Advances in surgery, anesthesiology, and information transfer and the availability of intensive care units and specialized hospital personnel have resulted in reduced mortality rates for diseases treated by surgery.

Pathology chairpersons continue their preeminence in US medical schools. The Hirsch (h) index of citation was analyzed for the chairpersons of 8 specialty departments in 41 US medical schools. The current h indices of department chairs (302 of 328 positions filled) were tabulated by specialty and medical school. The proportion of women was noted, as was whether the chairs had completed the first decade of this millennium continuously in post in the same medical school. Of the 8 specialties, pathology chairs at the 41 schools are the most likely to have been in the same post in 1999 and 2009, and the pathologists who remained are exclusively male. In the 41 medical schools studied, women chairs constituted only 3.7% of all heads of departments in 1999 and 7% in 2009. The paucity of female chairs 3 decades after women became at least one third of the medical student body is unfortunate.

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.

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).

In this article, leaders of the joint working group that developed a new international standard for alarms systems and ventilators in critical care report on key provisions of the standard.