Apnea monitor standard should not require back-up modality in hospitals -- SpaceLabs.
This article was originally published in The Gray Sheet
Executive Summary
INFANT APNEA MONITOR SECONDARY MONITORING MODALITY should not be required in hospital settings, SpaceLabs says in comments submitted to FDA May 19 on the agency's proposed infant apnea monitor standard. While the requirement for a back-up monitoring modality "may be appropriate for home use," hospitals often use separate devices for primary and secondary monitoring, the company says. Therefore, "requiring a secondary modality in a hospital setting goes beyond the control of any one device manufacturer."