Guest Lecture By:

Dr. Monica Weiler, Ph.D. (Human Factors Engineering)Co-founder and Design ResearcherStratos Innovation Group

How Human-centered Design of Medical Devices can save and enhance many lives

My Background

Biomedical Engineering Human Factors Engineering Human-centered Design Research

Human Factors Engineering (HFE), also known as Ergonomics, is the study of how humans (users, people) interact with machines and complex systems.

When the principles of this field is applied to the design of products, devices, services or systems, it is called

“Human-centered Design” or “Design Thinking”

Human Factors

The Big Picture

Medical Error

- 5th or 6th leading cause of death in the U.S and probably all over the world

100,000 deaths in a year.

- Huge cost - $1.1 billion a year just in the U.S.

- Almost half of all medical device recalls resulted from design flaws

- It is preventable

Why Human Factors?

Often times medical devices and environments are developed based on the technical specifications and not from the user’s or the human perspectives

The problem

- You may be part of a R&D team at a medical device company that is expected to implement Regulatory Requirements from FDA, ISO, ANSI, AAMI

ANSI/AAMI/ISO 14971:2007 Medical devices ISO/IEC 62366:2007 Medical devices AAMI/ANSI HE75:2009Quality System regulation: 21 CFR 820.30, Design Controls, Design Verifi-cation and Validation

- You may be in-charge of deciding what equipment to purchase

- You may be the person to conduct usability testing on the new device before purchase

- When errors or equipment failure happens you may be in the middle of the blame game

Why should you care?

Example 1: Infusion Pump Video

Infusion stopped prematurely

-The user fogets to resume the pump after suspend-ing it

- User is unaware of battery capacity

Consequence:

-Underdose-Delay of therapy

Example 1: Infusion Pumps

The user fails to detect or understand pump notifications

-Background noise or nuisance alarms cause user to fail to detect/ignore them

-User muffles pump’s speaker/audio, either intentionally or unintentionally

Consequence:

Delay of therapyIncorrect therapyOverdoseUnderdose

Wrong medication or concentration is delivered

- User selects and sets up pump with incorrect medication or concentration

- Medication is correct but user selects incorrect concentration or delivery rate

Consequence:

Delay of therapyIncorrect therapy

One or More Errors in 67% of the IV Infusions

Reference: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/HumanFactors/UCM320905.pdf

http://www.aami.org/htsi/infusion/jan2012/MarlaHusch_IVMedicationAdministrationErrorsStudy.pdf

Example 2: ICU Noise / False Alarm Video

High noise levels in ICUs - Noise levels play a significant role in making the ICU a hostile, and sometimes even dangerous, environment for patients.

- Distraction from work, confusion- Disturbance when resting

Consequence:

-Patient dissatisfaction-Patient safety threatened by distraction

Example 2: ICU Noise and False Alarms

Alarm fatigue: Clinicians can become desensitized, overwhelmed or immune to the sounds, and can suffer from ‘Alarm Fatigue.’

- Nurses are desensitized- Clinicians are overwhelmed and confused

Consequences:

- falls- delays in treatment- medication errors, or- in the worst case – death.

Avinash Konkani, Barbara Oakley, and Thomas J. Bauld (2012) Reducing Hospital Noise: A Review of Medical De-vice Alarm Management. Biomedical Instrumentation & Technology: Nov./Dec. 2012, Vol. 46, No. 6, pp. 478-487.

Example 3: Pediatric MRI Video

High noise levels during imaging- Noise levels play a significant role in making the MRI scary for the kids and causing them to be sedated

- 80% of pediatric patients have to be sedated- Scans have to be postponed if anesthesiologist is not available

Consequence:

-Patient anxiety-Repeating procedure due to movements, delay in treatment

Example 3: Pediatric MRI

http://www.gehealthcare.com/usen/accessories/adventure.html

We can either continue ignoring a very critical issue in the design and development of Medical Devices.

So, what now?

OR Consider the Human Factors approach to deliver solutions that are based on people’s needs and desires.

Five aspects of Human Factors

Cognitive

Cultural Context

Organizational

Emotional

Physical/ Environmental

Back to the Pediatric MRI Challenge -Video

How can you learn more...

Look up...

Human Factors Engineering

Human Computer Interaction

Human Centered Design

Ergonomics in Design

User Experience Research

Usability testing

FDA Human Factors Guidelines

AAMI Regulations for Medical Devices

ANSI Regulations for Medical Devices

Final words...

Always...

Go after your passion....

Dream bigger than yourself...

Keep up with best friends....

Thank you!