Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information for laboratory, clinic and supply staff. It is not medical advice and not a reprocessing procedure; follow the manufacturer’s written instructions and your facility’s infection-prevention policy.
Short answer
An automated endoscope reprocessor (AER, also called an endoscope reprocessor) is a machine that automates cleaning and, in many models, high-level disinfection of flexible endoscopes. FDA lists the cleaning-washer type under product code NVE as Class 2. What a given AER replaces, and what must still be done by hand, is set by that model’s cleared labeling, not by the machine category.
Definition and scope
The CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities (2008) says AERs offer several advantages over manual reprocessing: they automate and standardize important reprocessing steps, reduce the likelihood that an essential step is skipped, and reduce staff exposure to high-level disinfectants or chemical sterilants (CDC). The same guideline notes that AER failures have been linked to outbreaks of infection or colonization, and that an AER’s water filtration might not reliably deliver sterile or bacteria-free rinse water.
The FDA product classification database lists code NVE as “washer, cleaner, automated, endoscope”, under regulation 876.1500, Class 2, General Hospital panel. FDA describes it as an automated device intended to be used to clean endoscopes, with a chemical dispensing system that meters out a predetermined volume of detergent during the cleaning cycle. The same entry says endoscopes cleaned in such a system should already have been pre-cleaned and leak tested according to the instrument manufacturer’s instructions (FDA Product Classification). The NVE entry describes cleaning; it does not by itself state what a particular machine does for disinfection. Read each model’s 510(k) summary for that.
For the wider reprocessing sequence, see the CASRAI guide to endoscope reprocessing and the explainer on what an endoscope is.
How an AER is used in practice
Two points from primary sources shape day-to-day use.
- Connectors must match. The CDC guideline states that establishing the correct connectors between the AER and the device is critical to ensure complete flow of disinfectants and rinse water. Its Category IB recommendation ties the connector set-up to the AER manufacturer’s instructions, so that all internal surfaces are exposed to the high-level disinfectant or chemical sterilant.
- Point-of-use work comes first. In the FDA 510(k) summary K232918 for the STERIS enspire 300 series, users are instructed to do bedside (point-of-use) cleaning and manual leak testing before the machine cycle (FDA). That summary is one example of one model; it is an illustration, not a ranking or a statement about other brands.
Cycle times, temperatures and disinfectant concentrations vary by model and are in each manufacturer’s instructions for use; they are not given here.
Types and related concepts
Cleaning-only versus cleaning plus high-level disinfection
The K232918 summary describes that AER as an automated, self-contained device for cleaning and high-level disinfection of semi-critical, heat-sensitive devices including flexible endoscopes. It states that the validated cleaning process replaces manual cleaning for endoscopes other than duodenoscopes, and that manual cleaning is required before placing an endoscope in a high-level-disinfection-only cycle. The same summary’s predicate comparison notes another cleared model whose labeling requires manual cleaning before placement in that AER. So the cleared indications differ from model to model. Background on the disinfection level is in high-level disinfection and the Spaulding classification.
Endoscope brushes
Endoscope brushes are accessories, not part of the AER. Regulation 21 CFR 876.1500(b)(2) lists cleaning brushes for endoscopes as an example of a Class I device, and (b)(1) lists endoscope disinfectant basins as an example of a Class II device; both classes are exempt from 510(k) subject to the limitations in 21 CFR 876.9 (eCFR). The regulation text gives examples, so it does not name automated reprocessors. Brush sizing per scope model is covered in the endoscopy center supply checklist.
Where it matters for labs, clinics and supply decisions
| Question to settle | Why, according to the source |
|---|---|
| Is the AER cleared for the exact endoscope models in use, with the right channel connectors? | CDC: correct connectors are critical for complete flow of disinfectant and rinse water. |
| Does the cleared indication cover cleaning, high-level disinfection, or both? | FDA code NVE describes cleaning; K232918 describes a cleaning plus high-level disinfection device. |
| Does the labeling require manual cleaning first? | K232918: required before a disinfection-only cycle; labeling of another cleared model requires it before placement. |
| Are duodenoscopes handled differently? | K232918: its cleaning process replaces manual cleaning for endoscopes other than duodenoscopes. CDC (2008 text) said duodenoscopes need a flushing pressure most AERs did not achieve; that predates later duodenoscope design changes. |
| How is rinse water treated and maintained? | CDC: AER water filtration might not reliably provide sterile rinse water, and AER failures have been linked to outbreaks. |
This table does not rank products and makes no price, stock or “best” claim.
Common misunderstandings
- “An AER removes the need for manual cleaning.” Not as a category. Whether manual cleaning is replaced is stated in each AER’s cleared labeling, and bedside cleaning and leak testing still come first in the K232918 labeling.
- “Every AER is the same FDA class and code.” The NVE washer code is Class 2, while endoscope cleaning brushes are Class I in the same regulation. Do not carry one class over to the other.
- “An automated cycle makes the connector setup optional.” The CDC guideline says the opposite: the connectors determine whether all internal surfaces are exposed.
- “The 2008 CDC text describes today’s duodenoscopes.” It is a 2008 document; use current manufacturer labeling for current devices.
FAQ
What is an automated endoscope reprocessor?
A machine that automates cleaning, and in many models high-level disinfection, of flexible endoscopes.
Is an endoscope reprocessor regulated by FDA?
FDA’s classification database lists the automated endoscope washer under product code NVE, regulation 876.1500, Class 2.
Are endoscope brushes part of an AER?
No. They are separate accessories, listed in 21 CFR 876.1500(b)(2) as an example of Class I devices.
Sources
- FDA, Product Classification, code NVE: accessdata.fda.gov (checked 2026-10-31).
- eCFR, 21 CFR 876.1500: ecfr.gov (checked 2026-10-31).
- CDC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008): cdc.gov PDF (checked 2026-10-31).
- FDA 510(k) summary K232918, STERIS enspire 300 series: accessdata.fda.gov (checked 2026-10-31).
