Sop Bme GPH

Page 1 of 30
GRAND PORT HOSPITAL PVT. LTD.
STANDARD OPERATING PROCEDURE FOR Document No:

BIO MEDICAL ENGINEERING DEPARTMENT
BIO-MEDICAL
ENGINEERING
DEPARTMENT
AMENDMENT RECORD
Approved By: Issue No: 01
PROCEDURE
Issue Date: : NIL
Page 2 of 30

Sr. Page Section/Clause/ Date of Amendment Reasons of Signature Signature of Signature of

No No Para/Line (as applicable) Amendment Made Amendment of Deputy Quality CEO
Technical Manager
Manager
10
CONTENTS
TITLE PAGE No
PROCEDURE
Issue Date: : NIL
Page 3 of 30

Introduction 3
Purpose 4
Scope 4
Organogram 5
Roles & Responsibilities 6-9
Departmental Activities 9-16
Department Functional Procedure 17-20
Monitoring & performance Indicators 21-22
Records 23
Check list of various Biomedical Equipments 24
Associate enclosed documents
INTRODUCTION:-
 Bio – Medical Engineering (BME) is the application of engineering principles and

techniques to the medical field. It combines the design and problem-solving skills of
engineering with medical and biological sciences to help improve patient health care
and the quality life of individuals.
PROCEDURE
Issue Date: : NIL
Page 4 of 30

 The fusion of engineering science with clinical medicine is set to play a central role
in the development and improvement of treatment across a range of diseases and
medical conditions. Technology can be applied to help save lives through healing or
replacement of vital organs, and through the improvement of imaging techniques to
detect the onset of disease more effectively.
 Biomedical engineering (BME) is the application of engineering principles and
design concepts to medicine and biology. This field seeks to close the gap
between engineering and medicine: It combines the design and problem-solving
skills of engineering with medical and biological sciences to advance healthcare
treatment, including diagnosis, monitoring, treatment and therapy.
 Biomedical Engineers use engineering principles to solve health related and medical
problems. They do a lot of research in conjunction with life scientists, chemists, and
medical professionals to design medical devices like artificial hearts, pacemakers,
dialysis machines, and surgical lasers. Some conduct research on biological and
other life systems or investigate ways to modernize laboratory and clinical
procedures. They act as a Communication Bridge between the hospital management
and outsourcing supplied vendors/parties.
 Bio-Medical can be called as Medical Electronics. It’s a vast subject which can be
formed by clubbing of Engineering, Mathematics, Science, Anatomy, Analog –DSP,
Digital electronics, Communication theory, Microprocessors, Mechanical, Electrical
& Electronics, Embedded, Safety, Instrumentation and Measurements.
 Frequently, biomedical engineers supervise biomedical equipment maintenance
technicians, investigate medical equipment failure, and advise hospitals about
purchasing and installing new equipment, R&D and innovations.
 Biomedical engineers work in hospitals, universities, industry, and research
laboratories. They are the part of new inventions.
Purpose:-
 To ensure efficient routine, preventive and breakdown of all Medical

equipments maintenance.
 To ensure that all the medical equipment are kept in proper working
condition by reducing the break-down time.
 To ensure smooth running of all departments by personal functional
monitoring for increased performance and efficiency.
PROCEDURE
Issue Date: : NIL
Page 5 of 30

 To ensure periodic maintenance and calibration of hospital equipments

for accuracy.
 To ensure good customer relationship for service support and co-operation
along with efficient user interference and interaction.
 To ensure fabulous work culture with effective communication and co-
ordination with higher officials.
 To ensure Responsibility for planning, installations, certification,
demonstrations, and user trainings.
 To attend and solve the complaints in a minimum time period for prompt
service.
 To ensure the monitoring and implementing safety standards of medical
equipment and practices.
Scope: -
 Supporting services for clinical and hospital equipments.

 Supporting for emergency, medical, surgical, critical care, procedural, diagnostic
and treatment oriented equipments.
 All Bio-medical equipments located in O.T’s, casualty, ICU’s, laboratory,
cardiology, radiology, dialysis, endoscopy, physiotherapy, OPD’s and wards.
Organogram:-
General administrator / Medical
Administrator
BME In- charge

PROCEDURE
Issue Date: : NIL
Page 6 of 30

Bio-Medical Engineer
Bio-Medical Bio-Medical Trainees

Technician
1.COMPETENCY MATRIX
Sr Name Designation Qualification Experience
No
1 Biomedical Engineer In-charge BE in Biomedical 5+ years
2 Biomedical Engineer BE in Biomedical 3+ years
PROCEDURE
Issue Date: : NIL
Page 7 of 30

3 Biomedical Technician ITI in medical

Electronics 2 + years
4 Biomedical Trainee Interns Nil
2. STAFFING PATTERN
Sr No Designation Working Hours Number of staff
1 Biomedical Engineer In-charge 8.5 hours
2 Biomedical Engineer 8.5 hours
3 Biomedical Technician 8.5 hours
4 Biomedical Trainee 8.5 hours

Working hours will be according to the organizational norms and
policies.
Roles &
Biomedical In-charge
 The Bio-Medical In-charge is fully responsible to guide a team of Engineers and
Technicians in day-to-day maintenance of various Medical Engineering appliances
used in the hospital for effective usage.
 Responsible for giving input to decision on purchasing of new Medical equipments
being carried out inside the hospital premises.
PROCEDURE
Issue Date: : NIL
Page 8 of 30

 Taking policy decision in co-ordination with the management.

 Responsible to look after welfare of the staff in the Department.
 Long term planning in taking up gradations / modifications of medical
equipment. Having leadership qualities and navigation.
 Responsible for Warranty concern’s, AMC and CMC approvals and insurance
claims. Should take initiative & responsible.
 Monitor the Re-agent and Rental contracts, new equip. procurements.
 Planning for equipment procurement for next financial year.
 Responsible for implementing safety standards of medical equipments and
practices. Responsible for Quality improvement, safety concerns.
 Personalization of monitoring and verification of certifications and renewals.
 Responsible for new procurements, site planning, installations, demonstrations
and user training classes, pending follow-up’s.
 Key personal in equipment condemnation committee & planning.
 To ensure the responsibility of prompt decision making and problem-solving
capabilities with immediate attention & response to reduce the overall break-
down time, equipment planning & procurement.
 Responsible for taking the feedback and customer satisfaction report.
 Responsible for performance appraisals, punctual.
 Monitoring the duty rosters and shift duties.
 Monitoring the daily activities of the department.
 Supporting & reporting to management.
 Monitoring the incidence & facilitating the TEAM work.
 To verifying equipment records, break down timing and history cards.
 Reporting to higher officials and authorities.
 Implementing service utilities, immediate decision making.
 Proving certification for trainees.
 Planning for conducting end user training classes.
 Approvals, finalizations and quality progress.
Biomedical Engineer
 To assist with the BME INCHARGE for departmental activities.

 Daily monitoring the equipments and departments.
 To prepare PM’S planner and intimation.
 To monitor calibration dates.
 To maintain complaint log register.
 To ensure smooth running of all the departments.
 Responsible for functional checks.
PROCEDURE
Issue Date: : NIL
Page 9 of 30

 Filing and record maintenance.

 Daily check list monitoring.
 Monitoring TLD badges.
 Immediate call attendance.
 Equipment user and operating manuals.
 Support for Installations and demonstrations.
 Communication with superiors.
 Preparation of attendance records.
 Saving and collecting of software CD’s
 Verifying the back up and free space utilities.
 Carrying the periodic maintenance.
 Supporting to the staff and co-operating with management.
 Reporting the incidence for higher authorities.
 Service co-ordination and closing the issues.
 Monitoring over all voltage consumption.
 Preparation of equipment history cards.
 Training the end user for work efficiency.
 Daily reporting, best approach.
 Registering the complaints & dedication.
 Record maintenance & documentation.
 Warranty consignments & follow up.
 Stuffed & skilled work efficiency.
 Distribution of work, Creative thinking.
 Taking initiative, Motivation.
 Protection & prevention plan.
 Procedural fallow up’s & approach.
Biomedical Technician
 To assist the Biomedical Engineer for equipment maintenance.

 To carry out preventive maintenance.
 To attain break-down calls immediately.
 To maintain calibration registers.
 Interaction with higher level.
 Register maintenance & active learning.
 To maintain equipment records.
PROCEDURE
Issue Date: : NIL
Page 10 of 30

 Taking daily rounds for all the departments.

 Noticing the complaints and immediate attendance & response.
 Noticing the user mistakes, complex servicing.
 On line complaint logging and register.
 Immediate reporting, good planning.
 Intimating the pending issues & complaints.
 Announcing the dues and follow up’s.
 Periodic calibration of equipments.
 Ensures the smooth functionality of all the equipments.
 Registering the complaints & documentation.
 Round the clock availability, response and emergency services & support.
 Immediate response to minimize the break down time for service efficiency.
Biomedical Trainees
 To assist the Biomedical Engineer for equipment maintenance.

 Attending the breakdown calls.
 Maintaining the equipment records, break down records, check list of major
equipments.
 To inform the department after the repair of the equipment has been done.
 Department rounds on every alternate day.
 Reporting the daily activities with continuous learning.
 Generating a apprentice training report/ manual record.
Job Duties and Tasks for: "Biomedical Engineer"

1)Advise and assist in the application of instrumentation in clinical environments.
2) Conduct research, along with life scientists, chemists, and medical scientists, on
the engineering aspects of the biological systems of humans and animals.
3) Design and develop medical diagnostic and clinical instrumentation, equipment,

and procedures, utilizing the principles of engineering and bio-behavioral sciences.
4) Develop models or computer simulations of human bio-behavioral systems in
PROCEDURE
Issue Date: : NIL
Page 11 of 30

order to obtain data for measuring or controlling life processes.
5) Evaluate the safety, efficiency, and effectiveness of biomedical equipment.
6) Install, adjust, maintain, and/or repair biomedical equipment.
7) Research new materials to be used for products such as implanted artificial

organs.
8) Adapt or design computer hardware or software for medical science uses.
9) Advise hospital administrators on the planning, acquisition, and use of medical

equipment.
10) Analyze new medical procedures in order to forecast likely outcomes.
11) Design and deliver technology to assist people with disabilities.
12) Develop new applications for energy sources, such as using nuclear power for
biomedical implants.
13) Diagnose and interpret bioelectric data, using signal processing techniques.
14) Teach biomedical engineering, or disseminate knowledge about field through

writing or consulting.
Job Activities for: "Biomedical Engineer"

1)Making Decisions and Solving Problems -- Analyzing information and
evaluating results to choose the best solution and solve problems.
2) Analyzing Data or Information -- Identifying the underlying principles, reasons,
or facts of information by breaking down information or data into separate parts.
3) Interacting With Computers -- Using computers and computer systems

(including hardware and software) to program, write software, set up functions,
enter data, or process information.
4) Getting Information -- Observing, receiving, and otherwise obtaining

PROCEDURE
Issue Date: : NIL
Page 12 of 30

information from all relevant sources.
5) Updating and Using Relevant Knowledge -- Keeping up-to-date technically and

applying new knowledge to your job.
6) Thinking Creatively -- Developing, designing, or creating new applications,

ideas, relationships, systems, or products, including artistic contributions.
 Skills Needed for: "Biomedical Engineer"
 Science -- Using scientific rules and methods to solve problems.
2) Critical Thinking -- Using logic and reasoning to identify the strengths and
weaknesses of alternative solutions, conclusions or approaches to problems.
3) Complex Problem Solving -- Identifying complex problems and reviewing

related information to develop and evaluate options and implement solutions.
4) Reading Comprehension -- Understanding written sentences and paragraphs in

work related documents.
5) Judgment and Decision Making -- Considering the relative costs and benefits of
potential actions to choose the most appropriate one.
6) Active Listening -- Giving full attention to what other people are saying, taking
time to understand the points being made, asking questions as appropriate, and not
interrupting at inappropriate times.
7) Operations Analysis -- Analyzing needs and product requirements to create a

design.
8) Speaking -- Talking to others to convey information effectively.
9) Mathematics -- Using mathematics to solve problems.
10) Systems Analysis -- Determining how a system should work and how changes
in conditions, operations, and the environment will affect outcomes.
11) Systems Evaluation -- Identifying measures or indicators of system

performance and the actions needed to improve or correct performance, relative to
PROCEDURE
Issue Date: : NIL
Page 13 of 30

the goals of the system.
12) Writing -- Communicating effectively in writing as appropriate for the needs of

the audience.
13) Active Learning -- Understanding the implications of new information for both
current and future problem-solving and decision-making.
14) Monitoring -- Monitoring/Assessing performance of yourself, other

individuals, or organizations to make improvements or take corrective action.
15) Technology Design -- Generating or adapting equipment and technology to

serve user needs.
16) Learning Strategies -- Selecting and using training/instructional methods and

procedures appropriate for the situation when learning or teaching new things.
17) Time Management -- Managing one's own time and the time of others.
18) Programming -- Writing computer programs for various purposes.
19) Operation Monitoring -- Watching gauges, dials, or other indicators to make

sure a machine is working properly.
20) Quality Control Analysis -- Conducting tests and inspections of products,

services, or processes to evaluate quality or performance.
21) Social Perceptiveness -- Being aware of others' reactions and understanding

why they react as they do.
22) Coordination -- Adjusting actions in relation to others' actions.
23) Instructing -- Teaching others how to do something.
Abilities Needed for: "Biomedical Engineer"

1)Deductive Reasoning -- The ability to apply general rules to specific problems to
produce answers that make sense.
2) Inductive Reasoning -- The ability to combine pieces of information to form

general rules or conclusions (includes finding a relationship among seemingly
unrelated events).
PROCEDURE
Issue Date: : NIL
Page 14 of 30

3) Problem Sensitivity -- The ability to tell when something is wrong or is likely to

go wrong. It does not involve solving the problem, only recognizing there is a
problem.
4) Near Vision -- The ability to see details at close range (within a few feet of the
observer).
5) Written Comprehension -- The ability to read and understand information and

ideas presented in writing.
6) Oral Comprehension -- The ability to listen to and understand information and

ideas presented through spoken words and sentences.
7) Information Ordering -- The ability to arrange things or actions in a certain order

or pattern according to a specific rule or set of rules (e.g., patterns of numbers,
letters, words, pictures, mathematical operations).
8) Written Expression -- The ability to communicate information and ideas in writing

so others will understand.
9) Oral Expression -- The ability to communicate information and ideas in speaking

so others will understand.
10) Mathematical Reasoning -- The ability to choose the right mathematical methods
or formulas to solve a problem.
11) Category Flexibility -- The ability to generate or use different sets of rules for
combining or grouping things in different ways.
12) Originality -- The ability to come up with unusual or clever ideas about a given
topic or situation, or to develop creative ways to solve a problem.
13) Flexibility of Closure -- The ability to identify or detect a known pattern (a

figure, object, word, or sound) that is hidden in other distracting material.
14) Speech Recognition -- The ability to identify and understand the speech of
another person.
15) Visualization -- The ability to imagine how something will look after it is moved
around or when its parts are moved or rearranged.
PROCEDURE
Issue Date: : NIL
Page 15 of 30

16) Selective Attention -- The ability to concentrate on a task over a period of time
without being distracted.
17) Number Facility -- The ability to add, subtract, multiply, or divide quickly and
correctly.
18) Speech Clarity -- The ability to speak clearly so others can understand you.
19) Fluency of Ideas -- The ability to come up with a number of ideas about a topic
(the number of ideas is important, not their quality, correctness, or creativity).
20) Perceptual Speed -- The ability to quickly and accurately compare similarities
and differences among sets of letters, numbers, objects, pictures, or patterns. The
things to be compared may be presented at the same time or one after the other. This
ability also includes comparing a presented object with a remembered object.
21) Finger Dexterity -- The ability to make precisely coordinated movements of the
fingers of one or both hands to grasp, manipulate, or assemble very small objects.
Duties
Biomedical engineers work closely with life scientists, chemists and medical professionals
(physicians, nurses, therapists and technicians) on the engineering aspects of biological
systems.
Duties and responsibilities vary from one position to another but, in general, biomedical
engineers:
 Design and develop medical devices such as artificial hearts and kidneys,
pacemakers, artificial hips, surgical lasers, automated patient monitors and blood
chemistry sensors
 Design and develop engineered therapies (for example, neural-integrative
prostheses)
 Adapt computer hardware or software for medical science or health care applications
(for example, develop expert systems that assist in diagnosing diseases, medical
imaging systems, models of different aspects of human physiology or medical data
management)
 Conduct research to test and modify known theories and develop new theories
PROCEDURE
Issue Date: : NIL
Page 16 of 30

 Ensure the safety of equipment used for diagnosis, treatment and monitoring
 Investigate medical equipment failures and provide advice about the purchase and
installation of new equipment
 Develop and evaluate quantitative models of biological processes and systems
 Apply engineering methods to answer basic questions about how the body works
 Contribute to patient assessments
 Prepare and present reports for health professionals and the public
 Supervise and train technologists and technicians.
PROCEDURES/WORK PRACTISES FOLLOWED IN THE DEPARTMENT

a. Equipment Planning:
One month in advance to the start of financial year, user departments have to fill the
equipment requisition form and submit to the Management justifying the same. The
requests are certified by the Management and the same is handed to the Purchase
committee for further actions.
b. Procurement of Biomedical Equipment:

1. Biomedical department is also a part of Purchase committee.
2. Any new equipment requirement is intimated to the biomedical department and an
assessment for the same is done i.e. to check whether the requirement is appropriate
or not.
3. If found appropriate, then the suppliers are contacted to get the details regarding the
same equipment.
4. Technical and commercial comparison is prepared and verified.
5. Biomedical department co-ordinates with the Purchase committee in negotiating the
price.
6. Once the details like technical specifications, price etc. are finalized by the Purchase
Committee, these details are forwarded to Purchase department. The Purchase order
is generated & forwarded to vender.
7. Purchase department further takes steps to procure the same
PROCEDURE
Issue Date: : NIL
Page 17 of 30

c. Installation Flow:
1. The new equipment is received in General Stores and then bought to the location as
is mentioned in the purchase order.
2. The biomedical department is responsible for checking equipment details and spare
parts details
3. Before installation, the pre-installation details are acquired from the
manufacturer/dealer
4. The concerned department is informed regarding the pre installation requirements.
E.g. The Maintenance Department will be informed for any electrical and plumbing
work to be done on site before installation.
5. After arrival of the consignment, consignment is moved to storage room/installation
site.
6. Once the site is ready the company engineer is informed to visit the site and to start
installation if all the criteria are met.
7. Consignment is opened in presence of Biomedical Engineer.
8. Once the installation is complete the demo is given to biomedical department &
application training to the user end.
d. Process for Calibration:

1. A list of medical equipment/ devices of requiring calibration is prepared and
maintained.
2. The calibration is done, and status is updated continuously
3. Calibration is done through external sources.
4. Some instruments that are to be calibrated at an outside location are collected and
sent to the identified calibration agency.
5. Calibration record & reports are well maintained with biomedical engineer
6. The equipment is well maintained to preserve their accuracy and fitness for use.
PROCEDURE
Issue Date: : NIL
Page 18 of 30

e. Whenever the calibration is done, the following is checked up

1. Physical condition of instrument /test equipment.
2. Calibration checklist is followed i.e. to check whether the equipment is running as
per the norms.
3. Calibration certificate with traceability to be obtained from calibration agency with
verification marked as O.K. /Not O.K. The same is kept with the biomedical
department and a copy is provided to the user department too.
4. Calibration sticker is displayed on the machine which shows the last calibration date
and the next calibration due date.
f. Process of Preventive Maintenance:

1. The Preventive Maintenance of instrument having an AMC/CMC contract is done
by communicating with Bio-Medical engineer and company engineer.
2. The availability of necessary spares, consumables, tools and necessary materials are
ensured through standardization and /or advance planning, through Stores and
guidance by Head of Bio Medical Department.
3. Carrying out PM as per PM schedule-
● Preventive maintenance schedule is prepared periodically by BME
● BME identifies the equipment for PM for the applicable month from the PM schedule.
● BME Co-ordinate with the user department for available date/time of equipment for
PM within the month.
4. For PM to be carried out In-house-

● PM for equipment are carried on scheduled date by BME
● After PM, PM report is duly signed by BME and End user
● PM reports are filed
● BME places the sticker on the equipment for the PM done and next due date.
5. For PM to be carried out by vendor-

● Fix PM with vendor on scheduled date/time
PROCEDURE
Issue Date: : NIL
Page 19 of 30

● Carry out PM on scheduled date/time in presence of BME

● Company Engineer prepares PM report signed by End user
● Company Engineer submits PM report with checklist to BME
● PM reports are verified by BME and signed by BME
● PM reports are filed
● BME places the sticker on the equipment for the PM done and next due date.
g. Acquiring AMC Maintenance:

1. The details regarding the equipment are collected one month prior to the warranty
expiry date.
2. Depending on service history, the need determination for AMC is done.
3. The AMC Proposal is asked for from the respective company.
4. The price is negotiated and the number of breakdown and preventive maintenance
calls per annum is discussed.
5. The quotation is then approved by the Hospital Administrator.
6. The same is forwarded to the purchase department
7. Then the work order is released, and documentation of the contact is done.
h. Acquiring CMC maintenance:

1. The details regarding the equipment are collected one month prior to the warranty expiry
date.
2. Depending on service history, the need determination for CMC is done
6. The quotation regarding CMC is asked for from the respective company
7. The price is negotiated, accessories included in the contract and the number of
maintenance calls per annum are discussed.
8. The quotation is then approved by the Hospital Administrator.
9. The same is forwarded to the purchase department.
10. Then the work order is released, and documentation of the contact is done.
i. Breakdown Process:
1. The user department informs the biomedical department in case of a breakdown.
2. The complaint is registered in the breakdown log.
3. The in charge allots the complaint to the staff in the department.
4. The staff then tries to rectify the breakdown that has occurred.
5. If it cannot be repaired by in-house staff, the company supplying the equipment is
informed about the complaint.
6. The work of the company representative is supervised.
PROCEDURE
Issue Date: : NIL
Page 20 of 30

7. If the equipment is irreparable then it is considered for condemnation.
j. Break down Maintenance:

1. Breakdown of an equipment or device is entered in the repair note and then reported
to Bio Medical Department.
2. Junior Assistant Clerk logs the requirement of maintenance / repair in the complaint
Register.
3. Instruments / devices which are under AMC (Annual Maintenance Contract) /CMC
(Comprehensive maintenance contract) are given to respective Company for
maintenance.
4. A report of failure / break down is taken from company for monitoring purposes and
is documented.
5. In-house servicing is done for breakdowns like for the errors which arise due to
improper application or for which lie within the first level of servicing as well as
other errors.
6. Once the equipment is repaired internally, in-house service report is prepared, and
end user signature is taken on the same.
k. User End Training:

As and when new equipment is installed or when requested by the user departments,
a training session is conducted related to the respective equipment.
l. Condemnation of Equipment:
1. On finding out that equipment is beyond economical repair, an official letter is given
to the administrator describing its status and cost of repair.
2. Once the request for condemnation is approved by the higher authorities the
equipment is brought back to biomedical department.
3. The equipment then undergoes a process called cannibalization where as far as
possible the spare parts are used up.
4. On receiving intimation from General Stores that e-waste disposal is going to take
place in the institution, a list of all the equipment to be disposed is made.
5. The equipment are then sent to general stores from where it is given out for disposal
to the vendors authorized by the Pollution Control Board to buy e- waste.
PROCEDURE
Issue Date: : NIL
Page 21 of 30

m. Equipment Planning:
One month in advance to the start of financial year, user departments have to fill the
equipment requisition form and submit to the Management justifying the same. The
requests are certified by the Management and the same is handed to the Purchase
committee for further actions.
n. Procurement of Biomedical Equipment:
8. Biomedical department is also a part of Purchase committee.
9. Any new equipment requirement is intimated to the biomedical department and an
assessment for the same is done i.e. to check whether the requirement is appropriate
or not.
10. If found appropriate, then the suppliers are contacted to get the details regarding the
same equipment.
11. Technical and commercial comparison is prepared and verified.
12. Biomedical department co-ordinates with the Purchase committee in negotiating the
price.
13. Once the details like technical specifications, price etc. are finalized by the Purchase
Committee, these details are forwarded to Purchase department. The Purchase order
is generated & forwarded to vender.
14. Purchase department further takes steps to procure the same
Personal Characteristics

Biomedical engineers need the following characteristics:
 A strong interest in engineering and medicine
 The ability to think analytically and solve problems
 An aptitude for science and mathematics
 The ability to visualize complex processes and equipment
 Good oral and written communication skills
 Creativity and persistence
 A willingness to improve their knowledge and skills on an ongoing basis
PROCEDURE
Issue Date: : NIL
Page 22 of 30

 The ability to work effectively with people from various disciplines and educational
backgrounds.
DEPARTMENTAL ACTIVITIES:-
1. Daily rounds
2. Logging and registering the complaints
3. Solving the problems
4. Closing the pending issues
5. Listing of all equipments
6. Coding and asset numbering
7. Site planning
8. New installations and demonstrations
9. Servicing and repairing
10. Conducting training classes
11. Spreading awareness programs
12. Interacting with users
13. Allocation of equipments
14. Incident reporting
15. Gravience handling
16. Root cause analysis
17. Verification and validation
18. Selection and finalization
19. Choosing the best quality process
20. Safety concerns
21. Carrying calibrations
22. Camp supports
23. Warranty monitoring
24. Daily reporting
25. Filing and documentation
26. Certification & justification
27. Feedbacks on satisfaction reports
28. Maintenance and managing
29. QA/QC checks
30. Problem analysis
PROCEDURE
Issue Date: : NIL
Page 23 of 30

31. PM’s scheduling and planning

32. Traceability verifications
33. Supporting services
34. Team work
35. Helping in purchase
36. Collecting quotation’s
37. Taking responsibilities
38. Proper handling of equipments
39. Validity and due checks
40. Record works.
41. Register maintenance
42. Manuals listing.
43. Collecting backup’s & SW cd’s
44. Selection process
45. Day to day reporting
46. Follow up’s & daily monitoring
47. Co-ordination & co-operation
48. Affordable relations with vendors
49. Diplomatic dealing
50. Effective communication
51. Prior intimation to higher officials
52. Gate pass follow up’s
53. Identifying the problems
54. Functionality checks & scope of services.
55. Competitive techniques
56. Immediate response and decision making
57. Managing, operating & handling of various equipments.
58. Priority identification & emergency support.
59. Work allocation & segregation.
60. Controlling costs & incidence.
61. Knowledge of BME waste management
62. Awareness of everything
63. Enrollments & safety policies.
64. Idea of cost cuttings & safety concerns.
65. Technically skilled performance.
66. Emergency purchases, Replacements.
67. Service utilities with diplomatic dealing.
68. Should maintain a good relation and communication.
69. Interacting with user departments.
70. Friendly approach in equip. handling.
PROCEDURE
Issue Date: : NIL
Page 24 of 30

71. General checks and testing’s.

72. Quantitative differential approach.
73. Performance and Quality improvements.
74. Modifications, System & Software up gradations.
DEPARTMENTAL FUNCTIONAL PROCEDURE: -
PREVENTIVE MAINTENANCE PLAN
1) A detailed List of equipment with AMC & calibration list is maintained by biomedical
department.
2) Most of the medical equipments are serviced by the suppliers themselves.
3) In house preventive maintenance of various facilities and equipments are carried out as
per preventive maintenance checklist.
4) An operating manual of equipment is kept with respective departments for its daily
maintenance and for dusting.
5) A equipment log book with date, instrument start time, operated by, instrument
shutdown/unplug time, shutdown by, breakdown/complain data, informed to and time of
information, date & time of the problem withdrawal, remarks and signature is maintained by
department in-charge for checking the frequency level of breakdown complaints get
resolved.
6) Equipents are operated by authorized personnel only. Up-to date instructions, on
the use and maintenance of equipment given by manufacturers are made readily
available with Bio-Medical department.
7) AMC/CMC frequency and the records of AMC/CMC with are available in the
department.
WARRANTY:-
 To see what are all covered in warranty spares etc..,
 To verify warranty consumables and consignments.
 To monitor warranty considerations.
RENTAL OR REAGENT CONTRACTS:-

 To monitor what are all equipments covered in RC.
 To check the RC period.
 To verify the STD., terms and conditions.
 To monitor the legal bonds, agreements and commitments.
PROCEDURE
Issue Date: : NIL
Page 25 of 30

 Verifying legal issues.
INSURANCE POLICIES:-
 To see what are all equipments, scopes and probes covered under insurance.
 Insurance claims.
 Renewals, payments.
 Monitoring terms and conditions.
 To verify medical claim policies.
INSTALLATION PROCEDURE OF NEW EQUIPMENTS:-
 This process is to ensure the smooth installation and commissioning of all medical
equipments in the hospital. Following are the key elements associated with this
process.
 Pre Installation requirements get from the company.
 Receive the equipment.
 Verification of equipment along with the Purchase order.
 Installation of equipment at the site.
 Testing and commissioning.
 Handover the equipment to the user department.
 Equipment is added to the Asset list.
 Asset Number sticked should be mentioned on the Equipment.
Procedure for preventive maintenance of equipments:-
 Preventive maintenance schedule for all the Equipments made for the entire year.
 Prepare the list of equipments to preventive maintenance internal / external.
 Coordinating with the Companies for the preventive maintenance of the equipments.
 After preventive maintenance, Filing the reports and update in the stickers on the
equipments and equipment History card.
ASSET CODING/TAGGING:-
PROCEDURE
Issue Date: : NIL
Page 26 of 30

 Providing a unique sequential numbering for all medical equipments for permanent
and easy identification & addressing.
CALIBRATION OF EQUIPMENTS:-
 The objective of this process is to include all the relevant medical equipment in the
hospital under a calibration program as per the calibration schedule.
 Key elements of the process are listed below:-
 Prepare the calibration. Schedule for all the equipment for the entire year.
 Coordinating with the Companies for the calibration as per the schedule.
 Perform the calibration and get the calibration certificates from the company.
 Update the sticker label on the machine and the history cards.
CONDEMNATION:-
 Monitoring the cost, availability of spares, Clearance from management.
 Verifying the model, outdated status, Approvals.
 Monitoring total service cost spent on the equipment.
 Affordability, spare cost, Committee suggestions.
 Liability of service and functional performance.
EQUIPMENT SELECTION:-
The department follows hospital’s plan for equipment for new purchases, replacements and
additional technology / equipment. As per the plan and / or request by the user, a
multidisciplinary committee works together to get the required equipment. Comp rations,
feedbacks, evaluation, analysis, technology, working principles, economic, service, listing,
quality, choosing the best. The decision is taken in consultation with various people, which
includes the following,
 Top Level Management
 Consultant of concern department
 Purchase department
 Biomedical engineering department
 Finance department
PROCEDURE
Issue Date: : NIL
Page 27 of 30

Validation & verification of Breakdown / Preventive Maintenance:-
Validation of the proper functioning of the equipments after every preventive

maintenance & major break down is done by HOD before using for reporting by following
performance qualification protocol for the equipments.
BREAK DOWN PROCEDURE: -
1. In-case of breakdown user department informs the concerned person for repairing &
enters into maintenance call slip. record
2. Study the nature of breakdown, take necessary action accordingly. (Repairing/
replacing).
3. Check the work comes verify the work category, under in-house maintenance or service
contract or contractor.
4. Get the signature of the concerned user department after completion of job & take the
duplicate copy of Maintenance call slip.
5. Record the job done in the breakdown register.
6. Analyze the nature of the breakdown / complaint and take appropriate action for
contacting external service provider.
7. Should have a list of spares replaced and enclosed with proper documentation.
INCIDENT REPORTING:-
1. Noticing the incidents.
2. Intimating to concern HOD’s and top level management
3. Informing to top level management.
4. Incident report generation. & handling of the incidents
5. Handling of the incidents.
6. Retraining the concern user.
GATE PASSES:-
Sending the equipment outside of the hospital premises for repairing and service,
returning of damaged/defective goods etc.., with proper authentication.
1. RGP: - follow-up’s
2. NRGP: - closing
PROCEDURE
Issue Date: : NIL
Page 28 of 30

MONITORING OF PERFORMANCE INDICATORS:-

 Response time
 Down time
 Outsource Response time
METHODOLOGY:-
RESPONSE TIME:
 Bio-medical department will record the call received time and then Attended the call
and again record that time, means
The difference between: XY - ZZ = AA
Here, XY: Call received time

ZZ: Call attended time
AA: Response time.
DOWN TIME:
 Bio-medical department will record the call received time and then Attended the call
and again record that attended time and then handed over time to find Down time,
means
The difference between: YY - XX = BB
Here, YY: Handed over time

XX: Call attended time
BB: Down time.
OUTSOURCE RESPONSE TIME:
 In case bio-medical department need to call outsource agency then they will record
the calling time and when outsourced agency attend the call that time will be recorded
that, means,
Outsourced response time (OR): The machine total Down time (BB) + outsourced
attending time (OO): YY - XX = BB
Here, BB: Down time
OO: Outsourced attended time
OR: Outsource Response time.
MONITORING:-
PROCEDURE
Issue Date: : NIL
Page 29 of 30

 All response time, down time, will be Calculated of all equipment monthly basis and
improvement plan will be made, checked and monitored.
SERVICE EFFIENCY:-
Call Time-Response Time/Completion Time*100
RECORDS:-
1. Preventive Maintenance file.
2. Breakdown maintenance calls register.
3. Master equipment list.
4. Daily rounds register.
5. AERB files.
6. QA/QC reports.
7. Plan site approval and lay out files.
8. BME service reports.
9. Gate passes register.
10. Manuals’ and software CD’s.
11. Lab service reports.
12. Calibration reports.
13. Installation report file.
14. Department manual files.
15. Check list file.
16. Departmental SOP’s.
17. Warranty cards file.
18. AMC & CMC file.
19. Quotation file.
20. Purchase order file.
21. Daily complaints register.
22. Online log register.
23. Incident report file.
24. Inventory register file.
25. Departmental equipment list.
PROCEDURE
Issue Date: : NIL
Page 30 of 30

PREVENTIVE MAINTENANCE CHECKLIST OF ALL MEDICAL EQUIPMENT:-
1 PREVENTIVE MAINTENANCE CHECKLIST OF ANAESTHESIA WORK STATION

2 PREVENTIVE MAINTENANCE CHECKLIST OF C-ARM
3 PREVENTIVE MAINTENANE CHECKLIST OF MONITORS
4 PREVENTIVE MAINTENANCE CHECKLIST OF VENTILATOR
5 PREVENTIVE MAINTENANCE CHECKLIST OF PIPELINES,VACCUUM &AIR
COMPRESSORS
6 PREVENTIVE MAINTENANCE CHECKLIST OF DIATHERMY
7 PREVENTIVE MAINTENANCE CHECKLIST OF DIALYSIS MACHINE
8 PREVENTIVE MAINTENANCE CHECKLIST OF ULTRASOUND MACHINE
9 PREVENTIVE MAINTENANCE CHECKLIST OF ABG MACHINE
10 PREVENTIVE MAINTENANCE CHECKLIST OF CATH LAB
11 PREVENTIVE MAINTENANCE CHECKLIST OF CT SCAN
12 PREVENTIVE MAINTENANCE CHECKLIST OF X-RAY MACHINE
13 PREVENTIVE MAINTENANCE CHECKLIST OF PORTABLE X-RAY
14 PREVENTIVE MAINTENANCE CHECKLIST OF ACT MACHINE
15 PREVENTIVE MAINTENANCE CHECKLIST OF ECG MACHINE
16 PREVENTIVE MAINTENANCE CHECKLIST OF DEFIBRILLATOR
17 PREVENTIVE MAINTENANCE CHECKLIST OF HEART LUNG MACHIINE
18 PREVENTIVE MAINTENANCE CHECKLIST OF HEMOTHERM MACHINE
19 PREVENTIVE MAINTENANCE CHECKLIST OF STERNALSAW MACHINE
20 PREVENTIVE MAINTENANCE CHECKLIST OF INCUBATOR MACHINE
21 PREVENTIVE MAINTENANCE CHECKLIST OF WARMER MACHINE
22 PREVENTIVE MAINTENANCE CHECKLIST OF PORTABLE INCUBATOR
MACHINE
23 PREVENTIVE MAINTENANCE CHECKLIST OFO.T .LIGHT
24 PREVENTIVE MAINTENANCE CHECKLIST OF O.T.TABLE
25 PREVENTIVE MAINTENANCE CHECKLIST OF ELECTRIC SUCTION
APPARATUS
26 PREVENTIVE MAINTENANCE CHECKLIST OF E.T.O MACHINE
27 PREVENTIVE MAINTENANCE CHECKLIST OF AUTOCLAVE MACHINE
28 PREVENTIVE MAINTENANCE CHECKLIST OF IABP MACHINE
29 PREVENTIVE MAINTENANCE CHECKLIST OF PRESS.INJECTOR
30 PREVENTIVE MAINTENANCE CHECKLIST OF FULLY AUTO ANALYZER
31 PREVENTIVE MAINTENANCE CHECKLIST OF SEMI AUTO ANALYZER
32 PREVENTIVE MAINTENANCE CHECKLIST OF 2D-ECHO MACHINE
33 PREVENTIVE MAINTENANCE CHECKLIST OF TMT MACHINE
34 PREVENTIVE MAINTENANCE CHECKLIST OF PFT MACHINE
35 PREVENTIVE MAINTENANCE CHECKLIST OF ENDOSCOPY
36 PREVENTIVE MAINTENANCE CHECKLIST OF MRI MACHINE
PROCEDURE
Issue Date: : NIL

Sop Bme GPH

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Sop Bme GPH

Uploaded by

Copyright:

Available Formats

Page 1 of 30

GRAND PORT HOSPITAL PVT. LTD.

STANDARD OPERATING PROCEDURE FOR Document No:

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

Sr. Page Section/Clause/ Date of Amendment Reasons of Signature Signature of Signature of

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

Roles & Responsibilities 6-9

Departmental Activities 9-16

Department Functional Procedure 17-20

Monitoring & performance Indicators 21-22

Check list of various Biomedical Equipments 24

Associate enclosed documents

 Bio – Medical Engineering (BME) is the application of engineering principles and

STANDARD OPERATING PROCEDURE FOR Document No:

 To ensure efficient routine, preventive and breakdown of all Medical

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

 To ensure periodic maintenance and calibration of hospital equipments

 Supporting services for clinical and hospital equipments.

BME In- charge

STANDARD OPERATING PROCEDURE FOR Document No:

Bio-Medical Bio-Medical Trainees

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

3 Biomedical Technician ITI in medical

4 Biomedical Trainee Interns Nil

Sr No Designation Working Hours Number of staff

1 Biomedical Engineer In-charge 8.5 hours

2 Biomedical Engineer 8.5 hours

3 Biomedical Technician 8.5 hours

4 Biomedical Trainee 8.5 hours

STANDARD OPERATING PROCEDURE FOR Document No:

 Taking policy decision in co-ordination with the management.

 To assist with the BME INCHARGE for departmental activities.

STANDARD OPERATING PROCEDURE FOR Document No:

 Filing and record maintenance.

 To assist the Biomedical Engineer for equipment maintenance.

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

 Taking daily rounds for all the departments.

 To assist the Biomedical Engineer for equipment maintenance.

Job Duties and Tasks for: "Biomedical Engineer"

3) Design and develop medical diagnostic and clinical instrumentation, equipment,

4) Develop models or computer simulations of human bio-behavioral systems in

Approved By: Issue No: 01

STANDARD OPERATING PROCEDURE FOR Document No:

order to obtain data for measuring or controlling life processes.

5) Evaluate the safety, efficiency, and effectiveness of biomedical equipment.

6) Install, adjust, maintain, and/or repair biomedical equipment.

7) Research new materials to be used for products such as implanted artificial

8) Adapt or design computer hardware or software for medical science uses.

9) Advise hospital administrators on the planning, acquisition, and use of medical

10) Analyze new medical procedures in order to forecast likely outcomes.

11) Design and deliver technology to assist people with disabilities.

14) Teach biomedical engineering, or disseminate knowledge about field through

Job Activities for: "Biomedical Engineer"

3) Interacting With Computers -- Using computers and computer systems

4) Getting Information -- Observing, receiving, and otherwise obtaining

STANDARD OPERATING PROCEDURE FOR Document No:

information from all relevant sources.

5) Updating and Using Relevant Knowledge -- Keeping up-to-date technically and