Plain-English explanations of the technical terms and legislation used in this document.
- Adverse incident
- Any event linked to a medical device, such as a fault or wrong reading, that has harmed or could harm a patient or user.
- Asset register
- A single master list recording every medical device and item of clinical equipment the service holds, with its details and service history.
- Calibration
- Checking and adjusting a device so that its measurements stay accurate against a known standard.
- Care Quality Commission (CQC)
- The independent regulator of health and social care services in England.
- CE marking
- A mark showing that a product meets the relevant safety and regulatory requirements for sale and use, recognised in Northern Ireland and the European Union.
- Clinical waste
- Waste from healthcare, such as used dressings or sharps, that could pose a risk of infection or harm and must be disposed of safely.
- Commissioning
- The checks and set-up done when new equipment arrives to confirm it is complete, safe and ready for clinical use.
- Decommissioning
- Permanently taking a device out of service, for example because it is obsolete, beyond economic repair or withdrawn.
- Decontamination
- The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse or handle.
- Defibrillator
- A device that delivers a controlled electric shock to the heart to restore a normal rhythm in a cardiac emergency.
- Duty of candour
- The legal duty to be open and honest with a person and their family when something goes wrong with their care.
- Electrical safety testing (EST) / portable appliance testing (PAT)
- Checks to confirm that an electrical device is safe to use and free of electrical faults.
- Field Safety Corrective Action (FSCA)
- The action a manufacturer asks users to take to reduce a risk from a device, such as quarantining, modifying, removing or returning it.
- Field Safety Notice (FSN)
- A notice issued by a manufacturer to alert users to a safety problem with a device and tell them what action to take.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
- The regulations that set out the fundamental standards providers must meet, including Regulation 12 on safe care and treatment and Regulation 15 on premises and equipment.
- Instructions for use (IFU)
- The manufacturer's written guidance explaining how to use, clean and maintain a device safely.
- Medical device
- Any instrument, equipment, software or material the manufacturer intends to be used for a medical purpose, such as diagnosis, treatment or monitoring.
- Medical Devices Regulations 2002
- The UK law governing how medical devices are made available and used safely.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- The UK body that regulates medicines and medical devices and issues safety alerts about them.
- Planned preventive maintenance (PPM)
- Servicing carried out on a set schedule to keep equipment working safely and to prevent faults, rather than waiting for it to break down.
- Quarantine
- Setting a device aside in a designated place, separate from equipment in use, so it cannot be used until a problem is resolved.
- Recall
- A manufacturer or regulator action to remove or correct a device because of a safety concern.
- Registered Manager
- The person registered with the regulator as responsible for the day-to-day running of a service.
- Regulated activity
- A type of care or treatment the law requires a provider to register with the regulator to deliver.
- Single-use device
- A device intended by the manufacturer to be used once for a single patient and then disposed of, never reused.
- Standard Operating Procedure (SOP)
- A written step-by-step instruction setting out how a particular task or process must be carried out consistently and safely.
- UKCA marking
- The UK Conformity Assessed mark showing that a product meets the relevant requirements for sale and use in Great Britain.
- Yellow Card scheme
- The Medicines and Healthcare products Regulatory Agency's system for reporting problems with medicines and medical devices.