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EQUIPMENT
PLANNING
Dr. Syed Amin Tabish,
FRCP, FACP, FAMS, MD HA (AIIMS)
Postdoc Fellowship, Bristol University (England)
Doctorate in Educational Leadership (USA)
Equipment Planning
 When and why to buy what from
whom for how much!
 Avoid: buying what you don’t need
for a high price and at the wrong
time
 Buying the right equipment, for the
lowest price, for the right reasons
and at the right time.
ME Technology
 Technology to improve clinical outcomes,
reduce costs, and improve quality of life
for patients
 Major asset of the health care industry:
 Year 2001, total medical devices sales
volume ≈THB 15 Billion
 “Health care compression”
 Increasingly important to manage
medical equipment to contain costs and
improve quality and performance
Why Plan?
 A significant portion of equipment
(i.e. 25%-50%) that exists in
developing countries cannot be
used
 Main causes:
 Lack of funds
 Improper management
 “Preventative Medicine” approach
ME Planning Cycle
1. Planning-What?When?
2. Assessment-Why?Who?
3. Acquisition- How? Cost?
4. Disposition-What?When?
Equipment Life Cycle
 Installation
 Acceptance testing and
approval
 Clinical Use
 Planned Maintenance and
Unplanned Maintenance
(Corrective)
 Decommissioning/Disposition
Equipment Planning Cycle
Equipment Planning
 What? When?
 Systematic approach to determine
the hospital’s equipment needs
 Need a complete, accurate and up-
to-date medical equipment
inventory
 Purchase Cost
 Purchase Date
 EquipmentType
 Department Name
•Prioritizing equipment needs and
determining equipment replacement;
•Identifying how and when maintenance
is to be conducted and how much this
costs;
•Utilization records;
•Maintenance and repair records;
•Acceptance testing;
•Ease in locating medical equipment;
•Minimizing safety risks
Medical Equipment Inventory
i. Clinical Effectiveness
ii. Cost of Ownership
iii.Strategic medical
technology direction
iv.Client and Medical Staff
Perception
Planning Considerations
Clinical Effectiveness
 Availability (MTBF) – how often it breaks
 Downtime duration
 Age - over 7 years very difficult to get
parts from anywhere – thus may result in
longer downtimes
 Accuracy/Effectiveness of diagnosis and
treatment
 Speed of procedure
 Spare critical equipment for emergency
use
Cost of Ownership
 Consumables consumption
(cost, volume and usage
frequency)
 Speed (faster studies = more
patient throughput)
 Medical Expenditure Limit- Cost
of Maintenance and Repair
versus Replace
 2nd hand resale value/trade in
price
Strategic Med Tech Direction
 Equipment standardization- bundled
consumables/service contracts/ ease
of user training, etc
 Technology lifecycle of the equipment
 Latest medical technology- marketing
value
 Connectivity- internally and
externally
 Mobility and portability- multi-
location
Patient and Medical
Staff Perception
Age
Appearance
Technical look/feel
Advantages of Planning
Facilitates introduction of
new technology
Standardization of
equipment
Coordinated purchasing
approach
Multiple site/facility service
contract agreements
Equipment Assessment
 Why? Who?
 Collecting data for assessment
 Lifecycle cost analysis
 Historical utilization and consumption data
 Installation and construction needs
 Manufacturers profile/background
 On-site demonstration, clinical trials and bench
tests
 Upgrading current technology-“forklift” upgrade
 Alternative technologies
 Involve All key stakeholders
 Well documented, transparent and
accountable
Advantages of Assessment
 Select the correct equipment
to purchase
 All the hospital’s requirements
will be met
 Quicken the assessment
process for the same
equipment type
Equipment Acquisition
How? Cost?
Manage the acquisition
process
 Investigate best acquisition
option
 Refining quotations from
equipment suppliers
 Negotiating with suppliers
Acquisition Options
 Purchase Outright
 Operating Lease
 Finance Lease
 Vendor financing
 Rental (pay per use)
 Revenue sharing
 Group Purchase
Group Purchasing
 Central body that manages the purchasing
process for it’s members
 Scope: medical consumables and medical
supplies, pharmaceuticals, and medical
equipment
 HIGPA reported “Health care providers report
they save between 10-15 % by channeling
purchases through GPOs, totaling USD19-33.7
billion in savings for 2002”
 10% savings on purchasing inThailand will
result in a savings of ≈THB 1.5 billion per year
Equipment Disposition
 Final step, but also the 1st step-
medical equipment planning &
lifecycle
 Identification of equipment that can
no longer serve its primary purpose
 Assessment of a secondary and/or
tertiary purpose within the hospital
 Balance of the need for NEW versus
USED
Disposition Options
Relocation
Trade-In
Sell
Donate
Dispose/Scrap
Advantages of Managing
Disposition
Ensure complete and
effective use of equipment
Asset is formally removed
from the accounting
records by Finance and
Accounting
Example of an Annual
Medical Equipment
Planning Process
Med Equip Planning Process
1. Initial audit of existing medical
equipment in the hospital [January –
February]
2. Conduct a medical technology
assessment for new and emerging
technologies to fit with current or
desired clinical services [March-April]
3. Planning for replacement and selection
of new technologies [May-June]
Med Equip Planning Process
4. Prioritizing for technology
acquisition [July – August]
5. Provide input to the capital
budgeting process [September-
October]
6. Implement equipment acquisition
and monitor ongoing utilization
[on-going]
7. Dispose of equipment [on-going]
Example Short Term Project
 Profile all medical equipment in
the hospital with a purchase
cost above B500,000
 Analyze utilization, technology
trends, hospital’s strategic and
clinical directions
 Project their replacement costs
into a 5-year capital
expenditure plan
Take Away Message
 Medical equipment inventory
 Complete
 Accurate
 Up-to-date
 Set-up a MedicalTechnology
Advisory Committee
 Develop medical technology
strategic direction
Message (contd)
 Develop in-house medical
equipment planning,
assessment, acquisition and
disposition policies and
procedures
 Develop a 5-year major medical
equipment capital budget
Key Points
 Bio Medical Equipment and its
increasing use on a daily basis has
played a key role in the advances that
have taken place in Medicine in recent
years. We need to remind ourselves
that widespread placement and use of
Electro Medical equipment that we
now take for granted is a relatively
recent phenomenon.
Key Points
 It is not that long ago that Medical
Equipment was only seen in very
small clusters and even then only in
high acuity areas such as ICU, CCU,
Theatre, etc. In the modern
hospital every department now has
a compliment of sophisticated
Medical Devices.
Key Points
 Effective placement and safe use of
Medical Equipment does improve patient
care and enhance workflows, and
certainly improves efficiencies.There are
challenges though and these include
effective Care and Maintenance of
Equipment, UserTraining on an on-going
basis to ensure effective and safe use of
the equipment and your role in the
unlikely event that something unforeseen
happens that could or did contribute to a
patient injury.
Key Points
Medical equipment,
fittings and fixtures
layout follows the work
flow and must separate
the “dirty” and “clean”
zones.
Key Points
 Height of hospital equipment,
shelving and layout should allow
easy access to hospital staff of
an average height.The same
goes for all diagnostic units,
which should be suitably
adjustable to cater to all
heights/sizes of patients
Key Points
 While a great majority of medical equipment
is easy to relocate through attached wheels,
this is not the same for larger medical
equipment units such as MRI’s, and CT
scanners parts of which are bolted to the floor
or wall. Access and egress are both important.
So thought needs to be given not just to
facilitate the initial arrival and installation of
these large/oversize medical units before the
last wall is built, but also how to remove the
equipment when it needs servicing or
decommissioning and replacement.
Key Points
 It pays to consider if these big units
can be dismantled into smaller
modules and whether the equipment
can pass through the corridor corners?
Are any trolley options available? Is
the door large enough to
accommodate easy passage of these
units? Does it need to go in a lift? If
yes, are the service lifts large enough
to cater to the size and weight?
Key Points
 Over and above the size/movement
aspects of large hospital equipment,
building structure is another aspect to
consider well before the construction
starts.The hospital X-ray unit, for
example needs steel in the ceilings to
provide the ceiling tracks on which the
X-Ray head is mounted. Slab deflection
and vibration requirements should be
established with the equipment
providers.
Key Points
 Continuing with the example of the X-Ray,
the X-Ray table, the head on the gantry, the
wall mounted bucky, the control console and
the generator all need services and floor
trunking dimensions and locations should be
provided to the structural engineers to plan
that before the concrete is poured. Otherwise
cutting out the trunking will be an expensive
and time consuming job.
Key Points
 Special hospital equipment also
gets installed in stages, such as the
theatre pendant and lights; the
suppliers normally issue the steel
plate at the construction stage
which should be bolted to the
concrete ceiling.The rest of the
services and pendant is built just
before the false ceiling goes up.
Key Points
 Most advanced lasers and
radiation equipment require
interlocking doors as a safety
measure, which is automatically
turned on before switching on
the said units, in addition to the
warning lights outside the room
the medical equipment
professional's functions
 Equipment Control & Asset Management
 Equipment Inventories
 Work Order Management
 Data Quality Management
 Personnel Management
 Quality Assurance
 Patient Safety
 Risk Management
 Hospital Safety Programs
Functions (contd)
 Radiation Safety
 Medical Gas Systems
 In-Service Education &Training
 Accident Investigation
 Safe Medical Devices Act (SMDA) of
1990
 Health Insurance Portability and
Accountability Act (HIPAA)
 Careers in Facilities Management
 Service Contracts
Equipment Control & Asset
Management
 Every medical treatment facility should
have policies and processes on
equipment control & asset
management. Equipment control and
asset management involves the
management of medical devices within
a facility and may be supported by
automated information systems
Control (contd)
 Equipment control begins with the receipt of
a newly-acquired equipment item and
continues through the item's entire life-cycle.
Newly-acquired devices should be inspected
by in-house or contracted biomedical
equipment technicians (BMETs), who will
establish an equipment control / asset
number against which maintenance actions
are recorded.
 Once a number is established, the device is
safety inspected and readied for delivery to
clinical and treatment areas in the facility.
Work Order Management
 Work order management involves
systematic, measurable, and traceable
methods to all acceptance/initial
inspections, preventive maintenance,
and calibrations, or repairs by generating
scheduled and unscheduled work orders
 Work order management includes all
safety, preventive, calibration, test, and
repair services performed on all such
medical devices
Data Required
 Accurate, comprehensive data is needed
in any automated medical equipment
management system.
 The data needed to establish basic,
accurate, maintainable automated records
for medical equipment management
includes: nomenclature, manufacturer,
nameplate model, serial number,
acquisition cost, condition code, and
maintenance assessment.
Data Required
 Other useful data could include:
warranty, location, other contractor
agencies, scheduled maintenance
due dates, and intervals.These
fields are vital to ensure
appropriate maintenance is
performed, equipment is
accounted for, and devices are safe
for use in patient care.
Data Required
 Nomenclature: It defines what the device is,
how, and the type of maintenance is to be
performed. Common nomenclature systems
are taken directly from the Emergency Care
Research Institute (ECRI) Universal Medical
Device Nomenclature System.
 Manufacturer:This is the name of the
company that received approval from the
FDA to sell the device, also known as the
Original Equipment Manufacturer (OEM)
Data Required
 Nameplate model:The model number
is typically located on the front/behind
of the equipment or on the cover of the
service manual and is provided by the
OEM. E.g. Medtronic PhysioControl’s
Lifepak 10 Defibrillator can actually be
anyone of the following correct model
numbers listed: 10-41, 10-43, 10 -47, 10-
51, and 10-57.
Data Required
 Serial number:This is usually found on the
data plate as well, is a serialized number
(could contain alpha characters) provided by
the manufacturer.This number is crucial to
device alerts and recalls.
 Acquisition cost:The total purchased price
for an individual item or system.This cost
should include installation, shipping, and
other associated costs.These numbers are
crucial for budgeting, maintenance
expenditures, and depreciation reporting.
Data Required
 Condition code:This code is mainly used
when an item is turned in and should be
changed when there are major changes to
the device that could effect whether or not
an item should be salvaged, destroyed, or
used by another MedicalTreatment Facility.
 Maintenance assessment:This assessment
must be validated every time a BMET
performs any kind of maintenance on Equip
Quality Assurance
 QualityAssurance is a way of
identifying an item of supply or
equipment as being defective.A
good quality control/engineering
program improves quality of
work and lessens the risk of
staff/patient injuries/death.
Patient safety
Safety of our
patients/staff is
paramount to the
success of the
organizations mission.
Risk Management
 Avoid the likelihood of equipment related risks,
minimize liability of mishaps and incidents, and
stay compliant with regulatory reporting
requirements.
 The best practice is to using a rating system for
every equipment type. For example, a risk-rating
system might rate defibrillators as considered
high risk, general-purpose infusion pumps as
medium risk, electronic thermometers as low
risk, and otoscopes as no significant risk.This
system could be setup using Microsoft Excel or
Access program for a managers or technicians
quick reference.
Risk Management (contd)
 User error, equipment abuse, no
problem/fault found occurrences
must be tracked to assist risk
management personnel in
determining whether additional
clinical staff training must be
performed.
Hospital safety Program
 Safety includes a range of hazards
including mishaps, injuries on the job, and
patient care hazards.
 The most common safety mishaps are
"needle-sticks" (staff accidentally stick
themselves with a needle) or patient
injury during care.
 Ensure all staff and patients are safe
within the facility.
 It’s everyone’s responsibility!
FUNDAMENTALS
 Medical equipment is subject to
damage and wear.
 Regular maintenance and
evaluation are necessary to assure
that equipment delivers the
expected performance within
specified parameters.
Equipment Maintenance
 Preventive Maintenance (PM) – Medical
equipment is subject to effective periodic
maintenance
 Service Contracts/Warranty – Manufacturers or a
third party may cover specific ME under contract.
This equipment is repaired and maintained by the
 outside source. Upon receipt of their
documentation, hospital reviews it and, if
acceptable, enters it into the equipment
management program history
Maintenance
 Repairs - Clinical Engineering
staff perform in-house repairs .
 Manufacturers and other
outside vendors conduct
repairs of specific contracted
devices
Scheduled Maintenance
 Hospital defines intervals for inspecting, testing,
and maintaining appropriate equipment on the
inventory (that is, those pieces of equipment on
the inventory benefiting from scheduled
activities to minimize the clinical and physical
risks) that are based upon criteria such as
manufacturers’ recommendations, risk levels,
and current hospital
experience.
 All equipment included in the program is
inspected and tested prior to its initial use and at
set intervals, commonly referred to as preventive
maintenance

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Equipment Planning in Hospitals

  • 1. EQUIPMENT PLANNING Dr. Syed Amin Tabish, FRCP, FACP, FAMS, MD HA (AIIMS) Postdoc Fellowship, Bristol University (England) Doctorate in Educational Leadership (USA)
  • 2. Equipment Planning  When and why to buy what from whom for how much!  Avoid: buying what you don’t need for a high price and at the wrong time  Buying the right equipment, for the lowest price, for the right reasons and at the right time.
  • 3. ME Technology  Technology to improve clinical outcomes, reduce costs, and improve quality of life for patients  Major asset of the health care industry:  Year 2001, total medical devices sales volume ≈THB 15 Billion  “Health care compression”  Increasingly important to manage medical equipment to contain costs and improve quality and performance
  • 4. Why Plan?  A significant portion of equipment (i.e. 25%-50%) that exists in developing countries cannot be used  Main causes:  Lack of funds  Improper management  “Preventative Medicine” approach
  • 5. ME Planning Cycle 1. Planning-What?When? 2. Assessment-Why?Who? 3. Acquisition- How? Cost? 4. Disposition-What?When?
  • 6. Equipment Life Cycle  Installation  Acceptance testing and approval  Clinical Use  Planned Maintenance and Unplanned Maintenance (Corrective)  Decommissioning/Disposition
  • 8. Equipment Planning  What? When?  Systematic approach to determine the hospital’s equipment needs  Need a complete, accurate and up- to-date medical equipment inventory  Purchase Cost  Purchase Date  EquipmentType  Department Name
  • 9. •Prioritizing equipment needs and determining equipment replacement; •Identifying how and when maintenance is to be conducted and how much this costs; •Utilization records; •Maintenance and repair records; •Acceptance testing; •Ease in locating medical equipment; •Minimizing safety risks Medical Equipment Inventory
  • 10. i. Clinical Effectiveness ii. Cost of Ownership iii.Strategic medical technology direction iv.Client and Medical Staff Perception Planning Considerations
  • 11. Clinical Effectiveness  Availability (MTBF) – how often it breaks  Downtime duration  Age - over 7 years very difficult to get parts from anywhere – thus may result in longer downtimes  Accuracy/Effectiveness of diagnosis and treatment  Speed of procedure  Spare critical equipment for emergency use
  • 12. Cost of Ownership  Consumables consumption (cost, volume and usage frequency)  Speed (faster studies = more patient throughput)  Medical Expenditure Limit- Cost of Maintenance and Repair versus Replace  2nd hand resale value/trade in price
  • 13. Strategic Med Tech Direction  Equipment standardization- bundled consumables/service contracts/ ease of user training, etc  Technology lifecycle of the equipment  Latest medical technology- marketing value  Connectivity- internally and externally  Mobility and portability- multi- location
  • 14. Patient and Medical Staff Perception Age Appearance Technical look/feel
  • 15. Advantages of Planning Facilitates introduction of new technology Standardization of equipment Coordinated purchasing approach Multiple site/facility service contract agreements
  • 16. Equipment Assessment  Why? Who?  Collecting data for assessment  Lifecycle cost analysis  Historical utilization and consumption data  Installation and construction needs  Manufacturers profile/background  On-site demonstration, clinical trials and bench tests  Upgrading current technology-“forklift” upgrade  Alternative technologies  Involve All key stakeholders  Well documented, transparent and accountable
  • 17.
  • 18. Advantages of Assessment  Select the correct equipment to purchase  All the hospital’s requirements will be met  Quicken the assessment process for the same equipment type
  • 19. Equipment Acquisition How? Cost? Manage the acquisition process  Investigate best acquisition option  Refining quotations from equipment suppliers  Negotiating with suppliers
  • 20. Acquisition Options  Purchase Outright  Operating Lease  Finance Lease  Vendor financing  Rental (pay per use)  Revenue sharing  Group Purchase
  • 21. Group Purchasing  Central body that manages the purchasing process for it’s members  Scope: medical consumables and medical supplies, pharmaceuticals, and medical equipment  HIGPA reported “Health care providers report they save between 10-15 % by channeling purchases through GPOs, totaling USD19-33.7 billion in savings for 2002”  10% savings on purchasing inThailand will result in a savings of ≈THB 1.5 billion per year
  • 22. Equipment Disposition  Final step, but also the 1st step- medical equipment planning & lifecycle  Identification of equipment that can no longer serve its primary purpose  Assessment of a secondary and/or tertiary purpose within the hospital  Balance of the need for NEW versus USED
  • 24. Advantages of Managing Disposition Ensure complete and effective use of equipment Asset is formally removed from the accounting records by Finance and Accounting
  • 25. Example of an Annual Medical Equipment Planning Process
  • 26. Med Equip Planning Process 1. Initial audit of existing medical equipment in the hospital [January – February] 2. Conduct a medical technology assessment for new and emerging technologies to fit with current or desired clinical services [March-April] 3. Planning for replacement and selection of new technologies [May-June]
  • 27. Med Equip Planning Process 4. Prioritizing for technology acquisition [July – August] 5. Provide input to the capital budgeting process [September- October] 6. Implement equipment acquisition and monitor ongoing utilization [on-going] 7. Dispose of equipment [on-going]
  • 28. Example Short Term Project  Profile all medical equipment in the hospital with a purchase cost above B500,000  Analyze utilization, technology trends, hospital’s strategic and clinical directions  Project their replacement costs into a 5-year capital expenditure plan
  • 29. Take Away Message  Medical equipment inventory  Complete  Accurate  Up-to-date  Set-up a MedicalTechnology Advisory Committee  Develop medical technology strategic direction
  • 30. Message (contd)  Develop in-house medical equipment planning, assessment, acquisition and disposition policies and procedures  Develop a 5-year major medical equipment capital budget
  • 31. Key Points  Bio Medical Equipment and its increasing use on a daily basis has played a key role in the advances that have taken place in Medicine in recent years. We need to remind ourselves that widespread placement and use of Electro Medical equipment that we now take for granted is a relatively recent phenomenon.
  • 32. Key Points  It is not that long ago that Medical Equipment was only seen in very small clusters and even then only in high acuity areas such as ICU, CCU, Theatre, etc. In the modern hospital every department now has a compliment of sophisticated Medical Devices.
  • 33. Key Points  Effective placement and safe use of Medical Equipment does improve patient care and enhance workflows, and certainly improves efficiencies.There are challenges though and these include effective Care and Maintenance of Equipment, UserTraining on an on-going basis to ensure effective and safe use of the equipment and your role in the unlikely event that something unforeseen happens that could or did contribute to a patient injury.
  • 34. Key Points Medical equipment, fittings and fixtures layout follows the work flow and must separate the “dirty” and “clean” zones.
  • 35. Key Points  Height of hospital equipment, shelving and layout should allow easy access to hospital staff of an average height.The same goes for all diagnostic units, which should be suitably adjustable to cater to all heights/sizes of patients
  • 36. Key Points  While a great majority of medical equipment is easy to relocate through attached wheels, this is not the same for larger medical equipment units such as MRI’s, and CT scanners parts of which are bolted to the floor or wall. Access and egress are both important. So thought needs to be given not just to facilitate the initial arrival and installation of these large/oversize medical units before the last wall is built, but also how to remove the equipment when it needs servicing or decommissioning and replacement.
  • 37. Key Points  It pays to consider if these big units can be dismantled into smaller modules and whether the equipment can pass through the corridor corners? Are any trolley options available? Is the door large enough to accommodate easy passage of these units? Does it need to go in a lift? If yes, are the service lifts large enough to cater to the size and weight?
  • 38. Key Points  Over and above the size/movement aspects of large hospital equipment, building structure is another aspect to consider well before the construction starts.The hospital X-ray unit, for example needs steel in the ceilings to provide the ceiling tracks on which the X-Ray head is mounted. Slab deflection and vibration requirements should be established with the equipment providers.
  • 39. Key Points  Continuing with the example of the X-Ray, the X-Ray table, the head on the gantry, the wall mounted bucky, the control console and the generator all need services and floor trunking dimensions and locations should be provided to the structural engineers to plan that before the concrete is poured. Otherwise cutting out the trunking will be an expensive and time consuming job.
  • 40. Key Points  Special hospital equipment also gets installed in stages, such as the theatre pendant and lights; the suppliers normally issue the steel plate at the construction stage which should be bolted to the concrete ceiling.The rest of the services and pendant is built just before the false ceiling goes up.
  • 41. Key Points  Most advanced lasers and radiation equipment require interlocking doors as a safety measure, which is automatically turned on before switching on the said units, in addition to the warning lights outside the room
  • 42. the medical equipment professional's functions  Equipment Control & Asset Management  Equipment Inventories  Work Order Management  Data Quality Management  Personnel Management  Quality Assurance  Patient Safety  Risk Management  Hospital Safety Programs
  • 43. Functions (contd)  Radiation Safety  Medical Gas Systems  In-Service Education &Training  Accident Investigation  Safe Medical Devices Act (SMDA) of 1990  Health Insurance Portability and Accountability Act (HIPAA)  Careers in Facilities Management  Service Contracts
  • 44. Equipment Control & Asset Management  Every medical treatment facility should have policies and processes on equipment control & asset management. Equipment control and asset management involves the management of medical devices within a facility and may be supported by automated information systems
  • 45. Control (contd)  Equipment control begins with the receipt of a newly-acquired equipment item and continues through the item's entire life-cycle. Newly-acquired devices should be inspected by in-house or contracted biomedical equipment technicians (BMETs), who will establish an equipment control / asset number against which maintenance actions are recorded.  Once a number is established, the device is safety inspected and readied for delivery to clinical and treatment areas in the facility.
  • 46. Work Order Management  Work order management involves systematic, measurable, and traceable methods to all acceptance/initial inspections, preventive maintenance, and calibrations, or repairs by generating scheduled and unscheduled work orders  Work order management includes all safety, preventive, calibration, test, and repair services performed on all such medical devices
  • 47. Data Required  Accurate, comprehensive data is needed in any automated medical equipment management system.  The data needed to establish basic, accurate, maintainable automated records for medical equipment management includes: nomenclature, manufacturer, nameplate model, serial number, acquisition cost, condition code, and maintenance assessment.
  • 48. Data Required  Other useful data could include: warranty, location, other contractor agencies, scheduled maintenance due dates, and intervals.These fields are vital to ensure appropriate maintenance is performed, equipment is accounted for, and devices are safe for use in patient care.
  • 49. Data Required  Nomenclature: It defines what the device is, how, and the type of maintenance is to be performed. Common nomenclature systems are taken directly from the Emergency Care Research Institute (ECRI) Universal Medical Device Nomenclature System.  Manufacturer:This is the name of the company that received approval from the FDA to sell the device, also known as the Original Equipment Manufacturer (OEM)
  • 50. Data Required  Nameplate model:The model number is typically located on the front/behind of the equipment or on the cover of the service manual and is provided by the OEM. E.g. Medtronic PhysioControl’s Lifepak 10 Defibrillator can actually be anyone of the following correct model numbers listed: 10-41, 10-43, 10 -47, 10- 51, and 10-57.
  • 51. Data Required  Serial number:This is usually found on the data plate as well, is a serialized number (could contain alpha characters) provided by the manufacturer.This number is crucial to device alerts and recalls.  Acquisition cost:The total purchased price for an individual item or system.This cost should include installation, shipping, and other associated costs.These numbers are crucial for budgeting, maintenance expenditures, and depreciation reporting.
  • 52. Data Required  Condition code:This code is mainly used when an item is turned in and should be changed when there are major changes to the device that could effect whether or not an item should be salvaged, destroyed, or used by another MedicalTreatment Facility.  Maintenance assessment:This assessment must be validated every time a BMET performs any kind of maintenance on Equip
  • 53. Quality Assurance  QualityAssurance is a way of identifying an item of supply or equipment as being defective.A good quality control/engineering program improves quality of work and lessens the risk of staff/patient injuries/death.
  • 54. Patient safety Safety of our patients/staff is paramount to the success of the organizations mission.
  • 55. Risk Management  Avoid the likelihood of equipment related risks, minimize liability of mishaps and incidents, and stay compliant with regulatory reporting requirements.  The best practice is to using a rating system for every equipment type. For example, a risk-rating system might rate defibrillators as considered high risk, general-purpose infusion pumps as medium risk, electronic thermometers as low risk, and otoscopes as no significant risk.This system could be setup using Microsoft Excel or Access program for a managers or technicians quick reference.
  • 56. Risk Management (contd)  User error, equipment abuse, no problem/fault found occurrences must be tracked to assist risk management personnel in determining whether additional clinical staff training must be performed.
  • 57. Hospital safety Program  Safety includes a range of hazards including mishaps, injuries on the job, and patient care hazards.  The most common safety mishaps are "needle-sticks" (staff accidentally stick themselves with a needle) or patient injury during care.  Ensure all staff and patients are safe within the facility.  It’s everyone’s responsibility!
  • 58. FUNDAMENTALS  Medical equipment is subject to damage and wear.  Regular maintenance and evaluation are necessary to assure that equipment delivers the expected performance within specified parameters.
  • 59. Equipment Maintenance  Preventive Maintenance (PM) – Medical equipment is subject to effective periodic maintenance  Service Contracts/Warranty – Manufacturers or a third party may cover specific ME under contract. This equipment is repaired and maintained by the  outside source. Upon receipt of their documentation, hospital reviews it and, if acceptable, enters it into the equipment management program history
  • 60. Maintenance  Repairs - Clinical Engineering staff perform in-house repairs .  Manufacturers and other outside vendors conduct repairs of specific contracted devices
  • 61. Scheduled Maintenance  Hospital defines intervals for inspecting, testing, and maintaining appropriate equipment on the inventory (that is, those pieces of equipment on the inventory benefiting from scheduled activities to minimize the clinical and physical risks) that are based upon criteria such as manufacturers’ recommendations, risk levels, and current hospital experience.  All equipment included in the program is inspected and tested prior to its initial use and at set intervals, commonly referred to as preventive maintenance