Download assembly committee on business and professions

AB 1092
Page 1
Date of Hearing: April 28, 2015
ASSEMBLY COMMITTEE ON BUSINESS AND PROFESSIONS
Susan Bonilla, Chair
AB 1092 (Mullin) – As Amended April 20, 2015
SUBJECT: Magnetic resonance imaging technologists.
SUMMARY: Establishes a registration program for Magnetic Resonance Imaging (MRI)
technologists under the California Department of Public Health (CDPH).
EXISTING STATE LAW:
1) Establishes standards of education, training, and experience for persons who use X-rays on
human beings and prescribes means for assuring that these standards are met. (Health and
Safety Code (HSC) §§ 114840-114896)
2) Defines a radiologic technologist (RT) as a person, other than a licentiate of the healing arts,
applying X-rays to human beings for diagnostic or therapeutic purposes. (HSC § 114850)
3) Makes it unlawful to perform radiological imaging procedures on humans without a license,
certification, and supervision. (HCS §§ 116955-107111)
4) Requires general acute care hospitals, acute psychiatric hospitals, and dentistry and maternity
hospitals to report “adverse events” to the CDPH no later than five days after the adverse
event has been detected, or, if that event is an ongoing urgent or emergent threat to the
welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the
adverse event has been detected. (HSC § 1279.1)
5) Defines an “adverse event” as, among other things, 1) patient death or serious disability
associated with the use or function of a device in patient care in which the device is used or
functions other than as intended, and 2) an event or series of events that cause the death or
serious disability of a patient, personnel, or visitor. (HSC § 1279.1)
6) Defines “serious disability” as a physical or mental impairment that substantially limits one
or more of the major life activities of an individual, or the loss of bodily function, if the
impairment or loss lasts more than seven days or is still present at the time of discharge from
an inpatient health care facility, or the loss of a body part. (HSC § 1279.1(d))
7) Requires the CDPH to provide information regarding reports of substantiated adverse events
and the outcomes of inspections and investigations conducted on its website and in written
form, including each substantiated adverse event, including compliance information history.
(HSC § 1279.3)
EXISTING FEDERAL LAW:
8) Establishes mandatory requirements for manufacturers, importers, and device user facilities
to report certain device-related adverse events and product problems to the federal Food and
Drug Administration (FDA): (Title 21 Code of Federal Regulations (CFR) § 803)
AB 1092
Page 2
a) Requires manufacturers to report to the FDA when they learn that any of their devices
may have caused or contributed to a death or serious injury. Manufacturers must also
report to the FDA when they become aware that their device has malfunctioned and
would be likely to cause or contribute to a death or serious injury if the malfunction were
to recur. (21 CFR §§ 803.50-803.58)
b) Requires importers to report to the FDA and the manufacturer when they learn that one of
their devices may have caused or contributed to a death or serious injury. The importer
must report only to the manufacturer if their imported devices have malfunctioned and
would be likely to cause or contribute to a death or serious injury if the malfunction were
to recur. (21 CFR §§ 803.40-803.42)
c) Requires user facilities to report a suspected medical device-related death to both the
FDA and the manufacturer. User facilities must report a medical device-related serious
injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown.
Defines a “device user facility” as a hospital, ambulatory surgical facility, nursing home,
outpatient diagnostic facility, or outpatient treatment facility, which is not a physician’s
office. User facilities must also submit annual reports to the FDA by January 1. (21 CFR
§§ 803.30-803.33)
THIS BILL:
1) Defines an “MRI technologist” as a person who operates MRI equipment to produce crosssectional images of a patient’s body for diagnostic purposes.
2) Requires MRI technologists to register with the CDPH.
3) Requires the CDPH to maintain an official roster of registered MRI technologists, and
record:
a) The location, employer, and supervisor of each MRI technologist;
b) A description of the practice of each MRI technologist, including the services provided;
and,
c) Any certification possessed by the MRI technologist, if applicable.
4) Authorizes the CDPH to impose a fee for the registration of an MRI technologist in an
amount that is no greater than the amount reasonably sufficient to cover the administrative
costs of the registration program.
5) Requires a registered MRI technologist to report to the CDPH any accident, within 30 days
of its occurrence, resulting in injury or death to a patient, damage to the property of a patient,
or damage to the MRI equipment.
6) Authorizes the CDPH to issue a citation to a person, if acting in the capacity of, or engaging
in the practice of, an MRI technologist, not registered with the department.
7) Requires the citation to contain an order of abatement and a minimum civil penalty of two
hundred dollars ($200) up to a maximum of one thousand dollars ($1,000).
AB 1092
Page 3
8) States that MRI technologist are not authorized to practice medicine, surgery, or any other
form of healing.
FISCAL EFFECT: Unknown. This bill is keyed fiscal by the Legislative Counsel.
COMMENTS:
1) Purpose. This bill is author sponsored. According to the author, “Currently, California law
is silent on MRI technologists. AB 1092 will provide for a registry of all persons in the state
of California operating MRI. This bill will allow the Department of Public Health to collect
more data on specifically who is performing MRI; this language would also require reporting
of accidents within 30 days of occurrence. Registration of MRI technologists is the least
burdensome option for providers, and will permit collection of information relevant to the
regulatory strategy. This bill is a good step towards better MRI safety and practices.”
2) Background. According to the FDA, MRI is a medical imaging procedure that uses strong
magnetic fields and radio waves to produce cross-sectional images of organs and internal
structures in the body. MRI devices run an electric current through coiled wires to create a
temporary magnetic field around a patient’s body. Radio waves are sent from and received by
a transmitter/receiver in the machine, and the signals are used to produce digital images of
the area of interest.
The individuals that operate the medical imaging devices include technologists and
technicians. Technologists and technicians that operate MRI scanners may, among other
things: 1) provide instructions for patients, 2) assist patients on and off the scanning table, 3)
monitor vital signs, 4) keep the MRI suite clear of ferrous magnetic objects, and 5) adjust the
scanner to fix image quality issues. While technologists often interact with patients when
operating the equipment, they do not interpret the images produced and must be supervised
by a qualified healing arts licensee (HCS § 106960).
State Regulation of Medical Imaging. In California, MRI technologists are industry
regulated—there are no licensing or certification requirements for technologists or
technicians that operate MRI scanners. While an employer may hire any individual to serve
as an MRI technologist, the employer is unlikely to hire or keep the technologist if the
technologist is poorly trained, consistently produces poor quality images, or negligently
operates the machine.
Even if there are no mandatory educational requirements for MRI technologists, there are
several voluntary MRI certifications available, such as the American Registry of Radiologic
Technologists (AART) MRI certification and the American Registry of Magnetic Resonance
Imaging Technologists (ARMRIT) certification. Job searches for MRI Technologist using
websites such as Glassdoor and Indeed show that many employers in California require or
prefer candidates with MRI AART or ARMRIT certifications. There also voluntary MRI
safety guidelines published by the American College of Radiology (ACR), which the FDA
recommends (discussed below).
Under current law, the only medical imaging devices that require a license to operate are
those that use ionizing radiation, such as devices used for computed tomography (CT),
fluoroscopy, and radiography (X-ray). Ionizing radiation is regulated is because it can be
dangerous, even when used correctly. According to the FDA, ionizing radiation is high-
AB 1092
Page 4
energy radiation that can potentially cause damage to DNA, elevating a person’s lifetime risk
of developing cancer. Further, poorly produced images and retests unnecessarily increase
this risk.
In California, certified radiologic technologists (CRT) that work with ionizing radiation are
licensed by the Radiological Health Branch (RHB) under the CDPH. CRTs must meet
educational, training, and experience requirements designed to prevent “excessive and
improper exposure to ionizing radiation” (HSC § 114840). They must also be AART
certified, although not in MRI specifically.
Further, while not specific to MRI or imaging, there are mandatory reporting requirements
under state law—certain medical facilities are required to report adverse events. Adverse
events include any event, or series of events, including those involving MRI, that cause the
death or serious disability of a patient, personnel, or visitor. However, this is limited to
general acute care hospitals, acute psychiatric hospitals, and dentistry and maternity
hospitals. Other facilities, including facilities that only perform imaging, are excluded.
The CDPH posts the adverse event information on its website: https://hfcis.cdph.ca.gov/.
Hazards Associated with MRI. Unlike ionizing radiation, MRI is not inherently dangerous.
According to the FDA, there are no known harmful side-effects associated with temporary
exposure to the strong magnetic field used by MRI scanners. However, the FDA does note
the following safety concerns involved with the MRI environment:
a) The magnet can cause pacemakers, artificial limbs, and other implanted medical devices
containing ferrous metal to malfunction or heat up;
b) Loose, ferrous metal objects may cause damage or injury if pulled toward the magnet;
and,
c) Dyes from tattoos or tattooed eyeliner can cause skin or eye irritation;
d) Medication patches with ferrous metal can cause a skin burn;
e) The wire leads used to monitor an electrocardiogram (ECG) trace or respiration during a
scan must be placed carefully to avoid causing a skin burn;
f) Prolonged exposure to radio waves during the scan could lead to slight warming of the
body; and,
g) If a contrast agent is used, there is a slight risk of an allergic reaction. MRI contrast
agents can cause problems in patients with significant kidney disease. In California,
contrast agents require a license to inject, MRI technologists cannot perform this
procedure (HSC § 106985);
FDA Workshop on MRI Safety. In 2011, the FDA held a public workshop to obtain
information regarding the safety of MRI use (76 Federal Register (FR) 58281). It also held a
two-month public comment period, however it only received 20 comments. In the public
workshop notice, the FDA indicated:
AB 1092
Page 5
The number of MRI procedures performed each year continues to rise. At the same time, MRI
technology, implanted medical devices and medical device accessories (non-implanted) are
becoming more complex. There is increasing demand to scan patients with implanted or
accessory medical devices, and the presence of these devices are becoming commonplace in
the MRI suite during imaging procedures. While MRI procedures are relatively safe, there
are hazards inherent to the MRI environment that must be considered to ensure the safety of
patients, healthcare providers, and others who enter the MRI suite. The Agency recognizes
the need to work with stakeholders to identify hazard reduction strategies that minimize risk
in the MRI environment.
During the stakeholder meeting, the speakers and attendees discussed general MRI safety,
ferromagnetic detectors, scanning patients with medical implants, and the impact of
innovation on MRI safety concerns. The FDA also discussed its own MRI data—including
the fact that its reporting database, the Manufacturer and User Facility Device Experience
(MAUDE), was not meant to evaluate trends. It also noted that “preventing harm is likely
possible if the users are aware of the known hazards and follow existing [ACR]
recommendations pertaining to MRI safety.”
Federal Reporting Requirements. Federal law requires manufacturers, importers, and
healthcare facilities to report device related adverse events to MAUDE, including adverse
events related to MRI scanners. Manufacturers and importers must report when they learn
that a device sold may have caused or contributed to death or serious injury. Facilities using
the device must report any suspected device related death, but not device malfunction.
Although a user facility is not required to report a device malfunction, they can voluntarily
inform the FDA of such product problems through MedWatch, the FDA’s Safety Information
and Adverse Event Reporting Program. MedWatch is used to report adverse events relating
to medical products, including serious drug side effects, product use errors, product quality
problems, and therapeutic failures for, among other things, medical devices.
Other Regulation of MRI. MRI technologists require licenses in two other states, Oregon
and West Virginia. At the federal level, health plans may only receive Medicare
reimbursement for medical imaging, including MRI, if the facilities are accredited by the
ACR, Intersocietal Accreditation Commission, RadSite, or the The Joint Commission. The
four accreditation bodies each require MRI technologists to either be certified or be licensed
to practice MRI, but the certification does not necessarily have to be MRI specific (ACR, for
instance, requires a general ARRT certification).
ARGUMENTS IN SUPPORT:
The American Registry of Magnetic Resonance Imaging Technologists writes in support, “MRI
is an exceptionally safe imaging modality, with no inherent adverse biological affects when
performed correctly and safely. MRI is the preferred modality, especially for pediatric patients,
due to the need to avoid CT Scans and X-Ray (ionizing radiation). CT Scans and X-Ray have
been directly related to cancer. As stated by Speakers at our 2014 Annual Meeting in San Diego,
CA, the current and future applications of MRI are infinitesimal.
MRI is however not without unique safety issues. Ferrous objects can fly into the magnet bore
causing severe injury or death, radio-frequency burns could occur on the patient's skin, highdecibel acoustic noise can damage hearing, and gadolinium-based IV-contrast agents, while
AB 1092
Page 6
much safer than iodine based contrast agents, can be harmful in patients with compromised
kidney function.
MRI accidents reported to the FDA, it is estimated, amount to only 30-40 percent of the total
number that have occurred The MRI Technologist must be trained in preventing, and responding
to, all possible MRI hazards. The most horrific injuries that have occurred were due to ferrous
oxygen tanks and other ferrous items allowed near the MRI machine which were drawn into the
magnet bore with incredible levels of force. There have been a number of MRI related fatalities,
which occurred when a technologist failed to protect his/her patients. Lack of proper MRI safety
training is the cause.”
ARGUMENTS IN OPPOSITION:
None on file.
AMENDMENTS:
At this time, there is no clear data suggesting the industry is unable to properly regulate MRI
technologists. Further, there are licensed CRTs that currently perform MRI that are already
required to pay a fee. Therefore, the author should make the amendments below to narrow the
scope of the registration requirement.
Exempt RTs to prevent double registration:
3) On page 3, between lines 12 and 13, insert:
(b) A radiological technologist certified under subdivision (b) or (c) of Section 114870 of the
Health and Safety Code may provide the information described in subdivision (a) of this
section:
(1) In the technologist’s initial Radiologic Technology Certificate Application;
(2) In the technologist’s Renewal Application forms; or
(3) Using a method established by the department under this section.
4) On page 3, line 13, strike: (b) and before “The” insert:
(c)
5) On page 3, between lines 16 and 17, insert:
(b) A radiological technologist certified under subdivision (b) or (c) of Section 114870 of the
Health and Safety Code is not required to pay a registration fee under this chapter.
Switch the reporting from the individual to the facility:
6) On page 3, line 17, strike: A and before “registered” insert:
Each employer of a
AB 1092
Page 7
Narrow the reportable accidents:
7) On page 2, after line 12, insert:
(d) “Serious disability” means a physical or mental impairment as defined Section 1279.1(d)
of the Health and Safety Code. “Serious disability” may result from following MRI-specific
issues the following MRI-specific issues:
(1) Thermal-related issues.
(2) Medical device incompatibility.
(3) Faulty or lack of hearing protection.
(4) The presence of ferrous objects.
(5) Contrast media issues.
8) On page 3, line 18, strike: any accident, and after “department” insert:
an accident resulting from the use or malfunction of MRI equipment,
9) On page 3, line 19, strike: injury and after “in” insert:
serious disability
REGISTERED SUPPORT:
American Registry of Magnetic Resonance Imaging Technologists
REGISTERED OPPOSITION:
None on file.
Analysis Prepared by: Vincent Chee / B. & P. / (916) 319-3301