Equipment Standards: History, Litigation, and Advice

The 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, cost-effective 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.