Equipment Standards: History, Litigation, and Advice

Abstract

SummaryThe authors present a concise history of the development of national and international standards for surgical equipment. Standards-writing organizations, surgical and other specialty societies, universities, test houses, and the U.S. government have influenced this process, which is now manifested in complex interactions between national and international standards-writing organizations, and in CE (Conformité Europeene) marks being placed on surgical equipment in the United States and elsewhere. The history of litigation in standards development is also reviewed. Recommendations to maximize patient safety and to help ensure successful, costeffective defense in litigation for surgeons who use equipment and may suffer its malfunctions are given. Overall, the complicated oversight of surgical equipment standards and the approval process appears to be contributing to the improving and outstanding results of U.S. surgery reported by the U.S. government.

Instrumentation failure during microlaryngoscopy

“…However, in the Irish adaption of the checklist, the question regarding equipment concerns is addressed to the operating team rather than the nursing staff [ 11 ]. Furthermore, the operating surgeon is ultimately responsible for knowing the working of their equipment [ 12 ]. Despite the final responsibility lying with the operating surgeon, they are often not involved in laying out the equipment, and as such, may not be aware of faulty equipment until it is handed to them, or in use.…”

Professor George Archibald Grant Mitchell (1906–1993): his work with penicillin during World War II

“…27 The Allied invasion of Normandy included 8000 doctors, tons of medical equipment, 600,000 doses of penicillin and 50 tons of sulphonamides. 28 Mitchell landed in Normandy on D-Day, and was operational in North-East Europe until 8 May 1945, when hostilities ceased. 29 Shortly after, Porritt and Mitchell produced Penicillin therapy and control in 21 Army Group, 60 chapters authored by RAMC officers, including seven by Porritt and Mitchell, reporting the results of surgery and new techniques.…”

Lüer’s Lure

“…We have previously described the process of international standardization of medical equipment. 21 Two Geneva-based nongovernmental organizations bridge the public and private sectors to coordinate the development of international standards. The ISO was created in 1947 and the International Electrotechnical Commission (IEC) was founded in 1906.…”

“…The development of international standards by technical committees and their working groups is a formal process that proceeds in established stages to assure consensus of the National Member Bodies and National Committees of ISO and IEC, respectively. 21,22 In the United States, the private-sector American National Standards Institute, established in 1916, is the U.S. member body to ISO. American private sector standards development organizations, including the Association for the Advancement of Medical Instrumentation, ASTM International, and the Institute of Electrical and Electronics Engineers are recognized by and operate under American National Standards Institute bylaws and procedures.…”