Chapter 2 CENG Equipment Maintenance Program

Question 1

Why the need for equipment maintenance?

Answer 1

To promote safe and effective use of medical equipment for patient care

Question 2

Who provides the function of equipment maintenance?

Answer 2

In-house department or external organizations

Question 3

What does a comprehensive equipment management include?

Answer 3

• A program to control and monitor equipment performance.
• A program that monitors total equipment maintenance costs.
• Involve in new equipment acquisition and replacement decisions.
• Involve in the development of new services.
• Development of training programs for all equipment users.
• A quality assurance program.
• Risk management.

Question 4

Why are there strict policies and procedures when a hospital needs to purchase
replacement equipment or introduce new technology into its operation

Answer 4

1. To prevent conflict of interests.
2. To source for most reasonable deal.
3. To be precise in the specifications.

Question 5

What are the processes of equipment acquisition?

Answer 5

► Justification
► Selection
► Implementation
► Conclusion

Question 6

What are the 4 processes of justification to replace an existing equipment?

Answer 6

• Cost-effectiveness: if the acquisition of the new equipment can save
  more than the cost of the acquisition in 3-5 years.
• Safety: existing equipment can no longer operate within the accepted
  standards.
• Maintenance costs: continual maintenance of existing equipment is
  about 50% of replacement costs.
• Reasonable period: generally a 7-year guideline.

Question 7

How to assess a new technology?

Answer 7

Assess the technology:
- Does it provide a needed service?
- Will it be accepted?
- Determine the operating and maintenance costs.
- Determine any special requirements like special installation needs

Question 8

When discussed with groups of staffs to determine the suitability of a technology, what are the different concerns?

Answer 8

• Medical: concerned with the function.
• Nursing: concerned with the operation.
• Clinical engineering: concerned with the safety & performance.

Question 9

What is the last justification process?

Answer 9

Submit the proposal including the required budget.
The completed proposal will be submitted to the hospital administration
(i.e. the management) where the proposal will be reviewed for feasibility
according to the hospital’s long-term plans and patient population.

Question 10

What are included during the selection process of equipment acquisition?

Answer 10

1. Literature review
2. Call for tender
3. Preliminary review
4. Engineering evaluation
5. Clinical evaluation
6. Assessment
7. Final choice

Question 11

Pros of standardization of equipment? TELA

Answer 11

1. Technical staffs are more familiar with equipment.
2. Easier to obtain replacement parts.
3. Less expensive to keep in inventory.
4. Allows equipment movement to meet varying needs among clinical areas

Question 12

Cons of standardization of equipment?

Answer 12

1. Hospital is dependent on a limited number of vendors.
2. Interfere user acceptance if users have little say in the selection process.
3. Delay the introduction of new technology

Question 13

What are the 5 implementation processes? PIATF

Answer 13

1. Purchase order (PO)
2. Installation
3. Acceptance testing
4. Training
5. Follow-Up

Question 14

What are the objectives of an equipment control program?

Answer 14

1. Equipment that is appropriate and adequate for its purchased intent.
2. Equipment is properly maintained.
3. Equipment is included in a planned replacement schedule.
4. Equipment is monitored for its liability risks.
5. Equipment is tracked for the costs of repairs and maintenance.
6. Staff are adequately trained in equipment use

Question 15

What are the components of an equipment control program?

Answer 15

1. Inventory control.
2. Hazard awareness.
3. Quality assurance.
4. Cost effectiveness

Question 16

What are the 2 objectives of equipment hazard awareness?

Answer 16

1. To minimize risks to patients and staffs.
2. To reduce the risk of liability to the hospital

Question 17

What is quality assurance?

Answer 17

 Improve quality of health care:
1. Patient safety and risk management.
2. Evidence-based practice.
3. Continuous learning and improvement.
- Stimulate and improve integration and management of health services.
- Reduce variation in care and health care costs.
- Strengthen the public’s confidence in the quality of health care.

Question 18

What must be included in a quality assurance documentation? 3R

Answer 18

1. Equipment selection process.
2. Acceptance tests conducted
3. Maintenance records
4. Repairs records
5. User training records.
6. All related costs.

Question 19

What is the priority and PM intervals when EMC ≥ 16?

Answer 19

Priority: Life support
PM interval: Minimum twice per year

Question 20

What is the priority and PM intervals when EMC 12 - 15?

Answer 20

Priority: Non-life support & direct patient care
PM interval: Minimum once per year

Question 21

What is the priority and PM intervals when EMC ≤ 11?

Answer 21

Priority: Non-life support & indirect patient care
PM interval: Preferably once per year.

Question 22

What is the objective of a biomedical equipment maintenance program?

Answer 22

Provide safe, calibrated, and operational equipment for delivery of the
best health care possible

Question 23

What are the three known maintenance
strategies that can be implemented for a maintenance program?

Answer 23

Preventive Maintenance (PM)
Corrective Maintenance (CM)
Predictive Maintenance (PdM)

Question 24

What is preventive maintenance (PM)?

Answer 24

Maintenance strategy based on a schedule or timetable. Utilising the
equipment management code, equipment is evaluated for its function,
physical risk and maintenance requirement. The code assigned determines
the maintenance interval

Question 25

What is corrective maintenance? (CM)

Answer 25

Maintenance strategy is one that restores a piece of equipment to operational status only after an equipment failure or breakdown

Question 26

What is predictive maintenance? (PdM)

Answer 26

A maintenance strategy that provides a mean to achieve reliability levels that exceed the performance of a piece of equipment. Predictive analysis programs are used to confirm possible faults of the equipment and specific repairs needed even before the failure occurs. This maintenance strategy is usually used for equipment that may compromise its performance or safety to patient. For example, those in the critical care areas

Question 27

What are some problems affecting PdM strategy?

Answer 27

- For accurate prediction, advanced technologies are required to monitor every aspect of the equipment. - Repaired equipment ≠ ‘as good as new’ condition. - Variability in the skills of maintenance personnel. - Location and ease of accessibility of defect sites. - Complexity of the equipment. - Age of the equipment. - Quality of replacement parts

Question 28

What are problems affecting an effective PM strategy

Answer 28

- Equipment unavailable: especially when used for daily monitoring or in critical care areas. - Equipment cannot be located: may be in transit between clinical departments. - If the PM procedure is too detailed, resources can be wasted. - If the PM procedure is too superficial, maintenance may be inadequate.

Question 29

What is the typical Pm schedule?

Answer 29

Typical PM interval is 6 to 12 months

Question 30

What are the 4 PM procedure? VCFS

Answer 30

1. Visual inspection 2. Cleaning 3. Function testing 4. Safety testing

Question 31

What is resolution?

Answer 31

It is the least count or reading of a parameter which the instrument is capable of indicating. It shows how fine the reading can be.

Question 32

What is sensitivity?

Answer 32

Smallest input level of a quantity to which an instrument is capable of responding

Question 33

What is stability?

Answer 33

It indicates the instrument’s capability to retain its accuracy over a period

Question 34

What is PPM?

Answer 34

(parts per million). A unit of concentration often used when measuring levels of pollutants in air, water, body fluids, etc. One ppm is 1 part in 1,000,000.

Question 35

What are type tests?

Answer 35

Tests carried out by approved test houses under tightly specified environmental conditions. Eg The Cardio Vascular Device Testers verify the fatigue life of cardiovascular prostheses such as septal patches, stapling devices and balloon assist devices.

Question 36

What are routine tests?

Answer 36

Routine tests should be functionality and electrical safety tests without subjecting it to undue stress, which would be liable to cause deterioration. Eg. Non-invasive blood pressure (NIBP) simulator: simulates pressure, tests for leak and over-pressure

Question 37

When must medical equipment undergo routine test? 3

Answer 37

1. Newly acquired equipment prior to being accepted for use (i.e., acceptance testing). 2. During routine planned preventive maintenance. 3. After repairs have been carried out on equipment.

Question 38

What is accelerated testing?

Answer 38

The concept of accelerated testing is based on using ‘real life’ operational data and trying to accelerate fault conditions by applying key operational failure-causing stresses.

Question 39

What are the 3 key operational failure-causing stresses that contribute most commonly to the impairment of a product’s reliability?

Answer 39

-Thermal cycling: induces stresses due to differential expansion of components and materials. -Vibration and fatigue: tests mechanical failures due to cyclic stressing. -Power cycling: turning on and off the electrical power

Question 40

What are the 4 equipment maintenance approaches a hospital can adopt?

Answer 40

1. Contract for services with a variety of equipment manufacturers. 2. Contract as a shared service group. 3. Contract with an independent service company. 4. Create an in-house clinical engineering department.

Question 41

Advantages & disadvantages of In-house clinical engineering department?

Answer 41

Advantages:  Cost-effective for large facilities.  Fast response time.  Familiarity with hospital staff and protocol.  Always on-site Disadvantages:  Productivity low if not managed properly.  Staff turnover and absence can create issues.  Small staff number may not have adequate expertise.  Initial startup costs high

Question 42

Advantages & disadvantages of equipment manufacturers?

Answer 42

Advantages:  High expertise for specific equipment.  Repair usually accomplished quickly, once on-site.  Replacement parts are usually immediately available.  No capital equipment costs. Disadvantages:  Highest hourly cost.  Documentation may vary with different manufacturers.  Needs coordination if hospital has equipment from many manufacturers.  Representative is not familiar with hospital personnel and protocol

Question 43

Advantages & disadvantages of Shared service group?

Answer 43

Advantages:  Cost effective if shared by several hospitals.  Many levels of expertise is usually available.  Cost saving approach.  No capital equipment costs Disadvantages:  Response time is the longest as coordination is via the group office.  Weaker working relationship with manufacturers or vendors.  Group office staff turnover and absence can create issues.  Representative is not familiar with each hospital unique environment

Question 44

Advantages & disadvantages of independent service company

Answer 44

Advantages:  Cost-effective for small facilities.  No capital equipment costs.  Most replacement parts are usually available.  Proper documentations are usually provided. Disadvantages: Dependent on vendor (i.e. 3rd party) instead of manufacturer.  May not have specific equipment expertise.  Slow response time.  Representative is not familiar with hospital personnel and protocol.

Question 45

What are the typical biomedical equipment maintenance program? 7 BBPERIM

Answer 45

 Biomedical equipment safety and quality assurance testing.  Biomedical equipment repair.  Pre-purchase evaluation and post-purchase testing.  Environmental programs.  Risk management.  In-service training.  Management reporting

Question 46

What should a typical biomedical equipment maintenance program evaluated based on?

Answer 46

1.Cost 2.Quality 3.Training 4.Response time 5.Continuity of coverage