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 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
1. Equipment wise utilization time (i.e. Percentage utilization, specially 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