Medical Device Management Flashcards

1
Q

CMMS

A
  • Computerized Maintenance Management Systems
  • Equipment Tracking system
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2
Q

Why use CMMS

A
  • Accreditation Requirements
  • Important to keep to date the inventory for PMS,
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3
Q

CMMS components

A
  1. Projects (less common)
  2. Assets
  3. Work Orders
  4. Purchase
  5. Ressources
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4
Q

Asset Inventory

A
  • Department (ownership)
  • Location
  • Child/Parent relationship (sub-components)
  • Utilization infromation (scheduled PM)
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5
Q

Service Actions

A
  • Originial problem/request
  • Inteventation Type (repair, inspection, project, device alert)
  • Start and End dates
  • Labour Hours
  • Service Provider
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6
Q

4 Types of Procurement

A
  1. Capital Procurement
  2. Parts/Supplies Procurement
  3. Consumables Procurement
  4. Fee for Service Procurement
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7
Q

Resources

A
  • Parts and Supplies management
  • Human Resource Scheduling
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8
Q

Data Integrity

A
  • Enforced by the System
  • Enhanced by the System
  • Based on Departement-wide, standard operating procedures and definitions
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9
Q

5 Project Management Steps

A
  1. Define
  2. Plan
  3. Execute
  4. Monitor & Adjust
  5. Complete & Evaluate
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10
Q

Project Management Triangle

A
  1. Cost
  2. Scope
  3. Time
  4. Budget Resources
  5. Features Functionality
  6. Schedule
  7. Quality
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11
Q

Step 1: Define Scope

A
  • What needs to be achieved
  • Where will it be implemented
  • Who needs to be involved
  • When is it for
  • How will it be managed
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12
Q

Step 2: Plan

A
  • Create a project plan
  • Map out current and proposed processes and workflows
  • Set measureable milestones
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13
Q

Step 3: Execute

A

Maintain Communication, follow plan and processes

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14
Q

Step 4: Monitor and Adjust

A
  • Keep all stakeholders informed of progress
  • Monitor rsik and develop plans to address
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15
Q

Step 5: Complete & Evaluate

A
  • Transfer Knowledge
  • Complete and archive documentation
  • Debrief for lessons learned and improvements
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16
Q

3 Unique Challenges for Healthcare Project Management

A
  1. Priority is always the patient care
  2. Team members hold many roles
  3. Language
17
Q

What does inspection ensure?

A
  • The technology performs its intended function
  • Initial performance characteristics are measured and recorded
  • Incoming inspection and accpetance testing is performed and met
  • Remaining terms and conditions of sale are met.
18
Q

Schedule Maintenance by Accreditation Canada

A
  1. Preventive maintenance program for all medical devices, medical equipment, and medical technology
  2. Preventive maintenance reports documents
  3. Process to evaluate the effectiveness of the preventive maintenance program.
19
Q

Predictive services actions to? and Based on?

A
  • Maintain Calibration and proper operation
  • Reduce Predictable failures
  • Prolong effective useful life
  • Adhere to regulation and accreditation requirements.
    Based on:
  • Manufacturers recommended guidelines
  • Risk based assessment of equipment (AEM)
20
Q

3 Types of Device Failures

A
  1. Diagnostic
  2. Therapeutic
  3. Assistive/Rehabilitative
21
Q

Diagnostic Device Failures

A
  • Provide inaccurate information leading ro inappropriate medical decisions
  • Malfunction due to environmental effects
  • Used for other than intended use
  • Fail when alarm is turned off
  • Cause allergic response when in contact
22
Q

Therapeutic Device Failures

A
  • Failure to deliver adequate or execessive delivery of agent
  • Innappropriate delivery of therapy
  • Inadequate training or experience of user
  • Allergic response
  • Interaction between multiplee agents/devices
23
Q

Assistive/Rehabilitative Device Failures

A
  • Patient Inadequately informed or trained
  • Failure to report for checkup
  • Device inadequately protected from environmental conditions
24
Q

4 Preventative/Scheduled Maintenance Failure Codes

A
  1. Evident Failure (EF): Problem that can be detected but wasn’t reported without running special tests.
  2. Hidden Failure (HF): Problem that can’t be detected unless running special tests.
  3. Potential Failure (PF): Failure about to occur but that hasn’t cuased the equipment to stop working.
  4. No problem found (NPF)
25
Q

5 Corrective Maintenance Failure Codes

A
  1. Unpreventable (UPF): Evident to user, typically caused by normal wear and tear but unpredictable.
  2. Failure induced by use (USE): Doesn’t include errors
  3. Preventable and Predicatble Failure (PPF): Evident to User
  4. Service-Induced Failure (SIF): Failure induced by corrective or pm that was not properly completed.
  5. Can not duplicate (CND): Includes use errors
26
Q

3 Corrective or Preventative Maintenance Failure Codes

A
  1. Battery Failure (BATT): Batteires failed befroe the schedule replacement time
  2. ACC: Accessory failures evident to user, from normal wear and tear
  3. NET: Failure caused by network, while equipment is still wokring without problems.