Top Hospital Medical Device Hazards For 2008 RevealedDec 23, 2008 | Parker Waichman LLP
The ECRI Institute just released its annual list of top ten hospital medical device hazards for this year. The Institute is a nonprofit organization that “researches the best approaches to improving patient care” and is a designated Collaborating Center of the World Health Organization (WHO) as well as an Evidence-based Practice by the U.S. Agency for Healthcare Research and Quality. The 2008 list was published in a recent Health Devices guidance article.
Updated annually, the list is based on problems reported to and investigated by ECRI and includes detailed descriptions and information on how to avoid such hazards. “Our list is based on serious technology safety concerns that can be prevented with appropriate attention and planning,” says James P. Keller, Jr., vice president, health technology evaluation and safety, ECRI Institute.
The ECRI Institute’s 2008 list of the 10 most dangerous medical device hazards include:
- Alarm Hazards. In which alarm conditions are not effectively communicated, placing patients at risk for injury or death and includes reports involving patient monitoring equipment, ventilators, and dialysis units, among others.
- Needlesticks and Other Sharps Injuries. In which intravenous and other device administration can cause injuries to clinicians, patients, laboratory personnel, pharmacy staff, housekeeping personnel, and waste handlers by an exposed needle or other sharp. Consequences include serious cuts and exposure to blood borne pathogens such as HIV or the hepatitis B or C virus.
- Air Embolism from Contrast Media Injectors. In which X-ray imaging of blood vessels where contrast media is injected into the patient’s vasculature and can create the risk of injecting air, potentially resulting in a fatal embolism.
- Retained Devices and Un-retrieved Fragments Left in Patients: In which an entire device is left behind in surgery or a portion of a device breaks away within the patient. Sometimes, surgical items are intentionally placed in the patient, but can pose the risk of infection or burn hazards when the patient undergoes MRI examination.
- Surgical Fires: In which medical devices or other components ignite, such as electrosurgical units; electrocautery devices; lasers and related disposable components; oxygen, which can ignite easily and burn intensely; and fuel, such as from fenestration towels and gowns.
- Anesthesia Hazards due to Inadequate Pre-Use Inspection: In which staff discovers serious problems such as misconnected breathing circuits, ventilator leaks, and empty gas cylinders.
- Misleading Displays: In which ambiguous or counterintuitive displays create misinterpretation.
- CT Radiation Dose: In which high doses can present an increased risk of cancer, possibly linked to 6,000 additional cancers a year, roughly half being fatal.
- MR Imaging Burns: In which patients become burned from the Magnetic Resonance Imaging technology.
- Fiberoptic Light-Source Burns: In which light sources used in endoscopes, retractors, and headlamps cause burns to staff and patients from the light itself or from its heated cable connections.
Last year’s top five reported hazards were: Burns during electrosurgery, caster failures, infusion pump programming errors, misconnection of blood pressure monitors to IV lines, and radiation therapy errors.