BIOMEDICAL EQUIPMENT MANAGEMENT IN HOSPITALS

Biomedical Equipment

• Biomedical Equipment or Medical Equipment or Medical Device plays a vital role in hospitals
as they directly impact patient care
• Biomedical Equipment are used for diagnosis monitoring life support treatment and
therapeutic purposes
• Healthcare practitioner decides on the course of action based on the results/outputs
obtained from Medical Equipment
• Medical Equipment forms a combination from handheld devices such as Glucometers, Pulse
oximeters, Monitors etc, to major hi end equipment like Xray, CT, MRI, CATH Labs etc

Life cycle of Biomedical Equipment

Biomedical Equipment Management Program

• A Biomedical Equipment Management Program ( is a well defined and structured plan of activities
that covers the entire life cycle of Medical Equipment from planning till disposal

• Medical Equipment are valuable assets to a hospital and hence needs proper management and
maintenance

• BEMP is an essential tool for efficient management of Medical Equipment

World Health Organization

Medical Equipment maintenance, when well planned, managed and implemented, allows for all the
equipment in a healthcare institution to be reliable, safe and available for use when it is needed for
diagnostic procedures, therapy, treatments and monitoring of patients It also has the ability to
prolong the useful life of equipment and minimize the cost of ownership

Ref - Medical equipment maintenance programme overview WHO Medical device technical series

Importance of Biomedical Equipment Management Program

• Proper selection of Medical Technology

• Equipment reliability
• Equipment safety
• Equipment availability
• Minimize breakdowns
• Minimize maintenance cost
• Improves life of Equipment
• Improves efficiency
• Improves quality of care

Hospital Biomedical Engineering

• In order to implement such a program, you will require an in house Biomedical Engineering
department (for large hospitals) comprising of Biomedical Engineers and Technicians with
proper testing equipment and tools
• For small hospitals and nursing homes with less number of Medical Equipment, the
maintenance can be outsourced or managed with 1 or 2 in house Engineers/Technicians
BEMP - Committees

Biomedical Engineer will serve the following committees to implement BEMP or in other words the
following committees are part of BEMP

• Purchase committee
• Capital Budget committee
• Technology acquisition committee
• Quality & Safety committees
• Condemnation committee

Components of Biomedical Equipment Management Program

• Selection of Medical Equipment / Technology

• New Equipment Acceptance process
• Inventory Management
• Maintenance Management
• Calibration and Testing
• Stock Management
• Annual Maintenance Contract Management
• Training & skill development
• Condemnation
• Disposal
1. Selection of Medical Equipment / Technology
• Selection process should be done collectively by a committee or team comprising of
o Admin / Representative
o Purchase Manager
o Finance Manager
o Biomedical Manager
o Clinicians / Surgeons / Nursing
• Policy and procedures for Equipment procurement / Replacement
• End user requirements / specifications
• Available technologies / choices / vendors
• Tendering / quotations / technical / commercial comparisons
• Short listing & negotiations commercial, warranty, terms & conditions
• After sale service and Annual Maintenance contracts
• Maintenance and operational cost / spares cost
• Availability of other support services (Space, Electrical, UPS, AC etc.,)
• Statutory & Legal requirements (Licenses, Approvals, PNDT, AERB etc.,)
• Final approvals procurement & logistics

2. New equipment inspection, installation, acceptance & testing

• Pre installation testing : All new equipment should be inspected and tested for acceptance
• Equipment should be installed / tested in the presence of Biomedical Engineer
• Electrical safety testing & Functional testing to be done and recorded
• Service and Technical manuals
• Factory calibration & testing certificates
• Trainings for End user / Operator / Biomedical Engineer
 • Inspection report format
• Records and documentation (File / Software)
• Equipment hand over for patient use after inventory

3. Inventory Management

• As an Administrator / Manager you should know how many Medical Equipment are in use,
how many should be replaced, what is the maintenance cost for an equipment etc.,
• Hence all Medical Equipment should be inventoried
• An unique ID number can be provided to each Medical Equipment
• This inventory system will be of immense help to
o Identify and track each equipment
o Purchase details
o Maintenance history
o Cost of ownership
o Spares replaced details
o Analyze breakdowns
o Age of equipment
o Capital budgeting
o Asset control

4. Maintenance Management

• There are two types of maintenance

o Planned Preventive Maintenance (PPM)
o Breakdown or Corrective Maintenance (BM / CM)
• PPM should be scheduled for each piece of equipment based on its inventory and location
o PPM should be carried out as per manufacturer’s recommendations
o PPM helps to reduce breakdowns
o Helps to plan for spares or kits replacement in advance
o Regular PPM ensures safety and reliability
o Improves efficiency and life of equipment
• BM or CM is unexpected or sudden failure of equipment which requires corrective action in
order to get it functional
o Proper stock of spares should be maintained
o Should have service/technical manuals
o Staff should have been trained on servicing
o For AMC equipment, the service provider should respond within response time
• For both PPM and BM, proper records should be maintained. All activities should be
recorded
• In CMC we have online reporting system for breakdowns that captures events with time
• CMMS software records all maintenance activities and details can be retrieved anytime
• PPM and BM month reports should be sent to Management every month

5. Calibration and Testing

• Calibration in its simplest terms, is a process in which an equipment’s (DUT) accuracy is

compared with a known and proven standard (Master device)
• Calibration and testing is part of maintenance and should be performed at regular intervals
 • Calibration is mandatory and should be performed as per manufacturer’s recommendations
/ standards
• Calibration can be performed in house or can be performed by authorized agencies
• Calibration is essential for accreditation processes (NABH/NABL/JCI
• Testing includes functional testing and electrical safety testing
• Equipment should be tested and calibrated after repair or spare replacement
• Calibrated equipment can be labelled with details of due date etc.
• Calibration and test reports should be stored in CMMS against inventory number

6. Stock Management Spare & Accessories

• Stock of spares / accessories required for PPM/BM should be maintained in central stores or
biomedical stores
• Inventory of stock should be monitored
• Stock inventory should be updated during receipt and issue
• Spares should be issued against inventory number and work order
• Standardization of equipment models will help to reduce the investment on spares
• Standardization will also help to optimize spares utilization and better control over stock
management
• Standardization will help to salvage spare from similar condemned equipment

7. Annual Maintenance Contract Management

• There are 2 types of maintenance contracts

o Comprehensive Annual Maintenance contract
o Labour Annual Maintenance Contract
• AMC should be negotiated along with equipment purchase
• AMC will start after expiry of warranty
• AMC agreement should have PPM/BM visits
• Response time for BM calls should be defined
• End user / BME should ensure that the scheduled PPM are carried out
• End user / BME should ensure that BM calls are attended within response time
• All AMC related activities should be recorded in CMMS to find the compliance of services
provided during the period

8. Training and skills development

• Periodical training is essential for end user as well as biomedical engineer

• There are 2 types of training
o Application training
o Technical or service training
• End user or operator should be given application training during new installation and
upgrades on how to operate the equipment
• Technical or service training should be given to biomedical engineering staff
• Only trained personnel should operate or service an equipment
• Training ensures error free operation , gives confidence to operate equipment and helps to
save time
9. Condemnation and Disposal

• Equipment can be condemned or removed from service if

o Unrepairable or non functional
o Beyond economical repair, Service and spare cost is more
o Clinically obsolete
o Technically obsolete
o Manufacturer has given end of life or support
• Condemnation check to be performed and certified by Biomedical Engineer / Vendor
• Necessary support documents to be obtained
• Condemnation committee should assess all factors, equipment history and then approve for
condemnation/disposal
• Condemned equipment should be removed from inventory or in use list
• Condemned equipment should be disposed properly as per guidelines
• If similar models are still in use, then condemned equipment can be retained for spares
salvaging

Medical Device Recall

What is Medical Device Recall (MDR)?

When a company learns that there is a problem with one of their medical devices, it proposes a
correction or a removal depending on where the action takes place

FDA uses the term “recall ” when a manufacturer takes a correction or removal action to address a
problem with a medical device or group of device that violates FDA law. Recalls occur when a medical
device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

A medical device recall does not always mean that you must stop using the product or return it to
the company.

A recall sometimes means that the medical device needs to be checked, adjusted, or fixed

Who recalls medical devices?

Manufacturer, distributor, or other responsible party

What does the FDA Do about Medical Device Recalls?

FDA classifies and monitors the recall to ensure that the recall strategy has been effective. Only after
the FDA is assured that a product no longer violates the law and no longer presents a health hazard,
does the FDA terminate the recall

How does the FDA Notify the Public about Medical Device Recalls?

FDA posts information about the action in the Medical Device Recall Database

FDA may post company press releases or other public notices about recalls, market withdrawals, and
safety alerts

FDA notifies the public in the weekly Enforcement Report

Medical Device Incident Reporting

What is Medical Device Incident Reporting (MDIR)?

Medical Device related adverse events, injuries or deaths are reported to regulatory authorities in
order to monitor and take corrective actions for the affected device or to alert the potential hazard in
using the device

• Each county will have its own MDIR system (online reporting)
• India Drugs Controller General India launched Materiovigilance Program of India MvPI at
Indian Pharmacopeia Commission ( Ghaziabad on July 6 2015 The fundamental aim of this
program is to monitor medical device associated adverse events ( create awareness among
health care professionals about the importance of MDAE reporting and generate
independent credible evidence based safety data of medical devices and to share it with the
stakeholders
• The MvPI aims to enable data collection and evaluation in a systematic manner so that
regulatory decisions and recommendations on the safe use of medical devices in India can be
evidence based

Quality Indicators and Reports

• Biomedical Equipment Management program should be reviewed periodically

• The performance of BEMP can be measured by having proper Quality Indicators or Key
Performance Indicators like
o Ratio of PPM
o Ratio of BM
o Response Time Monitoring
o Trend Analysis of Breakdowns
o Fault Index Analysis of Critical Equipment
• Quarterly reports of Quality Indicators, MDR, MDIR etc., should be submitted to
Management, Quality and Safety departments
• Monitoring, Reporting and Periodical review of BEMP will help to improve the program