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Clinical Engineering > Patient Safety and Risk Management > Flashcards

Patient Safety and Risk Management Flashcards

1
Q

What is a Medical Device Incident

A
  • Failure of medical device
  • deterioration in its effectiveness
  • inadequacy in its labelling or in its directions for use
  • led to the death or serious deterioration in the state of health of a patient, user or other person.
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2
Q

What is serious deterioration in state of health

A
  • Life threatening disease, disorder of abnormal physiclal state
  • Permanent impairment of a body function
  • Permanent Damage fo a body structure
  • Condition that necessites an unexpected medical or surgical intervention to prevent the disease
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3
Q

What is a Serious Drug Reaction

A
  • Unintended response to a drug that occurs at any dose
  • Requires in-patient hospitalization
  • Prolongation of existing hospitalization, causes congenital malformation
  • Results in persisent or signigicant disability or incapacity, is life-threatening, or results in death.
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4
Q

4 recommendations for building a safer health system (LEPS)

A
  1. Leadership and knowledge
  2. Identifying and learning from errors
  3. Set performance standards and expectations for safety
  4. Implementing safety systems in Healthcare organizations
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5
Q

3 fundamental principles of best practices model in US

A
  1. An organization must know how its processes work
  2. Variability in processes must be reduced
  3. Repeatable processes must be implemented
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6
Q

Accreditation Canada

A
  • Provide national and international healthcare organizations with external peer review process to access and improve the services they provide to their patients and clients based on standards of excellence
  • Self assessment augmented by site-visits
  • Employ interviews and tracers as an evaluation method
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7
Q

Required Organizational Practices Definition

A
  • An essential practice that organiations must have in place to enhance patient/client safety and minimize risk.
  • Implement an effective preventative maintenance program for all medical devices, equipment and technology.
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8
Q

Required Organizational Practices (ROP) 6 Sectors (SMICWR)

A
  1. Safety Culture
  2. Medication USe
  3. Infection Control
  4. Communication
  5. Work life/ Work Force
  6. Risk Assessment
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9
Q

2 Risk Identification

A
  1. Proactive: Based on current knowledge and data
  2. Retrospective: Based on past history, data and experience
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10
Q

4 Human Factors Points that can Impact their work (AWLJ)

A
  1. Attention - Inattention Blindness
    Approprate reminders in the environment
  2. Working Memory
    Reduce need by building in side-by-side comparisons, and limiting memory tasks
  3. Learning
    Easier to learn when things are consistent and similar to previous experiences
  4. Judgement and decision-making
    Humans rely on ‘rules of thumb’ to save attentional resources
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11
Q

5 Human Factors Design (DOPFE)

A
  1. Device
  2. Operator
  3. Patient
  4. Facility
  5. Environment
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12
Q

10 Device/Technology Factors

A
  1. Design
  2. Manufacture
  3. Transportation
  4. Inspection
  5. Maintenance
  6. Recall and Modification Notices
  7. Variability
  8. Labelling
  9. Training
  10. Availability
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13
Q

10 Operator/Human Factors

A
  1. Misuse (lack or improper training)
  2. Abuse (intentional or unintentional)
  3. Inattention (most accidents occur during shift change or graveyard shift)
  4. Judgement
  5. Communication
  6. Teamwork
  7. Stress
  8. Compliance with Policies
  9. Emotions
  10. Workflow Limitations
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14
Q

3 Facility Factors

A
  1. Human Factors Design (not sufficient utilities)
  2. Deterioration (Repeated connect/disconnect of cable might affect its retention)
  3. Maintainer (lack of resources to maintain)
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15
Q

6 Patient Factor

A
  1. Behavioral Issues
  2. Language Issues
  3. Compliance (passive/active patient)
  4. Knowledge deficit
  5. Fear
  6. Disease acuity
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16
Q

2 Environmental Factors

A
  1. External (outside weather)
  2. Internal (Time of day, lighting)
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17
Q

The Swiss Cheese Model

A

When various of small errors occur that on their own would not be harmful but when all together might lead to the loss of a patient.

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18
Q

3 effective methods to ensure safety of medical device design

A
  1. Remove risk through device design
  2. Add alarms and safety mechanisms
  3. Provide instructions and training
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19
Q

4 Types of Controls with safety/human factors in mind

A
  1. Device controls (specific connections)
  2. Process controls (QA’s built into point of care devices)
  3. Environmental controls (sensors to shutdown system if inadequate cooling)
  4. User controls (design to make more intuitive, less likely to fail)
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20
Q

2 Types of Medical Device Design

A
  1. Heuristic Evaluation
  2. User testing
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21
Q

Heuristic Evaluation, 10 general principles for interaction design

A
  1. Visibility of system status
  2. Match between system and the real works
  3. User control and freedom
  4. Consistency and Standards
  5. Error prevention
  6. Recognition rather than recall
  7. Flexibility and efficiency of use
  8. Esthetic and minimalist design
  9. Help users recognize, diagnose, and recover from errors
  10. Help and documentation
22
Q

User Testing

A
  1. Gather information on how a user will interacts with the device in a real world setting
  2. Information should be gathered on performance(errors) as well as subjective data.
23
Q

Device Evaluartions, 4 points to ensure safety

A
  1. Performance and safety (alarms, limits)
  2. Ease of use to other human factors design
  3. Quality of construction - reliable/available
  4. Service and support
24
Q

What is FMEA

A
  • Failure Mode and Effect Analysis
  • Team-based, systemic, prospective hazard analysis technique used to prevent process and product problems before they occur.
  • Uses decision trees and flow diagrams and each step is analyzed for potential failure modes and weakenesses
25
Q

FMEA advantage

A

Prevents adverse occurrences, rather than simply reacting when they occur

26
Q

2 key items to identify in FMEA

A
  1. Severity of potential failure
  2. Probability of failure
    Results are collected to develop a scoring matrix
27
Q

FMEA Steps

A
  1. Define the FMEA Topic along with a clear definition of the process to be studied.
  2. Assemble the Team: need to be multidiscplinary including subject matter experts.
  3. Graphically Describe the Process: develop and verify the flow diagram
  4. Conduct a Hazard Analysis: List all possible failure modes under sub-processes, determine the severity and probability of the potential failure mode, use decision tree to determine if the failure mode warrants further action
  5. Actions and Outcomes Measures: Determine if you want to eliminate, control or accept the failure mode cause.
28
Q

Alerts and Recalls in Canada

A
  • Issued by manufacturer
  • Depends on the severity, manufacturer might completely remove the device or implement changes (mech, software or process)
  • HC wants voluntary recall when it contravenes the Act or Regulations or presents a risk in health to Canadians
29
Q

4 Processes in Recall Management of CE

A
  1. Audit/Review
  2. Identify Affected Products/Processes
  3. Assessment of Impact
  4. Develop resolution in coordination with CE, Clinical staff and clinical staff.
30
Q

What is Quality

A

Product or service free of deficiencies

31
Q

What is Quality Assurance

A
  • Applies to only Services
  • QA implies a measure of the level of service provided by a dept. or group
32
Q

General Objectives of QA

A
  • Increase the effectiveness, the efficacy and the quality of services delivered.
  • Help the organization to provide good patient care
  • Measured by comparing the actual results to the pre-established performance criteria.
  • Criteria must be realistic and achievable, contribute to increased quality service.
33
Q

4 Steps of QA (PDSA)

A
  1. Plan
  2. Do
  3. Study
  4. Act
34
Q

Plan

A
  1. Assign Responsibility (overall vs particular responsibility)
  2. Delineate Scope of Service (what services are provided by CE, what type of equipment, who provides the services, when are they provided)
  3. Identify Important Aspects of Service (Select services that have greatest impact on patient care/safety).
  4. Identify Indicators (used to define measurable, objective characteristics of each important aspect of service.
35
Q

What is an indicator?

A

Measurable variable relating to the structure, process, or outcome of care. Ideal would reveal wether or not progress has been made.

36
Q

What is a Structure

A

Elements that support services.

37
Q

What is Process

A

Actual procedure or activity

38
Q

What is the Outcome

A

Result of the process

39
Q

7 CE Quality Indicators

A
  1. Turnaround Time: time from initial call to final repair
  2. Response Time: time from inital call to initial response
  3. Downtime: time that system is down and unavailable to perform its primary function
  4. Repeat Repairs: nb of repairs due to same problem on particular device within short window
  5. PM Failure Rate: % of items that fail PM
  6. Use Error Rate: % of repair calls due to operator error
  7. Device Failure Rate: nb of repairs on particual device within a window.
40
Q

Do

A
  • Collect & Organize Data
  • Considet the source of info, what type of data, sample size, frequency of data, etc.
  • Cummulative data should be organized and compared to thresholds routinely
41
Q

Study

A
  • Evaluate Service
  • Evaluate the aspect of service when a threshold is met.
  • Problems may be related to: Insufficient knowledge of staff, defects in organizational system, communication breakdown, lack of conformity to policy/procedure.
42
Q

Act

A
  • Take Actions to Solve Identified Problems
  • Assess Actions & Document Improvement
  • Communicate/report information
43
Q

Why is there a poor detection of events

A
  • Most hospitals depend on spontaneus reporting
  • Culture of blamce (fault the person not the system)
  • Tedious to report
44
Q

How to improve reporting

A
  • Create a culture of safety
  • Maximize reports through simplified reporting, prompted reporting and assessments
45
Q

Incident Reporting

A
  • Internal process (consistent accross organization)
  • Patient incident involving medical devices (Critical injury or near miss)
  • Sourve of Identification (front-line staff and CE)
46
Q

Mandatory Reporting Requirements

A
  • By Health Canada
  • Hospitals are required to report all serious adverse drug reactions and medical device incidents.
47
Q

Vanessa’s Law

A
  • Amends Food and Drugs Act regarding therapeutic products in order to improve safety by introducing measures like
    1. Strenghten safety oversigh of therapeutic products throuhout their life cycle
    2. Take appropriate action when a serious risk to health is identified
    3. Promote greater confidence in the oversight of therapeutic products by increasing transparency
48
Q

Vanessa’s Law - Medical Devices Incidents

A
  • Report within 30 days
  • All Classes of medical devices are included
  • Only required to report information “withing the control of the hospital”
49
Q

Vanessa’s Law - Role of Hospitals

A
  • Develop and maintain internal policies/procedures to comply within reporting requirements
  • Reporting requirement is with hospital NOT individual
  • Not required to report to industry but it is recommended.
50
Q

MDP Reporting

A

Medical Device Problem
* Inadequation labelling or instructions for use
* Failure of the device or a deterioration in its effectiveness
* Actual or potential deficiency that may affect product performance or safety.

51
Q

RCA

A

Root Cause Analysis
* Process for identifying basic or causal factors

52
Q

RCA 5 Steps

A
  1. Define the Problem
  2. Gather Information
  3. Identify contributing issues
  4. Determine the root cause(s)
  5. Develop & implement recommendation to prevent reoccurrence

Clinical Engineering (10 decks)

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