Facilities strive to comply with new Act. The long-term effects of the Safe Medical Devices Act are still unknown.

Unlike previous medical device laws, the Safe Medical Devices Act of 1990 (SMDA), which became effective November 28, 1991 applies to "device-user facilities" such as hospitals and long-term care facilities. Final regulations are scheduled for release later this spring. The SMDA's primary goals are to: Ensure all devices currently in or entering the marketplace are safe and effective Enable the U.S. Food and Drug Administration (FDA) to learn quickly about serious problems with medical devices Remove defective devices (old and new) from the market To achieve these goals, Congress has given the FDA new review and enforcement powers, including the authority to impose fines on those in violation of the law. Incidents in which a medical device caused or contributed to the death, serious illness, or serious injury of a patient are referred to as medical device-reportable (MDR) events. A user must report MDR deaths to the FDA and to the manufacturer (if known). Serious illnesses and serious injuries caused by or attributed to the use of a device must be reported to the device manufacturer or, if the manufacturer is unknown, to the FDA. Facilities must report MDR events to the FDA semiannually and maintain incident files for two years after reporting the MDR event. The FDA may assess civil penalties against parties that do not comply with the SMDA's reporting provisions. Healthcare facilities must develop and implement employee training and education programs to help physicians, nurses, and other allied health employees identify and report MDR events.

A comparison of emergency medicine ultrasound training with guidelines of the Society for Academic Emergency Medicine.

STUDY OBJECTIVES: To compare the current state of emergency medicine residency ultrasound training with guidelines for that training from the Society for Academic Emergency Medicine (SAEM). METHODS: A brief questionnaire was sent to program directors from 119 emergency medicine residency programs in the United States. Responses were compared with the SAEM guidelines for clinical experience (150 total ultrasounds) and didactic experience (40 hours of didactic instruction). RESULTS: The overall response rate was 92%. Seventy-six (69%) of the programs own an ultrasound machine (ownership defined as 24-hour availability and complete discretion over use). Of these, 12 (16%) indicated that their average 1998 graduate had done at least 150 total ultrasound scans during residency, although none of the programs had average numbers that exceeded the minimum guidelines for all 4 procedure categories. Information on didactic curriculum was available from 74 ultrasound-owning programs: the duration was 0 to 20 hours in 49 (66%), 20 to 40 hours in 19 (26%), and 40 to 100 hours in 6 (8%). Only 1 program's average graduate met or exceeded the SAEM guidelines for both didactic and clinical training. CONCLUSION: Most emergency medicine residency programs own at least 1 ultrasound machine, with more than half of these obtaining their first machine within the past 3 years. Only 1 program currently meets SAEM training guidelines.

Comparison of tetracaine-adrenaline-cocaine (TAC) with topical lidocaine-epinephrine (TLE): efficacy and cost.

Topical anesthesia in the form of TAC (tetracaine, adrenaline, cocaine) solution has been used for wound repair. This pilot study was designed to determine if the topical anesthesia achieved using a mixture of lidocaine (5%) and epinephrine (1:2000) (TLE) is equivalent to the topical anesthesia obtained using a solution of tetracaine (0.5%), epinephrine (1: 2000), and cocaine (10.4%) (TAC). A prospective, randomized, double-blind trial was carried out from May 1992 to August 1992 at a community-based teaching hospital Emergency Department (ED) that receives 50,000 annual visits. Patients with facial or scalp lacerations suitable for topical anesthesia presenting to the ED were included when study physicians were in attendance. Exclusion criteria included the presence of a sensory altering substance (eg, ethanol), age younger than two years, hypertension, pregnancy, allergy to any of the study's pharmacological agents, wounds greater than six hours old, grossly contaminated wounds, and wounds longer than six centimeters. Either a TAC or TLE solution was applied to lacerations before suturing. The laceration was repaired and the patient or physician evaluated the degree of pain from the procedure by using a standardized visual pain scale. A total of 35 patients were studied. Seventeen patients were in the TLE group; 18 in the TAC group. The mean ages were compared and found to be similar (P = .40) between the two test groups. The pain scale values, the diameter of tissue blanch around laceration (halo size), and the time to laceration repair from the onset of application of anesthetic were compared and no difference was shown between the TAC and TLE groups.(ABSTRACT TRUNCATED AT 250 WORDS)