32. Requirements for labelling of magnetic resonance imaging apparatus

Each magnetic resonance imaging apparatus shall bear, on the external surface of its housing, the following information:

the name and address of the manufacturer;

the name and address of the distributor, if the distributor is not the manufacturer;

the type and model designation;

the serial number;

the month and year of manufacture;

the static magnetic field strength in Tesla (T); and

the line voltage used for normal operation.

Each magnetic resonance imaging apparatus shall display a label which contains, at least, the following information:

a contraindications section stating that —

the apparatus is contraindicated for patients who have electrically, magnetically or mechanically activated implants; and

scanning patients with intracranial aneurysm clips is contraindicated unless the physician is certain that the clip is not magnetically active;

a warning statement, warning of —

the risk of scanning patients with implanted surgical clips or other ferromagnetic materials or engaged in occupations or activities which may cause ferromagnetic metal implants;

the risk of scanning fetuses and infants;

the risk to patients and other persons that might result from the inadvertent introduction of ferromagnetic materials into proximity with the magnet, along with a recommendation advising the user to establish a security zone to prevent such a risk;

the risk to persons with cardiac pacemakers or other implanted devices who enter a zone where the magnetic field exceeds 5 gauss;

the risk to decompensated cardiac patients, febrile patients and patients with impaired ability to perspire;

the risk of scanning patients with permanent eye-liner tattoo or who are wearing facial make-up which may contain ferromagnetic particles;

the risk of scanning patients suspected of having embedded conductive or magnetically active fragments in or near the eye; and

in the case of a superconducting magnet system, the risk of asphyxiation related to quench, along with a recommendation that the magnet room be designed to vent gases directly to the outside; and

a precaution concerning the scanning of patients —

who have a greater than normal potential for cardiac arrest;

who are likely to develop seizures or claustrophobic reactions; or

who are unconscious, heavily sedated or confused and with whom no reliable communication can be maintained.

Each magnetic resonance imaging apparatus shall be equipped with an operator’s manual which shall, in addition to appropriate directions for use, contain —

a description of the recommended training needed by the physician and the operator to operate the apparatus safely and effectively;

a recommendation to the user to establish an appropriate plan and an emergency procedure for removing and treating any person, who requires emergency assistance, rapidly from the magnet’s influence;

a description of quality assurance procedures recommended for the user including a detailed specification of all phantoms to be used;

recommended maintenance schedules, including designation of whether the user or company service personnel should perform them; and

device specifications from the summary specification sheet with ranges where applicable.

Each magnetic resonance imaging apparatus shall bear, on the external surface of its housing, the following information:

the name and address of the manufacturer;

the name and address of the distributor, if the distributor is not the manufacturer;

the type and model designation;

the serial number;

the month and year of manufacture;

the static magnetic field strength in Tesla (T); and

the line voltage used for normal operation.

Each magnetic resonance imaging apparatus shall display a label which contains, at least, the following information:

a contraindications section stating that —

the apparatus is contraindicated for patients who have electrically, magnetically or mechanically activated implants; and

scanning patients with intracranial aneurysm clips is contraindicated unless the physician is certain that the clip is not magnetically active;

a warning statement, warning of —

the risk of scanning patients with implanted surgical clips or other ferromagnetic materials or engaged in occupations or activities which may cause ferromagnetic metal implants;

the risk of scanning fetuses and infants;

the risk to patients and other persons that might result from the inadvertent introduction of ferromagnetic materials into proximity with the magnet, along with a recommendation advising the user to establish a security zone to prevent such a risk;

the risk to persons with cardiac pacemakers or other implanted devices who enter a zone where the magnetic field exceeds 5 gauss;

the risk to decompensated cardiac patients, febrile patients and patients with impaired ability to perspire;

the risk of scanning patients with permanent eye-liner tattoo or who are wearing facial make-up which may contain ferromagnetic particles;

the risk of scanning patients suspected of having embedded conductive or magnetically active fragments in or near the eye; and

in the case of a superconducting magnet system, the risk of asphyxiation related to quench, along with a recommendation that the magnet room be designed to vent gases directly to the outside; and

a precaution concerning the scanning of patients —

who have a greater than normal potential for cardiac arrest;

who are likely to develop seizures or claustrophobic reactions; or

who are unconscious, heavily sedated or confused and with whom no reliable communication can be maintained.

Each magnetic resonance imaging apparatus shall be equipped with an operator’s manual which shall, in addition to appropriate directions for use, contain —

a description of the recommended training needed by the physician and the operator to operate the apparatus safely and effectively;

a recommendation to the user to establish an appropriate plan and an emergency procedure for removing and treating any person, who requires emergency assistance, rapidly from the magnet’s influence;

a description of quality assurance procedures recommended for the user including a detailed specification of all phantoms to be used;

recommended maintenance schedules, including designation of whether the user or company service personnel should perform them; and

device specifications from the summary specification sheet with ranges where applicable.