Reliability Engineering for

Medical Devices

Richard C. Fries
Manager, Reliability Engineering
Datex-Ohmeda
Madison, Wisconsin
 Definition of Reliability

The probability, at a desired confidence level,

that a device will perform a specified function,
without failure,
under stated conditions,
for a specified period of time
More General Definition of
Reliability

A reliable product:

one that does what the customer wants,

when the customer wants to do it
 Reliability Basics

Reliability cannot be tested into a product

It must be designed and manufactured into it

Testing only indicates how much reliability

is in the product
Purpose of the Reliability
Group

Determine the weaknesses in a design

and correct them

before the device goes to the field

Areas Covered by
Reliability

Electrical

Mechanical

Software

System
Failure Rate
Electrical Reliability

Time
Mechanical Reliability
Failure Rate

Time
Theoretical Software
Reliability
X-Axis
Failure Rate

Time
X-Axis
Practical Software
Reliability
X-Axis
Failure Rate

Time
X-Axis
 System Reliability
Failure Rate

Time
 Set the Reliability Goal

Based on similar equipment

Used as the basis for a reliability budget

 Parts Count Prediction

Uses MIL-HDBK-217

Indicates whether the design

approximates the reliability goal

Indicates those areas of the design with

high failure rates
 Chemical Compatibility

Test plastics with typically used chemical

agents (alcohol, anesthetic agents,
cleaning agents)

Cleaning agents are the worst

 Component Testing

Cycle/life testing of individual components

Comparison of multiple vendors of

components

Determine applicability for the intended

use
 HALT

Acronym for Highly Accelerated Life Teing

Used to find the weak links in the design
and fabrication process
Usually performed during the design
phase
 HASS

Acronym for Highly Accelerated Stress

Screen
Uses the highest possible stresses as
determined by HALT testing
Performed on 100% of the units being
manufactured
 HALT Testing

Possible stresses that can be applied:

random vibration
rapid temperature transitions
voltage margining
frequency margining
The product is stressed far beyond its
specifications
The test can be set up to find the destruct
limits
 Goal of HALT Testing

Overstress the product

Quickly induce failures
By applying the stresses in a controlled,
stepped fashion, while continuing
monitoring for failures, the testing results
in the exposure of the weakest points in
the design
This test does not demonstrate that a
product will function in its intended
 Goals of HALT Testing

The goal is more effectively met by

testing at the lowest possible
subassembly, typically individual PC
boards
Card cages are not usually used due to
the dampening effect of the cage on
vibration
Cages also can block air flow, thus
reducing stresses
 Environmental Testing

Operating temperature/humidity
Storage temperature/humidity
EMC
Surges/transients
Brown-outs
Cell phones
ESD
Altitude
 Environmental Testing

Autoclave
Shock
Vibration
Shipping
Tip testing
Threshold testing
 Customer Misuse

Excess weight on tabletop

Fluid spillage
Cross connection of wires
Pulling unit by non-pulling parts
Wrong order of pressing keys
“Knowing” how to operate the unit without
reading the manual
Making a Design Foolproof

The biggest mistake engineers make

when trying to make a design
completely foolproof
is underestimating the ingenuity
of complete fools
High Performance Air
Compressor
Prototype Front Panel for
Ventilator
Plastic Structure
Plastic Structure
Plastic Structure
Manifold Port
Prototype Switch
Autoclave Testing
Critical Care Ventilator
Critical Care Ventilator
 Life Testing

Operate the device in its typical

environment and application
Use appropriate on/off cycles
Can be used to verify the reliability goal
or a specific period of time, such as the
warranty period
 Tracking Reliability
Growth in the Field

Collect manufacturing data on how many

units were manufactured by month
Collect field failure data, by month
Develop a reliability growth chart
Reliability Growth Example

Ventilator Reliability Growth

80000
MTBF (Hours)

60000
40000
20000
0
1997 1998 1999 2000
Year of Report
Reliability Growth Example

Ventilator Reliability Growth

MTBF (hours)

50000

0
1996 1997 1998 1999 2000
Year of Report
Reliability Growth Example

Estimate of Two Vaporizer Builds

200000
MTBF (hours)

150000 Pre-June, 1997

Build
100000
Post-June, 1997
50000 Build
0

97 98 99 00 01 02 03
19 19 19 20 20 20 20
Year of Build
 Failure Analysis

Failure: device does not operate according to

its specification

Determine root cause of the failure

Suggest methods to address the failure

The Reliability Group

You make it,

We’ll break it