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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

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An Outline for:A User-Based Systems Approach to the Evaluation, Selection, and Institutionalization of Safer Medical Devices


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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


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PRELIMINARY

Need Finding

Identification of

Available Devices

Initial Screening

of All Devices

INTERMEDIATE

Task Analysis

Simulation Studies

Failure Analysis

FINAL

Clinical Pilot Testing

Institutionalization

of Device Use

Ongoing Surveillance

for Efficacy


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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


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II. Broad Identification of all Market Available Devices

A.Review of published lists or web sites

B. Product fairs

C. Manufacturers representatives


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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


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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 scenariosmethod as a guide

C.Use rating sheet for assessment

D.Retest for failure

E.Select device(s) for clinical testing


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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


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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


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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


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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


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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


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VII. Ongoing Training for Device Use (cont.)

3.Per diem staff

4.Medical staff who use the selected devices

5.Trainees


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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


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IX. Ongoing Surveillance for Better Devices

A. Impact of rapid device development.

B. SUBSTITUTION!!!!!


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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


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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


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Work Site Assessment for Sharps (cont.):

  • 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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