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Response to Professor Hedley-White's comment
- Judy Edworthy, Elizabeth Hellier (8 August 2006)
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Alarms and human behaviour
- John Hedley-Whyte (11 July 2006)
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Judy Edworthy, Professor of Applied Psychology University of Plymouth, Elizabeth Hellier
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Professor Hedley-White is of course correct in pointing out that we have made a typographical error by referring to the now obsolete ISO 9703 standard as IEC 9703. However, it is simply a typographical error and our comments about the potential problems which might arise from the use of the alarms specified in IEC 60601 remain, even though this standard has now been accepted worldwide. The final section of our paper is mostly focused on IEC 60601 and what we consider might be some shortcomings in the specification of the alarm sounds. Conflict of Interest:None declared |
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John Hedley-Whyte, Professor Harvard University
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Editor— Professor J. Edworthy's review (1) of the problems and usefulness of alarms in anaesthesia practice and in intensive care contains a misleading reference to IEC 9703, which is outside the 60000-69999 range of IEC numerical designations for standards publications. ISO 9703-1, 9703-2 and 9703-3 (2), incorrectly referenced in her review, have now been withdrawn and superceded by IEC 60601-1-8, Medical electrical equipment—Part 1-8: General requirements for safety—Collateral standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, first published in 2003. A subsequent 2006 edition was written to be compatible with the recently-published third edition of IEC 60601-1, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance (3). The alarm designations of the 2003 and 2006 editions are essentially the same. Professor Edworthy is correct in stating that there has been world-wide acceptance of the IEC alarm standard. This acceptance followed the Agreement on Mutual Recognition between the United States and the European Community of June 13, 1997 (4). The new alarms standard covers intelligent and alarms and regularizes visual alarms (5), both for inpatient and same-day surgery (6). John Hedley-Whyte, M.D. David S. Sheridan Professor of Anaesthesia and Respiratory Therapy, Harvard University Boston, MA USA E-mail: john_hedley-whyte@hms.harvard.edu 1. Edworthy J, Hellier E. Alarms and human behaviour: implications for medical alarms. Br J Anaesth 2006:97(1):12-17. 2. ISO 9703-1: 1992, Anaesthesia and respiratory care alarm signals—Part 1: Visual alarm signals; ISO 9703-2:1994, Anaesthesia and respiratory care alarm signals—Part 2: Auditory alarm signals; ISO 9703- 3:1998, Anaesthesia and respiratory care alarm signals—Part 3: Guidance on application of alarms. Geneva: International Organization for Standardization. 3. IEC 60601-1, Medical electrical equipment—Part 1: General requirements for basic safety and essential performance, 3rd edition. Geneva: International Electrotechnical Commission, 2006. 4. Hedley-Whyte J, Milamed DR. Equipment standards: history, litigation and advice. Ann Surg 1999, 230(1):120-27. 5. Hedley-Whyte J. Helping to ameliorate a healthcare crisis – General requirements and guidelines for the application of alarms in medicine. ISO Bulletin April 2003; 34:23-25. 6. Hedley-Whyte J, Milamed DR. The evolution of sites of surgery. Ulster Med J 2006;75(1):46-53. Conflict of Interest:None declared |
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