title: New Minimum Relative Humidity Requirements Are Expected to Lead to More Medical Device Failures.
abstract: In 2010, the Addendum D to ASHRAE Standard 170, "Ventilation of healthcare facilities," lowered the minimum relative humidity (RH) requirement of anesthetizing locations (including operating rooms, operating/surgical cystoscopic rooms, delivery rooms (Caesarean), recovery rooms, critical and intensive care, newborn intensive care, treatment rooms, trauma rooms (crisis or shock), laser eye rooms, newborn nursery suites, and endoscopy rooms) from 30 % to 20 %. The new minimum limit was adopted based on the results of a review paper that suggested that lowering humidity levels will have little or no impact on providing a safe environment for patients, staff, or medical equipment. That review paper reached this conclusion by assuming that there were no medical device failures due to electrostatic discharge (ESD). However, in an examination of the FDA's MAUDE database of reported defects and recalls, we identified numerous medical device failures explicitly due to ESD. This paper presents technical reliability and safety concerns regarding the new guidelines and recommends that such changes should not be implemented and that the guidelines should be revoked.
authors.affiliation: Center for Advanced Life Cycle Engineering (CALCE), University of Maryland-College Park, 1184 Engineering Lab Building, College Park, MD, 20742, USA. mkohani@calce.umd.edu.
authors.forename: Mehdi
authors.initials: M
authors.lastname: Kohani
authors.affiliation: Center for Advanced Life Cycle Engineering (CALCE), University of Maryland-College Park, S1103 Engineering Lab Building, College Park, MD, 20742, USA. pecht@calce.umd.edu.
authors.forename: Michael
authors.initials: M
authors.lastname: Pecht
mesh_terms: D004868:Equipment Failure; D006801:Humans; D006813:Humidity / Q000592:standards*; D009873:Operating Rooms / Q000592:standards*; D015203:Reproducibility of Results; D055672:Static Electricity / Q000009:adverse effects*; D014691:Ventilation / Q000592:standards*
keywords: Electromagnetic compatibility; Electrostatic discharge; Medical device failure; Relative humidity; Ventilation