BIOMEDICAL ENGINEERING DEPARTMENT
Bio-Medical Engineering defines the mechanisms for interaction and oversight of the medical
equipment used in the diagnosis, treatment, and monitoring of patients. The related policies
and procedures govern activities from selection and acquisition to incoming inspection and
maintenance of medical equipment
Functions of the Department
Inspecting incoming equipment and machinery and performing pre-acceptance checks
before officially accepting equipment and payment.
Setting standards and ensuring their compliance.
Organizing in-service a training programs and training for personnel in the bio-medical
engineering department as well as other user department to use equipment properly.
Evaluating the need for new replacement equipment and major repairs.
Organizing a planned maintenance programmer for all equipment and attending to
emergency breakdowns and repairs.
Establishing an inventory of all existing and incoming equipment.
Maintaining work record and maintenance history record.
Active involvement in the activities of the hospital’s safety committee and checking safety
hazards.
Technical evaluation of equipment during purchase by the hospital directly.
Daily visit to all the critical care centers and monitoring that all the equipment are functional.
POLICIES & PROCEDURES
EQUIPMENT MAINTANENCE POLICY
PREVENTIVE MAINTANENCE POLICY
BREAKDOWN MAINTENCE POLICY
CONDEMNATION POLICY
PURCHASE POLICY
EQUIPMENT MAINTANENCE POLICY
a) Equipment inventory
listing all the existing items of equipment and their location
record all details regarding every piece of equipment such as nomenclature,
manufacturer, model number, serial number, and date of acquisition, location
and a unique number
b) Tagging and labeling:
All the Biomedical Equipment of the hospital shall be controlled using a unique
Identification Number issued by BME department.
This number shall be visibly labeled / stenciled on all the biomedical equipment for
easy identification
c) Maintenance of Equipment Log book
A review maintenance history record shows what has gone wrong with an instrument
and what part of it is failed frequently so that repairs or troubleshooting can be done,
necessary stock of spare parts maintained
PREVENTIVE MAINTENANCE POLICY
Preventive maintenance is the most effective method of ensuring that instruments in a
hospital function reliably, accurately and safe.
It is also the most economical way of maintaining the equipment.
Pre-planned scheduling of maintenance work will limits the equipment breaks down.
Under preventive maintenance, equipment is cleaned, lubricated, adjusted and checked
for wear and tear at predetermined intervals, and components that might cause
breakdown or serious impairment are replaced.
This is done on a scheduled rather than a user-demand basis
Procedure
a) A preventive maintenance plan shall be scheduled at the beginning of every financial
year
b) Preventive maintenance must be performed on all equipment to prolong equipment
life and to ensure efficient operation and reliability of the facility.
c) The in-house preventive maintenance done is recorded in history card and the next
due date of preventive maintenance shall be mentioned.
d) If the preventive maintenance is done by related service provider shall be made in
documented with service report and entry in log book.
Maintenance Contract AMC/CMC:
The Equipment's on maintenance contract are identified and marked in the log book. The log
book contains the preventive maintenance frequency and calibration requirements and break
down maintenance details.
On the basis of the information gathered on the log book, Periodic Preventive Maintenance
(PPM) schedule is made
The biomedical 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 biomedical 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-medical 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
breakdown.
The Contract Period is reviewed and renewed accordingly by the Purchase committee.
The service provided during the visit by the AMC service 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
BREAKDOWN MAINTENANCE POLICY
The user departments shall intimate the BME on the breakdowns / complaints using the
Breakdown Requisition form.
On receipt on the Breakdown Requisition note the BME shall analyze the nature of the
breakdown / complaint.
In case an outside service agency is to be engaged for the repair / servicing activity, the
Bio-medical Engineering staff shall request administer for make arrangement for work
order detailing the nature and cost of work.
The details of the repairs / service done shall be recorded in the equipment log book.
Out Going Equipment for Repair and Servicing
Any equipment found defective shall be repaired locally. If the equipment is not able
to repair a gate pass shall be signed for vendors by head of biomedical department, head
of the user department and medical superintended.
A frequent flow up is done with vendor until the equipment reaches the hospital
EQUIPMENT CALIBRATION
1. All the equipment's once in year when purchased, the manufacturer defined
frequency of calibration is taken as frequency of calibration.
2. The frequency of calibration is entered in the history card.
3. As per the frequency stipulated the equipment's are calibrated internally or through
the AMC provider. All the necessary certification shall be maintained.
4. The next calibration due shall also be mentioned in the history card.
CONDEMNATION OF EQUIPMENT
Any equipment, which outlives its life and requires repairs or renewals, shall be
condemned Provided the cost of the repairs or renewals exceeds 50% of its original
value.
any equipment which consumes more energy and the version is out dated and hence
cannot compete with new version shall condemned by the purchase committee after
thorough Verification though it has not out lived its life prescribed by the manufacturer.
some of the equipment's are retained in the department, to use its spare parts for future
use.
However the machine shall be used. Such spares would generally be not available or
are expensive otherwise and are still useful.
QUALITY AND MONITORING SYSTEMS
1. All equipment's are checked for proper functioning on a daily basis.
2. Calibration of the equipment's are done as per manufacturer’s guidelines
3. Appropriate corrective and Preventive actions are taken if downtime of the equipment is
large or delay in repairs or missed calibration.
4. 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 when required.
EQUIPMENT TRAINING TO USER DEPARTMENT
All the equipment operating procedure is explained to end user during the installation and
every three months training program will be arranged and demonstrate to the staff to bring
the awareness of the medical equipment.
Departmental Documentation and Annexure
1) Equipment Inventory
2) Preventive maintenance schedule and service reports
3) Calibration reports
4) Equipment training forms
5) Quality Indicator(Critical equipment’s down time monitoring)
6) Equipment Condemnation file
7) Equipment complaint forms and register
8) Equipment outward register
9) Equipment log book
10) All clinical departmental equipment files
11) AMC & CMC file
12) Equipment Incidence report file
QUALITY INDICATORS
Equipment wise utilization time (i.e. Percentage utilization, especially for identified
high value equipment such as CT-scan, MRI, Cath lab machine etc.
Percentage downtime/up-time. (Equipment wise, for high value equipment)
Percentage of equipment calibrated as per the schedule
Average response time for complaints or service request
Average completion time for closure of complaints
