Appendix A: Product Evaluation

• Safety Feature Evaluation Form: Safety Syringes 
  
  
• Safety Feature Evaluation Form: I.V. Access Devices 
  
  
• Safety Feature Evaluation Form: Vacuum Tube Blood Collection Systems

Simulations for the evaluation of medical devices

The next step after screening devices with the written evaluation criteria forms is to use the simulation/scenario method. This method is based on evaluating devices in settings that closely reflect the proposed clinical use of a device.

1. Simulation and Intermediate Selection
   
   
   1. Create simulations to approximate proposed clinical use of a device.
   2. Use variables defined in the scenarios method as a guide.
      
      
      • Patient state
      • Lighting
      • Noise
      • Number of people at bedside
      • Condition of hands
      • Visibility
      • Floor conditions
      • Room temperature
      • Sharps containers
      • Room type
   3. Use rating sheet for assessment.
      
      
   4. Retest for failure.
      
      
   5. Select devices(s) for clinical testing.
2. Clinical Pilot Testing
   
   
   1. Determine sites where the device will be used. 
      
      
   2. Select representative test site. 
      
      
   3. Involve user in design of trial. 
      
      
   4. Have clearly defined protocol.
      
      
      1. Outcomes to be assessed
      2. Minimum number of devices to be tested
      3. Length of trial
      4. Who are the participants
      5. Impact on patients
         
         
   5. Data gathering in the real world.
      
      
      1. Evaluate each device at time of use
      2. Develop and use an easy recording format
      3. Collect and evaluate reports at regularly defined intervals