Risk Management and Safety in Healthcare Tobey Clark, MSEE, CCE University of Vermont USA

Risk Management and Safety in Healthcare

Tobey Clark, MSEE, CCEUniversity of VermontUSA

8º Congreso Colombiano de Hospitales y Clínicas

Agenda

Safety and Risk Management Concepts

Errors and Adverse Events Reporting and Improvement Efforts Medical Technology Safety Role of Education and Training Safety and Risk Management

Evaluation Summary


1

10

100

1,000

10,000

100,000

1 10 100 1,000 10,000 100,000 1,000,000 10,000,000

Total lives lost per year

Num

ber o

f enc

ount

ers

for e

ach

fata

lity

How hazardous is health care?

Dangerous(>1/1000)

Ultra-safe(<1/100K)

RegulatedHealthcare !!!

Driving

Scheduledairlines

Mountainclimbing

Bungeejumping

Chemicalmanufacturing

Chartered flights

European railroads

Nuclear power

(Lucian Leape, MD)


Definitions and Topics Safety – Freedom from danger

Risk- Probability of suffering harm or loss

How do these factors relate to health and medical technology?

How can these areas be improved?


Healthcare Safety Issues

Infection Control– Bloodborne

Pathogens Electrical Safety Chemical Safety Radiation Safety Fire safety Laser Safety MRI Safety


Risk Acceptance

Generallyacceptable

Generallyunacceptable

Acceptable consideringthe benefit

Probability

Severity


Managing Risk

CONTROLtake actions toavoid/m in im ize

risks

E VAL U ATEcom pute risk exposures anddeterm ine w hich risks posethe greatest threat, and how

they m ight be averted

ANAL Y ZEestim ate the like lihood

and loss of eachoutcom e, under a ll

a lternative choices ordecis ions

P L AN AC T IO Navoid/m in im ize risks

MO NITO Rm onitor risk preventionactiv ities and m odify as

needed

AS S E S SR IS K

identify, nam e andcategorize risks


Risk Management & SafetyIntegration into Healthcare

Medical Equipment

Drugs

HumanResources

Facilities

What ?

Guidelines

Inter-ventions

How ?

HealthPackage

How much ?

Procedure


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?

Hazardous Lagging behind other high-risk

industries Most complex system Fraught with obstacles to change


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:

ErrorsAdverseEvents


Why Do Adverse Events Occur?

Simultaneous problems in alignment lead to adverse events

Use error Equipment failure

or manufacturing defect

Environmental factors

Poor design Patient factors System or

combinational failure


Adverse Events Are An International Problem

Worldwide average in developed countries in the European Union, Australia, New Zealand, and the USA is…

About 10% of admissions! The cost is significant

– Longer hospital stays, litigation, lost patient income, disabilities

Billions of USD $$$$$


0

2

4

6

8

10

12

14

16

18

New York Australia Utah andColorado

London NewZealand

Canada Denmark

Adverse event rate (percentage)11% of adverse events are due to bad manufacturing of medical devices

11% of adverse events are due to bad manufacturing of medical devices

National Patient Safety AgencyJuly 2005 ©

Adverse Events in Acute HospitalsAdverse Events in Acute Hospitals

New York Australia Utah and

ColoradoLondon

New Zealand

Canada Denmark


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


WHO Medical Device Safety Efforts Development of national policy:

– tools to assess and strengthen national regulatory authorities

Quality and safety: – elaboration of new ISO standards

Access: – WHO Essential Healthcare Technology

Package Appropriate use of equipment in order

to reduce risks:– diffusion of materials


Joint Commission: Accreditation Organization

Accreditation guidelines sets quality standards for all areas including healthcare technology

– Accreditation means hospitals will receive payment for federally covered patients

Patient Safety Standards

– Annual FMEA (Failure Mode and Effect Analysis)

– Sentinel Events – RCA (RootCause Analysis)

– National Patient Safety Goals


Adverse Event Reporting in the U.S.

Food and Drug Administration (FDA)– Safe Medical Device Act of 1990

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

Patient Safety and Quality Improvement Act of 2005

ECRI Institute ECRI Alerts Health Device Evaluations Investigations

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

8º Congreso Colombiano de Hospitales y Clínicas F. Painter: BIOMEDEA III


Medical Device Errors Estimated at about 1-2% of

total in IOM report or 1000-2000/year

Shepherd 2001

50-70% human error– Devices, external, patient &

deliberate Devices

– Ventilator, transfusion, infusion, defibrillator, utility systems, electrosurgery, trocars & anesthesia units

Operating room & ER - Home!


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



Pad site burn

F. Painter: BIOMEDEA III


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

Source :ECRI Institute

What Medical Devices Are Most Commonly Associated with Events?


CLINICAL ALARMS HAZARDS!

ECRI Institute 2007

– Not responding to alarm condition

– Improper use or setup– Too much environmental

noise– Poor device designTOO MANY FALSE

ALARMS!

What is the most commonly reported medical device

problem in the US?

13-17 August 2007 Lima Peru13-15 August 2007 Lima, Perú

Impact Of Clinical Alarms On

Patient SafetyAmerican College of Clinical

Engineering Healthcare Technology Foundation (AHTF)

http://www.acce-htf.org/clinical.asp

http://www.acce-htf.org/clinical.asp

8º Congreso Colombiano de Hospitales y Clínicas 27

Actions to Improve AlarmsDesign Smart alarms Integration Usability/human

factors Standards

Care management Training Monitoring (rounds) Use best practice

guides Institutional standards

Environmental Better design of

facilities Monitoring (rounds) Communication

Alarm integration to pager, cell phone, etc.

Clinical engineering Evaluate purchased

items for usability Test alarms in their

environment Software setup/testing


The Importance of Education and Training Devices are very complex User error is a common cause of

adverse events Quality assurance and

maintenance are critical to safe care

Proper actions must be taken to resolve common problems & save lives


Latin America and the Caribbean countries are rapidly expanding their healthcare technology usage.

The effects of the new technologies have benefited patients, but problems have occurred due to a lack of management, training, guidelines, and local technical support especially in developing countries.

Medical Technology Revolution


Limited medical device regulations,

A high percentage of devices that are out of service,

Weak after sale device support with nearly all service from manufacturers or their representatives,

A shortage of technical staff in hospitals,

Very limited maintenance budget, and

Limited technology management.

Medical Equipment Situation in Latin America


Online – Accessible 24x7 Cover key aspects of many common

technologies– Principles, operation, safety, problem

resolution, maintenance, and management Collaboration between universities in the

Americas– Bilingual/multi-lingual

Value established at a high level Website: http://its.uvm.edu/medtech/index.html

http://its.uvm.edu/medtech/index.html


PAHO(OPS) Grant A collaborative effort

Pontifica Universidad Católica del Peru (PUCP) - Lima, Peru

Universidad Instituto de Ciencias de la Salud (CES) Medellin,

- Colombia- Course started 25 March at

CES/EIA with over 100 students

University of Vermont (UVM) - USA

Student internships at UVM


Needs analysis & strategic planningNeeds analysis & strategic planning

HTA(macro & micro)

HTA(macro & micro)

Pre-purchaseevaluation

Pre-purchaseevaluation

Selection & procurementSelection &

procurement

User & service training

User & service training

Risk management & quality assurance

Risk management & quality assurance

CE/HE management &

monitoring

CE/HE management &

monitoring

Operation, service & maintenance

Operation, service & maintenance

Acceptance & installation

Acceptance & installation

Healthcare Technology Management Spectrum

Healthcare Technology Management Spectrum

S a

f e

t y

Andrei Issakov, WHO


Healthcare technology stakeholdershared responsibility MANUFACTURER

CLINICIANS

HEALTHCARE SUPPORT

ORGANIZATION

PUBLIC/PATIENT

GOVERNMENT

COOPERATION COMMUNICATION

INFORMATION PARTICIPATION

EDUCATION REGULATION

RISK MANAGEMENT

Adapted from Andrei Issakov, WHO


Safety, Risk and Quality Management Summary

Healthcare safety and reliability is poor compared with many other industries

Healthcare technology has brought both benefits and risks

Specific efforts must take place to improve safety and reduce risk– Safety and risk are a subset of the overall

quality improvement in healthcare The Key Requirement for Change is

Strong Leadership


Gracias!

[email protected]

mailto:[email protected]

Documents

Risk Management and Safety in Healthcare Tobey Clark, MSEE, CCE University of Vermont USA