S T A T E O F N E W Y O R K
________________________________________________________________________
5237
2023-2024 Regular Sessions
I N A S S E M B L Y
March 7, 2023
___________
Introduced by M. of A. WILLIAMS -- read once and referred to the Commit-
tee on Health
AN ACT relating to enacting the "Endoscope Reform Act"
THE PEOPLE OF THE STATE OF NEW YORK, REPRESENTED IN SENATE AND ASSEM-
BLY, DO ENACT AS FOLLOWS:
Section 1. Short title. This act shall be known and may be cited as
the "Endoscope Reform Act".
§ 2. Within one hundred eighty days of the effective date of this act,
the commissioner of health shall promulgate rules and regulations to
govern the practice of all upper endoscopic procedures. For the purpose
of this act, "upper endoscopic procedures" shall be deemed to include
all examinations of a patient's vocal cords, esophagus, and/or stomach
by the use of a flexible endoscopic instrument.
In order to prevent the dangers of sedation and mitigate the risks
involved in these upper endoscopic procedures, there shall be require-
ment that all upper endoscopic procedures be performed by the use of the
transnasal esophagoscopy, hereinafter referred to as a TNE procedure,
which is performed with the patient fully awake and upright, instead of
the alternative method of upper endoscopic procedure, sedated upper
endoscopy, which requires anesthesia, is significantly more dangerous,
and much more expensive than the TNE procedure.
Exception shall be made to the general requirement that TNE be used
instead of sedated upper endoscopy in the event that: (a) the treating
physician determines that TNE is not an available or suitable procedure
in treating a patient; (b) the treating physician determines that
sedated upper endoscopy is a more suitable or effective procedure than
TNE in treating a patient; or (c) the patient, after being informed of
the upper endoscopic patient's bill of rights as set forth in section
three of this act and being advised of the respective risks and benefits
of both the TNE and sedated upper endoscopy procedures, elects to under-
go the sedated upper endoscopy procedure.
§ 3. All upper endoscopy patients shall, before undergoing any type of
upper endoscopic procedure for which TNE is an available and suitable
method of procedure, be so advised and informed by their treating physi-
EXPLANATION--Matter in ITALICS (underscored) is new; matter in brackets
[ ] is old law to be omitted.
LBD01740-01-3
A. 5237 2
cian that the upper endoscopic procedure can be performed without
sedation by the use of the TNE procedure, as opposed to a sedated upper
endoscopic procedure. The patient shall be further advised and fore-
warned of the risks attendant to sedated upper endoscopic procedures.
The commissioner of health shall promulgate and prescribe an "upper
endoscopic patient's bill of rights", which bill of rights shall be in a
standard written form and shall fully and clearly explain the respective
risks and benefits of both the TNE and sedated upper endoscopic proce-
dures, such to include but not be limited to the attendant risks of
sedation and the respective costs of the TNE and upper endoscopic proce-
dures. It shall be a requirement that treating physicians read and
advise all upper endoscopic patients of the "upper endoscopic patient's
bill of rights" in the form prescribed by the commissioner of health.
§ 4. Within one hundred eighty days of the effective date of this act,
the commissioner of health shall promulgate rules and regulations to
govern the use of flexible fiberoptic endoscopic instruments in accord-
ance with the following provisions. For the purposes of this act, the
term "flexible fiberoptic endoscopic instrument" shall be deemed to
include flexible endoscopes together with any accessory instrument or
device used in conjunction with a flexible endoscopic instrument when
such accessory or device comes into contact, or may come into contact,
with a patient. Such rules and regulations shall apply to every use of a
flexible endoscopic instrument by any health care provider using such
flexible endoscopic instrument.
In order to prevent the transmission of infectious contagious disease,
and in particular highly contagious pathogens that result in creutz-
feldt-jakob disease and tuberculosis, these protocols demand reprocess-
ing by sterilization, or having all surfaces completely covered by a
protective single use sterile barrier device. Flexible endoscopic
instruments shall be sterilized or shall have all surfaces completely
covered by a protective single use sterile barrier device before each
use in accordance with such method as the commissioner of health shall
prescribe, which shall be no less stringent than that recommended by the
federal Food and Drug Administration, if such a recommendation has been
made. If sterilization or covering by a protective single use sterile
barrier is not possible, in lieu thereof a high-level disinfection meth-
od shall be used, which method shall be prescribed by such commissioner
and shall be no less stringent than that recommended by the federal Food
and Drug Administration, if such a recommendation has been made.
When sterilization is not possible, patients shall be so informed
prior to use, and no disinfected but not sterilized flexible endoscopic
instrument shall be used unless the patient executes a written informed
consent document acknowledging that the difference between sterilization
and disinfection has been explained to and understood by such patient
and that such patient consents to the use of a disinfected but not ster-
ilized flexible endoscopic instrument.
The "upper endoscopic patient's bill of rights", set forth in section
three of this act, shall include a provision advising the patient, when
sterilization is not possible, that no disinfected but not sterilized
flexible endoscopic instrument shall be used unless the patient executes
a written informed consent document acknowledging that the difference
between sterilization and disinfection has been explained to and under-
stood by such patient and that such patient consents to the use of a
disinfected but not sterilized flexible endoscopic instrument.
§ 5. This act shall take effect immediately.