Plain-English explanations of the technical terms and legislation used in this document.
- Adverse incident
- An event linked to a medical device that harms, or could harm, a patient, member of staff or other person.
- Asset register
- A complete list of all the equipment a service owns, used to track maintenance, testing and replacement.
- Autoclave
- A machine that uses pressurised steam to sterilise instruments and equipment.
- Automated external defibrillator (AED)
- A portable device that checks the heart rhythm and can deliver an electric shock to restart a heart in cardiac arrest.
- Bariatric equipment
- Equipment designed and load-rated for safely supporting and moving people of higher body weight.
- Calibration
- Checking and adjusting a measuring device against a known standard so that its readings are accurate.
- 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 European safety, health and environmental standards needed to be sold.
- Central Alerting System (CAS)
- A national service that issues safety alerts and recalls about medicines, medical devices and equipment to healthcare providers.
- Competent person
- Someone with the training, knowledge and experience to carry out a task safely and correctly.
- Control of Substances Hazardous to Health Regulations 2002 (COSHH)
- The law for safely managing chemicals and other hazardous substances at work.
- Decontamination
- The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
- Defibrillator
- A device that delivers a controlled electric shock to the heart to correct a life-threatening abnormal rhythm.
- Dose error reduction system (drug error reduction software)
- Built-in pump software that warns staff or blocks a setting when an infusion dose or rate falls outside safe limits.
- Electrocardiogram (ECG) machine
- A device that records the electrical activity of the heart to help detect heart problems.
- Electronic and biomedical engineering (EBME)
- The specialist function responsible for maintaining, testing and repairing medical electronic equipment.
- Endoscope
- A thin, flexible tube with a camera used to look inside the body, which must be carefully cleaned and decontaminated after use.
- Field safety notice
- A notice issued by a manufacturer warning of a problem with a device and the action users must take.
- Fundamental standards
- The minimum standards of safety and quality below which care must never fall.
- Health and Safety at Work etc. Act 1974
- The main law setting out employers' general duties to protect the health and safety of staff and others.
- Health and Safety Executive (HSE)
- The national body responsible for regulating and enforcing workplace health and safety in Great Britain.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
- The law setting out the fundamental standards that registered care providers must meet.
- Health surveillance
- Ongoing health checks for staff exposed to certain hazards, to spot early signs of work-related illness.
- Healthcare-associated infection
- An infection that a patient picks up as a result of receiving healthcare, rather than from their original illness.
- Hoist
- A mechanical device used to lift and move a patient who cannot move themselves safely.
- Infection prevention and control (IPC)
- The measures used to stop infection spreading between patients, staff and visitors.
- Infusion pump
- A device that delivers fluids or medicines into a patient at a precisely controlled rate.
- Instructions for use (IFU)
- The manufacturer's official guidance on how to use, clean and maintain a device safely and correctly.
- Internal quality control
- Routine checks run on testing equipment to confirm that its results stay accurate and reliable.
- Ionising Radiation (Medical Exposure) Regulations 2017
- The law protecting patients from harm caused by radiation used in medical procedures such as X-rays.
- Ionising Radiations Regulations 2017
- The law protecting workers and the public from the harmful effects of radiation.
- Lifting Operations and Lifting Equipment Regulations 1998 (LOLER)
- The law requiring lifting equipment, such as hoists, to be strong enough, properly used and regularly examined.
- Local exhaust ventilation (LEV)
- An extraction system that captures harmful dust, fume or vapour at its source before it can be breathed in.
- Locum
- A clinician who works temporarily to cover for a permanent member of staff.
- Management of Health and Safety at Work Regulations 1999
- The law requiring employers to assess and manage risks to health and safety at work.
- Medical Device Alert
- An official safety warning about a specific medical device, telling users what action to take.
- Medical Devices Regulations 2002
- The law governing the safety, marking and marketing of medical devices in the United Kingdom.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- The national body that regulates medicines and medical devices and monitors their safety in the United Kingdom.
- National Patient Safety Alert
- An official alert telling healthcare providers about a safety risk and the actions they must take to reduce it.
- Near miss
- An event that could have caused harm but did not, by chance or because it was caught in time.
- Nominated Individual
- The senior person responsible to the regulator for supervising how a service is provided.
- Personal protective equipment (PPE)
- Items such as gloves, aprons and masks worn to protect against harm or infection.
- Planned preventive maintenance
- Servicing and checks carried out on a set schedule to keep equipment working safely and prevent breakdowns.
- Point-of-care testing (POCT)
- Medical tests carried out near the patient, such as at the bedside, rather than in a central laboratory.
- Provision and Use of Work Equipment Regulations 1998 (PUWER)
- The law requiring work equipment to be suitable, safe, maintained and used only by trained people.
- Quality statement
- A clear statement of the standard a service is expected to meet, used by the regulator to judge quality.
- Quarantine (of equipment)
- Removing a faulty or suspect device from use and clearly labelling it so no one uses it until it is checked or repaired.
- 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.
- Reporting of Injuries, Diseases and Dangerous Occurrences Regulations 2013 (RIDDOR)
- The law requiring certain workplace injuries, diseases and dangerous events to be reported to the Health and Safety Executive.
- Residual current device (RCD)
- A safety switch that quickly cuts the electricity supply if it detects a fault, helping to prevent electric shock.
- Residual risk
- The level of risk that remains once existing control measures are taken into account.
- Resuscitation trolley
- A mobile unit holding the equipment and drugs needed to treat a patient in a medical emergency.
- Risk assessment
- A structured check identifying what could cause harm and what is being done to prevent it.
- Single assessment framework
- The structure the regulator uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
- Single-use device (SUD)
- A device intended to be used once on a single patient and then thrown away, never cleaned and reused.
- Sling
- A fabric support used with a hoist to hold and lift a patient safely during a transfer.
- Syringe pump
- A device that pushes medicine from a syringe into a patient at a slow, precisely controlled rate.
- Traceability
- The ability to track which instruments or devices were used on which patient, and how they were decontaminated.
- UKCA marking
- A United Kingdom mark showing that a product meets the relevant Great Britain safety and quality standards.
- Validation (of decontamination)
- Documented proof that a cleaning or sterilising process consistently works and makes equipment safe to reuse.
- Washer-disinfector
- A machine that automatically cleans and disinfects medical instruments before they are sterilised.
- Yellow Card scheme
- The United Kingdom system for reporting suspected problems with medicines and medical devices to the regulator.