Clark Safety in HC Monday 13 30

SEGURAN AN A EM SA SA DE CURSO E OFICINA DE TRABALHO SOBRE GERENCIAMENTO DE RISCO E SEGUR
Sao Paulo - SP, Brazil Nov. 5 7, 2007
Tobey Clark, MSEE, CCE University of Vermont USA
Acknowledgment to many ACCE faculty and Andrei Issakov, WHO
Safety in Healthcare
Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007
Agenda Hour 1
Safety in healthcare overview

Patient safety Safety issues International improvement efforts U.S. improvement efforts
Medical device

How hazardous is health care?

100,000
Dangerous (>1/1000)
Regulated
Healthcare !!! Driving
Ultra-safe (<1/100K)
Number of encounters for each fatality
10,000
1,000
100
Scheduled airlines Mountain climbing Chemical manufacturing Bungee jumping

1 10 100 1,000
10
European railroads Nuclear power

1,000,000 10,000,000
Chartered flights
10,000 100,000
Total lives lost per year
(Lucian Leape, MD)
Institute for Medicine Report:

To err is human: building a safer health system

44,000-98,000 die each year due to medical errors
Failure to perform a
desired act or right action
Errors will always occur - goal is to reduce the negative outcomes

Mostly medication errors More than 2/3rds due to human error
Why are errors prevalent in health care?

Most complex system One of most hazardous activities Lagging behind other high-risk industries Fraught with obstacles to change
Human beings make mistakes because the systems, tasks and processes they work in are poorly designed
Dr Lucian Leape, testifying to the Presidents Commission on Consumer Protection and Quality in Health
Adverse Event vs. Error

Error definition bears upon concept of preventability, and is therefore process-focused Adverse event describes harm to the patient, and is thus outcome focused Relationship between errors and adverse events:
Adverse Events
Errors
Why Do Adverse Events Occur?

Use error Equipment failure/manufacturing defect Environmental factors Poor design Patient factors System failure Combinations

Any healthcare intervention, and thus a patient as its center, is at the point of a complex interaction of a tremendous variety of processes, technologies, health professionals and other elements of the system.
An International Problem

UK around 10% of admissions or at a rate of 850,000 adverse events a year Australia 250,000 adverse events 50,000 permanent disability 10,000 deaths N.Z. confirmed 10% of admissions Denmark confirmed 9% of admissions EU every tenth patient
Adverse AdverseEvents Eventsin inAcute AcuteHospitals Hospitals

Adverse event rate (percentage)
11% 11%of ofadverse adverseevents eventsare aredue dueto tobad bad manufacturing of medical devices manufacturing of medical devices
18 16 14 12 10 8 6 4 2 0
New New York York
Australia Australia Utah Utah and and Colorado Colorado
London London
New New Zealand Zealand
Canada Canada
Denmark Denmark
National Patient Safety Agency July 2005
What does it cost?

High toll in financial loss as well
UK
2 billion a year in additional hospital stays; 400 million annually in paid litigation claims plus potential liability of 2.4 billion in existing and expected claims;
HAI - 15% of which avoidable - 1 billion every year USA

$17-29 billion annually in lost income, disability and additional medical expenses
Litigation: An Important Consideration
ADE-associated litigation is costing $220 million per year in the US (J. Nagel)

International collaboration to accelerate improvements Focus on systems Improve detection and understanding of safety problems Build and spread knowledge base of interventions Action on topics which address significant risk Support regional and country programmes
BUILDING SAFE ENVIRONMENT FOR SAFER CARE

Global Patient Safety Challenge Clean Care is Safer Care, 2005-2006 Safe Environment for Safer Care, 2007-2008 Patients for Patient Safety Research for Patient Safety Patient Safety Solutions Reporting and Learning Systems Patient Safety Taxonomy
Needs Needs analysis analysis & & strategic strategic planning planning HTA HTA (macro (macro & & micro) micro) Pre -purchase Pre-purchase evaluation evaluation Selection Selection & & procurement procurement Acceptance Acceptance & & installation installation Operation, Operation, service service & & maintenance maintenance User User & & service service training training Risk Risk management management & & quality quality assurance assurance CE/HE CE/HE management management & & monitoring monitoring
Safety
Healthcare Technology Management Spectrum
WHO Medical Device Safety Efforts

Development of national policy: Quality and safety: Access:
tools to assess and strengthen national regulatory authorities elaboration of new ISO standards WHO Essential Healthcare Technology Package diffusion of materials

Appropriate use of equipment in order to reduce risks:
U. S. Patient Safety Movement Origin

Meeting of 300 experts held in 1996 in the Annenberg Conference Center near Palm Springs, CA.
in response to several error-induced sentinel events in the mid-1990s that captured the attention of the public media.

American Medical Association American Association for the Advancement of Science Veterans Administration Joint Commission
Accreditation Organization
Joint Commission:
Accreditation guidelines sets quality standards for all areas including healthcare technology
Accreditation means hospitals will receive payment for federally covered patients

Use in US hospitals and now internationally Survey process Interviews, on-site observation of patient care process, policies, procedures and other documents, and results of self-assessment Accreditation Decision Process - Each standard is scored fully met, partially met, or not met. Three-year accreditation
Joint Commission
Patient Safety Standards

Annual FMEA (Failure Mode and Effect Analysis) Sentinel Events RCA (Root Cause Analysis) National Patient Safety Goals
Joint Commission
International Center for Patient Safety

http://www.jcipatientsafety.org/

Standards Speak UpTM programs System design and redesign, product safety, safety of services, and environment of care,
Medical Device Errors (from Shepard)

Estimated at about 1-2% of total in IOM report or less than 1000/year 50-70% human error
Devices, external, patient & deliberate
Devices
Ventilator, transfusion, infusion, defibrillator, utility systems, electrosurgery, trocars & anesthesia units
Operating room & ER - Home!
Adverse Event Reporting in the U.S.

Food and Drug Administration (FDA)

Safe Medical Device Act of 1990

Patient Safety and Quality Improvement Act of 2005 Joint Commission

Reporting of death and serious injuries Medwatch (manual) and MedSun (Web based)
ECRI Institute

Patient Safety Goals Sentinel Event Reporting Accreditation Survey Process ECRI Alerts Health Device Evaluations Investigations

VA National Patient Safety Center Many state programs e.g. Pennsylvania
What Medical Devices Are Most Commonly Associated with Events?

Top
10 Medical Devices
1. Infusion Pump wrong dose, infiltration, free flow 2. Ventilators and Anesthesia systems breathing circuit leaks, disconnections, failure to detect alarm 3. Patient monitors improper settings, alarms 4. Defibrillators lack of familiarity with devices 5. Electrosurgical units and lasers fires due to excessive oxygen and improper preparations procedures 6. Heart-lung bypass units failure to detect leaks
What Medical Devices Are Most Commonly Associated with Events?

Top
10 Medical Devices (continued): 7. Catheters and needlestick prevention devices shearing during insertion of catheter, and failure to use needlestick prevention devices 8. Trocars and staplers improper use 9. Endoscopy equipment issues of contamination during endoscope cleaning 10. MRI ferrous metal objects entering MRI suite
U. S. National Organizations Focused on Safety

Food and Drug Administration

Center for Devices and Radiological Health http://www.fda.gov/cdrh/
Device Recalls
approval
Example Alert: More Patient Deaths
from Luer Misconnections
Design of luer connectors makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results
FDA
Video webcast
Misconnections

MEDSUN Pilot program for FDA

Adverse event reporting
http://www.medsun.net
Occupational Health and Safety Administration

Health Facility Workers
http://www.osha.gov/SLTC/healthcarefacilities/index.html

ECRI Institute Free Medical Device Safety Resources

www.ecri.org Safety Precautions in the MR Environment Improper Use of Helical Tacks Can Harm Patients Sharps Safety and Needlestick Prevention Bed Rail Safety White Paper: Event Reporting Proactive Hazard Analysis and Health Care Policy Bariatrics Risk Assessment

National Patient Safety Foundation

http://www.npsf.org/
Veterans Administration National Center for Patient Safety

http://www.patientsafety.gov/
CENETEC MEXICO
http://www.cenetec.salud.gob.mx/htmls/ cenetec.html

ACCE Healthcare Technology Foundation

http://www.acce-htf.org/
Anesthesia Patient Safety Foundation

http://www.apsf.org/
Premier Safety Institute

http://www.premierinc.com/safety/
University of Chicago Cognitive Technologies Lab

http://www.ctlab.org/
U. S. Patient Safety Movement Progress

The 100,000 Lives Campaign

3000 participating hospitals 6 interventions

medication reconciliation to prevent adverse drug events and reduction of central-line-associated bloodstream infections
The 100,000 Lives Campaign had exceeded its 18month goal of preventing 100,000 deaths
Donald Berwick, CEO of the Institute for Healthcare Improvement
Premier, Inc., an alliance of nonprofit hospitals and healthcare systems, announced that its 3-year demonstration project with the Centers for Medicare and Medicaid Services is resulting in better care at lower costs.
The Next Ten Years?

From a culture of reporting incidents to one of learning from incidents; From an accounting approach that tabulates events to a synthetic approach that searches for patterns; From looking backward at past events to looking forward in anticipation of future risks; From a focus on error to a focus on complexity.
Authors: David Woods and Richard Cook
Questions
Discussion
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SEGURAN AN A EM SA SA DE CURSO E OFICINA DE TRABALHO SOBRE GERENCIAMENTO DE RISCO E SEGUR

Sao Paulo - SP, Brazil Nov. 5 7, 2007

Tobey Clark, MSEE, CCE University of Vermont USA

Acknowledgment to many ACCE faculty and Andrei Issakov, WHO

Safety in healthcare overview

How hazardous is health care?

Number of encounters for each fatality

Scheduled airlines Mountain climbing Chemical manufacturing Bungee jumping

European railroads Nuclear power

Total lives lost per year

(Lucian Leape, MD)

Institute for Medicine Report:

To err is human: building a safer health system

desired act or right action

Errors will always occur - goal is to reduce the negative outcomes

Mostly medication errors More than 2/3rds due to human error

Why are errors prevalent in health care?

Adverse Event vs. Error

Why Do Adverse Events Occur?

Adverse AdverseEvents Eventsin inAcute AcuteHospitals Hospitals

Australia Australia Utah Utah and and Colorado Colorado

New New Zealand Zealand

National Patient Safety Agency July 2005

What does it cost?

HAI - 15% of which avoidable - 1 billion every year USA

Litigation: An Important Consideration

BUILDING SAFE ENVIRONMENT FOR SAFER CARE

Healthcare Technology Management Spectrum

WHO Medical Device Safety Efforts

Development of national policy: Quality and safety: Access:

Appropriate use of equipment in order to reduce risks:

U. S. Patient Safety Movement Origin

Patient Safety Standards

International Center for Patient Safety

Medical Device Errors (from Shepard)

Operating room & ER - Home!

Adverse Event Reporting in the U.S.

Food and Drug Administration (FDA)

Patient Safety and Quality Improvement Act of 2005 Joint Commission

VA National Patient Safety Center Many state programs e.g. Pennsylvania

What Medical Devices Are Most Commonly Associated with Events?

What Medical Devices Are Most Commonly Associated with Events?

U. S. National Organizations Focused on Safety

Food and Drug Administration

Example Alert: More Patient Deaths

from Luer Misconnections

U. S. National Organizations Focused on Safety

U. S. National Organizations Focused on Safety

MEDSUN Pilot program for FDA

Occupational Health and Safety Administration

U. S. National Organizations Focused on Safety

ECRI Institute Free Medical Device Safety Resources

U. S. National Organizations Focused on Safety

National Patient Safety Foundation

Veterans Administration National Center for Patient Safety

U. S. National Organizations Focused on Safety

ACCE Healthcare Technology Foundation

Anesthesia Patient Safety Foundation

Premier Safety Institute

University of Chicago Cognitive Technologies Lab

U. S. Patient Safety Movement Progress

The 100,000 Lives Campaign

3000 participating hospitals 6 interventions