2015-01-19-世界卫生组织-Medical_device_donation_guidelines_for_Ebola_outbreak_1页_84kb

Ebola Outbreak Medical Device Donation Guidelines Summary (2015)

Requirements

A. Appropriate, Robust, Durable/Disposable Medical Equipment

• High-quality devices must be regulatory cleared, operate with limited electricity, water, and compressed gas resources, and have a minimum six-month shelf life.
• User manuals, service manuals, disposal instructions, and software must be available in the health workers' native language (French for Guinea and Democratic Republic of Congo; English for Liberia, Nigeria, and Sierra Leone).
• Supplies for at least one year of operation must be available per country, including accessories, consumables, reagents for operation and cleaning, maintenance materials, test and calibration equipment, and reagents.

B. Water Supply Considerations (Unstable or Lacking)

• Devices may need to be disposable due to unreliable water; cleaning, disinfection, and sterilization must use appropriate agents, and barriers can be added to patient surfaces if device allows.
• Cleaning procedures and consumables should be included with the device shipment.

C. Power Supply Considerations (Limited or Unstable)

• Medical devices should be designed for battery operation, include extra batteries or re-chargeable options, backup generators, and current stabilizers.
• Specific energy sources and specifications for Ebola-affected countries:
  • Democratic Republic of Congo: Voltage 220 V, Frequency 50 Hz, Plug Types C, D, or E.
  • Guinea: Voltage 220 V, Frequency 50 Hz, Plug Types C, F, or K.
  • Liberia: Voltage 120 V or 220 V, Frequency 50 Hz or 60 Hz, Plug Types A, B, C, E, or F.
  • Nigeria: Voltage 230 V, Frequency 50 Hz, Plug Types D or G.
  • Sierra Leone: Voltage 230 V, Frequency 50 Hz, Plug Types D or G.
• Ease of use and maintenance must be good, and additional equipment may be needed for gas supply or compression.