News briefs: Patient safety; FDA medical device rules; bioterrorism preparedness
Patient safety partnership boosts medical error fight
Joint Commission links up with big business
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The Joint Commission on Accreditation of Healthcare Organizations has jumped into a formal partnership with a leading patient safety advocate, The Leapfrog Group. In the first major collaboration effort between the two parties, the Joint Commission and Leap-frog leaders will try to identify a specific set of outcome and process measures in intensive care units. These measures eventually may be used to supplement or even replace the current Leapfrog measures, which recommend that hospitals have board-certified or board-eligible intensivists.
The new partnering arrangement relationship cements a previously informal relationship with the health care purchaser group. The Leapfrog Group is a growing consortium of more than 90 Fortune 500 companies and other large private and public health care purchasers founded by the Business Roundtable. The group launched a national effort in November 2000 to educate employees, retirees, and their families about medical errors and the importance of hospital efforts to make advances in patient safety, and to reward hospitals for their efforts in improving patient safety.
Leapfrog purchasers provide health benefits to more than 26 million Americans and spend more than $46 billion on health care annually. The group was established in the wake of the 1999 Institute of Medicine report, To Err is Human, which made medical errors a national issue.
Joint Commission standards issued in 1999 require the internal definition, reporting, and analysis of adverse events in accredited health care organizations, and the implementation of indicated improvements. New patient safety standards that were implemented last year encourage the creation of a culture of safety in hospitals, set forth expectations for the identification and redesign of error-prone systems, and require the disclosure of unanticipated outcomes to patients and/or their families.
FDA revises reprocessing dates, seeks label input
Class II devices deadline extended to Aug. 14th
The Food and Drug Administration (FDA) is notifying hospitals and independent reprocessors of single-use medical use devices (SUDs) of some changes in enforcement deadlines of its regulations. The enforcement policy for classes I, II, and III SUDs is as follows:
Class II devices: The FDA is extending the deadline for active enforcement of premarket notification submission requirements for class II SUDs until Aug. 14, 2002, provided that the reprocessor:
- submitted a premarket notification submission (also known as a "510(k) submission") by Aug. 14, 2001;
- has not received a not substantially equivalent determination;
- provides timely responses to the FDA’s requests for additional information in accordance with 21 C.F.R. §807.87(l).
Class III devices: The FDA may actively enforce premarket approval requirements for class III SUDs as of Feb. 14, 2002.
Class I devices: The FDA may take enforcement action against any class I SUD if a 510(k) submission has not been submitted to the agency as of Feb. 14, 2002, or if the class I device does not have FDA marketing clearance by Aug. 14, 2002.
The FDA also is asking for comments and suggestions on the labeling of reprocessed SUDs with respect to the name of the original equipment manufacturer and the reprocessor. The agency is considering developing a labeling guidance.
Submit written or comments by March 20, 2002, to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments.
Teleconferences are tops for bioterrorism training
AHRQ report addresses training effectiveness
Teleconferences are an effective way to reach geographically diverse groups and train large numbers of clinicians on bioterrorism preparedness, according to a report by the Agency for Healthcare Research and Quality (AHRQ) in Rockville, MD. Furthermore, satellite teleconferences may be as effective as classroom training, according to the report, which was produced by the AHRQ Evidence-based Practice Center (EPC) at Johns Hopkins University in Baltimore. The report, Training of Clinicians for Public Health Events Relevant to Bioterrorism Preparedness, reviewed 60 studies on the most- and least-effective strategies for training clinicians in bioterrorism preparedness. Models used included infectious disease outbreaks and hospital disaster drill training.
Hospital disaster drill training appears to improve clinicians’ knowledge of the disaster plan and allows them to identify problems in plan execution. However, the scarcity of studies on this type of training made it difficult for researchers to draw conclusions about the overall efficacy of disaster drills as a way to help prepare for a bioterrorist event. In fact, the report points out that very few bioterrorism preparedness training programs have been rigorously evaluated. The report provides a framework for developing evidence-based educational programs.
"This information will help health care leaders select educational strategies for frontline professionals who are likely to be involved in the assessment and management of victims of a bioterrorist attack," says Lisa Simpson, MD, AHRQ deputy director. A summary of the report is available by calling the AHRQ Publications Clearinghouse at (800) 358-9295 or sending an e-mail to [email protected]. Copies of the full report will be available in March.
[Editor’s note: Thomson American Health Consultants will present Disaster Planning and Bioterrorism: Is Your Hospital Prepared? — a 60-minute audio conference that will explain step-by-step how to develop a sustainable, long-range bioterrorism and disaster plan. Scheduled for Wednesday, March 6, from 2-3 p.m. EST, the educational program will be presented by Bettina M. Stopford, RN, clinical supervisor, USPHS National Medical Response Team, and Robert E. Suter, DO, MHA, FACEP, president, Texas Emergency Physicians, PA. The facility fee is $249 for HIC subscribers, which includes free CE and CME for your entire staff. To register, call (800) 688-2421 or go to www.ahcpub.com.]