Debra R. Milamed

Contributions of the surgical sciences to a reduction of the mortality rate in the United States for the period 1968 to 1988.

ObjectiveThe authors sought to determine whether advances in the surgical sciences have led to a reduction in mortality rates for diseases treated by surgery during the past 25 years. They also wished to study changes in health care manpower for perioperative care during this period. Summary Background DataSurgical operations requiring general anesthesia in the United States have risen to 25 million per year at an annual cost of approximately

Chairpersons of Pathology in the United States: Limited Benchmarks for Publications

125 billion. During the period 1968 to 1988, the number of anesthesiologists per 100,000 persons in the United States increased 98%, although the number of surgeons remained relatively constant. Between 1980 and 1989, the number of radiologists per 100,000 persons decreased to 29% below the figure for 1965. Membership in specialized nursing societies increased dramatically. MethodsThe authors used vital statistics data from the National Center for Health Statistics (NCHS) to examine the mortality rates for diseases of the prostate, appendix, and gallbladder; hernia and intestinal obstruction; and ulcerative disease of the stomach and duodenum for the years 1968, 1978, and 1988. NCHS hospital discharge data were used to derive the rates of hospitalization and surgery for these conditions. Information on changes in health care manpower was obtained from published and other sources. ResultsThe mortality rates for the five diseases studied decreased from 40% to 69% between 1968 and 1978. Between 1978 and 1988, the mortality rates caused by benign prostatic hyperplasia declined an additional 54% and by appendicitis, an additional 43%. Deaths attributable to the other conditions remained relatively constant. The rates of hospitalization and surgery for these conditions varied. Conclusionsadvances 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.

Equipment standards: history, litigation, and advice.

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.

Laminectomy and the Treatment of Lower-Back Pain in Massachusetts

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.

Improving Patient Safety and Essential Device Performance: International Standards for Home Respiratory Care Equipment

During 1984-85, laminectomy rates in Massachusetts demonstrated a 2.2-fold variation among districts. Thirty-five percent of laminectomies occurred in 7 of the 108 hospitals studied. Approximately 81% of laminectomies were performed by neurosurgeons. Rates of laminectomy decline with increasing age after 65, while rates of hospitalization for lower-back pain rise.

Highlights of the New International Standard: Alarm Systems and Ventilators in Critical Care

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). Establishment of a New Joint Working Group In April 2011, a project team of ISO/TC121/SC3 met at the British Standards Institution (BSI), London, to begin revision of ISO 18779:2005, Medical Devices for Conserving Oxygen and Oxygen Mixtures—Particular Requirements (Table 1). By October 2011, a committee draft had been circulated for comment as part of a new work item proposal—the new JWG’s first work item. JWG12 held its first official meeting in Lübeck, Germany, Oct. 24-28, 2011, where the first dual logo (IEC/ISO) Draft International Standard was completed for oxygen-conserving devices, as well as Working Drafts for revised standards on oxygen concentrators and sleep apnea therapy devices. The JWG is now addressing the remaining devices within its remit, shown in Table 2.

Blood and War

Over twenty years ago, an international effort to address the problems relating to visual and auditory alarm signals in operating rooms and intensive care units began.1,2,3 International Organization for Standardization (ISO) Technical Committee (TC) 121, Anaesthetic and Respiratory Equipment, Subcommittee 3, Lung Ventilators and Related Devices (ISO/TC121/ Subcommitee [SC] 3), chaired by John HedleyWhyte, MD, developed Anaesthesia and respiratory care alarm signals—Part 1: Visual alarm signals (ISO 9703-1:1992), Part 2: Auditory alarm signals (ISO 9703-2:1994), and Part 3: Guidance on application of alarms (ISO 9703-3:1998). Recognizing the need to harmonize alarm systems for all medical electrical equipment, in 1998, Hedley-Whyte and ISO/TC121/SC 3 Secretary David Osborn issued a call for experts in both the International Electrotechnical Commission Technical Committee 62A, Some Aspects of Electromedical Equipment (IEC TC/ SC62A) and ISO/TC121/SC3, and convened the ISO/TC121/SC3-IEC/TC/SC62A/Joint Working Group 2 on Medical Alarm Systems (JWG2). This joint working group held its first meeting at the British Standards Institution (BSI) in London in June of that year. The efforts of clinicians, engineers and regulatory authorities’ representatives culminated in publication of IEC 60601-1-8, Medical electrical equipment— Part 1-8: General requirements for basic safety and essential performance—Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems, as an IEC-ISO dual logo standard in 2003.4 This standard was replaced by the second edition in 2006, which aligned it with the 2005 edition of IEC 60601-15 and made the clause numbering adhere to that specified in ISO/IEC Directives Part 2:2004.4,6 In 2010, JWG2 reconvened under the same leadership to revise IEC 60601-1-8 and further address distributed alarm systems, the electronic health record and related concerns. Early this year, ISO will publish the first edition of ISO 80601-2-12, Medical electrical equipment—Part 2-12: Particular requirements for About the Authors