Risk Assessment: It's a Risky World Out There

“Risk Assessment: It’s a
Risky World Out There.”

By
Richard Meyst
President/CEO

Fallbrook Engineering, Inc.
355 W. Grand Ave. Suite 4
Escondido, CA 92025
richardm@fallbrookeng.com
www.fallbrookeng.com
1
© 2010 Fallbrook Engineering, Inc.

Fallbrook Overview
Medical Product Design & Development

2

Fallbrook Overview

Fallbrook Engineering is a privately held
engineering consulting firm headquartered
in San Diego County.

Fallbrook has been facilitating the
advanced design and development
of medical technology products
for healthcare companies for
over 25 years.
3

Fallbrook History
 Founded 1981, celebrating 29 years of
continuous service
 Incorporated 1993
 Expanded to 60+ associates in 1997
 Located in new offices in Escondido in 2007

4

Richard Meyst, President/CEO
Fallbrook Engineering, Inc.
 BSME, MSME
 Owner & principal
 38 years in engineering, project management, product
design and development
 Principal Investigator on Phase I & II
National Institutes of Health SBIR grants
 Awarded 14 patents

5

Project Experience
Biotech applications
Therapeutic apparatus
Diagnostic devices & consumables
Electro-mechanical instrumentation
High volume, sterile disposables
Software driven systems
Regulatory compliance
FDA, ISO, CE, UL, CSA

Risk Management
6

Client Profiles
BioMed - Biotech - Pharmaceutical

Large-cap, well established corporations
Mid-cap companies
Research Institutes
Start-up Companies
Individuals
Joint ventures
7

Some Fallbrook Success Stories

8

Background
All products and processes have an associated
risk. Every enterprise should have a
methodology for identifying and evaluating
the risks it faces and should have a process for
generating intervention plans to reduce the
risks to an acceptable level. This process is
generally referred to as a
Risk Management Plan (RMP).
9

Introduction
Application of Risk Management to Medical Devices

Risk Management is “a procedure for a manufacturer to
identify the hazards associated with medical devices and their
accessories, including in vitro diagnostic medical devices,
estimate and evaluate the risks, control these risks, and
monitor the effectiveness of the control.” 1
Today we will cover an overview of the basics, benefits, need,
methods, and standards used in doing risk management of
medical devices. We will also touch on the use of risk in the
Pharmaceutical Industry.

1 ANSI/AAMI/ISO 14971:2007
10

Agenda
 Some basic definitions
 What is Risk Management?
 Benefits to using Risk Management
 Why use Risk Management?
 What standards apply?
 What are the tools used to do the analysis?
 When do you do Risk Management?
 Who should participate in the process?
 Some examples
11

Overview
Risk management tools can be applied from
product concept generation all the way to
the end of the product life cycle.

This approach can enhance your odds of
producing a product that will meet the
needs of the marketplace, be given
marketing clearance by regulatory agencies,
ensure safety to the user/patient and be
financially successful.
12

Vocabulary: some basic definitions
 risk management: Systematic application of
management policies, procedures, and practices
to the tasks of analyzing, evaluating, and
controlling risk
 risk analysis: Systematic use of available
information to identify hazards and to estimate
the risk

13

Vocabulary, cont.
 hazard: A (foreseeable) potential source of harm
to the patient or other persons arising directly
from the device
 harm: Physical injury or damage to the health of
people, or damage to property or the
environment

14

Vocabulary, cont.
 severity: Measure of the possible consequences of
a hazard
 risk: Combination of the probability of occurrence
of harm and the severity of that harm
Risk = Severity X Probability of Occurrence
 intended use/intended purpose: Use of a product,
process, or service in accordance with the
specifications, instructions, and information
provided by the manufacturer

15

The Risk Management Process
“… a process for identifying hazards associated
with a medical device, estimating and evaluating
the
associated risks, controlling these risks, and
monitoring the effectiveness
of the control.”

— risk analysis
— risk evaluation
— risk control
— post-production monitoring
16

Why use risk management?
It will:
– save development time
– maintain competitiveness
– result in a safer product
– save development costs
– speed regulatory approval
– limit downstream liability

And… it is a requirement.
17

Schematic of Risk Management Process 1

1 ANSI/AAMI/ISO 14971:2007 18

Overview of
Risk
Management
for Medical
Devices
ANSI/AAMI/ISO 14971:2007

19

Or, in a more “logical” view…

20

21

Who should participate?

 Management  Clinical

 R&D  Marketing

 Manufacturing  Regulatory

 Quality  Real users

22

When do you do Risk Management?

It is a full life-cycle process for your products

– When you select a product to develop
– Throughout the development process
– During clinical testing
– At the beginning of manufacturing
– While the product is being sold

23

Summary of Main Standards that
apply to Risk Management
 Federal Register, FDA, 21 CFR, Parts 808, 812 and 820 Medical
Devices; Current Good Manufacturing Practices (CGMP); Subpart C,
820.30(g)
 AAMI/ANSI/ISO 14971:2007 - Medical devices—Application of risk
management to medical devices. This standard, used by the FDA
and the EC Notified Bodies, provides a full life-cycle process for
corporate Risk Management.
– The Association for the Advancement of Medical Instrumentation (AAMI) is a unique
alliance of over 6,000 members united by the common goal of increasing the understanding
and beneficial use of medical instrumentation.
– The American National Standards Institute (ANSI) is a private, non-profit organization that
administers and coordinates the U.S. voluntary standardization and conformity assessment
system.
– The International Organization for Standardization (ISO) is a worldwide federation of
national standards bodies.

24

Summary of Main Standards that
apply to Risk Management, cont.
 ISO 10993 Biological Evaluation of Medical Devices
 IEC 60601 Medical Electrical Equipment
 IEC 60812 Analysis techniques for system reliability – Procedures
for failure mode and effects analysis (FMEA)
 IEC 61025 Fault Tree Analysis (FTA)
 IEC 61882 Guide for hazard and operability studies (HAZOP studies)

 IEC 61010 Safety Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use

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Tools to get the job done
 Fault Tree Analysis (FTA)
 Failure Mode Effects Analysis (FMEA)
 Failure Mode Effects Criticality Analysis (FMECA)

26

Fault Tree Analysis (FTA)
A technique that determines how top-level system
failure effects can be caused by individual
or combined lower level faults.
 It is a deductive top-down approach
– Considers multiple failures originating
from any system element
– Disposables
– Mechanical Devices
– Electrical and software components
– Manufacturing process
– Operator
 An FTA can also be used to identify areas where
additional investigation is required using Failure Modes,
Effects Analysis (FMEA) or using experimental testing.
27

FTA Illustrative Example
HOUSE IS
ROBBED

BURGLAR BURGLAR
ENTERS ALARM DOESN’T
HOUSE GO OFF

BURGLAR BURGLAR
ENTERS THRU ENTERS THRU ALARM OPERATOR
DOOR WINDOW FAILS OR IS FAILS TO ENABLE
DEFEATED ALARM

DOOR WINDOW
DOOR LOCK IS WINDOW WINDOW
BROKEN FORCED
LEFT OPEN DEFEATED LEFT OPEN BROKEN
DOWN OPEN

LOSE KEY LOCK IS
PICKED
28

Failure Modes and Effects
Analysis (FMEA)
FMEA is a qualitative approach suited for
reviews of medical devices. The FMEA
technique
 considers how the failure modes of each
system component can result in system
performance problems and
 ensures that appropriate safeguards
against such problems are in place.

29

Failure Modes, Effects, and
Criticality Analysis (FMECA)
FMECA is the quantitative analysis and
evaluation of potential component failure
modes, the effects each failure would have
on overall unit performance, and the
criticality of the resulting degraded
performance relative to safety or system
functions.

30

The difference between
a FMEA and a FMECA
A FMEA is qualitative, while a FMECA is quantitative. In a
FMECA, the probability of a specific failure occurring is
given as a numerical prediction. FMEAs employ
probability of failure categories based on probability
ranges. The proper category is determined by the
experience and expertise of the analyst, instead of a
mathematical probability calculation involving actual
component failure rates used in the FMECA.

31

Some comments about IVD’s
 In vitro diagnostic medical devices do not create a
“direct risk” to the patient
– They are not applied in or on the human body
 However “indirect risks” can result
– Erroneous decisions
– False positives
– False negatives

32

More on IVD’s
Some common hazards for the patient
– Batch variations, batch to batch inconsistency
– Common interfering factors
– Carry-over effects
– Specimen ID errors
– Stability problems of reagents
– Problems with specimen collection,
preparation, stability
– Inadequate specifications
– Inadequate test characteristics

33

More on IVD’s
Some potential hazards for the user

– Radioactive, infectious, toxic or
other harmful ingredients
– Packaging design
– Potential contamination during handling,
operation and maintenance
– Non-specific instrument-related energy hazards

34

Users and Human Factors Engineering

Identifying, Understanding, and Addressing Use-Related Hazards

Center for Devices and Radiological Health
© 2010 Fallbrook Engineering, Inc. Office of Health and Industry Programs
Division of Device User Programs and Systems Analysis 35

The frequency and consequence of hazards
resulting from medical device use might far exceed
those arising from device failures. 1

1 Medical Device Use-Safety:
Incorporating Human Factors
Engineering into Risk Management
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidanc
© 2010 Fallbrook Engineering, Inc. e/GuidanceDocuments/ucm094460.htm
36

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Use-related hazards occur for one or more of the following
reasons:
 Devices are used in ways that were not anticipated
 Devices are used in ways that were anticipated,
but inadequately controlled for
 Device use requires physical, perceptual, or cognitive abilities
that exceed those of the user
 Device use is inconsistent with user’s expectations
or intuition about device operation
 The use environment affects device operation
and this effect is not understood by the user
 The user’s physical, perceptual, or cognitive capacities are exceeded when
using the device in a particular environment

38

“Can the intended users use the device safely and effectively?”

 Apply HFE principles
 Do both analytic and
empirical reviews.
 Evaluate throughout the
development cycle

39

Pharmaceutical Risk Management
The FDA’s Risk-Based Approach Initiative

Some comments on where this is headed…

“Pharmaceutical Current Good
Manufacturing Practices (cGMPs) for the
21st Century: A Risk-Based Approach”
were proposed in August 2002.
40

Process Analytical Technology
This was followed by FDA's PAT (Process Analytical
Technology) initiative in 2004.
PAT is “a system for designing, analyzing, and controlling
manufacturing through timely measurements (i.e., during
processing) of critical quality and performance attributes of raw and
in-process materials and processes with the goal of ensuring final
product quality.”
It is important to note that the term analytical in PAT is viewed
broadly to include chemical, physical, microbiological, mathematical,
and risk analysis conducted in an integrated manner.

41

Risk Goals for Pharma
 ensure that the most up-to-date concepts of risk management
and quality systems approaches are incorporated into
pharmaceutical manufacturing systems
 encourage manufacturers to use the latest scientific advances
and technologies
 make sure review and inspection programs operate in a
coordinated and synergistic manner
 ensure standards are applied consistently
 promote innovation
 encourage effective and efficient use of resources to address the
most significant health risk
42

Risk Analysis, Sterile Drugs
“Sterile Drug Products Produced by Aseptic Processing” (draft)
 Incorporates risk-based approaches
– Promotes innovation
– Encourages technologies that increase sterility assurance
 Liberalizes some old standards
– Promotes drug quality
 Clear and consistent communication promotes voluntary
compliance with FDA regulations
– Unprecedented outreach:
 Extensive advisory committee, PQRI, industry organization,
and public input
 CDER/CBER/ORA consensus document
– Reference:http://www.fda.gov/ohrms/dockets/ac/03/slides/3951S2_04_Famulare
%20Friedman-Wright_files/slide0003.htm
43

Summary
Risk management is woven throughout US and
international medical regulations.
It’s really a matter of applying common sense…

44

Where to Get More Information
 AAMI Medical Device Software Risk Management
(http://marketplace.aami.org/eseries/scriptcontent/docs/Preview
%20Files/TIR320412%20preview.pdf)
 FDA’s Medical Device Reporting data files
(http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmdr/search.cfm)
 FDA’s Manufacturer and User Facility Device Experience Database
(http://www.fda.gov/cdrh/maude.html )
 CDRH Safety Alerts, Public Health Advisories, and Notices
(http://www.fda.gov/cdrh/safety.html )
 FDA Enforcement Reports – recalls and legal actions
(http://www.fda.gov/opacom/Enforce.html )
 ECRI’s Medical Device Safety Reports
(http://www.mdsr.ecri.org/)
 The Institute of Safe Medical Practices (ISMP's) Medication Safety Alert
(http://www.ismp.org/MSAarticles/Calendar/calendar.html)
 Joint Commission on Accreditation of Healthcare Organizations (JCAHO’s) Sentinel Events
(http://www.jcaho.org)
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Thank you for your interest.

I look forward to answering your
questions.

Richard Meyst
richardm@fallbrookeng.com

46

Don’t let
your project
become a
train wreck!

47

Risk Assessment: It's a Risky World Out There

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