. Inaccurate readings from faulty or poorly calibrated machines can impact on quality of care and treatment. For example, errors in blood pressure determination could result in patients receiving treatment they do not need. Their clinical risk could increase if blood pressure is underestimated.
Equipment that should be checked regularly includes:
- fridge(s) used for storage of medicines (including thermometers)
- other thermometers
- Nebuliser compressors
- Pulse oximeters
- weighing scales
- electronic ear irrigators
Staff responsibilities and training
GP providers should maintain a log of all medical equipment used and should be clear about:
- which member(s) of staff have responsibility for medical equipment
- intervals between inspections
- logging of checks, calibration and maintenance
- the system for reporting faults
Healthcare professionals should have received training to operate medical equipment. They have a responsibility to check the suitability of the equipment they are using. They should report any faulty equipment.
Medicines & Healthcare products Regulatory Agency (MHRA)
The MHRA’s role is to protect and promote public health and patient safety.
The MHRA carries out market surveillance of medical devices on the UK market. They take decisions over the marketing and supply of devices in the UK.
The MHRA is responsible for the designation and monitoring of UK Approved Bodies. They have published guidance on medical devices regulations and how they are enforced.
When we inspect
We use these Regulations when we review if the practice is:
- caring and
When we inspect the safety of premises and equipment, we look at:
It is part of our key lines of enquiry (KLOEs). In particular: