Clark Safety in HC Monday 14 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
Safety in Healthcare
Tobey Clark, MSEE, CCE University of Vermont USA
Acknowledgement to AHTF Clinical Alarms Task Force and Fletcher Allen Health Care
Advanced Clinical Engineering Workshop - Healthcare Risk Management and Safety Sao Paulo - SP, Brazil Nov. 5 7, 2007
Agenda Hour 2
Clinical engineering
Example patient safety improvement project
ACCE Healthcare Technology Foundation

Clinical Alarms Management and Integration
Hospital safety programs

General Environment of Care focus Medical Equipment Safety Management
Example teaching hospital program
Impact Of Clinical Alarms On Patient Safety

American College of Clinical Engineering Healthcare Technology Foundation (AHTF)
Limitations of clinical alarm systems
Difficulty in learning more than 6 different alarm signals

Surgery and ICU environment >> 6 different alarms
Difficulty in discerning between high and low priority alarms Perceived urgency of alarms may not be consistent with criticality of situation
Better safe than sorry mentality increases the number of alarms included in devices Some devices do not need alarms
more problems than benefits
Limitations of clinical alarm systems
to be false with less than 1% of all alarms resulting in a change of patient management.
American Journal of Emergency Medicine, 2006
99.4% of the alarms were determined
False alarms/nuisance alarms Procedures Patient conditions Design
High false-positive rates loss of credibility disabling of alarms by medical personnel
Reported Clinical Alarm problems

Environmental

Design
Alarms can be defeated/turned off False positive alarms
Patient condition Poor design
Too much background noise Competing alarms Poor design of facility Patient condition
Maintenance

Alarm failure Interconnects defective
Alarm tones and displays not recognized Poor human factors design Poor integration
Reported Clinical Alarm problems

Care management
No response to alarms
Attending other patients Ignored Confused as to source Volume off or set too low
Alarm not set correctly Priority of alarm not recognized Training inadequate Staffing inadequate Over reliance on alarm systems
FDA MAUDE Database Review
The FDA MAUDE database was queried (2002-2004) using search terms:
alarm in the Product Problem field death as the Event Type selection
237 reports were found

Of 139 events that could be analyzed:
58
(42%) were related to operator education and training 67 (48%) were related to work conditions or personal problems
Deaths by Year
Joint Commissions Alarm-Safety Goal
Sentinel Event Alert February 26, 2002

Ventilator incidents related to clinical alarms
National Patient Safety Goals for 2003 and 2004

Maintenance and care management Focus on alarm-safety was effective in:
Raising awareness of deaths and injuries that occur due to ineffective alarms and inappropriate alarm use Promoting a better understanding of the importance of effective alarm management strategies
Despite the two year focus on alarm improvement, clinical alarm management still requires attention
IEC 60601-1-8

Design Standards
General requirements for alarm systems Only focused alarm standard Defines visual and audible alarm signals that can be used to prioritize degree of urgency Not widely implemented in the U.S. Some devices have the option to employ the IECdefined alarm tones Adopted by the FDA as a reference standard
Current AAMI/ANSI standards
Do not address the need for prioritization of alarms emitted from different devices Alarms are generally handled on a device-specific basis
Clinical Alarm Survey

The survey was completed by 1,327 individuals
Nearly all from acute care hospitals Over half of respondents were Registered Nurses (RNs) One-third from critical care units 2/3rds had more than 11 years of experience
Clinical Alarm Survey:
Results Summary
Biggest issue: False Alarms and Nuisance Alarms

Reduce
attention and response Disrupt care and reduce trust in alarms
The majority support:

Smart alarms and alarm integration systems
Not reported as significant:

Alarm training
Observations
The number and complexity of alarm systems in critical care environments challenge human limits for recognition and action Alarms in critical care environments may not significantly affect care management decisions Alarms are a tool in assessing patient conditions
Should be used in conjunction with direct clinical measurements and observations
Disagreement about the role of user operation of alarm systems in alarm system performance False alarms - consistently reported as a major issue
Observations
If well designed, remote alarm communication devices can be of value

Problems occurred when used as primary alert method
The IEC/ISO standards are viewed by many as a way to improve alarms by:
Standardizing audible and visual alarms Priority and parameter differentiation
The alarm problem is a systems issue and actions toward specific areas must consider their impact on the system
Actions to Improve Alarms

Design

Care management

Smart alarms Integration Standards Usability/human factors Better design of facilities Monitoring (rounds) Communication Alarm integration to pager, cell phone, etc.
Process change Training Monitoring (rounds) Use best practice guides Evaluate purchased items for usability Test alarms in their environment Software setup/testing
Environmental

Clinical engineering

Healthcare Recommendations
Review and revise existing policies related to clinical alarm management: Use of defaults, changing of alarm limits, expected clinical
responses to alarm conditions, & consider institutional/departmental standardization
Perform frequent clinical alarm monitoring rounds, to alert users to any variations from unit specific guidelines Develop audit tools to measure compliance with established policies related to clinical alarm management Develop and complete a checklist associated with clinical alarm management and document compliance at shift change Conduct in-service and simulation training associated with new equipment Improve device alarms evaluation prior to purchase
Industry/Standards Recommendations
The medical device industry must focus on reduction of false alarms

Accurate parameter recognition Smart alarms employing advanced signal processing, event recognition and parameter/alarm integration Usability/human factors design
Consider the scientific basis and value of the IEC 60601-1-8 standards
Prioritization Annunciation
Audible and Visual
Healthcare Technology Management and Patient Safety

Government Maintenance providers
Equipment Users
Patient Safety
Public, Patients
Healthcare Providers
Constructors, manufacturers, Vendors
Healthcare Integrated Program

Risk Management Safety Management

Employee Safety Environmental Safety Patient Safety
Quality
Benchmark Measure Improve
Healthcare Safety Issues
Bloodborne Pathogens Infection Control Electrical Safety Chemical Safety Radiation Safety Fire safety Laser Safety
Safety Structure in the Hospital
Healthcare Technology Patient Safety Activities

PLANNING

Assessment of technology risk and safety Pre-purchase Human Factors and Safe Design Safety history Product to enhance safety Acceptance evaluation of safety Installation to reduce risk, errors and enhance safety Failure mode and effect analysis (FMEA)
Healthcare Technology Patient Safety Activities

LIFE CYCLE
Patient safety monitoring, reporting, and actions Care management Education Maintenance Facilities Adverse event investigation Root cause analysis Action Education
Healthcare Institution/System Efforts to Improve Patient Safety

Assessment/Acquisition Review
Human Factors Design/Usability Research
Risk-based inspections Education Recall/alert system Root-cause analysis of incidents & near misses Systems Solutions
Hospital Safety Committees
Environment of Care Committee

Focused on seven areas of safety
Safety,
Equipment
Security, Hazardous Materials, Emergency, Fire, Utilities, and Medical
Work based on continuous quality improvement and the need to meet regulatory, accreditation and standards
Joint
Commission
Environment of Care Committee
Meets monthly
Chair, Vice President for Support Services Leaders from all seven areas Also Patient Safety, Infection Control, Nursing, Safety Specialist, Education
Quarterly reports by each area Monthly reports by Clinical Engineering on Recalls and Alerts
FAHC = Fletcher Allen Health Care; Burlington VT USA
Medical Equipment Management
Joint Commission International Standard
Joint Commission International Standard
Program Scope:
The Medical Equipment Management Plan is intended to outline practices, procedures and systems related to the use and support for equipment utilized in patient care. The plan is intended to guide, identify, evaluate and improve the processes associated with creating a safe and secure environment for all people utilizing the services of Fletcher Allen Health Care.
Subcommittee Objectives:
Oversee the identification and evaluation of all medical equipment at the time of procurement, prior to utilization at FAHC. Ensure the maintenance of an equipment inventory to control, track, maintain, and manage all direct patient care equipment. Review maintenance strategies including inspection intervals to minimize the clinical and physical risks to patients and staff posed by medical equipment. Assist/support in the education of staff to properly operate and use medical equipment.
Subcommittee Objectives:
Ensure the development and utilization of methods to identify and report equipment management problems, failures and user errors. Ensure FAHC complies with Safe Medical Devices Act (SMDA) requirements. Meet compliance guidelines related to Joint Commission EC.6.10, 6.20, and HR.2.20. Meet compliance guidelines of patient safety goals impacting medical equipment
Basic 2007 Subcommittee Goals:

Maintain consolidation of existing medical equipment inventories to include Philips Multivendor Services, and medical equipment supported by contracted/purchased services. Review and propose changes to the Medical Equipment Management Plan and maintain an institution wide Medical Equipment Management Policy. Using the risk assessment process establish an equipment priority to define/justify preventive maintenance and recurring inspection requirements.
Basic 2007 Subcommittee Goals:
Educate equipment users regarding PM requirements, recurring inspection requirements, proper methods for taking equipment out of service when damaged or inoperable, and assist with re-education of staff/supervisors on equipment when user error appears to be the causative factor of equipment nonperformance. Oversee, coordinate, and provide written response, to all medical equipment recalls and JCAHO reported or FAHC identified sentinel events involving medical equipment. Provide technical consultation and support to medical equipment selection committees

Specific 2007 Subcommittee Goals & Targets: Complete recall notification and closure improvement project in conjunction with IS, Supply Chain, and Medical Equipment Subcommittee. Review device problems classified as DAMAGED. Develop preventative measures if found to result from reasons outside of normal use. Target:
<10% of work orders classified as damaged.
>90% correct answers on the Staff Knowledge evaluation question.
Improve staff knowledge in the area of procedures when a device malfunctions. Target:

Specific 2007 Subcommittee Goals & Targets: Actively communicate with departments regarding life support equipment PM/inspections and improve device access protocols. Target: 100%
PM/inspection on Life Support devices.
Target: Module development
Assist the Safety Education Committee in developing clinical alarms education modules. Continue to support the Selection and Acquisition process especially related to the project to replace infusion devices. Monitor, review and improve on quality indicators for maintenance, use, education, regulatory/accreditation compliance, and safety of medical devices
Medical Equipment Management Subcommittee

RECENT AGENDA: 1. Acceptance of previous meeting minutes 2. Recall review
3. 4. 5. 6. 7.
Performance indicators Alarms assessment Clinical equipment incident follow-up and reporting JCAHO/CMS Readiness Specific device issues
Discussion about Safe Reporting changes
Recall system improvement update
8.
New business
Device damage reduction Infusion device replacement project update Staff education knowledge improvement Thermometers variability between techniques
Medical Equipment Management Reporting

Corrective Work Order Counts by Work Order Type (04/01/06 - 6/30/07 by Quarter)
500 Work Order Count 400 300 200 100 0 6/30/06 9/30/06 12/31/06 3/31/07 6/30/07 Quarter Ending Maintenance Random Use Error Damaged No Problem Found

Corrective Work Order Counts Detail (04/01/06 - 6/30/07 by Quarter)
Work Order Counts 140 120 100 80 60 40 20 0 6/30/06 9/30/06 12/31/06 3/31/07 6/30/07 Quarter Ending Maintenance Use Error Damaged No Problem Found

% Errors Per Device Type Per Quarter User Error and No Problem Found Work Orders By Device Type 4/1/07 6/30/07 (Excludes Devices With Inventory Count <15)
13.00% 12.00% 11.00% 10.00% 9.00% 8.00% 7.00% 6.00% 5.00% 4.00% 3.00% 2.00% 1.00% 0.00%
Criteria is less than 10 %

% Damaged Per Device Type Per Quarter Damaged Work Orders By Device Type 4/1/07-6/30/07 (Excludes Devices With Inventory Count <15)
8.00% 7.00% 6.00% 5.00% 4.00% 3.00% 2.00% 1.00% 0.00%
Criteria is less than 10 %
Medical Equipment Management Reporting:
Recalls
Contact Date Letter dated July 2007
New
Description
Priority
Action
Status
Philips Information Centers
It is possible for a networked Information Center to incorrectly associate one patients 12-lead capture with multiple patients on Information Centers connected to the same database server.
High
Contact Philips for software upgrade. While awaiting software correction, use Interim operation procedures to avoid this problem.
PENDING: Philips Medical Systems contacted. Awaiting information on software correction.
Medtronic LifePak 500 Automated External Defibrillators
August 10, 2007 ECRI
AEDs with software High version 4.4 and below may deliver a shock of 100J when the AED set to flexible energy protocol. The minimum factory default setting is 200J.
AEDs need to be set to fixed energy protocol to avoid this problem. Contact Medtronic for possible software fix.
PENDING: Affected units identified. Greg Ward contacted. All LifePak 500 AEDs will be set to fixed energy sequence to be consitent throughout the hospital.
Medical Equipment Management Reporting:
Recalls
Contact Date June 1, 2007 ECRI
Existing
Description
Priority
Action
Status
Smiths, Level 1 H-1200 Fast Flow Fluid Warmers
Quick reference guide released including warnings related to a February 2007 recall.
Normal
Verify the safety alert letter and guide has been received. Attach guide to all machines.
COMPLETED: Quick reference guides attached to units. Acknowledgement form faxed to Smiths Medical.
Smiths, Level 1 H-1200 Fast Flow Fluid Warmers
May 25, 2007 ECRI
The plastic clamp slot door latch may break or bend. Alarm will occur. Related to February 2007 recall.
High Priority
Verify the safety alert letter received and discontinue use of any unit with a bent or broken door latch.
COMPLETED: Replacement metal door latches received from Smiths. Door latches installed on units. Acknowledgement form faxed to Smiths Medical.
Adverse Medical Events
Investigative Activities
Deaths Serious
injuries Other injuries Malfunctions which if repeated could cause one of the above Other close calls
Incident Investigation: Arthroscopic Irrigator
Incident: Irrigator did not stop infusing expanding the patient shoulder joint causing nerve injury Reporting review: Five similar incidents found in FDA Maude database. ECRI reports problem with specific unit. Tool: Digital pressure meter with analog output Analysis: Failure not reproduced. Design issue found Overpressure relief set to 500mmHg, recommended is 250mmHg Recommendation: Return to manufacturer for further evaluation. In future, use irrigator with over pressure relief set for lower value
Test setup for irrigator
Safety, Risk and Quality Management Summary

Healthcare safety and reliability is worse than 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

Quality improvement, reduced risk and better safety
Questions
Discussion
Comments

Clark Safety in HC Monday 14 30

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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

ACCE Healthcare Technology Foundation

Hospital safety programs

Example teaching hospital program

Impact Of Clinical Alarms On Patient Safety

Limitations of clinical alarm systems

Difficulty in learning more than 6 different alarm signals

more problems than benefits

Limitations of clinical alarm systems

99.4% of the alarms were determined

False alarms/nuisance alarms Procedures Patient conditions Design

High false-positive rates loss of credibility disabling of alarms by medical personnel

Reported Clinical Alarm problems

Alarm failure Interconnects defective

Reported Clinical Alarm problems

FDA MAUDE Database Review

237 reports were found

Joint Commissions Alarm-Safety Goal

Sentinel Event Alert February 26, 2002

National Patient Safety Goals for 2003 and 2004

Current AAMI/ANSI standards

Clinical Alarm Survey

Clinical Alarm Survey:

Biggest issue: False Alarms and Nuisance Alarms

attention and response Disrupt care and reduce trust in alarms

The majority support:

Not reported as significant:

If well designed, remote alarm communication devices can be of value

Actions to Improve Alarms

responses to alarm conditions, & consider institutional/departmental standardization

The medical device industry must focus on reduction of false alarms

Audible and Visual

Healthcare Technology Management and Patient Safety

Constructors, manufacturers, Vendors

Healthcare Integrated Program

Risk Management Safety Management

Healthcare Safety Issues

Safety Structure in the Hospital

Healthcare Technology Patient Safety Activities

Healthcare Technology Patient Safety Activities

Healthcare Institution/System Efforts to Improve Patient Safety

Hospital Safety Committees

Environment of Care Committee

Security, Hazardous Materials, Emergency, Fire, Utilities, and Medical

Environment of Care Committee

FAHC = Fletcher Allen Health Care; Burlington VT USA

Medical Equipment Management

Joint Commission International Standard

Medical Equipment Management

Joint Commission International Standard

Medical Equipment Management

Medical Equipment Management

Medical Equipment Management

Medical Equipment Management

Basic 2007 Subcommittee Goals:

Medical Equipment Management

Basic 2007 Subcommittee Goals:

Medical Equipment Management

<10% of work orders classified as damaged.

>90% correct answers on the Staff Knowledge evaluation question.

Medical Equipment Management

PM/inspection on Life Support devices.