BILL ANALYSIS Ó
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
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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
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federal Food and Drug Administration (FDA): (Title 21 Code of
Federal Regulations (CFR) § 803)
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:
9)Defines an "MRI technologist" as a person who operates MRI
equipment to produce cross-sectional images of a patient's
body for diagnostic purposes.
10)Requires MRI technologists to register with the CDPH.
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11)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.
12)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.
13)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.
14)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.
15)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).
16)States that MRI technologist are not authorized to practice
medicine, surgery, or any other form of healing.
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FISCAL EFFECT: Unknown. This bill is keyed fiscal by the
Legislative Counsel.
COMMENTS:
17)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."
18)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
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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-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
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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,
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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:
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
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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
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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,
high-decibel acoustic noise can damage hearing, and
gadolinium-based IV-contrast agents, while 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
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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:
19)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;
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(2) In the technologist's Renewal Application forms; or
(3) Using a method established by the department under this
section.
20)On page 3, line 13, strike: (b) and before "The" insert:
(c)
21)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:
22)On page 3, line 17, strike: A and before "registered" insert:
Each employer of a
Narrow the reportable accidents:
23)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.
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"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.
24)On page 3, line 18, strike: any accident , and after
"department" insert:
an accident resulting from the use or malfunction of MRI
equipment,
25)On page 3, line 19, strike: injury and after "in" insert:
serious disability
REGISTERED SUPPORT:
American Registry of Magnetic Resonance Imaging Technologists
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REGISTERED OPPOSITION:
None on file.
Analysis Prepared by:Vincent Chee / B. & P. / (916) 319-3301