Improving Patient Safety and Essential Device Performance: International Standards for Home Respiratory Care Equipment

Abstract

Recognition of the increasing use of medical devices in the home environment led to the establishment in 2006 of the International Electrotechnical Commission (IEC)Technical Committee 62A(IEC62A)-International Organization for Standardization (ISO)Technical Committee 121, Subcommittee 3: Anaesthetic and Respiratory Equipment, Lung Ventilators and Related Devices, (ISO/TC121/SC3), Joint Working Group 6 (JWG6) on medical electrical equipment and medical electrical systems used in the home healthcare environment. Publication of IEC Collateral Standard 60601-1-11 on home healthcare environment followed in June 2010, 1,2 with recognition in the Official Journal of the European Union as of Jan. 18, 2011. 3 This International Standard is also used to demonstrate the presumption of conformity with the Essential Requirements in the framework of the European Medical Device Directive, the precondition to enter the European market. Subsequently, the leadership of ISO/TC121/SC3 reviewed its Work Programme to identify respiratory care devices commonly used in the home. Existing standards covering those devices were also identified (Table 1).

A Growing Fire Hazard Concern in Communities: Home Oxygen Therapy and Continued Smoking Habits

“…Existing national and international consensus codes and standards for both home medical oxygen and industrial oxygen systems offer relevant guidance for improved home oxygen equipment. For example, ISO 8359:1996/AMD 1:2012 (Oxygen concentrators for medical use-safety requirements) requires a thermal fuse (or fire break) located close to the nasal cannula in oxygen concentrators to prevent the spread of fire from the cannula to the oxygen concentrator [38]. Another standards body, the International Electrotechnical Commission (IEC), charged with revising its standards on oxygen concentrators, infers that most instructions for medical device use, including the warnings, are never read.…”

“…Another standards body, the International Electrotechnical Commission (IEC), charged with revising its standards on oxygen concentrators, infers that most instructions for medical device use, including the warnings, are never read. IEC standards are therefore based on the expectation that devices designed for home use must be intrinsically safe [38].…”