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FDA关于医用病床产品的风险提示

http://www.fda.gov/cdrh/medicaldevicesafety/tipsarticles/bedentrapment.html

Waking up to hospital bed entrapment risks  

By Joan Ferlo Todd, RN, BSN, MS

(Article reprinted from Nursing2008, January issue, p.14-15.)

A VISITOR DISCOVERED a patient who’d died after becoming entrapped in a hospital bed. The patient’s head was within a head side rail (Zone 1), his torso was caught in the space between the head and foot rails (Zone 5), and his buttocks were on the floor. (See Zoning in on bed dangers and safety measures illustration.)

ZONING IN ON BED DANGERS AND SAFETY MEASURES - Bed dangers
Focus on these areas where patients are most often entrapped.
Zone 1. Within the rail
Zone 2. Under the rail, between the rail supports, or next to a single rail support
Zone 3. Between the rail and the mattress
Zone 4. Under the rail, at the ends of the rail
Zone 5. Between split bed rails
Zone 6. Between the end of the rail and the side edge of the headboard or footboard
Zone 7. Between the headboard or footboard and the mattress end

Safety measures
To lessen the dangers, eliminate gaps in all seven zones. Zone 5 can be eliminated by not raising the foot end side rail. Go to http://www.nst-usa.com to view an instructional video and obtain a measuring tool to test four critical entrapment areas.

In another case, an unresponsive 80-year-old woman was found sitting on the floor with her head entrapped between a head side rail and the mattress (Zone 3). Her left arm was entrapped within the foot side rail. Staff took the patient to the ED, but she couldn’t be revived.

In yet another case, a patient was found with his head wedged within the bars of the side rail (Zone 1); his head was bruised. The facility had to call the fire department to free the patient. The bed wasn’t equipped with the manufacturer’s side rail upgrade kit to reduce the size of this gap.

These hospital bed entrapment events were reported to the Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health. Patient entrapment is uncommon, but when it occurs, it’s often fatal. The consequences of entrapment are devastating to the patient, the family, and the staff of the health care facility.

What went wrong?

Patient entrapment occurs when a patient gets caught or entangled in the openings or gaps around the hospital bed; it usually involves a side rail. Deaths and injuries from entrapment result when the patient slips between the mattress and side rail or gets entrapped within the side rail itself. Entrapment of a patient’s head, neck, or chest is life-threatening.

Patients at highest risk for entrapment are older or frail adults and those who have conditions such as agitation, delirium, confusion, pain, uncontrolled body movement, hypoxia, fecal impaction, or acute urinary retention. These conditions make them likely to move about in the bed or try to get out of it.

The risk of entrapment increases with large gaps or openings in the bed system that could entrap a patient’s neck, head, or chest. Gaps can be caused by mattresses that aren’t the recommended size, loose side rails, or design elements such as wide spaces between the openings in the rails. Entrapment occurs in all patient-care settings—in long-term-care (LTC) facilities, in hospitals, and at home—but most entrapments are reported by LTC facilities.

What precautions can you take?

Familiarize yourself with the seven zones in the hospital bed where entrapment can occur. To protect your patients from entrapment, follow these general guidelines.

• Don’t automatically use side rails. Base any decision about using or removing side rails on an individual patient assessment, according to your facility’s policies and procedures on side rail use. Because of increased fall risk associated with side rails, they’re no longer routinely recommended for all situations.
   
• Establish an interdisciplinary group that will be responsible for evaluating existing bed systems for entrapment risks and taking corrective actions as needed to maintain and upgrade existing beds, mattresses, and side rails.
   
• Make sure that the hospital bed frame, mattress, and rails are compatible with each other. Not all mattresses and rails are designed to work safely with every bed frame.
   
• Contact the hospital bed manufacturer, which is your best source of information about the safety of a bed and its accessories.
   
• Educate yourself about entrapment. The FDA has developed information with the Hospital Bed Safety Workgroup, manufacturers, and other federal agencies to reduce patient entrapment and ensure patient safety, which can be accessed for free online.¹

Many health care facilities are now using this information to reduce entrapment deaths and injuries. The FDA’s goal is to continue to raise awareness about hospital bed entrapments and reduce the occurrence of these tragic events.

REFERENCE
1. Food and Drug Administration. Hospital bed safety. http://www.fda.gov/cdrh/beds.

Although you need to support your health care facility’s adverse event—reporting policy, you may voluntarilyreport a medical device that doesn’t perform as intended by contacting MedWatch at 1-800-FDA-1088 (fax: 1-800-FDA-0178) or online at http://www.fda.gov/medwatch/how.htm. The opinions and statements in this report are those of the author and may not reflect the views of the Department of Health and Human Services. Beverly Albrecht Gallauresi, RN, BS, MPH, who coordinates Device Safety, is a cardiovascular nurse-consultant at the Center for Devices and Radiological Health at the Food and Drug Administration in Rockville, Md.

Joan Ferlo Todd is a nurse-consultant at the Center for Devices and Radiological Health.

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