MRI Safety Organizations
Who regulates/sets standards for MRI equipment and safety? |
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Across the world a large number of regulatory bodies claim some jurisdiction over the production, sale, and safe use of MRI-related devices. At least four major international organizations have promulgated standards for MR performance and safety that have been most widely accepted and strongly influenced policies at the local or national levels.
International Organizations
The National Electrical Manufacturers Association (NEMA) provides detailed methods and standards for evaluating all types of electrical devices. Those relating specifically to MRI are designated MS 1 to MS 12 and include how to measure signal-to-noise (MS 1, 6, & 9), geometric distortion (MS 2 & 12), uniformity (MS 3), acoustic noise (MS 4), slice thickness (MS 5), Specific Absorption Rate (MS 8 & 10), and gradient-induced fields (MS 7 & 11).
The International Electrotechnical Commission (IEC) also has interest in the safe operation of MRI equipment. Its most recently published standard (IEC 60601-2-33) covers a wide range of topics and incorporates some of the NEMA guidelines above. A strong emphasis is on patient safety, including electrical and mechanical. It sets limits for peripheral nerve stimulation, specific absorption rate, and temperature changes, widely used in Europe (but not the US). The three-level operating mode hierarchy (described in another Q&A) is first defined in this document.
The International Commission on Non-Ionizing Radiation Protection (ICNIRP) is concerned with human exposure to electromagnetic radiation in all forms and frequencies, and has issued statements and guidelines concerning both static and radiofrequency fields both for patients and workers in the MRI environment. Their suggested restrictions for workers are somewhat more conservative than those of the IEC and have more influence in Europe.
The American Society for Testing and Materials (ASTM International) has developed standards for testing of medical devices and implants. These include methods for measuring magnetic displacement force (F2052), torque (F2213), RF-induced heating (F2182), and implant-related artifacts (F2219). The ASTM is also responsible (F2503) for defining the terms “MR Safe”, “MR Unsafe”, and “MR Conditional”, and developing the familiar icons associated with each.
Additional international societies involved in promulgation of MRI guidelines and exposure of humans to electromagnetic fields include: the International Organization for Standardization (ISO), American National Standards Institute (ANSI), the Institute of Electrical and Electronics Engineers (IEEE) and the World Health Organization (WHO).
Regional and National Organizations
In the United States the Food and Drug Administration (FDA) has statutory authority to regulate the sale and use of MRI equipment. MRI scanners are considered Class II devices, meaning that they have the potential for human harm and require pre-market 501(k) clearance prior to marketing. The FDA has issued guidance documents with non-binding (but strongly suggested) criteria — including those related to hardware, software, performance, site planning, and safety — to attain this premarket approval. Once approved, however, the FDA does not have authority to inspect MRI facilities to insure the equipment is being used in a safe or prudent fashion. Such activities lie under the domain of various state government agencies. Other organizations such as the American College of Radiology (ACR) or The Joint Commission (TJC) provide quality and safety criteria to certify MRI centers for operation and potential reimbursement for services.
The European Union (EU) has established several MRI-related directives and regulations that apply to its member states, including restrictions on exposure to magnetic fields and certification of devices. In Canada, approval of an MR system granted by Health Canada, with details of operation and certification left to individual provinces. Canadian Safety Code 6 sets limits on electromagnetic field exposures. The Canadian Association of Radiologists (CAR) plays a role similar to that of the ACR in the US, issuing practice guidelines for MRI. Australia and New Zealand have generally followed EU guidelines and together with their Royal College of Radiologists (RANZR). In the UK, the Medicines and Healthcare Products Regulatory Agency (MHRA) issues safety, management and exposure guidelines, while the Health and Safety Executive (HSE) oversees workplace-related issues.
References
American College of Radiology Committee on Safety. ACR manual on MR Safety. Ver 1.0. 2020.
ASTM International. ASTM F2503-13 Standard practice for marking medical devices and other Items for safety in the magnetic resonance environment. ASTM International; 2013 (accessed July 2020).
Delfino JG, U.S. federal safety standards, guidelines and regulations for MRI systems: an overview. Appl Radiol 2015 (Apr); 20-23. [Link]
Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields); 2013 (accessed July 2020)
Health Canada. Safety Code 6. Limits of human exposure to radio frequency electromagnetic energy in the frequency range from 3 kHz to 300 GHz. 2015. (accessed July 2020)
IEEE International Committee on Electromagnetic Safety Technical Committee. Synopsis of IEEE Std C95.1™-2019 “IEEE standard for safety levels with respect to human exposure to electric, magnetic, and electromagnetic fields, 0 Hz to 300 GHz”. [DOI Link]
International Commission on Non-Ionizing Radiation Protection. ICNIRP Guidelines on limits of exposure to static magnetic fields. Health Phys 2009; 96:504-514. [DOI Link]
International Commission on Non-Ionizing Radiation Protection. ICNIRP Guidelines for limiting exposure to electromagnetic fields (100 kHz to 300 GHZ). Health Phys 2020; 118:483-524. [DOI Link]
International Electrotechnical Commission. IEC 60601-2-33:2010: Medical Electrical Equipment - Part 2-33: Particular Requirements for the Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnosis. 3rd ed. with amendments. International Electrotechnical Commission; 2015. (accessed July 2020)
Medicines and Healthcare Products Regulatory Agency (MHRA). Safety guidelines for magnetic resonance imaging equipment in clinical use. 2015.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (includes criteria to obtain the CE Mark, European Equivalent of US FDA 510(k) approval)
Royal Australian and New Zealand College of Radiologists (RANZR). MR safety guidelines. 2017.
The Joint Commission. Diagnostic imaging requirements. 2015. (accessed July 2020)
US Food and Drug Administration. Submission of premarket notifications for magnetic resonance diagnostic devices. Guidance for industry and Food and Drug Administration staff. FDA.gov. (Revised 12/22/16)
American College of Radiology Committee on Safety. ACR manual on MR Safety. Ver 1.0. 2020.
ASTM International. ASTM F2503-13 Standard practice for marking medical devices and other Items for safety in the magnetic resonance environment. ASTM International; 2013 (accessed July 2020).
Delfino JG, U.S. federal safety standards, guidelines and regulations for MRI systems: an overview. Appl Radiol 2015 (Apr); 20-23. [Link]
Directive 2013/35/EU of the European Parliament and of the Council of 26 June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical agents (electromagnetic fields); 2013 (accessed July 2020)
Health Canada. Safety Code 6. Limits of human exposure to radio frequency electromagnetic energy in the frequency range from 3 kHz to 300 GHz. 2015. (accessed July 2020)
IEEE International Committee on Electromagnetic Safety Technical Committee. Synopsis of IEEE Std C95.1™-2019 “IEEE standard for safety levels with respect to human exposure to electric, magnetic, and electromagnetic fields, 0 Hz to 300 GHz”. [DOI Link]
International Commission on Non-Ionizing Radiation Protection. ICNIRP Guidelines on limits of exposure to static magnetic fields. Health Phys 2009; 96:504-514. [DOI Link]
International Commission on Non-Ionizing Radiation Protection. ICNIRP Guidelines for limiting exposure to electromagnetic fields (100 kHz to 300 GHZ). Health Phys 2020; 118:483-524. [DOI Link]
International Electrotechnical Commission. IEC 60601-2-33:2010: Medical Electrical Equipment - Part 2-33: Particular Requirements for the Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnosis. 3rd ed. with amendments. International Electrotechnical Commission; 2015. (accessed July 2020)
Medicines and Healthcare Products Regulatory Agency (MHRA). Safety guidelines for magnetic resonance imaging equipment in clinical use. 2015.
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices (includes criteria to obtain the CE Mark, European Equivalent of US FDA 510(k) approval)
Royal Australian and New Zealand College of Radiologists (RANZR). MR safety guidelines. 2017.
The Joint Commission. Diagnostic imaging requirements. 2015. (accessed July 2020)
US Food and Drug Administration. Submission of premarket notifications for magnetic resonance diagnostic devices. Guidance for industry and Food and Drug Administration staff. FDA.gov. (Revised 12/22/16)
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