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Role of Bio-Medical Engineers in Patient Safety

Conference Paper · November 2011

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Sahajanand Medical Technologies
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 Role of Bio-Medical Engineers in
Patient Safety
By

L Ramanan. BE, MS (IITM), MS (BITS)

6 Sigma Quality Champion, Medical Device Design & Mgmt. Consultant & CEO of RAISE
Membership & Titles

Plenary Lecture Delivered at… Material Not intended for Commercial Use

One Day Work-Shop For the Sr. Executives of:

LR/BSAR/001
Acknowledgements
• Prof. Ramesh, Chairs, & Organisers of
ICMBE, Management, learned Professors
of Mnipal Univ and you august audience
• My former employers – GE & GE
Healthcare and Lucas TVS for the
Opportunity & Quality that Fueled my
Passion in Medical Device
• All my professional associations, all my
past employers, my Institute - IITM, my
teachers, all my Indian, European & US
friends and my family for my tinniest
career accomplishments
Note:
• The material & opinions expressed are purely
from academic purpose. No other interpretations
are implied or shall be made. Examples /
Pictures are from references presented and or
available in public domain, referenced
appropriately at respective locations to reinforce
Patient Safety. If there are any miss in
2/
references my regrets & is not intentional. LRamanan, January 11, 2012
Naming... Blaming… Shaming… A Recent Incident?

Most of the time this what happens… Is there a

RCA?
Safety - Patient & Hospital Staff

Most of the time this what happens… Is there a

RCA?
Cost of an Incident - Surgical Or Adverse Incident
from Medical Device or In Hospital Environment
Mortality or Morbidity?

Is there a control? WHO Checklist?

What to do after error happened?

remedial measures directed primarily
at the error-maker
o naming
o blaming
o shaming
o retraining

Or

Consider it as a System or process

failure and trigger RCA / CAPA /
PDCA or PDSA / Six Sigma – Learn
from HRO (Aero , Nuclear)
 Medical Device is Unique
• Customer – Doctor or Patient?
• Helps in Diagnosis – Aids in
Decision
Phineas P Gage
• Touches Life – To Remove Pain (1823-1860)
Ref: www.en.wikipedia.org
& Agony
• Involves Emotion (Fear,
Anxiety, Stress…) – Doctors &
Patients World’s Shocking X-Ray

Ref: www. in.news.yahoo.com

Useful in Saving Lives from Un-Safe Incidents

 Patient Safety - Multiple factors
Usually Involved
 Patient factors
 Provider factors

 Task factors

 Technology & Tool

Factor – We Engineers
Play a Critical Role
 Team factors

 Environmental factors

 Organizational factors
A “System” - As viewed by WHO
“any collection of
two or more
interacting parts”
OR
“an interdependent
group of items
forming a unified
whole”
NPSEF (p. 202)
 Medical Device is “Very Complex”

Ref: L Ramanan (2010), “Six Sigma – An Ingredient of Innovative

Ref: Patient Safety – World Health Organization Product Design”, Proceedings of the Indo-US Workshop on “Product
“Learning from Error” Design – Impact from Research to Education to Practice,

But Physicians, Surgeons, Luminaries Love Them

 Complex… Safety & Robustness Embedded
Design for Safety – “Quality is Patient Safety”

Design for Usability –“User Centric”

Design for Reliability - “Robust Product”

Design for Regulation – “Reliable & Safe”

Design for Serviceability – “Customer Centric”

Design for Manufacturability – “Do Able”

Design for Functional Need – “Integration”

Design for Mitigating Risk – “CPR, CTS…”

Design for Cost – “Affordable”

Design Challenges: Bio-Compatibility, Magnetic…

Ref: L Ramanan (2010), “Six Sigma – An Ingredient of
Ref: L Ramanan (2009) “Creativity & Innovation in New Product Innovative Product Design”, Proceedings of the Indo-US
Development – Healthcare Industry”, National Conf on New Product Workshop on “Product Design – Impact from Research to
Innovation, Anna University Education to Practice,
 Successive Layers of Defense
Successive layers of defences, barriers and safeguards

Mistake Proof
Eg: Labels Eg: Bar Coding Eg: Minimise Eg: Foresee –
on Wrist Band of Human Abuse and Worst
Patient Interventions case scenarios
Embed Robustness - Quality is Patient Safety
Design for Safety – Account for Abuse

Looked for “foreseeable misuse”

Ref: From IEC 60601-1, 3rd Edn 2005

(Only for Indicative Purpose on
Importance of considering abuse
in Design… Sections referred are not
Exhaustive… Pl. consult your product
RA & regulation Standards for Design)
Sections 3.7, 4.1, 4.9, 9.2.1, 9.2.2.3,
11.2.1, 14.8 (m), A.2, Sub-Clause 4.1,
4.9, 5.9.2.1, 11.6.3, 13.2, 13.4, 15.3.3,
15.3.4.2, 15.3.5 …

Robustness is Embedded - Quality is Patient Safety

 Design for Safety – Leverage Technology
Ref: Method of Testing Patient Table
Top, IP.COM, IPCOM000193362D

Picture Reference as below

Ref: L Ramanan (2007) “CAE
Simulation an Inspiring Engineering
in Medical Device Design”,
Conference Proceedings of Key
Note Address at ANSYS India Users
Conference, India

Looked for “worst case” regulatory Standards

Ref: From IEC 60601-1, 3rd Edn 2005 (Only for Indicative Purpose on Importance of considering abuse
in Design… Sections referred are not Exhaustive… Pl. consult your product RA & regulation Standards for
Design) Sections 8.4.3, 8.7.4.6, 8.7.4.7, 9.4.2.2 e., 9.4.3.1, 9.4.3.2, 9.6.2.1, 9.8.3.2 ….

Robustness is Embedded - Quality is Patient Safety

Summary
• Constantly Keep
Thinking enhancing
Patient Safety... SW,
HW…
• Adopt Math Modeling
• Involve Yourself
• Safety - provides lot
of Opportunity to
Innovate & Touch Life

To Be a Bio-Medical Engineer… Be Proud

About The Inspiring & Motivational Speaker

RAISE to RICE… Earn to Educate

16 /
LRamanan, January 11, 2012
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