Doc-2-Bio Medical Engineering Manual
Doc-2-Bio Medical Engineering Manual
CONTROL COPY
Issue date: 23/06/2017
NHI/FMS/Doc No 2
Issue No.:01
Effective Date: 07/07/2017
Rev No.: 06
Bio Medical Engineering Manual
CEO
Approved By : Name : Dr. O.P. Yadava
Signature :
Vice CEO
Reviewed By : Name : Dr. Vinod Sharma
Signature :
Accreditation Coordinator
Coordinator
Issued By : Name : Wg. Cdr. B. Jena
Signature :
Amendment Sheet
Table of Contents
1. Purpose
2. Scope
3. Responsibility
4. Prime Activity
5. Equipment under Monitoring
6. Departmental Hierarchy
6.1. Hierarchy chart
7. Job Description
7.1. Biomedical Engineer
8. Departmental Policies
8.1. Statutory Requirement
8.2. Annual Maintenance Contract (AMC)
8.3. Equipment profile
8.4. Engineering department / services safety
8.5. Inspection of biomedical equipment
8.6. Condemnation
8.7. Quality and Monitoring systems
9. Departmental procedure
9.1. Complaint / Breakdown management
9.2. Preventive Maintenance
9.3. History Card
9.4. Annual Maintenance Card
9.5. Fire safety for Bio medical equipment
9.6. Equipment Calibration
10. Quality Indicator
11. Annexure
11.1. Forms / Document
11.2. Breakdown slip / Register
11.3. Mechanical maintenance Schedule and Record
Introduction
The appropriate and safe operation of clinical equipment is paramount to the proper
functioning of any health care facility. The Biomedical Engineering department is
responsible for testing, repairing, and maintaining in proper and safe operating condition,
the hospital’s diagnostic and therapeutic equipment
1 Purpose
2 Scope
3 Responsibility
Bio Medical Engineer and all the Technicians of the user departments
4 Prime activities
Equipment Process
Medical equipment Maintenance of all the medical equipment viz.
therapeutic, diagnostic equipment
Ambulance ACLSambulance is maintained with life support
systems ventilator with oxygen backup and
other facilities such as suction, defibrillator, &
water supply
Clinical Assist in all the medical studies relating to the
Engineering engineering aspects.
Supports in all the purchase of ward equipment
work out feasibility
6 Departmental hierarchy
6. 1 Hierarchy chart
CEO/VCEO
Director
Operations
HEAD USER
DEPARTMENT
BIOMEDICAL
ENGINEER
7 Job Description
7. 1 Bio Medical Engineer
POSITION GUIDELINES
Name: Year
Job title: Biomedical Department
Engineer
Qualification& Experience (minimum requirements preferred)
Degree in Engineering:
Engineering:-BE 1. Worked with MAQUET
2. Worked with ARTEMIS Health Institute
Key responsibilities
• Perform a variety of routine tasks associated with the installation, maintenance, and
repair of a diverse range of clinical equipment, typically non-life support.
• Maintain effective working relationships with fellow workers, clinical and medical staff,
and others they may come in contact with.
• Report all patient safety issues to Executive Quality and assist in taking corrective and
preventive actions.
• Notify user departments regarding status of repairs and works with departments to
obtain loaner or replacement equipment as and when required.
FINANCIAL RESPONSIBILITIES
• To ensure expense lines of equipment maintenance and calibration are within
forecast.
CUSTOMER RESPONSIBILITIES
• To take appropriate measures to prevent complaints related to functioning of
any biomedical equipment.
• To undertake a quick response time to all such complaints
• To ensure safety of the staff and the patient using the equipment
PROCESSS RESPONSIBILITIES
• Coordinate special projects and perform specialized technical tasks involved in
the installation and maintenance of clinical equipment. Interpret engineering
and vendor information, schematic diagrams, and graphic illustrations utilizing
clinical physiologic and electronic principles.
• Improve or make special test setups to conduct functional checks with
biomedical test equipment
• Execute a scheduled preventive maintenance program for clinical equipment
• Assist departments in capital equipment planning; assist in identifying and
recommending replacement of equipment that is obsolete, has extensive repair
history, or has identified safety issues.
• Work with Procurement Services and departments to ensure that all incoming
clinical equipment is inspected, installed and used as per departmental policy.
Direct reports:
reports Head of the Departments
Indirect reports:Technicians
reports:
Main stakeholders
External: Patients, Vendors, Contract Agencies.
Internal: Consultants, Staff and Contract Staff.
Please Note: This is not an exhaustive list of responsibilities but provides a general guideline
of the duties assigned to the position. Position Guidelines are dynamic and will change
depending on the organizational requirement.
8 Departmental Policies
8. 1 Statutory Requirements
• The Equipment on AMC are identified and marked in the History card
• The record contains the following:
Name of the Equipment
Equipment ID number
Service provider’s name
Contact person
Address
Frequency of the service annually
Tenure of the contract
• The history card contains the preventive maintenance frequency and calibration
requirements and break down maintenance details
• On the basis of the information gathered on the history card, Periodic Preventive
Maintenance (PPM) schedule is made
• The bio-medical engineer follows the PPM schedule in conjunction with the user
department on the availability of the machine to conduct the preventive
maintenance by the contract agency
• The bio-medical engineer collects and documents the Service report of the
maintenance conducted on the equipment by the AMC contractor :
The break down time is recorded
All the spares details are recorded
The response time of the AMC contractor is recorded
• After the Service, the Machine is thoroughly tested by the bio-medial engineer and
handed over to the User department.
• The user department signs the service order/ work order request if the service was
done on a break down.
• Internal calibration for equipment not covered under the annual maintenance
contract are done and recorded.
• The Contract Period is reviewed and renewed accordingly by the Purchase
committee
• The service provided during the visit by the AMC service provided is documented
and filled as Service Reports. The service reports are retained at least till completion
of the Contract tenure.
• Instruction/operating guidelines are provided to all personnel handling the
Equipment
• The frequency and visits of the AMC service provider is monitored. Reminder are
sent in case of delay and purchase committee is also informed
8. 3 Equipment profile
• If the Equipment is not under Annual Maintenance Contract or the nature of the
repair is out of the scope of the AMC then, the requisition for repair is raised to the
Purchase committee, quotations will be called for and analysed for issue of contract.
• In case the equipment requires any service at AMC Service provider’s premises then,
the equipment will be sent for repairs through a gate pass. No equipment will be
taken out of the Hospital premises without a gate pass. The gate pass will be signed
by the Department In charge and ultimately by the Security Officer.
Wherever possible the defective equipment will be replaced for working.
8. 4 Engineering Department/Service
Department/Service Safety
Scope: Biomedical
Procedures:
• Department head is responsible for maintaining safety standards, developing safety
rules, supervising and training personnel in departmental standards.
• Department head is responsible for notifying the Bio-medicalEngineer in case of any
safety hazard.
• All department employees shall report defective equipment, unsafe conditions, acts
or safety hazards to biomedical engineer.
• Keep electrical cords clear of passageways. Only use electrical extension cords in
compliance with policy.
• All equipment and supplies will be properly stored. Heavy items will not be stored
on top shelves.
• All personal electric appliances shall be inspected by the Engineering Department
for safe use.
• Scissors, knives, pins, razor blades and other sharp instruments will be safely stored
and used. Use of sharp spindles is prohibited.
• All electric machines with heat producing elements will be turned off when not in
use.
• Smoking is prohibited in the hospital.
• Report faulty equipment to Biomedical Engineer.
• Warning signs will be obeyed.
• Oil or grease from a tool will be cleaned before using it. A tool which slips out of
the user's hand is likely to cause an injury.
• Steady and secure material to be cut, sheared, chiselled or filed to prevent the tool
from slipping.
• Extreme care will be taken in the use of torches and soldering irons to prevent
explosions and burns. Always wear protective gear. The soldering iron willbe
placed so that the hot point cannot come in contact with flammable material or with
the body.
• Floors will be kept clean and free of sawdust, scraps of wood and other objects
which might cause tripping or slipping.
• Ensure that starting and stopping switches are within immediate reach of the person
operating the machine.
• Good body mechanics will be practised.
• Equipment will not be left standing in traffic lanes. Equipment will be returned to
its proper location after service.
Scope: Biomedical
Procedures:
• Basic biomedical engineering inspection of equipment shall be performed by: Bio
Medical Engineer
• Inspection
Visual Inspection
Performance Tests
Calibration
Lubrication
Other operations specified for equipment by preventive maintenance tables
• Performance tests willbe made by bio medical engineer, or a request shall be made
for the operator to perform the check while the service engineer of the company
8. 6 Condemnation
• Any equipment, which out lives its life and requires repairs or renewals will be
condemned provided the cost of the repairs or renewals exceeds 50% of its original
value.
• Or any equipment which consumes more energy and the version is out dated and
hence can not compete with new version will condemned by the purchase
committee after through verification though it has not out lived its life prescribed by
the manufacturer.
• Condemnation Committeedecide’s upon the method of condemnation. The
Maintenance department forwards the repair status of the Machine to the Purchase
committee. This report is studied by the purchase committee and arrives at a
conclusion.
• All records pertaining to condemnation of equipment shall be maintained.
Options of condemnation:
• Scrap: If the equipment is totally Obsolete or irreparable then the equipment is sold
as scrap
• Buy back: Such equipment are replaced by new equipment and returned to the
Vendor in replacement of new equipment at discounted price. The decision for such
an option is completely on discretion of the Purchase committee.
• Sold at discounted price to any taker
• All equipments are checked for proper functioning on a daily basis by user.
• Calibration of the equipment are done as per manufacturer’s guidelines
• Appropriate corrective and Preventive actions are taken if downtime of the
equipment is large or delay in repairs or missed calibration.
• The personnel using the equipment are educated about the safe and effective
operation and functioning of the equipment at the time of installation and as and
when required.
• The staff is trained to handle and prevent of the hazards. Supplement Guidance and
training are imparted to the concerned department. In case of any incidence
reported such accidents etc are analysed, and appropriate corrective ad preventive
actions are taken.
• Organization safety committee will also study these actions.
9 Departmental procedures
9. 1 Complaint/ Breakdown management
Receives Complaints
User verification
Biomedical engineer validates done and sign’s the
the equipment for use work order
9. 2 Preventive Maintenance
Routine
machinemaintena
nce
9. 3 History card
• All the Equipment in the hospital will have an individual History card
• All the history cards will be maintained by the engineering services department and
a copy maintained at the user department
• These history cards would be updated by the Engineering service team as per the set
parameter requirements
• The Equipment on AMC are identified and marked in the History card
• The history card contains the preventive maintenance frequency and calibration
requirements and break down maintenance details
• On the basis of the information gathered on the history card, Periodic Preventive
Maintenance (PPM) schedule is made
• The bio-medical engineer follows the PPM schedule in conjunction with the user
department on the availability of the machine to conduct the preventive
maintenance by the contract agency
• The bio-medical engineer collects and documents the Service report of the
maintenance conducted on the equipment by the AMC contractor
• The break down time is recorded
• All the spares details are recorded
• The response time of the AMC contractor is recorded
• After the Service, the Machine is thoroughly tested by the bio-medial engineer and
handed over to the User department.
• The user department signs the service order/ work order request if the service was
done on a break down.
• In the event of Fire the area is electrically isolated by cutting of the Main circuit
Breaker
9. 6 Equipment Calibration
10 Quality Indicator
Quality Indicator is based on average downtime for rectification, repair or purchase of the
required product.
• Internal Repair : ______hrs
______hrs
• External Repair : _____hrs
_____hrs (in case of delay beyond 72 hours the
reasons have to be vetted by the Department head
head and the CEO/ VCEO)
VCEO)
• Out station assistance : within
within a week
Sl. Objectives Performance Parameters Measurement Criteria
# Method Period
1 Reduce cost of Reduce break down Break down Records Quarterl
maintenance y
Stand arise the spares Number Quarterl
y
2 Response Time Time of repair Days / hours Quarterl
y
11 Annexure
11.1 Forms/ Documents
11.
• Master List
• Preventive Maintenance Plan (PMP) schedule
• Preventive maintenance Monthly Check list
• History card
• Complaints Register: Retention period: 1 yr
• Equipment Log book: Retention Period: Till the life of the equipment
• AMC Contract Records
• Service Reports: Retention period: Till the tenure of the contract
• Equipment Manual: Retention period: Till the life of the Equipment
• Spare Catalogue: Retention period: Till the life of the Equipment
11.
11.2 Breakdown Slip/ Register
Equipment/ Instrument
Location
Nature of Breakdown
Date :
Received Signature of Maintenance concerned
Remarks: Section Head
11.
11.3 Mechanical Maintenance Schedule and Records
Check Points
11.
11.4 History Card
Unit Name:
Model :
11.
11.5 Calibration Record & History
11.
11.6 Equipment Log Sticker