Transcript Mechanisms of Harm and Human Factors

Mechanisms of Harm and Human
Factors: SFDA Presentation
November 2005
Joel J. Nobel, MD
Founder & President Emeritus
ECRI
©ECRI 2002 Risk Management-09
Discussion Topics
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Consequences of adverse events
Perspectives on risk
Mechanisms of harm
Human factors
Priorities
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Consequences of Adverse Events (1)
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Prolonged hospital stays
Injury, disability, and death
Liability and lawsuits
Loss of time and money
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Consequences of Adverse
Events(2)
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Loss of the ethical and moral high ground
Loss of reputation of individuals
Loss of reputation of institutions
Evolution of a fearful, self-protecting
institutional culture that is left behind
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General Observations on Risk
(1)
Most device related adverse events are
preventable because the requisite body of
knowledge exists.
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General Observations on Risk
(2)
Most adverse events occur because this
knowledge is unknown by some
individuals at a critical time and place or,
if known, is not applied consistently.
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General Observations on Risk
(3)
Knowledge, even when known to an
individual, is not applied consistently
because of competing priorities,
overwork, rushing, fear, fatigue, and
psychological distraction.
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General Observations on Risk
(6)
Some critical knowledge has not yet evolved.
What we don’t know yet can lead to adverse
events. Therefore, all adverse events require
reporting and competent analysis to determine
cause and advance knowledge.
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Perspective on Risks
Of all healthcare technologies, medications
and medical and surgical procedures lead to
many more injuries and deaths than do
devices.
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What is the most common cause of patient
injuries after medication- and procedurerelated adverse effects?
Falls from beds!
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Perspective on Risk
The most common cause of equipment-related
harm to patients is user error, not machine
failures caused by design errors, manufacturing
quality control, maintenance, service problems or
ergonomic design of devices.
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The Causes of Medical-DeviceRelated Incidents (1)
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Device failure
Device interaction
User error
Maintenance error
Packaging error
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The Causes of Medical-DeviceRelated Incidents (2)
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Tampering
Support system failure
Environmental factor
Idiosyncratic patient reaction
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Causes of Device Failure
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Design/labeling error
Manufacturing error
Software deficiency
Random component failure
Power-supply failure
Failure of accessory
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Mechanisms of Device-Related
Injury and Death (1)
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Overdose
Suffocation/barotrauma
Infection
Embolism (gas/particulate)
Skin lesion (puncture/cut/burn)
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Mechanisms of Device-Related
Injury and Death (2)
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Electrocution
Fire
Performance failure
Crushing
Exsanguination
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Perspective on Risk
Device-related harm to patients is
frequently caused by failure to follow
standard procedures, suboptimal skills at a
critical moment, and failure to understand
the basic principles of operation and
limitations of the device.
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Human Factors & Device
Incidents
• Human factors design (ergonomics) of
medical devices impacts ease and safety of
use and contributes to user error
• Human factors design of the care
environment, culture and educational
processes causes many more errors and
inhibits prevention of risk
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Deficient Human Factors Design
of Devices: Historical Examples
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Defibrillator failures (mode switches)
Infusions pumps
Patient beds
Electrosurgical units
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What Inhibits Recognition &
Reporting of Device Adverse
Events? (1)
• Because adverse events only happen occasionally,
they lie outside the experience of most personnel.
• Physicians and nurses frequently compensate for
suboptimal conditions and their own errors, adjust
on the fly, and regard some problems as “routine.”
• They are more gratified by their own effort to
overcome a problem than to prevent one.
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What Inhibits Recognition of
Device Adverse Events? (2)
Failure to be open to questioning or
corrections because of:
– Authoritative environment or personalities
– Superior-subordinate psychodynamics
– Male-female psychodynamics
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Risk Management Strategies
and Approaches
1. Systematically report incidents
2. Prevent adverse events by reducing existing
knowledge to consistent practice
3. Educate and train healthcare personnel
continuously
4. Determine the causes of adverse events by rootcause analysis
5. Incorporate lessons learned from analysis into
routine practice
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Strategies in Risk Management
• Prevent errors and adverse events.
• When adverse events occur, determine the root
causes through careful analysis.
• Redesign and implement processes, procedures,
and behavior to neutralize such causes.
• Reevaluate frequently.
• Train frequently.
• Facilitate upward and downward communication.
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Why Problem Reporting?
Lessons learned from analysis must be:
– Openly shared
– Incorporated into the general body of medical,
nursing, and administrative knowledge
– Incorporated into revised practices
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To Minimize Device-Related Risks:
• Emphasize prevention according to a
rational order of priorities.
• Base priorities on history of frequency
and severity of harm.
• Begin by understanding which devices do
the greatest harm.
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Setting Device Priorities
• If data is available, which types of devices most
frequently cause significant harm?
• If data is available, does the incidence of harm
vary with the service supplier? If so, why?
• If data is not available, establish a program to
get data, and base priorities on the experience
of other national health systems.
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U.S. Experience (1)
Most Frequently Reported Harmful
External Devices
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Anesthesia machines
Cardiac interventional catheters
Cardiopulmonary bypass systems
Defibrillators
Dialysis systems
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U.S. Experience (2)
Most Frequently Reported Harmful
External Devices
• Disposable surgical trocars
• Electrosurgical (surgical diathermy)
units
• IV pumps
• Surgical staplers
• Ventilators
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Observation (1)
• Of these top 10 harmful devices, half (5)
are used only in the operating theatre.
• 3 additional ones may be used in the
operating theatre.
• 3 are used in almost all areas of the
hospital.
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Observation (2)
• The most frequently reported problem
device is the infusion pump.
• 3 of the 10 devices are highly dependent
on physician technique with very simple
devices (i.e., interventional catheters,
trocars, and staplers)
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Observation (3)
• 7 of these 10 devices require mains voltage
electrical energy.
• But in 6 of these 7 devices, almost all reported
problems are mechanical.
• One device, the defibrillator, has frequently
reported battery- and power-supply problems
(i.e., too little rather than too much electricity).
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Address User Error!
• Train, test, retrain, and retest.
• Physicians, nurses, and clinical technologists all
require frequent training.
• Select and buy devices with good human
factors (i.e., ergonomic) design.
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Educate Device Users
Have them:
– Explore www.mdsr.ecri.org
– Read case histories of deaths and injuries
caused by devices they use in their
specialty
– Download and publicize safety posters
for specific devices
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Detailed Case Histories
ECRI maintains a detailed description of
many device-related safety issues based
on critical case histories on a special Web
site. You can search by hospital
department specialty, device type, or
failure mechanism.
Go to www.mdsr.ecri.org
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ECRI Problem Reporting
Network
ECRI is a member of the Global
Harmonization Task Force, Study
Group 2—Medical Device Vigilance—PostMarket Surveillance
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Accident Investigation
• Undertaken for hospitals, public health
agencies, health professionals, and insurers
• Purpose: determine what happened, why,
and design prevention techniques
• On-site and laboratory investigations
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Accident Investigation
• Rapid response by interdisciplinary team
• Investigated soon after incident
• Performed worldwide
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Which is most dangerous if used
excessively?
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EEG?
ECG?
EGG?
EMG?
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Thank you
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