Care of the Flexible Endoscope
Attached below is correspondence received from the New York State Governers Office regarding recent legislation regarding endoscopic reprocessing
"January 20, 2015
Dear Chief Executive Office:
This letter is to inform you about Public Health Law §2824, which was added by Chapter
177 of the Laws of 2013. This new law describes the rules, requirements, and use of central
service technicians in general hospitals and diagnostic and treatment centers that are authorized
to provide ambulatory surgery services. All such facilities employing central service technicians
(CSTs) are required to comply with the law, effective January 1, 2015.
The Department expects that general hospitals and diagnostic and treatment centers
authorized to provide ambulatory surgical services which have central service departments that
perform decontamination, preparation, packaging, sterilization, and storage and distribution of
reusable medical instrumentation or devices and employ CSTs, will be impacted by this law and
will need to develop policies and procedures to comply with its provisions.
If the medical services you provide do not require the use of sterilization, but the standard of care
is to use high level disinfection, (e.g., endoscopy reprocessing), this law does not apply to those
services. While a CST is not required, it is expected that the facility follows its infection control
policies as per NYCRR Part 405.11 or Part 702.4. These policies should include appropriate high
level disinfection processes, the education and training of, and appropriate use of, licensed and
unlicensed personnel. The Centers for Disease Control and Prevention (CDC) has published
standards regarding these processes which can be found at:
The main components of the law are:
1) It defines a central service technician as a person who provides the services of
decontamination, preparation, packaging, sterilization, and storage and
distribution of reusable medical instrumentation or devices in healthcare facilities,
other than in the course of practicing as a healthcare professional licensed or
certified pursuant to title eight of the education law.
2) A person cannot function as a CST in a healthcare facility and a healthcare
facility cannot employ or otherwise contract for the services of a CST unless the
person meets one of the following:
(a) has successfully passed a nationally accredited central service exam for
central service technicians; and holds and maintains one of the following
credentials administered by a nationally accredited central service technician
credentialing organization: the certified registered central service technician
Empire State Plaza, Corning Tower, Albany, NY 12237│health.ny.gov
credential, the certified sterile processing and distribution technician credential,
or a substantially equivalent credential; or
(b) provides evidence that the person was employed or otherwise
contracted for the services as a CST in a healthcare facility for a cumulative
period of one year, occurring within the four years immediately prior to January
1, 2015; or
(c) is a student or intern performing the functions of a CST if the student
or intern is under the direct supervision of an appropriately licensed or certified
healthcare professional and is functioning within the scope of the student's or
3) Any contractor or employer of persons functioning as a CST on the effective
date of the law shall confirm in writing to each employee or contractor his or her
employment as a CST.
4) A CST who does not meet the requirements as outlined above shall have
eighteen months from the date of hire to obtain the certified registered central
service technician credential or the certified sterile processing and distribution
5) CSTs must annually complete ten hours of continuing education credits to
remain qualified to function as a CST. The law does allow some limited waivers
and extensions regarding this requirement.
6) Facilities may employ or otherwise contract with a person who does not meet
these requirements to function as a CST if:
(a) after a diligent and thorough effort has been made, the facility is
unable to employ or contract with a sufficient number of qualified central service
technicians who meet the requirements of this law;
(b) the healthcare facility makes a written record of its efforts and retains
the record; and
(c) the person meets the requirements of the law within two years of the
start of employment or contracting for the performance of CST duties.
7) A facility that employs or contracts with a CST must, upon request, verify the
dates of employment or contract of the person.
8) This law contains scope of practice protections for healthcare professionals,
licensed or certified pursuant to title eight of the education law.
Empire State Plaza, Corning Tower, Albany, NY 12237│health.ny.gov
The entire law may be accessed by going to:
Please note that there are two sections 2824 of the public health law, one concerning
central supply technicians and the other surgical technologists.
If you have any questions concerning this law, please contact the Division of Hospitals
and Diagnostic & Treatment Centers, 875 Central Avenue, Albany NY, 12206 at 518-402-1004.
Division of Hospitals and Diagnostic
The procedures we perform at this institution do not involve instruments which require sterilization. Endoscopic reprocessing only necessitates High Level Disinfection. Our organization has interpreted, based on the language of the above letter that the requirement for persons reprocessing endoscopes to be certified as Central Service Technicians does not apply.
Only individuals, who are able to read, understand, and implement instructions on the proper cleaning and high level
disinfection of gastrointestinal endoscopes and accessories should be given the responsibility to reprocess such
instruments(American Society for Testing and Materials [ASTM], 2007; AAMI, 2010). These individuals must meet
competency standards for endoscope reprocessing(AAMI, 2010). Temporary personnel should not be allowed to
clean or disinfect instruments in either a manual or an automated reprocessing system until competency has been
established (American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee et al.,
2011). Competency review and infection control updates should be validated and documented annually. Flexible endoscope reprocessing has been shown to have a narrow margin of safety. Any slight deviation from the recommended
reprocessing protocol can lead to the survival of microorganisms and an increased risk of infection. If new
models of endoscopes, accessories or endoscope reprocessors are obtained by the organization, training and documented
competency must be completed. Supervisory personnel must be familiar with the principles and practices of instrument
reprocessing if they are to properly train and monitor staff.
The flexible endoscope is a delicate instrument that must be treated with care if it is to work properly. Because the
glass optical fibers are contained in the body of the flexible endoscope, they can be broken if the instrument is
kinked or dropped. Inspecting an endoscope should include looking at the endoscope's exterior for dents or other signs
Reprocessing and Cleaning
Reprocessing of flexible endoscopes can be a complex task. Blood and other body fluids can flow into the channels and
may be difficult to remove, and many of the parts cannot be disassembled to facilitate cleaning. The potential for the
transmission of infectious agents to patients undergoing endoscopic procedures is substantial, and therefore a number
of guidelines relating to the processing of endoscopes have been published.
The Association for Professionals in Infection Control and Epidemiology, Inc. (APIC) http://www.goapic.org published Guidelines for Infection Prevention and Control in Flexible Endoscopy. This APIC guideline focuses on the processing of flexible endoscopes, specifically gastrointestinal endoscopes and bronchoscopes, to prevent infection. The Society for Gastroenterology Nurses and Associates, Inc. (SGNA) www.sgna.org, presented standards to be used for all settings where gastrointestinal endoscopy is practiced.
Remove the Bio-Burden.
Blood, respiratory secretions, and feces can contribute to the failure of final reprocessing; therefore, endoscopes must
be clean and free of all bio-burden before sterilization or high-level disinfection. Bio-burden can accumulate in
channels, ports, crevices, and other movable parts of the endoscope during use. When appropriate during actual usage,
the endoscope should be periodically flushed and wiped down with a sponge soaked in sterile water to prevent debris from
drying on or in the instrument, making the cleaning process more difficult. Some disinfectants used in the processing of
endoscopes are inactivated by bio-burden, so the removal of this is a crucial first step in reprocessing.
Immediate cleaning after finishing the procedure :
The initial steps in the reprocessing protocol begin in the procedure room immediately after removal of the insertion
tube from the patient and prior to disconnecting the endoscope from the power source. Pre-cleaning should be
performed quickly, before bioburden has an opportunity to dry and before complete decontamination
(American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee et al., 2011).
After removing the endoscope from the patient, the gastroenterologist dips the end of the scope in water, suctions water, attaches the suction tubing to the biopsy port, places the A-W channel plug for continuous irrigation of the channel with air and leaves the scope in the sink. The procedure room assistant then wipes the insertion tube with the wet cloth or sponge, passes the cleaning brush through the appropriate channels to remove bioburden immediately, before it can solidify. Protective video cap is then attached. Scope is then prepared for transportation to the cleaning room.
Soiled endoscopes need to be transported in a way to prevent exposure to staff and patients. The scopes should be
transported in a closed container or bag.(American Society for Gastrointestinal Endoscopy Quality Assurance in Endoscopy Committee et al., 2011).
Clean with Enzymatic Detergent:
Manual cleaning of endoscopes is necessary prior to automated or manual disinfection. This is the most important step in
removing the microbial burden from an endoscope. Retained debris may inactivate or interfere with the capability of the
active ingredient of the chemical solution to effectively kill and/or inactivate microorganisms.
a. Fill a sink or basin with freshly-made solution of water and a medical grade, low-foaming, neutral pH detergent
formulated for endoscopes that may or may not contain enzymes - this detergent may change brand names over time but will have the same function.
b. Dilute and use according to the detergent manufacturer's instructions.
1) Freshly prepared detergent solution should be used for each endoscope to prevent cross-contamination.
2) Low-foaming detergents are recommended such that the device can be clearly visualized during the cleaning process,
preventing personnel injury and allowing for complete cleaning of lumen surfaces. Excessive foaming can inhibit
good fluid contact with the device surfaces.
3) Endoscopes exposed to synthetic lipids may require additional pre-cleaning with a detergent formulated to remove
synthetic lipids - our organization does not use it.
c. Ensure video cap is secure. Immerse the endoscope.
d. Wash all debris from the exterior of the endoscope by brushing and wiping the instrument while submerged in the
detergent solution. The endoscope should be submerged in the detergent solution when performing all subsequent cleaning steps to prevent splashing of contaminated fluid and aerosolization of bioburden.
e. Use a small, soft brush to clean all removable parts, including inside and under the suction valve, air/water
valve, and biopsy port cover and openings. Use non-abrasive and lint-free cleaning tools to prevent damage to the
f. Brush all accessible endoscope channels including the body, insertion tube and the umbilicus of the endoscope. Use a brush size compatible Standards of Infection Control in Reprocessing of Flexible Gastrointestinal Endoscopes with each channel. Be knowledgeable of the specific instructions for each model of endoscopes.
g. After each passage, rinse the brush in the detergent solution, removing any visible debris before retracting and
h. Continue brushing until there is no debris visible on the brush.
i. Clean any high-level disinfect reusable brushes between cases. Note that reusable brushes should be inspected between
uses and replaced when worn, frayed, bent, or otherwise damaged. Worn bristles are ineffective in cleaning, and
damaged brushes may damage endoscope channels. We use disposable brushes, thus the brushes should be disposed off after each case.
j. Attach the endoscope manufacturer's cleaning adapters for suction, biopsy, air, and water channels. Note: Automated
pumps are available for this step that eliminate the manual flush, but our organization has elected to continue doing manual process as the staff found the automated pumps too cumbersome.
k. Attach the manufacturer's cleaning adapters for special endoscope channels ie the auxillary channel.
l. Flush all channels with the detergent solution to remove debris.
Note: All steps should be completed sequentially and immediately following the procedure.
Rinse After Manual Cleaning
a. Thoroughly rinse the endoscope and all removable parts with clean water to remove residual debris and detergent.
b. Purge water from all channels using forced air. Dry the exterior of the endoscope with a soft, lint-free cloth to
prevent dilution of the liquid chemical germicide used in subsequent steps.
The Spaulding Classification System (see Volume 5, PR.2, Class of Instruments) used by infection control professionals
specifies that endoscopes that come into contact with mucous membranes are considered 'semi-critical equipment' and should be either sterilized or receive a high-level disinfection.
High-level disinfection is defined as the inactivation of all vegetative bacteria, mycobacteria, fungi, and viruses, but
not necessarily all bacterial endospores. Depending on the type of endoscope, it should then be processed either with sterilization or high-level disinfection.
The minimum recommended reprocessing for endoscopes is high-level disinfection with a liquid sterilant/disinfectant
approved by the Food and Drug Administration. Examples of such disinfectants are orthophthalaldehyde (also called OPA) preparations, Gluteraldehyde (GTA) preparations, (see Volume 5, MC.11 regarding the use of Glutaraldehyde) hydrogen peroxide, and paracetic acid. Manufacturer's recommendations must be followed for the individual scope as well as the individual disinfectant that is to be used.
( Conduct routine testing with documentation of testing, of the liquid high-level disinfectant to ensure efficacy and discard
the disinfectant solution on its expiration date according to manufacturer's instructions.
Note: Some chemical test strips recommend the use of quality-control procedures to ensure the strips perform
properly, if recommended the user should follow manufacturer's instructions )
Manual High Level Disinfection :
1. Completely immerse the endoscope and all removable parts in a basin of high-level disinfectant.
a. The basin must be of a size to accommodate the endoscope without undue coiling, and must have a tight-fitting lid to
contain the chemical vapors .
b. To prevent damage to the endoscope, the endoscope should not be soaked with other sharp instruments that could
potentially damage the endoscope.
2. Flush disinfectant into all channels of the endoscope
3. Scope remains immersed for a full 20 minute period, timed by a timer. After that the scope is rinsed in plain water, channels are then irrigated with clean water, flushing with air is done and final flushing is done with alcohol to effectively dry the channels.
Perform a Leak Test
At this point in the cleaning process, the endoscope must be tested for leaks. Leak testing detects damage to the interior or exterior of the endoscope. A leak test involves applying air pressure to the mechanical channel of the endoscope insertion tube and watching for air bubbles where there are leaks in the covering or channel wall. Leak test the endoscope following manufacturer's instructions and staff training is done to instruct them how the light/air source is connected to the endoscope. If there is a leak, the medical director/gastroenterologist is informed and scope is removed from further use until repairs are done.
We have elected to do this procedure of leak testing after the disinfection is done because if a leak is found, the scope should be disinfected before transporting it for repairs.
4. If no leak is found, the endoscope is then hung in the endoscope closet to allow any excess fluid to drip down. The scope is now ready to be used on the next patient.
Approved By Governing Board