guest lecture: human factors in healthcare applications for the bme dept. at srm university
DESCRIPTION
Often times, front-end research and human factors are ignored resulting in negative impact on the user experience. This lecture covers three healthcare applications where addressing Human factors and capturing the emotional experience would make a big difference. This lecture was given to 250 Biomedical Engineering students from SRM University in Chennai, India.TRANSCRIPT
![Page 1: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/1.jpg)
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
![Page 2: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/2.jpg)
My Background
Biomedical Engineering Human Factors Engineering Human-centered Design Research
![Page 3: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/3.jpg)
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
![Page 4: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/4.jpg)
The Big Picture
![Page 5: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/5.jpg)
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?
![Page 6: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/6.jpg)
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
![Page 7: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/7.jpg)
- 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?
![Page 8: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/8.jpg)
Example 1: Infusion Pump Video
![Page 9: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/9.jpg)
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
![Page 10: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/10.jpg)
Example 2: ICU Noise / False Alarm Video
![Page 11: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/11.jpg)
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.
![Page 12: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/12.jpg)
Example 3: Pediatric MRI Video
![Page 13: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/13.jpg)
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
![Page 14: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/14.jpg)
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.
![Page 15: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/15.jpg)
Five aspects of Human Factors
Cognitive
Cultural Context
Organizational
Emotional
Physical/ Environmental
![Page 16: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/16.jpg)
Back to the Pediatric MRI Challenge -Video
![Page 17: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/17.jpg)
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
![Page 18: Guest lecture: Human Factors in Healthcare Applications for the BME Dept. at SRM University](https://reader034.vdocuments.site/reader034/viewer/2022051817/547900d65906b55d048b4642/html5/thumbnails/18.jpg)
Final words...
Always...
Go after your passion....
Dream bigger than yourself...
Keep up with best friends....
Thank you!