New Minimum Relative Humidity Requirements Are Expected to Lead to More Medical Device Failures

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• 作者：Mehdi Kohani ; Michael Pecht
• 关键词：Medical device failure ; Electromagnetic compatibility ; Electrostatic discharge ; Ventilation ; Relative humidity
• 刊名：Journal of Medical Systems
• 出版年：2016
• 出版时间：March 2016
• 年：2016
• 卷：40
• 期：3
• 全文大小：1,043 KB
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• 作者单位：Mehdi Kohani (1)
  Michael Pecht (2)
  
  1. Center for Advanced Life Cycle Engineering (CALCE), University of Maryland-College Park, 1184 Engineering Lab Building, College Park, MD, 20742, USA
  2. Center for Advanced Life Cycle Engineering (CALCE), University of Maryland-College Park, S1103 Engineering Lab Building, College Park, MD, 20742, USA
  
• 刊物类别：Mathematics and Statistics
• 刊物主题：Statistics
  Statistics for Life Sciences, Medicine and Health Sciences
  Health Informatics and Administration
  
• 出版者：Springer Netherlands
• ISSN：1573-689X

文摘

In 2010, the Addendum D to ASHRAE Standard 170, 鈥淰entilation of healthcare facilities,鈥?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鈥檚 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. Keywords Medical device failure Electromagnetic compatibility Electrostatic discharge Ventilation Relative humidity