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					         An Outline for:

A User-Based Systems Approach to the
       Evaluation, Selection, and
 Institutionalization of Safer Medical
                Devices
                 Overview
   I. Needs assessment
  II. Broad identification of all market available
       devices.
 III. Initial screening of devices
 IV. Simulation and intermediate selection
   V. Clinical pilot testing
 VI. Institutionalizing selected device
VII. Ongoing training for device use
VIII. Ongoing surveillance for efficacy
  IX. Ongoing surveillance for better devices
                      PRELIMINARY


Need Finding          Identification of       Initial Screening
                     Available Devices         of All Devices

                      INTERMEDIATE
Task Analysis
                     Simulation Studies             Failure
                                                    Analysis
                            FINAL

                     Clinical Pilot Testing



     Institutionalization           Ongoing Surveillance
       of Device Use                    for Efficacy
       I. Needs Assessment
A. Institutional data
   1..Data as usually collected
   2. Assessment of reporting rate
   3. Reporting campaign
   4. Post reporting campaign data
B. Published data
C. Site Specific TASK ANALYSIS by HCWs
D. WORKSITE health and safety
    walk around
II. Broad Identification of all
  Market Available Devices

A. Review of published lists or web sites
B. Product fairs
C. Manufacturers representatives
 III. Initial Screening of Devices
A. Establish a trained screening team which
  represents diverse units
B. Review all market available devices and
  sizes in category
C. Use written criteria to evaluate devices
D. Screen all devices
E. Test devices that passed for failure
F. Do preliminary selection
IV. Simulation and Intermediate
           Selection
A. Use Task Analysis of work site to create
  simulations for approximating clinical use
  of device being evaluated
B. Use variables defined in the scenarios
      method as a guide
C. Use rating sheet for assessment
D. Retest for failure
E. Select device(s) for clinical testing
        V. Clinical Pilot Testing
A. Determine sites where the device will be used
B. Select representative test site
C. Involve user in design of trial
D. 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
V. Clinical Pilot Testing (cont.)
E. 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
  4. Examine contents of sterilized sharps
     boxes on a regular basis
V. Clinical Pilot Testing (cont.)
F. Determine whether there will be access to
  old devices-(remember that old devices
      will turn up regardless of policy-role of
      subversion factor)
G. Training of all participants
H. Evaluate devices
I. User selection of device
   VI. Institutionalizing Selected
                Device
A. Re-determine where device use is
      appropriate
B. Understand the limitations of the device
C. Based on Task Analysis, determine legitimate uses
  of old device
D. Retain of old device where appropriate
E. Institute appropriate training of all users
F. Assure ongoing availability of device
G. Allow time for learning curve
VII. Ongoing Training for Device Use
 A. Develop a system for user feedback
 B. Incorporate user concerns into ongoing
       training
 C. Create a device lab for ongoing skills
       training on an ongoing basis
 D. Reach all users
    1. All shifts
    2. Floaters
VII. Ongoing Training for Device
          Use (cont.)

3. Per diem staff
4. Medical staff who use the selected devices
5. Trainees
 VIII. Ongoing Surveillance for
           Efficacy
A. Establish a true baseline for sharps
     injuries
B. Do a depth review and analysis of any
     reported injury
C. Establish a method for reporting and
     analyzing near misses
D. Monitor patient outcomes
IX. Ongoing Surveillance for Better
             Devices
  A. Impact of rapid device development.
  B. SUBSTITUTION!!!!!
Items to Be Included in Sharps Injury
          Reporting Form:
 (Interviewer should be familiar with devices available and
    all sharps devices used in the institution should be
    posted in the interview area)
 1. Device, manufacturer
 2. Procedure
 3. Familiarity with device
 4. Training with device
Items to Be Included in Sharps Injury
       Reporting Form (cont.):
 5. Hours worked prior to injury
 6. Consecutive days worked
 7. Unit staffing
 8. Devices available on unit
 9. How device failed
 Work Site Assessment for Sharps
• What procedures involve sharps/ specify sharps?
      - Type of patients receiving procedure.
      - Where procedure is done.
      - Who does the procedure.
      - Are there alternative methods of procedure
• What kind of sharps are available on the unit?
      - Are safer devices available
      - Are they widely used/ if not, Why
• Are the needle boxes within arm’s reach and in
  sight?

				
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posted:12/4/2011
language:English
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