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

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 Overview

Need Finding Identification of Available Devices Initial Screening of All Devices Simulation Studies Clinical Pilot Testing Institutionalization of Device Use Ongoing Surveillance for EfficacyPRELIMINARYINTERMEDIATE FINAL Failure Analysis Task Analysis

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 arms reach and in sight?