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Publication Type: Patient Safety Advisory
Single or Multiple Incident: Multiple
Date: 12/1/2018 12:00:00 AM
This alert discusses the patient safety incidents which can occur related to the use of magnetic resonance imaging (MRI) procedures. MRI uses a magnetic field and radio waves to produce images. Strict attention to MRI screening to prevent ferromagnetic objects and devices from reaching the MR scanner's magnetic field is important for safe MRI. Significant injury can occur to individuals in the MR scanner suite if a ferromagnetic object or a device with ferromagnetic components is exposed to the magnetic field and radiofrequency energy of the MR scanner. To prevent injuries, MRI screening is done to identify ferromagnetic objects before patients, staff, or equipment enters the MR scanner room. This article addresses the identification and analysis of MRI screening events submitted to the Pennsylvania Patient Safety Reporting System (PA-PSRS) from 2009 through 2017 and reviews strategies for keeping ferromagnetic objects and devices from reaching the MR scanner's magnetic field. Of the 1,108 MRI screening events, 83 events involved two or more objects and/or devices. Of the MRI screening events with identifiable objects or devices, 64.8% involved internal medical devices and nonmedical objects; the most frequently involved items were pacemakers (32.3%). More than one-third of events involved external objects, carried in by or attached to the patient or healthcare staff. Of the events involving projectiles, 10 of the 51 projectiles struck either a patient or a healthcare provider. Other safety concerns specifically associated with projectiles are the potential for damage to the MR scanner and the need to turn off, or "quench," the magnet in response to the event. Quenching the magnetic involves releasing a cooled gas that can lead to displacement of oxygen in the room if not appropriately ventilated, which can cause loss of consciousness and death for anyone in the MR scanner room. Analysis shows that the number of reported MRI screening events submitted has decreased, possibly as a result of focused attention, education, and informational resources on MRI safety; but the increasing number and variety of internal medical devices, nonmedical objects, and medical equipment makes determination of MR compatibility an ongoing challenge. The increase of the potential risk for ferromagnetic devices entering the MRI suite highlight the need for continued awareness and focus on MRI screening. Risk reduction strategies are provided in the alert.

Additional Details

Device:
embolization coil, breast tissue expander, breast tissue clip, key ring, battery, contraceptive diaphragms, MRI Scanner, pacemaker, hearing aid, infusion pump, stent, implantable cardioverter-defibrillator,cardiac valve, dental implant, esophageal implant, penile impalnt, uterine implant, surgical clip, bladder stimulator, bone stimulator, bowel stimulator, nerve stimulator, cerebrospinal fluid (CSF) shunt, wires/leads, loop recorder, internal cardiac monitor, fixator, metal plate, screw, staple, cochlear implant, inferior vena cava (IVC) filter, otologic (ear) tubes/implant, EKG leads/electrodes and pulse oximetry probes, arterial line, central line wire, intraosseous line, endotracheal, feeding tube, urinary catheter, endoscopy capsules, digital pill, wheelchair, gas cylinder, walker, stethoscope, laryngoscope
Medication/Gas/Fluid:
medication patches, medication cream

Environment / Equipment
  1. Ensure the MR system is equipped with and patients are instructed on the use of an MR-safe device (e.g., call bell) in the scanner for alerting MR personnel of an emergency or discomfort.
  2. Provide gowns free of metal fasteners and private facilities for all patients to change out of personal/street clothes.
  3. Restrict Zone III and Zone IV access for all persons not trained in MR safety or screened by MR trained personnel.
  4. Physically restrict Zone III and Zone IV access with a reliable, physically restricting method, such as a passkey locking system (use of a combination lock is discouraged).
  5. Ensure restricted MRI areas (i.e., Zone II, Zone III, Zone IV) are controlled by and under the direct supervision of MR-safety-trained personnel.
  6. Ensure that all MRI areas are clearly identified as Zone III and Zone IV, demarcated, and clearly identified as being potentially hazardous.
  7. Ensure that Zone IV is clearly marked with a red light and lighted sign indicating that the magnet is always on.
  8. Provide level 2 personnel direct visualization of the access pathway to Zone IV either by line of site or by video monitors.
  9. Use FMDS devices only as an adjunct to thorough MRI screening (use of common metal detectors is not recommended).
  10. Do not allow equipment or medical devices containing ferromagnetic parts within the five-gauss (5 G) line (the line that delineates the boundary between areas where the MR system's static magnetic field strength is greater than 5 G) unless tested by the manufacturer and labeled as MR-safe or MR-conditional for the facility's specific MR environment.
  11. Provide clear documentation of MR-safe or MR-conditional devices (i.e., personnel should not assume that a device or equipment is MR safe or MR conditional).
  12. Ensure that all equipment or medical devices used in the MRI environment are labeled with the appropriate MR safety label.
  13. Maintain an up-to-date list of all MR-safe and MR-conditional equipment.
  14. Use a strong magnet or hand held FMDS to test all unknown external devices or objects prior to entry into Zone III.
Communication
  1. Interview patients and review their medical records, including previous radiologic or MR imaging, to determine the presence of any internal medical devices or nonmedical objects.
Rules / Policies / Procedures
  1. Designate an MR safety officer and/or medical director responsible for ensuring that MRI safety policies and procedures are in place and monitored for compliance.
  2. Provide MRI screening education for non-MR personnel who are ordering, scheduling, and/or sending patients for MRI procedures.
  3. Develop and implement policies to ensure that all MR safety events, including near-miss events, are reported in a timely manner to the medical director or MR safety officer and to other parties, such as the U.S. Food and Drug Administration (FDA), if applicable.
  4. Develop and implement policies that use MR safety events for quality improvement efforts.
  5. Create screening processes and forms for patients, non-MR personnel, and MR personnel that are essentially identical.
  6. Screen all patients and non-MR personnel for ferromagnetic or conductive medical devices and nonmedical objects internal or external to their bodies.
  7. Complete MRI screening for non-emergent patients onsite by two different individuals, one screen by level 2 MR personnel and one of the two screens done verbally. - Develop processes for patients undergoing emergent scans and accompanied by non-MR personnel that allow for MRI screening to be completed once instead of twice, provided the screening is done by level 2 MR personnel.
  8. Level 2 MR personnel physically examine patients for scars or deformities that may indicate internal medical devices or nonmedical objects or foreign bodies when a reliable patient history is unavailable and the MRI procedure cannot be reasonably delayed.
  9. Ensure removal of all metallic personal belongings and/or devices from every individual before they enter Zone IV, including cell phones, jewelry including body piercings (if removable), metallic medication-delivery patches, cosmetics containing metallic particles (e.g., eye makeup, nail polish), contraceptive diaphragms, hearing aids, clothing with metallic fasteners (e.g., underwire bras, clothes with zippers, rivets, snaps, or buttons) and hair barrettes/clips.
  10. Check all internal medical devices for MR compatibility. - Develop a process for times when written documentation of MR safety status for an internal medical device by the manufacturer or by independent testing is unavailable. The process should include a discussion by the radiology and medical team about the risks and benefits for the MR imaging specific to the patient, with the final decision to proceed or not determined by the radiologist.
  11. Develop protocols and patient-specific plans for safely monitoring patients who are unable to communicate and/or sense pain or burning (e.g., patients who are anesthetized, sedated, very young, or have altered mental status).
  12. Develop policies and training for scenarios, such as MR imaging of patients, prisoners, or parolees wearing ferromagnetic security devices; emergency service personnel (e.g., firefighters, police, security) responding to an emergent call requiring access to Zones III or IV; and non-MR healthcare providers responding to a cardiac or respiratory arrest in Zones III or IV5 - Designate an area outside of Zone IV where a patient can be rapidly moved for cardiopulmonary resuscitation (CPR).
Training
  1. Have two levels of MR personnel who function under the direction of the MR medical director: - Level 1: Personnel have passed minimal safety education training to ensure their own safety as they work within Zone III - Level 2: Personnel have had extensive training and education in the broader aspects of MR safety issues
  2. Provide MRI training for non-MR personal who are frequently in the MRI environment, such as surgical, transport, cardiac catheterization, anesthesia, environmental, maintenance, and emergency response staff.
  3. Provide information to patients and/or caregivers when scheduling an MRI such as the following: - Risks and benefits of MRI - Importance of completing MRI screening form - Importance of providing a complete medical history, including any internal medical devices or nonmedical objects, exposure to metals, use of medication patches, and previous imaging11 - Clarification of medical terms such as "implant" - Reminder to bring any medical device information and/or implant cards, if applicable - Expectations for the day of the MRI procedure such as the following: -- Need to change from street clothes (i.e., clothes with metal zippers, snaps, rivets) into a metal-free hospital gown, and removal of all objects with metal (e.g., jewelry, coins, cell phones) before entering the MR scanner room -- Notification of MR personnel of any tattoos or nonremovable body-piercing jewelry -- Potential of body scanning with a ferromagnetic detection system (FMDS) or strong magnet -- Availability of a patient call system in the MR scanner for use in the event of an emergency or patient discomfort

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