May / June 2006
NEWS ITEMS FROM SOURCES WORLDWIDE
Pulse
Responding to Adverse Events
Prepared by physicians, nurses, risk managers, and patients from the Harvard teaching hospitals, When Things Go Wrong: Responding to Adverse Events attempts to summarize the current thinking about the best practices to follow when a patient suffers injury from medical treatment. Its objectives are to provide a deeper understanding of the issues involved to help hospitals and caregivers develop more effective policies for managing patients and caregivers following injury. The concepts and principles are supported by the Harvard teaching hospitals.
The report is available from the Massachusetts Coalition for the Prevention of Medical Errors (www.macoalition.org/publications.shtml) and the Institute of Healthcare Improvement (www.ihi.org).
FDA Proposes Regulations for Preventing Deaths and Injuries From Medical Gas Mix-Ups and Contamination
The Food and Drug Administration (FDA) is issuing a proposed rule designed to make the contents of medical gas containers more readily identifiable, in order to prevent deaths and injuries from inadvertent use of incorrect medical gas or from use of contaminated medical gas.
In some cases, injury or death has resulted from a medical gas mix-up caused by one of several factors, including mistaken administration of industrial gas to patients, improper connection of industrial gases to medical oxygen supply systems, and contamination of medical gas cylinders with residues of industrial cleaning solvents. Between 1996 and 2006, the agency received reports of medical gas mix-ups that resulted in at least 8 deaths and 18 serious injuries.
"By issuing this proposal, FDA is heightening consumer and industry awareness about this specialty area of regulated products. Greater understanding of the possible problems associated with the use of medical gases and the steps we can take to eliminate them will only lead to safer use of these products," said Steven Galson, MD, director, Center for Drug Evaluation and Research.
This regulation would apply to medical gas manufacturers and distributors and will require that certain portable medical gas containers comply with the following requirements:
- have gas use outlet connections (used to connect these containers to gas supply systems) that cannot be readily removed;
- be identified by labels that wrap all the way around the tops of these containers;
- have high-pressure medical gas cylinders painted according to a standard color-coding system that corresponds to the gases stored in them; and
- be dedicated to medical use and not converted from industrial use.
The proposed rule is intended to supplement existing FDA regulations and guidance regarding the safe use of medical gases by adding requirements—based largely on current, recommended, industry practice—to minimize the incidence of medical gas mix-ups and contamination. It is intended to ensure that healthcare facilities and patients receive only appropriate, safe, effective, and high-quality medical gases.
There is a 90-day public comment period on the proposed regulation before FDA develops the final rule. For more information please visit www.fda.gov/cder/dmpq/MedGas_QA_20060410.htm.
CCHIT Seeks Jurors
for EHR Certification Program
The Certification Commission for Healthcare Information Technology (CCHIT) is seeking approximately 30 qualified jurors to assess ambulatory EHR products and how well they conform to the CCHIT certification criteria. Prospective applicants can read the juror job description and application posted at www.cchit.org.
A team of three clinical jurors—one of whom must be a physician—and an IT security evaluator will assess each product's compliance to the certification criteria. The inspection involves critiquing a product's performance during execution of a series of tests and reviewing documentation supplied by the vendor. Testing is Web-based and is expected to take one day with an additional day for re-testing, if necessary, plus documentation review and completion of surveys. Jurors must be available to participate in a minimum of six tests during a 6-month period, preferably with a minimum of one test per month.
Jurors must complete an orientation and are expected to observe at least one inspection as a non-voting auditor before serving as a voting juror. Juror performance will be monitored by CCHIT for consistency, reliability, and lack of bias. Jurors will be compensated for each test and must execute a contract with CCHIT covering conflict of interest and confidentiality. Vendors are not eligible to become jurors. Additional information can be found at www.cchit.org.
CCHIT was founded in 2004 with support from three leading industry associations in healthcare information management and technology: the American Health Information Management Association (AHIMA), the Healthcare Information and Management Systems Society (HIMSS), and The National Alliance for Health Information Technology (Alliance). In September 2005, CCHIT was awarded a contract by the U.S. Department of Health and Human Services to develop, create prototypes for, and evaluate the certification criteria and inspection process for EHRs and the networks through which they interoperate.
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