Written and maintained by CASRAI Editorial Board
Last updated
Short answer: A disposable bronchoscope, also called a single-use bronchoscope, is a bronchoscope intended to be used on one patient and then discarded instead of cleaned and reprocessed. FDA regulates it under the same rule as reusable scopes, 21 CFR 874.4680, as a Class II device.
General product information only, not medical advice and not a procedure guide. Clinical decisions belong to the treating team and the facility’s infection-prevention program.
Definition and scope
The federal regulation for this device group is titled “Bronchoscope (flexible or rigid) and accessories.” It identifies the device as a tubular endoscopic device, with accessory devices that attach to it, intended to examine or treat the larynx and tracheobronchial tree. It is typically used with a fiberoptic light source and carrier for illumination, and the regulation says the device is made of materials such as stainless steel or flexible plastic. The classification is Class II (21 CFR 874.4680, checked on Cornell LII’s copy of the eCFR on 2026-10-31).
The regulation does not create a separate category called “disposable.” Whether a particular bronchoscope is single-use or reusable is set by the manufacturer’s labeling and instructions for use, not by a different regulation number. That is why searches for a single-use bronchoscope and a disposable bronchoscope describe the same product attribute.
FDA’s product classification database lists the code EOQ, “Bronchoscope (Flexible Or Rigid),” under regulation number 874.4680, device class 2 (openFDA device classification endpoint, database last updated 2026-10-19, checked 2026-10-31). Its definition adds two reprocessing conditions: if the device is reprocessed, reprocessing validation data must be included in a 510(k) submission, and if the device is reusable, validated reprocessing instructions and reprocessing validation data must be included. A separate code, QNW, is titled “Reprocessed Bronchoscope” and is also class 2.
How single-use and reusable scopes differ in practice
The difference that the sources support is what happens after use. A reusable flexible bronchoscope goes through reprocessing between patients, following the manufacturer’s instructions. A single-use scope is discarded, so that reprocessing step does not exist for the scope itself.
FDA’s safety communication of 25 June 2021, “Flexible Bronchoscopes and Updated Recommendations for Reprocessing,” supplemented a 2015 communication. According to FDA’s announcement bulletin (checked 2026-10-31), it reminded health care facilities to follow manufacturer instructions for reprocessing and device maintenance, provided “a new recommendation for health care providers on single-use bronchoscopes,” and gave updated information on medical device adverse event reports. The stated goal was to reduce potential infection transmission between patients.
Published evidence also compares the two types. A systematic review and cost-effectiveness analysis in Anaesthesia (Mouritsen and colleagues, 2020, PMC7079200, checked 2026-10-31) pooled 16 studies of reusable flexible bronchoscopes, covering 2,351 patients and 3,120 procedures. It reported a cross-contamination or infection incidence of 2.8% for reusable scopes. For single-use scopes it took the risk to be 0%, because it found no reported cases of cross-contamination with them.
Types and related concepts
The regulation names the following members of the bronchoscope group. Each row below comes from 21 CFR 874.4680.
| Type listed in 21 CFR 874.4680 | Where it appears |
|---|---|
| Rigid ventilating bronchoscope | Generic type list |
| Rigid nonventilating bronchoscope | Generic type list |
| Nonrigid (flexible) bronchoscope | Generic type list |
| Laryngeal-bronchial telescope | Generic type list |
| Accessories: flexible foreign body claw, bronchoscope tubing, flexible and rigid biopsy forceps, flexible and rigid biopsy curettes, flexible biopsy brush, rigid aspirating tube | Generic type list |
The fiberoptic light source and carrier are excluded from this device group. “Disposable” is not one of the listed types, which supports reading it as a use attribute of a product within the group. For the broader instrument family, see what an endoscope is; for the throat-side airway scope that is often confused with a bronchoscope, see what a laryngoscope is.
Where it matters for labs, clinics and supply decisions
The sources do not say which type a facility should use. They do identify the inputs a facility can compare when it reviews single-use against reusable scopes. The checklist below ties each input to the source that raises it.
| Input to compare | What the source says |
|---|---|
| Reprocessing requirements | FDA reminds facilities to follow manufacturer instructions for reprocessing and device maintenance (2021 bulletin). A reusable device’s 510(k) must include validated reprocessing instructions (openFDA, code EOQ). |
| Infection outcome assumptions | The Anaesthesia analysis used 2.8% for reusable scopes and 0% for single-use. The conclusion depends on those inputs. |
| Cost inputs | The study’s sensitivity analysis varied cost inputs by plus or minus 50%. The cost of the clinical outcome (treating an infection) had the greatest effect on the result and the reprocessing cost per use of a reusable scope the least. The conclusion did not change within that range. |
| Adverse event reporting | FDA’s 2021 communication includes instructions for reporting bronchoscope problems to the agency. |
For how reprocessing is structured in practice, see endoscope reprocessing, medical device reprocessing and high-level disinfection and the Spaulding classification. A related single-use comparison for instruments is autoclavable vs single-use surgical instruments. Regulatory background on device classes is in FDA medical device classification, 510(k) and PMA.
Common misunderstandings
“Disposable bronchoscopes are a lower regulatory class.”
No source supports this. The regulation covers flexible and rigid bronchoscopes together and assigns Class II. Single-use is a labeling and use attribute.
“Single-use means the infection risk was measured at zero.”
In the Anaesthesia analysis, 0% is an assumption drawn from the absence of reported cross-contamination cases with single-use flexible scopes. It is not a measured rate from a controlled comparison.
“The cost study proves single-use is cheaper everywhere.”
The study costed one UK centre in pounds sterling and was framed around the peri-operative setting. It could not run a formal risk-of-bias assessment of the included studies, and two of its authors disclosed past consulting honoraria from Ambu, a single-use scope manufacturer, while stating that no industry was involved in the study. Read the figures as one model with stated assumptions, not as a universal price comparison.
“The study covers rigid scopes too.”
It concerns flexible bronchoscopes only.
FAQ
What is a single-use bronchoscope?
It is a bronchoscope designed and labeled for use on one patient and then disposal, instead of reprocessing. In FDA’s classification it sits under the same bronchoscope regulation, 21 CFR 874.4680, as reusable scopes.
Is a disposable bronchoscope the same as a single-use bronchoscope?
Yes. Both terms describe a scope intended for one use. Product labeling and the manufacturer’s instructions for use state the intended use for a specific model.
What FDA class is a bronchoscope?
Class II, under 21 CFR 874.4680, product code EOQ in FDA’s classification database.
What did FDA say about single-use bronchoscopes in 2021?
The 25 June 2021 safety communication included a new recommendation for health care providers on single-use bronchoscopes, alongside a reminder to follow manufacturer reprocessing instructions.
Sources
- 21 CFR 874.4680, Bronchoscope (flexible or rigid) and accessories: law.cornell.edu/cfr/text/21/874.4680, checked 2026-10-31.
- FDA device classification database via openFDA, product codes EOQ and QNW: api.fda.gov/device/classification, checked 2026-10-31.
- FDA, Flexible Bronchoscopes and Updated Recommendations for Reprocessing, FDA Safety Communication, bulletin of 25 June 2021: content.govdelivery.com/accounts/USFDA/bulletins/2e5144d, checked 2026-10-31.
- Mouritsen JM et al., A systematic review and cost effectiveness analysis of reusable vs. single-use flexible bronchoscopes, Anaesthesia 2020;75(4): pmc.ncbi.nlm.nih.gov/articles/PMC7079200, checked 2026-10-31.
