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

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1 A User-Based Systems Approach for the Evaluation, Selection, and Institutionalization of Safer Medical Devices Dr. June Fisher, MD Sustainable Hospitals Sao Paolo 12 November 2010

2 NR32 Ministry of Labor and Employment Requires health care employers to implement safety-engineered sharp devices in order to reduce employees' occupational exposure to HIV, HBV, HCV and other bloodborne diseases. Portaria MTE N. 939, 11/18/ months to inform and to train 18 months afterwards for implementation and market adjustment. Employers must promote the sharps substitution for safer devices in no more than 24 months. (October, 2010).

3 This Lecture Is Dedicated to: Bunny Doe, R.N. Jane Doe, R.N. Patty Doe, R.N. Anonymous Phlebotomist Anonymous Emergency Room Nurse Ellen Dayton, R.N., M.S.. *Philip Trabulsy, MD And in Memory of: Richard Bluett, M.D. Melissa Campbell, R.N. *Cindy Culpeper, R.N. *Edward Falces.MD Peggy Ferro, L.V.N. Edward Rodriguez, M.D. Anonymous Physician

4 The Human Side of Epidemiology Three faces from San Francisco

5 Rabbi Cindy Culpepper Died of AIDS in 2005 approximately 10 years after an occupationally acquired parenteral exposure while working as an OR nurse at San Francisco General Hospital

6 Why Has It Been Difficult to Implement Effective Measures to Prevent Occupational Exposure to Blood?

7 Institutional Resistance to the Introduction of Engineering Controls to Prevent Occupational Exposure to Blood Lack of awareness of hierarchy of controls Higher costs of devices Training demands/costs of institutionalizing device Need for different devices in same category Inventories of old devices Poor design of some devices Lax governmental regulation Health Care Worker resistance

8 Health Care Worker Resistance to Introduction of Engineering Controls to Prevent Occupational Exposure to Blood Increased workload / short staffing / fatigue Unsatisfactory experiences with first generation of devices Inadequate training / long training curves Available device may not be appropriate for certain clinical procedures Devices not consistently and easily available Lack of confidence in competency with device FEAR OF COMPROMISING PATIENT CARE

9 Fear of Compromising Patient Care

10 The Best Job You Can Do for Your Patient Is Take Care of Yourself

11 Interrelationship Between Patient and Healthcare Worker Health and Safety PATIENT SAFETY AND HEALTH HEALTH CARE WORKER SAFETY AND HEALTH

12 Strategies for Addressing Patient Needs and Protecting Health Care Workers from Occupational Exposure to Blood

13 Training for the Development of Innovative Control Technologies Project

14 The TDICT Project is a collaborative effort of health care workers, product designers and industrial hygienists dedicated to preventing exposure to blood borne pathogens through the design and evaluation of control technology. Health Care Workers Product Designers Industrial Hygienists

15 Hierarchies of Control Elimination / Substitution Engineering controls Administrative controls Personal protective equipment

16 Why Involve Line Health Care Workers in All Phases of Control Tap their expertise Technology? Assure that products are user-friendly and truly effective Develop systems that improve compliance Improve employee morale Improve patient care

17 Outcomes Include: Task analysis instrument for frontline healthcare workers Criteria for safety devices Systematic simulation methods Performance standards Systematic user-based methods for evaluation, selection, and implementation of safer medical devices

18 U s a b i l i t y Screen devices using TDICT criteria sheets Failure analysis Patient outcomes Task Analysis Test devices using scenarios Acceptability TDICT Safety Needle Testing Protocol Failure analysis Pilot testing in the workplace Worker outcomes Diagram to be used in conjunction with the scheme presented in An outline for a User-Based Approach to the Evaluation, Selection, and Institutionalization of Safer Medical Devices located at E f f i c a c y

19 Task Analysis: The Matrix for a Systematic Approach for Prevention of Occupational Exposure to Blood

20 Task Analysis is a systematic method for evaluating and analyzing work procedures as they are performed in the comprehensive work environment.

21 Task Analysis Provides... An inventory of sharps devices on a unit A systematic review of clinical procedures using sharps Identification of use of unprotected sharps

24 U s a b i l i t y Screen devices using TDICT criteria sheets Failure analysis Patient outcomes Task Analysis Test devices using scenarios Acceptability TDICT Safety Needle Testing Protocol Failure analysis Pilot testing in the workplace Worker outcomes Diagram to be used in conjunction with the scheme presented in An outline for a User-Based Approach to the Evaluation, Selection, and Institutionalization of Safer Medical Devices located at E f f i c a c y

25 Safety Feature Evaluation Forms

31 Passive Easy S imple Throughout

32 Safety Feature Evaluation Forms Tool for healthcare worker screening of devices Industry benchmarks Suggested by the FDA as a guideline for 510(k) simulations Featured in the appendix of the OSHA Bloodborne Pathogens Compliance Document, 2001 Featured in the British and Scottish National Health Service Directives

37 U s a b i l i t y Screen devices using TDICT criteria sheets Failure analysis Patient outcomes Task Analysis Test devices using scenarios Acceptability TDICT Safety Needle Testing Protocol Failure analysis Pilot testing in the workplace Worker outcomes Diagram to be used in conjunction with the scheme presented in An outline for a User-Based Approach to the Evaluation, Selection, and Institutionalization of Safer Medical Devices located at E f f i c a c y

38 Scenarios for the Evaluation of Medical Devices Allow actual users to test drive new products Approximate real life situations without endangering healthcare workers or patients Draw attention to unforeseen difficulties, benefits, and patterns of use before final manufacturing or mass purchase of product

39 How to Simulate Variables 1. Patient State Helpful Still Uncooperative Thrashing One member of the simulation team will lie in the bed and act the part of the patient. Any invasive procedure should be done on a fake arm that the patient is holding. 2. Lighting Dark Dim Normal Bright Surgical Bright Adjust the lights and/or shades in the room to get the desired light level. 3. Noise Very Loud Noisy Bursts Conversation Sleep Silence Very Loud - all alarms sounding, people talking, and the patient making some noise Noisy Bursts - people talking, alarms turn on and off, patient groans intermittently Conversation - people talking Sleep - quiet conversation Silence - no talking, only machine operating noise (not alarms) If you need to simulate the noise of equipment use a radio/ tape recorder.

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

43 I. Needs assessment Overview 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

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

45 Contact Information for June M. Fisher,MD Phone

46 Web Sites For lists of safety devices, check out: Other resources:

Collaboration: From User Based Design to Co-Design

Collaboration: From User Based Design to Co-Design June Fisher, MD Retired Associate Clinical Professor of Medicine, University of California, San Francisco Chief Elder Officer, Aging 2.0 Director of the