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Radiation in Medicine: A Need for Regulatory Reform
The Health Care Financing Administration has used error rates determined by direct observation as an indicator of quality for long-term care facilities, with a limit of 5 percent medication error rate regarded as acceptable. A 1988 study indicated that more than 4,000 of the nation's 15,000 nursing homes that participate in the Medicare and Medicaid programs fail to follow physician's orders in administering medications (Anonymous, 1989). Outpatient prescription error rates have been measured at 3.4, 4.2, 5.2, and 12.4 percent (Guernsey et al., 1983; Allan and Barker, 1990).
Exact data regarding untoward risks of anesthesia are also difficult to quantify. Many confounding variables may interact with such an estimate, including surgical complications, co-morbidity factors, or other patient variables. The medical literature, however, cites certain estimates for anesthesia risks. According to an ECRI technology assessment, more than 2,000 healthy Americans die each year during general anesthesia; an estimated 50 percent of these deaths are preventable (Anonymous, 1985). Derrington and Smith (1987) estimate the mortality rate from the use of anesthesia at 1:5,000 to 1:10,000 patients/ procedures.
More than 12 million units of red blood cells, 5 million units of platelets, and 2 million units of plasma are administered to patients in the United States each year. Adverse reactions are estimated to be as high as 20 percent (Surgenor et al., 1990). Hemolytic blood transfusion reactions occur as often as 1 in 7,000 red blood cell transfusions and carry a mortality rate of 10 percent (Welborn and Hersch, 1991).
Since 1975, fatal errors involving blood transfusions, collection of blood, and plasmapheresis (a procedure by which blood is withdrawn from the donor, the plasma and red blood cells are separated, and the red blood cells are returned to the donor) must be reported to the Center for Biologics Evaluation and Research of the FDA. From 1976 through 1985, a total of 355 fatalities associated with blood transfusions and plasmapheresis were reported; 99 were excluded from further review because they were deemed unrelated to the transfusion itself (Sazama, 1990). Of the 256 analyzed transfusion deaths, 51 percent resulted from acute hemolysis due to transfusion of ABO-incompatible blood products. The remaining causes of transfusion deaths were attributed to pulmonary injury (15 percent), bacterial contamination of the blood product (10 percent), delayed hemolysis (10 percent), damaged product (3 percent), and graft-versus-host disease (0.4 percent).