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November 6, 2018, To:HospitalsSubject:URGENT MEDICAL DEVICE FIELD SAFETY NOTICEREMOVALReference:ZFA201800391Affected Product: Various Trauma Guide Wires Item Number 00222802400 00225502500 00225502600 47223703300 47223703700 47223703800 47225500800 47225500801 47249009700 47249009701 47249009800 47249009801 00222802400CF04108
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How to fill out medical-device related pressure injuries

01
Identify the medical device causing the pressure injury.
02
Clean the area around the pressure injury with mild soap and water.
03
Apply a thin layer of antibiotic ointment to the wound.
04
Cover the pressure injury with a sterile dressing or bandage.
05
Monitor the pressure injury for any signs of infection or worsening symptoms.
06
Follow up with a healthcare provider for further evaluation and treatment.

Who needs medical-device related pressure injuries?

01
Patients who are using medical devices such as catheters, braces, or prosthetics.
02
Those who are bedridden or have limited mobility and are at risk for pressure injuries.
03
Healthcare professionals who are treating patients with medical devices.
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Medical-device related pressure injuries are wounds that occur as a result of the use of medical devices, such as oxygen tubing, catheters, or braces. These injuries can be caused by pressure, friction, or shear.
Healthcare facilities and providers are required to file reports on medical-device related pressure injuries.
Medical-device related pressure injuries should be reported using the appropriate forms provided by the regulatory agency.
The purpose of reporting medical-device related pressure injuries is to track and monitor incidents, identify trends, and improve patient safety.
Information to be reported on medical-device related pressure injuries includes patient information, device details, injury description, and contributing factors.
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