Chattem, Inc. and FDA informed consumers and healthcare professionals of a voluntary nationwide recall of its Icy Hot Heat Therapy products, including consumer “samples” that were included on a limited promotional basis in cartons of its 3 oz Aspercreme product.

The products were recalled because of consumer reports of first, second and third degree burns as well as skin irritation. All lots and sizes of the following Icy Hot Heat Therapy products were recalled:

Icy Hot Heat Therapy Air Activated Heat – Back
Icy Hot Heat Therapy Air Activated Heat – Arm, Neck, and Leg
Icy Hot Heat Therapy Air Activated Heal – Arm, Neck, and Leg single consumer use “samples” on a limited promotional basis in cartons of 3 oz. Aspercreme Pain Relieving Cream

Consumers who have the Icy Hot Heat Therapy products under this recall should immediately stop using the products, discard them, and /or return them to the manufacturer.

Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer’s press release regarding this issue at:

http://www.fda.gov/medwatch/safety/2008/safety08.htm#Chattem

LA Times (2/9, Engel, Lin II) reported, “The long waits that government inspectors say endanger” ED “patients at [California's] Harbor-UCLA Medical Center can also be found in backlogged hospitals across the country, according to emergency care experts.” Dr. Linda Lawrence, president of the American College of Emergency Physicians, said, “We no longer have the capacity to serve as the safety net for society.”

The ACEP “surveyed 1,000 emergency care physicians in September and found that one in five knew of a patient who had died because of having to wait too long for care,” according to Dr. Lawrence. The problem of lengthy wait times “is exacerbated by a chronic, nationwide nursing shortage and a dearth of specialists willing to be on call for emergencies.” Furthermore, the increasing “number of people without medical insurance…has turned many” EDs “into money-losers.” This “crisis is especially acute in Los Angeles County,” as six EDs in the South Los Angeles area “have closed since 2003.” Dr. Bruce Chernof, L.A. County’s director of county health services, said, “What we have is a persistent erosion of” ED “services,” which “creates increasing pressure on every other hospital that runs an” ED.

HealthDay (2/9, Preidt) reported, “Medical residents who are depressed are about six times more likely to make medication errors than those who aren’t depressed,” according to a study published online Feb. 7 in the British Medical Journal.

For the study, Amy Fahrenkopf, M.D., M.P.H., of Children’s Hospital in Boston, and colleagues “looked at 123 pediatric residents at three children’s hospitals.” According to the researchers, one in five “residents were depressed, and” nearly three-quarters “were burned out.”

The researchers found that, “[d]uring the study period, the residents made a total of 45 medication errors, and those who were depressed made 6.2 times more medication errors than those who weren’t depressed.” However, the researchers, did not find an association “between higher medication error rates and burnout.”

In Academic Emergency Medicine 2008; Jan;15(1):1-8.

Authors: Hohl CM, Sadatsafavi M, Nosyk B, Anis AH

OBJECTIVES: To synthesize the evidence comparing the adverse event (AE) profile and clinical effectiveness of midazolam and propofol for procedural sedation (PS) in adults in the emergency care setting.

METHODS: The authors conducted a systematic review of randomized controlled trials (RCTs) and observational studies reporting the use of either midazolam and/or propofol for adult PS in the emergency department (ED). A systematic search strategy was developed and applied to six bibliographic reference databases. Three emergency medicine journals, the Canadian Adverse Drug Reaction Newsletter, and conference proceedings were hand-searched. Retrieved articles were reviewed and data were abstracted using standardized data collection. Trial quality was assessed using the Jadad score. The outcomes assessed were the proportion of patients with AEs and the pooled mean difference in the proportion of patients with successful PS.

RESULTS: Of 229 articles identified, 28 met the inclusion criteria for the analysis of AEs. Only one major AE to PS was found, resulting in no statistically significant difference in the proportion of major AEs between agents. Four studies were RCTs that met the inclusion criteria for the analysis of clinical effectiveness. Two trials met criteria for good quality. The RCTs enrolled between 32 and 86 patients, and the most common indications for PS were orthopedic reductions and cardioversions. There was a nonsignificant difference in the proportion of patients with successful PS in favor of propofol (effect difference 2.9%, 95% confidence interval (CI) = -6.5 to 15.2).

CONCLUSIONS: The authors found no significant difference in the safety profile and the proportion of successful PS between midazolam and propofol for adults in the ED.

In Journal of Emergency Medicine, 2008 Jan 31.

Authors:  Adhikari S, Blaivas M, Lyon M.

BACKGROUND:  Tubo-ovarian Abscess (TOA) is a complication of pelvic inflammatory disease (PID) requiring admission, i.v. antibiotics and, possibly, aspiration or surgery.

OBJECTIVE:  The purpose of this study was to describe the role of emergency department (ED) bedside transvaginal ultrasonography (US) in the diagnosis of TOA.

DESIGN:  This was a retrospective review of non-pregnant ED patients presenting with pelvic pain who were diagnosed with TOA using bedside transvaginal US.

INTERVENTIONS:  ED US examinations were performed by emergency medicine residents and ultrasound-credentialed attending physicians within 1 h after clinical assessment. ED US logs were reviewed for the diagnosis of TOA. Medical records were reviewed for risk factors, medical and sexual history, physical examination findings, laboratory results, additional diagnostic testing, hospital course, and a discharge diagnosis of TOA by the admitting gynecology service.

RESULTS:  A total of 20 patients with TOA were identified over a 3-year period. Ages ranged from 14 to 45 years (mean 27 years). Seven (35%) patients reported a prior history of PID or sexually transmitted disease, and 1 (5%) was febrile. All had lower abdominal tenderness and 9 (45%) had cervical motion or adnexal tenderness. The sonographic abnormalities included 14 (70%) with a complex adnexal mass, 5 (25%) with echogenic fluid in the cul-de-sac, and 3 (15%) patients with pyosalpinx. The discharge diagnosis was TOA by the admitting gynecology service for all patients.

CONCLUSION: Our study illustrates the limitations of clinical criteria in diagnosing TOA and supports the use of bedside US when evaluating patients with pelvic pain and symptoms that do not meet classic Centers for Disease Control and Prevention criteria for PID.

In American Journal of Roentgenology, 2007; 189:1371-1379 

Authors: MacKenzie JD, Nazario-Larrieu J, et al

OBJECTIVE. The purpose of this study was to evaluate the effect of reduction in radiation dose on CT detection of pulmonary embolism.

SUBJECTS AND METHODS. Emergency department patients were evaluated for pulmonary embolism with standard and simulated reduced-dose CT angiography. Simulated lower-dose CT angiograms obtained at 90, 45, 22, and 10 mAs_eff were reconstructed by mathematical addition of noise to the standard dose (180 mAs_eff) data from the images of 18 patients with and 20 patients without pulmonary embolism. Four radiologists blinded to the study parameters separately interpreted each CT angiogram. Dose trends for subjective measures (diagnostic certainty, image quality, and perceived technical limitations) were evaluated, test characteristics for the detection of pulmonary embolism were computed, and clot burden was measured.

RESULTS. Readers indicated significant reductions in diagnostic certainty (p < 0.02) and image quality (p < 0.02) and an increase in perceived technical limitations (p < 0.01) as the simulated radiation dose was decreased. These subjective measures also showed significant adverse dose trends when the mAs_eff was reduced (p < 0.001). At reduced radiation doses, the sensitivity and positive predictive value for detection of pulmonary embolism diminished significantly. The sensitivity was 0.94 (lower bound of 0.95 CI, 0.92); specificity, 0.99 (lower bound of 0.95 CI, 0.98); positive predictive value, 0.95 (lower bound of 0.95 CI, 0.92); and negative predictive value, 0.99 (lower bound of 0.95 CI, 0.97). All patients had a low to moderate clot burden.

CONCLUSION. Reduction in dose for CT angiography in the detection of pulmonary embolism has a significant adverse effect on readers’ subjective assessment of diagnostic confidence and image quality. Detection of pulmonary embolism also decreases as the tube current dose is reduced.

In American Journal of Roentgenology 2007; 189:1533-1538 

Authors:  Dillman JR, Ellis JH, et al. 

OBJECTIVE. The purpose of our study was to determine the frequency and severity of acute allergic-like reactions to IV-administered gadolinium-containing contrast media in children and adults.

MATERIALS AND METHODS. Pediatric (younger than 19 years) and adult department of radiology contrast material reaction forms involving patients who experienced acute allergic-like reactions to gadolinium-containing contrast media from January 1, 2001, through December 31, 2006, were retrospectively evaluated for the specific types of acute allergic-like reactions, reaction management, and patient outcomes. Relevant patient medical information, including documentation of prior gadolinium- or iodine-containing contrast material reaction, premedication before acute allergic-like reaction to IV gadolinium-containing contrast material, previous allergic reactions to substances other than contrast media, and history of asthma, was obtained by reviewing electronic medical records.

RESULTS. Seventy-eight thousand three hundred fifty-three (65,009 adult and 13,344 pediatric) IV administrations of gadolinium-containing contrast material were performed during the study period. Acute allergic-like reactions were documented after 54 injections (reaction frequency, 0.07%). Forty-eight reactions involved adult patients (adult reaction frequency, 0.07%), and six reactions occurred in pediatric patients (pediatric reaction frequency, 0.04%). Forty (74%) acute allergic-like reactions were mild, 10 (19%) were moderate, and four (7%) were severe. No gadolinium-containing contrast material–related death occurred during the study period. Twenty-six (50%) of 52 patients had one or more presumed risk factors for contrast material reaction.

CONCLUSION. Adult and pediatric acute allergic-like reactions to IV-administered gadolinium-containing contrast media are rare. Most of these reactions are mild; however, moderate and severe reactions that require immediate management do occur.

From Healthcare Security Weekly, 2/11/08:  Employee charged with embezzling money from hospital A former marketing assistant allegedly embezzled more than $100,000 from a Columbus, OH hospital by hiring two friends and paying them for work they never did, prosecutors said.

The Franklin County prosecutor’s office said employee Rana Miller, 43, embezzled money from Nationwide Children’s Hospital for more than a year, starting in 2003, reported the NBC 4 television station. A grand jury indicted Miller and two of her friends Feb. 5 and accused them of diverting money into their personal accounts, the Columbus Dispatch reported.

Miller was charged with theft and tampering with records after a Columbus police investigation of questionable activity with vendor invoices at the hospital. Prosecutors said she created fraudulent invoices for work that was never done and wrote checks to two of her friends. Investigators said security became suspicious of Miller in 2007 after an internal investigation at the hospital.

From HealthCare Security Weekly, 2/11/08:  Pickpockets have targeted people in hospital elevators at several South Carolina hospitals, reported News Channel 7.

Investigators say the thieves have struck at Greenville Memorial Hospital, St. Francis Hospital, Newberry Hospital, and Spartanburg Regional. Police said one of the men fakes an injury and acts as if he is falling. When a Good Samaritan reaches out to help, the other man takes his wallet. The men are reported to be well-dressed and well-mannered.