Catalog of Regulatory Science Tools to Help Assess New Medical Devices
This regulatory science tool (RST) is an air monitoring method that uses commercially available monitoring badges to evaluate volatile organic compound (VOC) emissions from newly manufactured neonatal incubators.
Technical Description
This RST utilizes commercially available air monitoring badges to assess volatile organic compound (VOC) emissions from newly manufactured neonatal incubators. The method employs two badge types to monitor ten aldehyde compounds and cyclohexanone over a 7-day period under clinically relevant conditions. The tool consists of a protocol outlining badge positioning, data collection, and sampling periods. This tool captures time-dependent emission patterns and allows assessment of whether VOC concentrations decrease over time, providing information about emission and off-gassing trends.
Intended Purpose
This RST is intended to be used for testing for the presence of VOCs from newly manufactured neonatal incubators (product code FMZ or FPL). It is intended to enable the rapid screening of multiple incubators without requiring specialized equipment or extensive technical expertise.
Testing
Testing is outlined in manuscript titled “Simplified method for measuring volatile organic chemicals in newly manufactured neonatal incubators” and is linked in the Supporting Documentation
Limitations
This method has not been used on other types of medical devices or enclosed patient environments. The method has not been used for emissions from devices after extended clinical use or following multiple cleaning and disinfection cycles. Testing was conducted in a controlled laboratory environment and does not capture potential VOC contributions from other sources present in clinical NICU settings, such as emissions from other medical equipment, cleaning products, or building materials. The method evaluates a limited panel of VOCs (10 aldehydes and cyclohexanone) based on the specific badge types used and does not provide comprehensive screening of all potential volatile organic substances that may be emitted from incubator materials. Badge performance and environmental operating limits may vary between manufacturers and badge types. Different badge manufacturers may have different environmental specifications, analyte panels, and detection capabilities. Detection and quantification limits are analyte specific and dependent on the analytical laboratory's capabilities.
Supporting Documentation
- User Manual
- Alexander Herman, Alan Hood, Oleg Vesnovsky, Kathleen White & Peter L. Goering (15 May 2026): Simplified method for measuring volatile organic chemicals in newly manufactured neonatal incubators, Toxicology Mechanisms and Methods, DOI: 10.1080/15376516.2026.2655744
Contact
Tool Reference
- RST26PM01.01
- 7/14/2025
- U.S. Food and Drug Administration. (2026). Method for Evaluating Volatile Organic Compound Emissions from Newly Manufactured Neonatal Incubators (RST26PM01.01). https://cdrh-rst.fda.gov/method-evaluating-volatile-organic-compound-emissions-newly-manufactured-neonatal-incubators