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Outline Equipment Control Program
Significant Program Components Computerized Maintenance Management and Information Systems Standard Information Included in any Equipment Control Additional Data Element Required for Services Computerized Database Information
Inventory Control Existing Equipment Departmental Interaction New Equipment
Medical Equipment Management Maintenance Activities Medical Equipment Management Administrative Considerations during Initial Inspection Maintenance Schedules
217
Equipment Control Program
Structure for the clinical utilization of equipment in the hospital to apply technical competence, management techniques and organizational skills to the control and application of technology
218
Equipment Control Program Needs
Acquisition of instrumentation from small, portable electronic thermometers to massive, fixed, radiological systems
Preventive maintenance and repair: average of 5-15% of equipment cost
Technical support in management of technology: minimize costs and help allocate resources to real needs.
Financial, quality and hazard control to assure health and safety of patients
Applicable Code Requirements Such as food and drug requirements, electrical
requirements and accreditation standards set by the government authorities
220
Equipment Control Program Definition
System employed by the hospital to ensure efficient and effective procurement and utilization of medical devices and instrumentation
Significant Program Components Policies and Procedures Interdepartmental relationships Integration with other clinical engineering
functions Communications
221
Significant Program Components Policies and Procedures
Policy may be considered as a formal recognition of an institution-wide set of desired behavioral objectives
Formalized the expectations of management in order to legally protect the institution and the employees
Provide the patient assurance of safety and quality care
Provides a framework for common communication and disciplinary action
222
Significant Program Components
measure effectiveness of the policies and procedures in terms of the number of occasions ion which they are correctly implemented, as compared to the number of occasions on which they are not
Policies and procedures that are found to be ineffective should be rewritten or eliminated
223
Significant Program Components Interdepartmental Relationships
Equipment Control Program Objectives Control cost, quality and hazards Establishment of a focus for the management of
technology in the hospital Equipment exists in every department, is often
shared by departments and is also often mobile Necessary to know how equipment functions, how
and where it is used and its typical modes of failure
224
Normal Flow of new Equipment
Using department
Identify equipment
requirements
Select best available products
Develop specifications
Obtain bids Select Vendor
Receive and inspect
Document
Label
Deliver to using
department
Train usersApprove payment
Use clinicallyPreventive
maintenance or repair
Start
Stop
Review of records for
management information
Review of records for
safety information
Modification and
Upgrading
QA on vendor support
225
Significant Program Components Integration with other clinical engineering
Functions Success in equipment control program relies on
the ability to utilize the personnel, functions and data relating to other clinical engineering responsibilities
Materials generated in one aspect of the clinical engineering program will be of great importance to the other aspects of the program
226
Significant Program Components Communication
Must gather information then communicate data and recommendations in a clear and forthright manner
Communication channels Written memoranda and reports Scheduled meetings with administrative personnel Committee meetings and frequent informal discussions
with department heads, unit managers and special-care nursing staffs
227
Computerized Maintenance Management and Information Systems Produce maintenance schedules and track
inspection and work order requests
Produce reports to determine personnel productivity, notify departments with higher than average equipment repair costs, identify repeat repairs on the same device, and document potential user errors or equipment abuse
Provide documentation for malpractice suits involving medical equipment
228
Computerized Maintenance Management and Information Systems Demonstrate to accreditation inspectors that
equipment is being properly maintained
Support repair-versus-replacement decisions with historical data
Forecast equipment replacement requirements
Determine if and where recalled devices are located in the hospital
Determine charges to user departments and prepare operating budgets
229
Standard Information Included in any Equipment Control Equipment control number
Unique number identifying a specific equipment item; individual equipment modules may also be given specific control-number
Manufacturer Name of the company that manufactured the
equipment
Model number An equipment type identifier assigned by the
manufacturer and labelled on the equipment.
230
Standard Information Included in any Equipment Control Serial Number
An identifier assigned by the manufacturer for a specific piece of equipment
Manufacturer code A unique code identifying the company that manufactured
the equipment
Device Code A code indicating the type or class of the device
Device code description An industry-accepted standard nomenclature for the device
231
Standard Information Included in any Equipment Control Vendor
The name of the company that sold the device
Vendor code A unique code indicating the company that sold the device
Department code The department to which the equipment was assigned
Location The building or room where the device is normally located
232
Standard Information Included in any Equipment Control Contractor code
The equipment contractor if the item is under a maintenance contract or warranty
Risk code The relative risk to a patient in the event of equipment
failure or misuse
Purchase date The date the item is ordered
Received date The date the item is received
233
Standard Information Included in any Equipment Control Installation date
The date the hospital accepted the equipment for use
Warranty/contract expiration date The date the device is no longer under warranty
or contract
Purchase price The total amount paid for the device
234
Additional Data Element Required for Services Work order number
A unique number to identify a particular maintenance request Includes date and time of request
Requestor The name and department of the individual placing the service
request
Requestor’s telephone number A phone number for contacting the requestor
Service required A narrative description of the perceived problem or the service
that is required
235
Additional Data Element Required for Services Service source
The provider of the service
Service response time/date The time and date that the technician responded to the
work order
Service complete time/date The time and date that the work order was completed
Work order action code A code indicating the status or completion of the work order
236
Additional Data Element Required for Services Equipment status code
A code that indicates if the device was still serviceable upon initiation of the work order
Priority The relative urgency of the work order
Service time The actual labor time expended
Repair parts cost The total cost of repair parts used
237
Additional Data Element Required for Services Contract cost
The labor/travel costs of contract maintenance
Technician code A unique code identifying a specific technician
238
Computerized Database Information With a computerized database, it provides unique
opportunities for managing and documenting activities within a department.
The following information can thus be obtained: Computation of downtime: can be expressed as service
completed, time and date – work order opened, time and date. Estimated time the equipment is not available for patient treatment
Average time to repair: total service time / total service calls, which can be broken down by device code to determine devices that exceed the expected repair times, by manufacturer to identify poor-quality products or by technician to determine the need for training.
239
Computerized Database Information
Response time: service response, time and date – work order opened, time and date. Customer satisfaction is directly linked to responsiveness of service
Operator error / no defect actions: use work order actions: codes to identify problems.
Repeat repair: historical data are used to identify repeat repairs. Excessive repeats can indicate that a technician may need training, operators may abuse the equipment, or equipment has become unreliable.
240
Existing Equipment First step in the effort to manage the variety and
number of instruments utilized is to identify: What they are Where they are Who is responsible for ownership Use of device
Orderly method for recording information related to the instrument must be established for existing and future data retrieval, analysis and application to future decisions and solutions to problems
242
Existing Equipment
Steps in the control of existing equipment Initial inspection; (manufacturer, model number,
serial number, and description of the equipment must be obtain) General safety inspection – identify malfunction,
damaged or worn instruments Acquire or develop test utilized for incoming inspection
or preventive maintenance and apply these to obtain baseline data for future performance testing
243
Existing Equipment
Add control number (acquisition number/ or institutional property control number) and place a tag bearing this number on the equipment
Obtain items such as warranty expiration date, purchase order number, acquisition cost, owner, manufacturer's address and equipment location
244
Existing Equipment
Problems or difficulties that may be encountered Some of the information to be gathered, might not
exists May no longer be possible to obtain
documentation on older equipment Difficulty in determining
whether maintenance contracts exists Who provides maintenance coverage and at what
cost
245
Existing Equipment
Points to Remember Gathering information on existing equipment is
not only time consuming but also frustrating Vendor is not often the manufacturer but a local
sales representative Each clinical department may be responsible for
the purchase and maintenance of its own equipment so it is necessary to deal with each department in obtaining the needed information
246
Existing Equipment
Be alert to nuances of user satisfaction and dissatisfaction with the instrumentation in performing inventory, identifying such causes as instrument condition, vendor support and training
Identify sources of user satisfaction so that in-house effort can replace external vendor services without loss of confidence or credibility
247
Departmental Interaction
Anticipate concerns on the part of the client departments when expressing an interest in their equipment
Keep in mind that the hospital departments have traditionally owned and been solely responsible for the instrumentation
248
New Equipment
As data is obtained on existing equipment, hospital organization and personnel is known and been known to them it is advantageous to initiate procedures for purchase of new equipment
249
Maintenance Activities Initial inspection / acceptance testing Scheduled maintenance services Repair services Scheduled maintenance services Equipment disposition
251
Medical Equipment Management Initial Inspection/ Acceptance Testing
Verify that all components, accessories, and options listed on the purchase request were received
Verify the safety and performance features of the device prior to its initial use for patient care within the facility. Safety and performance should be verified against the manufacturer’s specifications
Record initial performance and safety values, which can be used for comparison during future inspections if questions arise about the device performance
Satisfy the requirements of the Joint Commission on Accreditation of Healthcare Organizations. As a part of their Plant, Technology and Safety Management (PTSM) standards, JCAHO requires documentation of equipment testing prior to initial use
252
Administrative Considerations during Initial Inspection Ensuring that the hospital identification tag or
unique control number is affixed to the equipment
Starting the equipment data file (EDF). This file should include a copy of the original purchase order, the initial performance and safety values, and any warranty/guarantee data
Filing the manufacturer’s service and operator manuals
253
Administrative Considerations during Initial Inspection Entering information about the device into
the computerized maintenance management system and determining the appropriate scheduled maintenance frequency
Stocking appropriate accessories and user supplies, including replacement parts
Setting up training programs for users254
Maintenance Schedules
Inspections that are not frequent enough may adversely affect reliability, accuracy and safety. A device should be scheduled for periodic inspection, maintenance, or performance verification only if there is a good reason to provide such support
255
Maintenance Schedules Reasons:
Reducing risk of injury to patients, staff or visitors
Minimizing equipment down time
Avoiding excessive repair costs by providing maintenance at appropriate intervals
Correcting minor operational problems before they result in major system failures or inaccurate results
Complying with codes, standards, and regulations or the strict recommendations of equipment manufacturers
256
Maintenance Schedules Although risk alone does not define the scheduled
maintenance frequency, it is an important factor.
High-risk devices are those life-support, therapeutic, and diagnostic devices whose failure or misuse is reasonably likely to cause injury to patient or staff or whose absence or failure could have an immediate or serious impact on patient care
Medium-risk devices are those devices whose failure, misuse, or absence is not likely to cause serious injury to patients or staff but may have an impact on patient care
Low-risk devices are those devices whose failure, misuse or absence is unlikely to result in injury to patient or staff and will have minimal impact on patient care
257
Maintenance Schedules Simple scoring system can be established to
determine whether scheduled maintenance should be performed and at what frequency.
Three factors to be considered in order to arrive at an equipment management (EM) number Equipment function Physical risk Required maintenance
Function Risk Required MaintenanceEM
258
Maintenance Schedules Equipment Function
Categories Therapeutic – applies some form of energy to the patient
and hence has the highest risk score Diagnostic Analytical Miscellaneous
Physical Risk Considers what the possible consequences might
be to the patient or operator if the equipment fails or malfunctions
259
EM number computation example of a Ventilator Equipment Function Score: 10 Physical Risk Score: 5 Required Maintenance Score: 5 Total EM Score: 20
ONLY those items with an EM number of 12 or greater are included in the equipment control program.
266
Maintenance Schedules Required Maintenance
Equipment that is predominantly mechanical, pneumatic, or fluidic usually requires the most extensive maintenance
Ex. Ventilators, intra-aortic balloon pumps and hemodialysis machines
Devices requiring only performance verification and safety testing are classified as average maintenance level
Ex. Physiological monitors and infusion pumps
Devices that require only a visual inspection are assigned a minimal maintenance level
Ex. Water baths, light sources and otoscopes
267
Scheduled Maintenance Services Preventive Maintenance
Periodic procedure to minimize the risk of failure and to ensure continued proper operation. (ECRI, 1990)
Includes cleaning, lubricating, adjusting, and replacing certain parts but exclude operational maintenance normally carried out by the user
Functional Testing, Performance Verification and Calibration (AHA,1988)
To verify that the equipment is fully operational and performing within reasonable, previously specified limits
Safety Inspection Leakage current and ground integrity should be tested in
accordance with NFPA 99, Standard for Health Care Facilities. A visual Inspection for mechanical safety should also be conducted to ensure both the patient and operator are safe from possible harm
268
Repair Services The bread and the butter of every clinical
engineering program
Repair can be defined as trouble shooting to isolate the cause of device malfunction and then replacement or adjustment of components or subsystems to restore normal function, safety, performance, and reliability (ECRI, 1990)
Repair Services are offered by manufacturers, shared-service organizations, third-party service organizations, and in-house departments, with the extent of the repairs varying from circuit board exchange to component-level repairs (Betts,1987)
269
Repair Services Requests for repair services
Identify the device requiring the repair, usually by use of the hospital identification number or equipment control number
Provide as much information as possible regarding the problem
Identify the operator of the device at the time of malfunction
Give the time and date of malfunction
Provide the equipment location, the department, a point of contact, and a phone number
270
Types of Maintenance Services In-house Equipment Services
Advantages: Immediate availability of service technicians to troubleshoot and repair equipment, Facilitation of other aspects of equipment operation and provision of prompt, ongoing support for clinical personnel
Disadvantage: relative costs associated with operating an in-house clinical engineering service
271
Types of Maintenance Services Manufacturer Service
Services offered Full-function service contract
Includes all labor-related costs and may include all or certain parts-related costs
Demand service agreement in which the hospital pays on a time-and-materials basis for each service call, as needed
A combination of the two basic methods
Disadvantages Cost may be greater Response time is dependent on the location of the manufacturer’s
service center Technician experience and qualifications may be suspect if
subcontractors or dealers are used Clinical engineers must closely monitor the contractors to ensure
acceptable performance and to ensure that the terms of the contract are met
272
Types of Maintenance Services Third-Party Services
Services from a third-party organizations
Disadvantages: Requires at least as much as management oversight as
does manufacturer service May be particularly difficult in fulfilling the hospital’s
needs for support functions beyond narrowly defined equipment repair, and it may be at a serious disadvantage, especially for servicing high-tech equipment, if the manufacturer is unwilling to provide needed parts and diagnostic equipment
273
Cost Analysis for In-House Services One way to determine costs is to set a price
or value on services provided to users
Establishing the price of services Determine actual hourly labor costs Evaluate cost-volume-profit relationships Establish pricing options and service contract
rates
274
Hourly Labor Costs Represents the total effective hourly cost of doing business
and becomes the hourly labor rate at which the department’s services are billed
Reasons of use It permits direct comparisons between the costs of the clinical
engineering department and those of the equipment manufacturers, other clinical engineering departments, or third-party service providers
It represents the single best aggregate measure of overall department efficiency by acknowledging all department costs and the effects of staff productivity
It becomes a useful measure of clinical-engineering management effectiveness
It serves as the basis for all service cost estimates or contracts
275
Hourly Labor Costs Hourly Labor Rate
Variable costs (direct, incremental or marginal) Costs that are assumed to vary with production volume or
service output Cost that would not exist if there were no labor force Examples:
Salary and wages of the active service staff Employee benefits Continuing education expenses Office supplies and forms Liability insurance costs All variable telephone charges Repair parts and service supplies Other costs that would vary with department workload: travel and fuel costs.
(Variable costs + Fixed Costs)Hourly Labor Rate ($/Hr.) =
Chargeable Hrs.
276
Hourly Labor Costs Hourly Labor Rate
Fixed costs (overhead or burden) Costs that do not fluctuate with the level of activity Examples:
Effective cost of hospital floor space and associated utilities Capital depreciation Fixed telephone charges Administrative and clerical labor costs Repair parts inventory carrying costs
Chargeable hours Maximum number of labor hours the department can
realistically expect to charge, or bill out, in the fiscal year
(Variable costs + Fixed Costs)Hourly Labor Rate ($/Hr.) =
Chargeable Hrs.
277
Hourly Labor Costs
Total Chargeable Hours
Number of employees Combined number of full- and part-time staff whose time will
be charged out Available Labor Hrs. / Employee
Only regular and overtime hours Does not include sick time, breaks, vacations and holidays
Productivity Number of chargeable hours divided by the number of
available work hours for a given fiscal period Throughout the service industry: the range is from 75-80%
Available Labor HrsTCH = (Number of Employees) (Productivity)
Employee
278
Repair Parts Management
Required to prevent overstocking or accumulation of rarely needed or unusable repair parts
Repair parts maintained should be classified as bench stock
279
Parts and Quantities to be Placed in Bench Stock Critical nature of equipment
If the hospital can function safely without the equipment for a short period of time, minimize or eliminate bench stock levels for repair parts
Cost of downtime If the item is out of service, will patient
appointments be cancelled and hospital revenue significantly affected? The loss of revenue may be more than the cost of maintaining repair parts in inventory
280
Parts and Quantities to be Placed in Bench Stock Number of units on hand
The greater the number of units on hand, the greater the probability that repair parts will be required and should be in bench stock. However in some cases, the urgency of repair may be lessened since there may be sufficient items for exchange.
Consumption rate If the repair part is being used on recurring basis , it
should be considered for inclusion in bench stock
281
Parts and Quantities to be Placed in Bench Stock Lead time
If the time from when the repair part is ordered until it is received is excessive, some should be kept in stock
Cost of repair parts Three factors that determine the overall cost of repair
part Monetary value of the part Administrative cost of processing the purchase order Minimum order level of vendor
When ordering low-cost items, it is reasonable to stock a one-year supply since it is less costly than ordering the item several times during the year
282
Parts and Quantities to be Placed in Bench Stock Shelf life
Low levels should be kept on items that deteriorate while in storage to ensure that they are used before they deteriorate
Age of equipment As equipment gets older, breakdowns normally
increase, resulting in greater demand for repair parts. Increasing bench stock to meet these demands can result in large money losses if new equipment is purchased
283
Objective of Initial Inspection and Acceptance Testing Verify that all components, accessories, and
options listed on the purchase request were received
284
Mini-Case: get a host hospital and do the following:
Get the equipment control program by identifying these details: Fundamental objectives Policies and Procedures; Create a flow diagram Interdepartmental relationships Integration with other clinical engineering functions Communications Computerized Maintenance Management and
Information Systems Standard information included in the equipment control
program
286
Mini-Case: get a host hospital and do the following: Based on the identified information: make an analysis by identifying specific problems and weakness in the hospital’s current equipment control program. Make recommendations as well.
Based on the gathered information on Computerized Maintenance Management and Information Systems: evaluate how efficient is the computerized system; how accurate and fast it generates the report; get the users feedback.
Explain how the equipment control/management program may be integrated with other clinical management activities
287
Mini-Case: get a host hospital and do the following: Inventory control program
Know the fundamental objectives of their equipment
Identify the steps in the control of existing equipment. Analyze the process and significant components of their equipment management and inventory control program: Enumerate the problems or difficulties that may be encountered, made recommendations on how to solve these problems or difficulties
288
Mini-Case: get a host hospital and do the following: Inventory control program
Gather and explain possible resistances from other departments when gathering information for an equipment control file
289
Mini-Case: get a host hospital and do the following: Medical Equipment Management
Identify the process or steps in the hospital’s maintenance schedules
Identify the important factors being considered in the medical equipment management
Find out if there are risk scores being employed by the hospital. Determine how they assign risk scores and analyze the process.
290
Mini-Case: get a host hospital and do the following: Medical Equipment Management
Know how do they compute cost and basis for their costing in their equipment management program
Common problems being experienced in medical equipment management program.
291