MRI safety and screening policy (diagnostic imaging)

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))

ensuring that the premises used by the service provider are safe to use for their intended purpose and are used in a safe way, (Reg 12(2)(d) (premises safety))

ensuring that the equipment used by the service provider for providing care or treatment to a service user is safe for such use and is used in a safe way, (Reg 12(2)(e) (equipment safety))

The full text is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

For MRI specifically, the detailed safety standard sits in the MHRA Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use, in Society of Radiographers guidance, and in the scanner manufacturer's safety manual. This policy operationalises those sources within the Regulation 12 duty.

3. Purpose

This policy sets out how the Service screens patients, staff, visitors and contractors before access to MRI controlled areas, manages MRI Zone 1 to Zone 4 access and responds to MRI safety incidents.

It covers ferromagnetic risk, implant risk, radiofrequency burn risk, quench response and local escalation.

Modality applicability: this policy applies to MRI only. Imaging centres without MRI record this policy as not applicable unless they add MRI equipment or refer patients into an MRI unit under their own governance.

4. Scope

This policy applies to:

• MRI referral acceptance
• patient MRI safety screening
• implant and device verification
• pregnancy screening where relevant
• claustrophobia and anxiety support
• MRI Zone 1, Zone 2, Zone 3 and Zone 4 controls
• staff, contractor, cleaner, engineer, visitor and family access to MRI areas
• ferromagnetic incident response
• thermal or radiofrequency burn response
• planned and unplanned quench response
• MRI equipment faults and manufacturer escalation

The policy applies to fixed MRI, mobile MRI hosted at the Imaging Centre and any subcontracted MRI session controlled by the Service.

4.1 Local arrangements before adoption

Before adoption, the Service records:

• the named MR Responsible Person and the written extent of their delegated authority
• the appointed MR Safety Expert and how staff obtain advice during operating hours and out of hours
• the current list of MR Authorised Personnel, their access and supervision level, their training evidence and the staff entitled to act as MR Operators
• the locally defined MR Controlled Access Area, MR Environment and any Zone 1 to Zone 4 model used, with a current map, door controls and signs
• the exact screening forms, implant and device information sources, escalation criteria and people authorised to approve a scan where risk is uncertain
• the emergency roles, resuscitation area, evacuation route, quench response, oxygen-depletion response, fire-service liaison and manufacturer contact route
• responsibility boundaries for mobile, hosted or subcontracted MRI, including who owns screening, access, equipment safety, incident reporting and record retention
• the retention location for patient, staff, visitor, contractor, equipment and emergency-exercise records

The Service must issue local rules, work instructions and emergency procedures after consultation with its MR Safety Expert. The four-zone model may be retained where it is used locally, but it must map clearly to the MHRA terms MR Controlled Access Area and MR Environment.

5. MRI screening and access process

The Service does not allow any person or object into Zone 4 until MRI safety screening is complete and recorded.

5.1 Pre-appointment screening

Booking staff issue or complete a screening form before the appointment where possible.

The screening form covers:

• cardiac pacemaker or implantable defibrillator
• neurostimulator, cochlear implant or programmable shunt
• aneurysm clip, stent, filter or vascular device
• metallic foreign body, including eye injury history
• prior surgery involving implants or metalwork
• infusion pump, glucose monitor or wearable device
• pregnancy or possible pregnancy
• renal-risk or contrast question where contrast MRI is booked
• claustrophobia, anxiety or need for support
• mobility, communication or pain needs

If an answer is uncertain, booking staff escalate to the supervising MR Operator or MR Responsible Person before confirming the appointment.

5.2 On-arrival screening

An appropriately trained MR Authorised Person reviews the screening form with the patient on arrival. Both sign or electronically authenticate the completed review. Staff do not rely solely on the booking form.

The on-arrival check includes:

• patient identity
• procedure requested
• screening form completion
• implant evidence or device card where relevant
• removal of metal and electronic items
• clothing check
• pregnancy question where relevant
• consent to continue
• support need and communication method

The MR Operator stops the scan if the patient cannot answer safely and no lawful alternative confirmation route is available.

5.3 Zone access control

The Service defines local controls for each MRI zone.

• Zone 1: public access area before MRI screening.
• Zone 2: supervised interface where initial screening and preparation take place.
• Zone 3: controlled area with restricted access for screened staff and patients.
• Zone 4: scanner room, accessible only when authorised by MR Authorised Personnel under the local access model.

The Service displays local signage, controls doors and records exceptions. Contractors and visitors do not enter Zone 3 or Zone 4 unless screened and escorted under the local procedure.

5.4 Implant and device verification

Staff verify implants and devices before scanning.

Verification may include:

• manufacturer implant card
• medical record
• referrer confirmation
• device database checked under local procedure
• radiologist, MR Responsible Person or MR Safety Expert advice, according to the local decision route
• manufacturer advice where needed

If compatibility cannot be confirmed, the Service does not scan until a competent role holder has completed and recorded the risk decision.

5.5 Pregnancy and claustrophobia

Staff follow the local pregnancy-screening procedure for patients of childbearing potential.

For claustrophobia or anxiety, Staff consider:

• preparation call before attendance
• patient visit to the scanner area before the appointment
• agreed communication signal
• mirror, music or support person where safe
• rescheduling with referrer advice where sedation or medication may be needed

The Service records any decision to stop or abandon the scan.

5.6 In-scan monitoring

The MR Operator keeps contact with the patient during the scan.

Monitoring covers:

• call-bell or agreed signal
• pain, heating or burning sensation
• anxiety or panic
• movement that may affect safety or image quality
• equipment warning
• staff line of sight or communication route

Staff stop the scan if the patient reports burning, pain, distress or a safety concern.

6. MRI incident response

The Service records MRI incidents in the incident register and reviews whether external reporting is required.

6.1 Ferromagnetic or projectile incident

If a ferromagnetic item enters Zone 4 or moves towards the magnet, Staff:

• stop patient movement into the room
• keep people away from the object
• call the MR Responsible Person or supervising MR Operator
• assess patient and staff harm
• do not attempt unsafe retrieval
• contact the manufacturer or engineer where required
• record the incident
• review screening, signage and access control

The Service considers MHRA Yellow Card reporting where the incident involves equipment, device or safety-system failure.

6.2 Thermal or radiofrequency burn

If a patient reports heating or burning, Staff:

• stop the scan
• assess the patient
• arrange medical review where needed
• preserve scan protocol and coil details
• record patient position, padding and contact points
• record clothing, monitoring leads and devices involved
• escalate to the MR Responsible Person, MR Safety Expert and manufacturer where needed
• assess duty of candour where harm occurred

6.3 Quench event

The Service has a written quench response procedure.

The procedure covers:

• evacuation route
• oxygen-depletion risk
• door opening procedure
• emergency service call point
• manufacturer contact
• patient evacuation
• room access restriction
• post-event engineering sign-off
• service interruption communication

Staff do not re-enter or restart scanning until the manufacturer, engineer or competent local role confirms it is safe.

7. Training and drill requirements

Staff who work in MRI areas complete MRI safety training before unsupervised access.

Training covers:

• MRI zone controls
• patient screening
• implant escalation
• ferromagnetic risk
• burn prevention
• emergency stop process
• quench response
• contractor and visitor screening
• incident reporting

The MR Responsible Person keeps the list of MR Authorised Personnel and training evidence current and restricts access where training, certification or screening has expired.

8. Responsibilities

• Registered Manager: owns this policy, ensures MRI safety governance is reviewed and signs off annual review.
• MR Responsible Person: holds delegated day-to-day responsibility for MRI safety, local rules, access authorisation, incident escalation, emergency exercises and training oversight.
• MR Safety Expert: gives independent scientific advice on the MRI safety framework, complex examinations, equipment, incidents and the effectiveness of local procedures. The MR Responsible Person and MR Safety Expert must not be treated as the same role.
• MR Authorised Person: works within their documented access and supervision level, completes screening where authorised and controls access by people who are not authorised.
• MR Operator: operates the scanner, completes the final visual and verbal safety check, monitors the patient and stops an unsafe scan.
• Radiologist or other authorised clinician: advises on clinical risk, implant uncertainty, contrast-linked MRI decisions and clinical alternatives within the local scope of authority.
• Operations Manager: ensures booking, signage, contractors, maintenance visits and room access follow the local process.
• All staff: do not bring unscreened people or objects into controlled MRI areas.

9. Recording requirements and evidence fields

Each patient screening record should include:

• patient identifiers and the examination requested
• dates, times and outcomes of pre-booking, on-arrival and immediately pre-entry checks
• the person's answers, communication support used and any uncertainty identified
• patient and MR Authorised Person authentication of the reviewed screening form
• implant or device make, model, manufacturer, source checked, MR safety conditions and decision-maker
• relevant pregnancy, metallic foreign-body, prior imaging, clinical record and contrast information
• items removed, equipment approved for entry and any escort or carer screening
• the final authorisation or decision not to scan, including reasons, advice obtained and alternative plan
• any scan stop, abandoned examination, adverse event or post-scan advice

The Service also keeps an evidence trail for:

• current local rules, MR Controlled Access Area and MR Environment map, and access-control exceptions
• the delegation to the MR Responsible Person and appointment of the MR Safety Expert
• the list, access level, training, certification and annual screening of MR Authorised Personnel
• visitor, contractor, carer and engineer screening and escort records
• equipment inventory, MR Safe or MR Conditional status, servicing, interlock checks, faults, recalls and remedial action
• emergency procedures, annual MRI evacuation and resuscitation drill, other emergency exercises and resulting actions
• MRI incidents, manufacturer or engineer advice, Yellow Card assessment and duty of candour decision where applicable
• audit findings, linked risk-register entries and completed improvement actions

Patient-related safety information forms part of the patient record even where it is held in a separate MRI system. Staff-related screening forms part of the relevant employment record. The Service applies its approved retention schedule and limits access to authorised roles.

10. Audit cadence

The Service uses the following Verivius default audit rhythm unless current MHRA, SCoR, manufacturer, CQC or local source material requires a different rhythm:

• Per scan: the MR Operator confirms that repeated screening is complete before entry to the scanner room.
• Monthly: the MR Responsible Person audits a sample of screening forms and access exceptions.
• Quarterly: the Registered Manager reviews MRI incidents, abandoned scans and contractor access.
• Annually: the Service completes an MRI evacuation and resuscitation drill, exercises relevant emergency procedures without initiating a quench, checks MR staff screening and reviews access controls. Superconducting-magnet services also evidence the annual visual inspection of vent piping recommended by MHRA.
• After any MRI safety incident: the Service reviews screening, signage, training, equipment and improvement actions.

Audit findings are recorded as improvement actions with an owner and review date.

11. Version control and review date

The Service keeps a controlled copy of this policy. The footer or document-control table records:

• policy owner
• version number
• date approved
• next review date
• changes made since the last version
• source material checked during the review

12. Related policies and companion artefacts

Use this policy with the following local artefacts:

• MRI screening form and implant or device verification record
• MR Controlled Access Area, MR Environment and zone map
• MR Authorised Personnel register and visitor or contractor screening log
• equipment inventory, service record and emergency-exercise record
• incident register, risk register and improvement-action register

Read it with:

• Safe Care and Treatment Policy
• Premises and Equipment Policy
• Medical Emergencies and Deteriorating Patient Policy
• Incident Reporting, Investigation and Learning Policy
• Training, Competency and Mandatory Training Policy
• Contrast Media Safety and Reaction Management Policy

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

13. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

• CQC Regulation 12: Safe care and treatment
• Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (https://www.legislation.gov.uk/uksi/2014/2936/regulation/12)
• MHRA Safety Guidelines for Magnetic Resonance Imaging Equipment in Clinical Use, February 2021 edition (https://www.gov.uk/government/publications/safety-guidelines-for-magnetic-resonance-imaging-equipment-in-clinical-use)
• Society of Radiographers professional guidance and publications (https://www.sor.org/)
• Local MRI rules and the current MRI scanner manufacturer safety manual and service contract documents
• MHRA Yellow Card reporting (https://yellowcard.mhra.gov.uk/)
• HCPC standards of proficiency for radiographers (https://www.hcpc-uk.org/standards/standards-of-proficiency/radiographers/)
• CQC assessment framework and sector-specific guidance, as updated by CQC from time to time

14. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

15. Document control

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the provider's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.