Biomedical Medical Equipment Key performance Indicators (KPI /QPs)
1. Biomedical Equipment Inventory/Asset management
2. Checking the equipment against the Purchase order
3. Checking the document for Quality Patient safety and accreditations standards
4. Installation and testing commissioning
5. Handing over the equipment to end user for operation
6. Preventive Maintenance schedule
7. Equipment Calibration schedule
8. Corrective Maintenance
9. Regulatory follow-up
10. Quality assurance test
11. Decommissioning
12. Condemnation;
13. Medical device related accident investigation;
14. Equipment on Loan and Trial; Medical Device
15. Alert Notification or Equipment recall
16. Calibration of Biomedical Test Instrument.
17. User training records in case of new equipment or equipment upgrade
The KPI must be specified for each of the Quality processes, for example
The response time for corrective maintenance, turnaround time for both Preventive Maintenance and
Corrective Maintenance, etc.
Note: Setting KPI varies as per our hospital policies and Standard operating protocol
Bio-medical engineering department
In a hospital serves a very important purpose of ensuring that medical equipment in various
departments are in their best functional condition and are being effectively utilized. The performance
of the department is reflected from how well the patient care staff are able to use medical equipment.
To be able to effectively manage medical equipment there are several standards and practices that the
department must follow. The NABH has also outlined these standards, largely in its FMS chapter. The
complete checklist of all requirements that bio-medical engineering department must fulfil is given
below.
1. There should a documented equipment plan for the hospital. An equipment plan should typically
have speciality wise list of equipment required, with brief specification and their quantity. The plan
should be based on clinical need and workload. Such plan should be developed in consonance with
the doctors of the clinical departments. A reference for minimum equipment requirement should
followed, such as Indian Public Health Standards.
2. There should be an equipment procurement policy that specifies authority of taking procurement
decision, as per the cost level of equipment. For e.g. Decision of procuring low cost equipment can be
taken at the department level, while decision of procuring high cost equipment can only be taken by a
committee. The indicative level of low cost, medium cost and high cost should be defined.
3. There should be a committee who takes decision on equipment selection, purchase and renting
(beyond the specified cost of equipment). Committee also decided on technology upgrades.
The minutes of meeting of the committee should be available, in which decisions taken should be
recorded.
4. The committee should consist of a representative from clinical department where the equipment
will be used (doctor, nurse or technician who will be using the equipment), representative from
management (CEO, COO, VP etc.), a representative from finance department, and a representative
from biomedical engineering department.
5. The bio-medical engineering department should maintain an inventory record of all medical
equipment in the hospital
6. Following points must be ensured for each medical equipment in the hospital
a. Necessary documents related to equipment should be available. Such as purchase orders
Service order, Rental agreements, regulatory clearance certificate (such as type approval
certificates of X-ray machines), quality conformance certificates or marks (such as ISI
certified), factory test certificate by manufacturer, CE certificates, FDA certificate etc.
b. Equipment log (history sheet) is maintained for each equipment. The log should be used to
record all important information pertaining to the equipment, such as, date of purchase, date
of calibration, preventive maintenance, date and details of upgrades done, change of spare
parts etc.
c. A preventive maintenance schedule is prepared and followed.
d. A preventive maintenance checklist is available, which should be used during each
servicing
e. A breakdown maintenance plan is available, which specifies who will check the equipment
in case of breakdown and from where will it be repaired. Warranty and AMC must be
considered while making this plan
f. The calibration certificate and calibration schedule should be available
g. A label on equipment specifying its latest calibration status and due date of calibration
7. For any new equipment purchased or equipment upgrade in the hospital a training must be
organized for the users on how to use the equipment, along with its safety features. Record of such
trainings should be maintained.
8. A documented procedure is available for disposal of (condemnation) equipment. The document
should specify the period or conditions after which the equipment will be disposed off and the method
of disposal of equipment
9. A documented procedure should be available that describes what to do in case a communication
of equipment recall is received from the manufacturer of the equipment. Equipment which has been
recalled by manufacturer should not be used for patient care activity
10. The bio-medical engineering department must maintain a record of all complaint/service
requests received from user department. The record should specify date and time of receiving
complaint, date and time of attending the complaint and date and time of closure of complaint. This
data should be used to calculate average response time and average completion time, on monthly
basis.
11. A documented timeframe of responding to service request should be available. Time frame can
be different for different user areas depending upon criticality, for e.g. Request from ICU or OT
should be attended on priority.
12. Biomedical engineering department must be able to provide round the clock service, at-least for
critical equipment
List of important records that bio-medical equipment department must maintain.
1. Meeting records of committee for equipment procurement
2. Purchase records (POs, SOs RA, invoices, bills certificates etc.)
3. Documents received along with equipment such as regulatory clearances, quality/safety certificates,
factory testing certificate, periodic check-up reports etc.)
4. Calibration records along with traceability certificate
5. Inventory record
6. Log/history sheet of each equipment (This is an important record which contains all information
pertaining to that equipment)
7. Preventive maintenance and calibration record of each equipment.
8. List of equipment under warranty, AMC and CMC.
9. Records related to equipment disposal.
10. User training records in case of new equipment or equipment upgrade
11. Complaint/Service request register.r
Topics on which staff of Bio-medical engineering department must be aware of
1. Equipment procurement policy and process
2. Equipment condemnation policy and process
3. Preventive and breakdown maintenance plan
4. Calibration of equipment
5. Turn-around time for responding to complaints or service requests
6. Occupational health hazards they face and prevention strategies
7. Equipment hygiene and infection control practices
8. Safety practices to be followed with each equipment
9. Other general topics like, employee rights, use of fire extinguisher, emergency codes etc.
Topics on which users of medical equipment should be aware of
1. Safety instructions pertaining to the equipment
2. Hygiene practices to be followed to prevent cross infection from equipment
3. Calibration status of the equipment
4. Complaint process in case of breakdown
Quality indicators
1. Equipment wise utilization time (i.e. Percentage utilization, especially for identified high value
equipment such as CT-scan, MRI, Cath lab machine etc.
2. Percentage downtime/up-time. (Equipment wise, for high value equipment)
3. Percentage of equipment calibrated as per the schedule
4. Average response time for complaints or service request
5. Average completion time for closure of complaints
