What's happening
This bill requires new safety protocols and informed consent for upper endoscopic procedures, emphasizing awake transnasal esophagoscopy and stricter sterilization standards.
Why it matters
Mandates patient choice and transparency. Patients must be fully informed about the differences between awake, upright transnasal esophagoscopy (TNE) and traditional sedated endoscopy—including risks, benefits, and costs—before consenting to a procedure. This aims to empower patients to make better-informed decisions about their care.
Prioritizes safer, less invasive procedures. By making TNE the default for upper endoscopies (unless medically inappropriate or declined by the patient), the bill aims to reduce risks associated with sedation, such as complications from anesthesia, and potentially lower overall healthcare costs.
Imposes stricter infection control measures. All flexible endoscopic instruments must be either fully sterilized or covered with a single-use sterile barrier, with high-level disinfection as a last resort. This is particularly important for preventing the transmission of serious diseases like Creutzfeldt-Jakob disease and tuberculosis.
Requires explicit consent for non-sterile equipment. If sterilization isn’t possible and only disinfection can be achieved, patients must be clearly informed and must sign a written consent acknowledging the difference. This increases accountability for providers and may reduce the risk of litigation or harm from improperly disinfected equipment.
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Who cares
Headline styles
Reform Endoscopy Patient Safety
Plain English, a few words. Used as the page title.
Sponsors
No co-sponsors yet.
History
- Referred to health
- Referred to health
Companion bill
The same bill in the other chamber. A bill becomes law when one version passes both houses and the governor signs it, so either number can carry it.
Reform Endoscope Safety Rules
In Assembly Committee · Health · Sponsor Felix Ortiz
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
1052
2019-2020 Regular Sessions
IN SENATE
January 10, 2019
Introduced by Sen. PERSAUD -- read twice and ordered printed, and when printed to be committed to the Committee on Health
AN ACT relating to enacting the "Endoscope Reform Act"
The People of the State of New York, represented in Senate and Assembly, 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 requirement 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 undergo 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.
LBD00933-01-9
S. 1052 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 forewarned 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 procedures, such to include but not be limited to the attendant risks of sedation and the respective costs of the TNE and upper endoscopic procedures. 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 accordance 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 creutzfeldt-jakob disease and tuberculosis, these protocols demand reprocessing 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 method 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 sterilized 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 understood 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.
Reflowed for reading: line numbers and page breaks removed. Cite the official text.
Sponsor's memo
Title of bill
An act relating to enacting the "Endoscope Reform Act"
Purpose
The purpose of this bill is to promulgate rules and regulations to govern the practice of all upper endoscopic procedures. Currently, the vast majority of upper endoscopic procedures are being performed through a method involving sedation, which carries significant health risks and great financial cost. These risks and costs could be avoided by estab- lishing regulations that allow a TransNasal Esophagoscopy (TNE) to be in wider use.
Summary of provisions
Section 1: Short title
Read the full memo (671 words)
Section 2: Directs the commissioner of health to promulgate rules and regulations for the practice of all endoscopic procedures. Upper endo- scopic procedures will include all examinations of a patient's vocal cords, esophagus, and/or stomach by the use of a flexible endoscope instrument.
To avoid the dangers of sedation, all upper endoscopic procedures will be required to be performed through a TNE. TNEs are performed with the patient fully awake and upright and require no anesthesia. Exceptions to the requirement that TNEs be used will be made in the event that the treating physician determines that TNE is not available or suitable in treating a patient; the treating physician determines that a sedated upper endoscopy is more suitable or effective for a patient; or the patient, after being informed of the TNE procedure, elects to use the sedated procedure instead.
Section 3: Patients will be informed of the TNE procedure and will also be advised of the risks of a sedated procedure. The commissioner of health will create an "upper endoscopic patient's bill of rights," which will include the risks and benefits of each procedure, including the risks of sedation and respective costs.
Section 4: The commissioner of health shall also establish rules and regulations to govern the use of flexible fiberoptic endoscopic instru- ments. The instrument must be sterilized after each use or have all surfaces completely covered by a single use protective sleeve. If steri- lization is not possible, the patient must give written consent indicat- ing the difference between disinfection and sterilization has been explained.
Section 5: Effective date.
Justification
Approximately ten million upper endoscopic procedures are performed annually in the U.S., and that number is growing. While these procedures are of great and critical value in examining a patient's vocal chords, esophagus, and/or stomach, and in diagnosing and treating serious diseases such as acid reflux disease and esophageal cancer, these upper endoscopic procedures are currently being widely performed using only a sedated upper endoscopic procedure. This procedure carries significant health risks and great financial costs to patients.
These health risks and financial costs can be avoided by an alternative method of upper endoscopic procedure, TransNasal Esophagoscopy ("TNE"), which is performed with the patient fully awake and upright. This method avoids the health risks attendant to sedation and saves patients and the health care industry billions of dollars in costs that are needlessly incurred when the sedated method is utilized. Every time a sedated upper endoscopic procedure is performed, facilities and sedation are required that cost patients approximately three thousand dollars ($3,000.00).
Accordingly, with revenues from these sedated upper endoscopic proce- dures accounting for approximately thirty billion dollars annually, there is a distinct financial disincentive for certain healthcare providers to offer the safer, less expensive TNE procedure. Moreover, sedated upper endoscopic procedures carry approximately a 5% risk of complications such as "cardiopulmonary unplanned events", some of which result in fatalities, and these health risks can be completely avoided by the use of the TNE procedure.
By requiring that all upper endoscopic procedures be performed by the use of the safer and more affordable TNE procedure, with exceptions, patients and the healthcare industry as a whole will save billions of dollars that have previously been paid toward unnecessary sedation and facilities, and the significant health risks attendant to sedated upper endoscopic procedures will be completely avoided.
Legislative history
2017/2018: Referred to Health
Fiscal implications
There are no fiscal implications.
Effective date
This act shall take effect immediately.
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