Lecture 03

Mission, Function &

Organizational Structure of
Clinical Engineering Services
 Part II
Policies & Procedures
 Content
Policies & Procedures (P&P)
1. P&P - Introduction
2. P&P - Example: Hazard Recalls and Alerts
3. P&P HT Program - Policies & Procedures
Life Cycle Of Medical Device In A Hospital
 Policies & Procedures

Remark:
• The old systems are based on a hardcopy
documentation systems using papers
• The new systems are based on softcopy
computerized documentation systems using
paperless
• For convenience, I will explain the idea of
difference between a papered inventory system
and paperless inventory system.
Introduction
 Policies & Procedures

Policies
Statements of principles and values that guide
organizational activities … Effective policies are
flexible, coordinated, comprehensive, ethical,
and clear
Procedures
Defined courses of established methods used
to achieve an objective
 Example
Hazard Recalls and Alerts
 Hazard Recalls and Alerts
POLICY:

The Clinical Engineering Department shall follow the prescribed course of action (if
any) for recalls, take such action, and document actions taken.

PURPOSE:

To ensure that clinical equipment in the environment of care is safe and poses no
threat to the patients or staff, and to ensure that necessary actions are taken to correct
any equipment hazard or recall event.
 Hazard Recalls and Alerts
PROCEDURE:

A. Procurement Services receives all hazard recall and alerts. When notice of an
equipment hazard or recall is received by Clinical Engineering, the Technical Support
Manager will ensure that the equipment inventory database is reviewed to
determine if any Hospital equipment is affected.

B. If there is equipment in the inventory which has been identified in the alert or recall,
the Technical Support Manager will:
1. Notify the Department Manager of the alert or recall.
2. Locate the equipment.
3. Take the recommended steps described in the alert.
4. Make an appropriate entry in the alerts database
5. Document the actions in the work order system, or log the report in a
database named Hazard Alerts/Recalls for those items which do not have a CE
Number.
6. Notify the department manager of the action taken.
Hazard Recalls and Alerts
 Hazard Recalls and Alerts

Manufacturer FDA Enforcement ECRI/Health Centralized Medical

Recalls & Alerts Reports Devices Alerts Equipment Documentation

Action Reports
Clinical Engineer

Biomedical
Equipment Inventory
Clinical Engineering Department
Policies & Procedures
Typical Medical Devices
 Typical Medical Devices
Neonatal Intensive Care Unit(NICU/ICN)
Volumetric Infusion Pump
Infant Warmer
Infant Incubators
Typical Medical Devices
Operating Theatres (OT/OR)
Surgical OR Table
Anesthesia Machine
C-Arm X-ray Unit
Typical Medical Devices
Radiology Department
Ultrasound Unit
MRI Machine
Life Cycle Of Medical Device In A Hospital
 Policies & Procedures (P&P)
Management Part
1. Rounds 11. New Employee Orientation
2. Work Order System 12. In-service Education
3. Equipment Initial Testing and 13. Emergency Repair Procedures
Evaluation 14. Equipment Management
Program
4. Electrical Safety Testing
15. Periodic Maintenance
5. Maintenance Priority 16. Operator (User) Errors
Guidelines 17. Clinical Equipment
6. On-Call and Work Hours Repair/Replace Determination
7. Test Equipment 18. Notification of Delay in
8. Quality Improvement Plan Maintenance of Equipment
19. Infection Control
9. Work Request System
20. Hazard Recalls and Alerts
10. Outside Service Control 21. Corrective Actions Found On PM
 Policies & Procedures (P&P)

P&P - Planning Part

1. Medical Equipment Planning

P&P - Management Part

2. Education/Training ~ Regarding proper use, testing &
troubleshooting
3. Incoming inspection of all medical devices & systems
~ Installation & acceptance testing of all purchased,
leased, loaned devices
4. Equipment Classification System ~ Criteria for including
equipment categories in program
 Policies & Procedures
P&P - Management Part

5. Medical equipment inventory management ~ Process for

adding, deleting
6. Inspection & PM ~ Determining protocols & frequencies
7. Medical Equipment Service Request ~ Corrective maintenance
6. Medical Device Tracking ~ Dealing with hazards and recalls
7. Incident reporting & investigation
8. Performance & Benchmarking
9. Storing & Retiring medical equipment
 Policies & Procedures
Remarks:
• The policies and procedures will be based on the old system
(paper-Based) for the clarification
• However, the new system is paperless (computerized
maintenance management system - CMMS).

The CMMS has advantages:

- Generating Reports: Work request, Work orders (CM or PM)…
- Performance Study: through performance indicators
- Cost effective: Analysis of problems, Saving on the staff time
- PM Scheduler: it’s important of large number of medical devices
in the inventory
 Medical Equipment Planning
1. Assess Need ~ Determine Specifications
2. Compare available manufacturers &
models. Assess ease of use, ease of
maintenance, operating & life cycle costs
3. Make selection & prepare purchase order
with specifications including operator &
service manuals, user & service training,
warranty, etc.
4. Acceptance/payment conditional on
passing incoming technical inspection,
inclusion of manuals, provision of user &
service training, adequate warranty
 Medical Equipment Educational Program
• Clinical Staff
– Basic operation & proper use
– Basic Troubleshooting
– Potential hazards
– Equipment management (dealing with obtaining equipment service,
equipment related incidents

• Clinical engineering staff

– Professional (mission, ethics, conduct)
– Codes & standards
– Technical (troubleshooting & use of equipment)
– Clinical equipment operation & inspection procedures
– Policies, procedures & documentation
Medical Equipment Inventory
Old System (using Hardcopy)
 Medical Equipment Inventory
New System (using Softcopy)
C.M.M.S.

Inventory
1 ID or Control # 011178
2 Description Defibrillator
3 Manufacturer Zoll
4 Model # R Series ALS
5 Serial # ZD20190211
6 Location/Cost Center Emergency Department
7 Acquisition Date/Cost 13/02/2019

8 Maintenance requirements
(frequency/schedule)
9 Accessories List SpO2 Sensor, 3-Lead ECG….
10 Supplier CareTek
 Centralized Documentation System
Old Hardcopy (paper)
Defibrillator Operator’s &
Service Service Manuals
Reports

Recalls &
Inspection
Hazard Reports
Forms
 Centralized Documentation System
New Softcopy (paperless)
Computerized Maintenance Management System (CMMS)
Incoming Inspection of Medical Equipment
Purchased,
Leased,
Demo or
Loaner
Equipment

Biomedical Equipment
Clinical Engineer Technician (BMET)

Centralized Biomedical
Equipment Documentation

Inspection Form
 Equipment Management Program
“Risk-based Classifications”

Equipment Categories

Included in program

High EM Rating/Score
Equipment Management (EM)
Category Classification Policy/Procedure
Application
+ Risk
+ Maintenance Requirements
+ History
= Total EM Rating/Score
Low EM Rating/Score

Exempt from program

 Biomedical Inspection/PM Program
Inspection Schedule Inspection
Procedures
Biomedical & Forms
Equipment
Inventory

Centralized
Biomedical
Equipment
Documentation
 Medical Equipment Tagging System

Inventory Tag

Inspection Tag Operator Warning Tag

Exempt Tag

Red
Storage Tag (Remove
from Service) Tag
Biomedical Equipment Tagging System
Fluke Biomedical
Medical Equipment Tagging System
Fluke Biomedical
 Medical Equipment Service/Repair

Equipment Clinical
Service
User Engineering
Request

Biomedical Equipment
Centralized Biomedical Technician (BMET)
Equipment Documentation

- Or

Service
Report
 Equipment Hazard/Recall Program

Manufacturer FDA Enforcement ECRI/Health Centralized Biomedical

Recalls & Alerts Reports Devices Alerts Equipment Documentation

Action Reports
Clinical Engineer

Biomedical
Equipment Inventory
 Equipment Related Incident Investigation
1. Minimize further injury to patients & personnel
2. Minimize any damage to equipment & facilities
3. Impound all equipment, supplies, disposables, wrappers,
etc.
4. Identify witnesses
5. Notify Risk manager, clinical engineering
6. Complete incident report
7. Notify authorities
 Equipment Management Program
Benchmarking
Safety Committee
How to measure program performance
& effectiveness?

Establish Goal & Compare with

Actual
For example:
– User related equipment problems
– Scheduled vs Actual inspections
– Percent of inspections with problems
found
Medical Equipment Storage/Retirement

- Temporarily removed
from service

- Obsolete
- Repair not cost-effective