Indoor Air Quality Considerations for Laboratory Animals in Wildfire-Impacted Regions-A Pilot Study.

Wildfire events are increasing across the globe. The smoke generated as a result of this changing fire landscape is potentially more toxic than air pollution from other ambient sources, according to recent studies. This is especially concerning for populations of humans or animals that live downwind of areas that burn frequently, given that ambient exposure to wildfire smoke cannot be easily eliminated. We hypothesized that a significant indoor air pollution risk existed for laboratory animal facilities located proximal to fire-prone areas. Here, we measured real time continuous outdoor and indoor air quality for 28 days at a laboratory animal facility located in the Rocky Mountain region. We demonstrated that during a wildfire event, the indoor air quality of this animal facility is influenced by ambient smoke events. The daily average indoor fine particulate matter value in an animal room exceeded the Environmental Protection Agency's ambient annual standard 14% of the time and exceeded the World Health Organization's ambient annual guideline 71% of the time. We further show that specialized cage filtration systems are capable of mitigating air pollution penetrance and could improve an animal's microenvironment. The potential effects for laboratory animal physiology that occur in response to the exposure levels and durations measured in this study remain to be determined; yet, even acute wildfire exposure events have been previously correlated with significant differences in gene regulatory and metabolic processes in vivo. We believe these findings warrant consideration for indoor laboratory animal facility air quality monitoring and development of smoke exposure prevention and response protocols, especially among facilities located downwind of fire-prone landscapes.

Conflicting information from the Food and Drug Administration: Missed opportunity to lead standards for safe and effective medical artificial intelligence solutions.

The Food & Drug Administration (FDA) is considering the permanent exemption of premarket notification requirements for several Class I and II medical device products, including several artificial Intelligence (AI)-driven devices. The exemption is based on the need to rapidly more quickly disseminate devices to the public, estimated cost-savings, a lack of documented adverse events reported to the FDA's database. However, this ignores emerging issues related to AI-based devices, including utility, reproducibility and bias that may not only affect an individual but entire populations. We urge the FDA to reinforce the messaging on safety and effectiveness regulations of AI-based Software as a Medical Device products to better promote fair AI-driven clinical decision tools and for preventing harm to the patients we serve.