What's happening
This bill requires new safety standards for upper endoscopic procedures, mandating patient notification, consent, and stricter sterilization protocols.
Why it matters
Mandates less risky, less expensive procedure be the default. The bill requires that transnasal esophagoscopy (TNE)—a safer, sedation-free, and typically cheaper technique—be the standard for upper endoscopic procedures, unless it is unsuitable or the patient specifically chooses an alternative. This could reduce complications and healthcare costs.
Strengthens patient rights and informed consent. Patients must be given a standardized “upper endoscopic patient’s bill of rights” that clearly lays out the risks, benefits, and costs of both TNE and sedated endoscopy. This ensures patients are fully informed and able to make choices based on their own preferences and risk tolerance.
Introduces rigorous sterilization and patient notification protocols. Flexible endoscopic instruments must be either fully sterilized or protected by a single-use sterile barrier, with high-level disinfection only allowed if sterilization isn’t possible. If only disinfection is used, patients must provide written informed consent acknowledging the difference—potentially reducing the risk of infection transmission and increasing transparency.
May change clinical practice and operational costs. By mandating new protocols and documentation, the bill could increase administrative responsibilities for healthcare providers and require investment in equipment or training, possibly affecting how endoscopy services are delivered and billed.
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Who cares
Physicians performing upper endoscopy
The bill would require awake, upright transnasal esophagoscopy unless a physician determines an exception applies or an informed patient chooses sedated endoscopy, and would require physicians to explain a patient bill of rights.
Upper endoscopy patients
Patients would receive information on procedure risks, benefits and costs, and would have to give written informed consent before a disinfected but unsterilized flexible endoscope is used.
Health care providers using flexible endoscopes
The bill would require sterilization or complete coverage with a single-use sterile barrier before each use, with high-level disinfection allowed when neither is possible.
New York State Department of Health
The commissioner would have 180 days to issue rules governing upper endoscopy and flexible endoscope use, and would prescribe a standardized upper endoscopy patient bill of rights.
Headline styles
Make Endoscopies Safer
Plain English, a few words. Used as the page title.
Sponsors
1 Multi-sponsor
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 Endoscopy Safety Rules
In Senate Committee · Health · Sponsor Roxanne J. Persaud
Full text
2 pagesUnderlined is new[Struck] is removedOfficial text on nysenate.gov ↗
STATE OF NEW YORK
7187
2017-2018 Regular Sessions
IN ASSEMBLY
April 12, 2017
Introduced by M. of A. ORTIZ -- read once and referred 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.
LBD02133-01-7
A. 7187 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.
Summaries, headlines and scores are AI-generated from the official bill text. How we score bills. Source: NYS Open Legislation.