Medical Device Management

Question 1

CMMS

Answer 1

• Computerized Maintenance Management Systems
• Equipment Tracking system

Question 2

Why use CMMS

Answer 2

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

Question 3

CMMS components

Answer 3

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

Question 4

Asset Inventory

Answer 4

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

Question 5

Service Actions

Answer 5

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

Question 6

4 Types of Procurement

Answer 6

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

Question 7

Resources

Answer 7

• Parts and Supplies management
• Human Resource Scheduling

Question 8

Data Integrity

Answer 8

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

Question 9

5 Project Management Steps

Answer 9

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

Question 10

Project Management Triangle

Answer 10

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

Question 11

Step 1: Define Scope

Answer 11

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

Question 12

Step 2: Plan

Answer 12

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

Question 13

Step 3: Execute

Answer 13

Maintain Communication, follow plan and processes

Question 14

Step 4: Monitor and Adjust

Answer 14

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

Question 15

Step 5: Complete & Evaluate

Answer 15

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

Question 16

3 Unique Challenges for Healthcare Project Management

Answer 16

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

Question 17

What does inspection ensure?

Answer 17

• 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.

Question 18

Schedule Maintenance by Accreditation Canada

Answer 18

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.

Question 19

Predictive services actions to? and Based on?

Answer 19

• 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)

Question 20

3 Types of Device Failures

Answer 20

1. Diagnostic
2. Therapeutic
3. Assistive/Rehabilitative

Question 21

Diagnostic Device Failures

Answer 21

• 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

Question 22

Therapeutic Device Failures

Answer 22

• 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

Question 23

Assistive/Rehabilitative Device Failures

Answer 23

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

Question 24

4 Preventative/Scheduled Maintenance Failure Codes

Answer 24

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)

Question 25

5 Corrective Maintenance Failure Codes

Answer 25

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

Question 26

3 Corrective or Preventative Maintenance Failure Codes

Answer 26

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.