Politics + Electricity = Death

Politics + Electricity = Death

The laws of physics cannot be changed to suit a particular purpose. Lives saved by accomplishments of product safety and hospital biomedical professionals are in the tens of thousands and possibly more. The science behind prevention of death from electricity has guided the requirements of national and international safety standards. The history of electrical safety for medical equipment is the history of U.S. industry, engineering, government and testing laboratory professionals developing consensus safety standards. These requirements cannot be sacrificed to suit the plans of any special interest group. It’s a formula for disaster: Politics + Electricity = Death. Where electrical safety is concerned it’s better to abandon politics and just do the right thing. In the case of medical equipment and electrical safety testing, we need to be allowed and encouraged to keep doing the right thing to protect our families, friends and communities.

References

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2 UL 544: Medical and Dental Equipment, 4th ed., (Northbrook, IL, Underwriters Laboratories,1998).

3 Eisner L, R. M. Brown, and D. Modi: “Leakage Current Standards Simplified.” Medical Device & Diagnostic Industry Regulatory Outlook, (2004).

4 ANSI/AAMI ES60601-1:2005, Association for the Advancement of Medical Instrumentation, (2006).

5 UL 60601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety. (Northbrook, IL, Underwriters Laboratories, 2003).

6 UL 1950. Safety of information technology equipment, including electrical business equipment, 2nd ed. (Northbrook, IL, Underwriters Laboratories, 1993).

7 American National Standards Institute, ANSI C101-1992: American National Standard for Leakage Current for Appliances. (Northbrook, IL, Underwriters Laboratories, 1992).

8 “The FDA’s Deadly Gamble with the Safety of Medical Devices,” Project on Government Oversight, (February 19, 2009).

9 S-540: Medical Device Safety Act of 2009, (HR 1346), 111th Congress of the United States.
10 Mundy, Alicia. “FDA Chief Eyes Device Group.” The Wall Street Journal, (June 17, 2009).
11 Bruner, J. M. R., MD. “Hazards of Electrical Apparatus.” Anesthesiology 28 (Mar.-Apr. 1967):396–425.

12 Linko, K. “Testing a New In-Line Blood Warmer.” Anesthesiology 52 (1980):445-456.

13 Singleton, R. J., G. L. Ludbrook, R. K.Webb, and M. A. Fox. “Accidental Toppling of a Fluid Container Causing Spillage onto a Blood Pressure Monitor.” Anaesthesia and Intensive Care, (1993).

14 Singleton, R. J., G. L. Ludbrook, R. K. Webb, and M. A. Fox. “Electric Shocks to Anaesthetists after Touching a Faulty Device and the Chassis of Another Device Simultaneously.” Anaesthesia and Intensive Care, (1993).

15 Atkin, D. H. and L. R. Orkin. “An anaesthetised patient was connected to an ECG device that had been wired wrongly with the earth and neutral connections transposed.” Anaesthesiology, (1973).

16 Federal Register (at www.osha.gov). For more information on SDoC, go to www.osha.gov and type “SDoC” into the search box.