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?