Checklist of Bio-medical engineering department

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 specialty 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 IPHS standards.

2. There should be an equipment procurement policy that specifies authority of taking

procurement decision, as per the cost level of equipment. For eg. 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 bill,

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

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 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 eg. 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 (invoices, bills 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
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. % of equipment calibrated as per the schedule
4. Average response time for complaints or service request
5. Average completion time for closure of complaints