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ECRI, the pioneering not for profit healthcare research Institute, has published the 10 most important medical technology hazards for 2010. ECRI is among a handful of organizations designated as both a Collaborating Center of the World Health Organization and an Evidence-Based Practice Center by the U.S. Agency for Healthcare Research and Quality...

The 10 most important medical technology hazards for 2010, are:

1. Cross-Contamination from Flexible Endoscopes: Incidents of pathogen transmission related to flexible endoscopy continue to be reported ... Often in these cases, large numbers of patients must be notified of exposure to potentially contaminated endoscopic equipment.

2. Alarm Hazards: Clinical alarms, which warn caregivers of hazards, can be instrumental in preventing patient injury or death—as long as caregivers get the message. But, if alarm conditions aren’t effectively communicated, or alarm limits aren’t set appropriately, then patients are at risk.

3. Surgical Fires: Surgical fires don’t happen often, but when they do, patients can be seriously injured, disfigured, or killed. Our latest estimates are that 550 to 650 surgical fires occur in the United States each year, making them roughly as frequent as other surgical mishaps like wrong-site surgery.

4. CT Radiation Dose: Computed tomography (CT) is fast, reliable, and convenient—so much so that only recently has its comparatively high x-ray dose begun to garner significant attention. That dose can pose a significant cancer risk: In the United States alone, CT is thought to be responsible for about 6,000 additional cancers a year, roughly
half of them fatal.

5. Retained Devices and Unretrieved Fragments: ECRI Institute and the U.S. Food and Drug Administration (FDA) frequently receive reports of foreign bodies left inside patients following treatment. Reports typically describe one of two adverse events:

- Retained devices, in which an entire device is unknowingly left behind.

- Unretrieved device fragments, in which a portion of a device (e.g., catheter tip, forceps jaw) breaks away and remains inside the patient.

6. Needlesticks and Other Sharps Injuries: Accidental needlesticks and other sharps related injuries keep happening, despite the common use of needles, intravenous administration sets, and other devices that include mechanisms to protect against such injuries. It’s not only clinicians who are at risk: Patients, laboratory personnel, pharmacy staff, housekeeping personnel, and waste handlers can also be injured by an exposed needle or other sharp. Consequences can include serious cuts and exposure to bloodborne pathogens such as HIV or the hepatitis B or C virus.

7. Problems with Computerized Equipment and Systems: Computers have become an increasingly integral and critical component of many medical devices—they read, analyze, display, disperse, and record patient data, and they facilitate the exchange and communication of medical information to and from different clinical and data systems. This convergence of medical technology and information technology (IT) is evident in many areas, including medication management systems, the routing of medical alarms to clinician-worn devices (e.g., cell phones and pagers), and the incorporation of medical data from devices such
as physiologic monitors and ventilators into electronic medical records. Convergence presents many benefits, but also many risks. If systems and interfaces are poorly planned, implemented, or managed, they can threaten patient safety and can lead to inefficiencies, significant interruptions in operations, and uncaptured or lost revenue.

8. Surgical Stapler Hazards:
Surgical staplers expedite surgical procedures by replacing tedious manual suturing. But like any medical device, staplers occasionally fail to perform as expected. Although not all failures harm the patient, ECRI Institute is aware of numerous instances that have resulted in prolongation of surgery, serious tissue injury, and even death.

9. Ferromagnetic Objects in the MR Environment: The clinical literature and problem
reporting databases continue to include numerous reports of injuries and equipment damage in magnetic resonance (MR) centers attributed to the presence of ferromagnetic devices and equipment, including implants, in the MR environment.

10. Fiberoptic Light-Source Burns: Fiberoptic light sources are designed to illuminate treatment sites through a number of devices, among them endoscopes, retractors, and headlamps. Frequently referred to as “cold” light sources, these devices are anything but. In fact, each year, ECRI Institute receives reports of burns to staff and patients resulting from use of these devices. The two burn hazards most commonly reported are:

- Burns from the light itself. This hazard is frequently presented when a clinician places the endoscope or the distal end of the fiberoptic cable (after disconnecting it from the instrument)
on the patient without shutting off or otherwise suspending the light source. The light that is continually emitted can generate enough heat to burn objects in very close proximity, sometimes even resulting in fires.

- Burns from heated cable connections. This hazard can occur when the diameter of the light cable is too large for the light post on the connected device. Some of the light emitted from the cable can contact the metal portion of the light post (rather than the fibers within, which transmit light to the treatment site), heating the connection. If the connection contacts skin, a burn may result.

Read the full ECRI report at:


Tags: devices, hazards, medical, safety, technology

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