Medical Device Maintenance and Maintainability

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Medical Device Maintenance and Maintainability
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Introduction

• The maintenance of engineering equipment is
  as important as the equipment's design and
  development. Usually, much more money is spent on
  maintaining a piece of equipment over its life
  span than on its procurement.

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TERMS AND DEFINITIONS

• Maintenance. This is all actions appropriate for
  retaining and equipment/item in, or restoring to,
  a given condition.
• Maintainability. This is the probability that a
  failed piece of equipment or item will be
  restored to its acceptable operational condition.
• Corrective maintenance. These are actions taken
  because of a failure to restore an item or
  equipment to a stated condition.
• Preventive maintenance. These are actions taken
  in an attempt to retain an item or equipment in a
  stated condition by providing orderly inspection,
  detection, and prevention of incipient
  failure(????).

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TERMS AND DEFINITIONS

• Failure. This is the inability of a piece of
  equipment or item to function within previously
  stated limits.
• Downtime. This is that component of time during
  which the equipment or item is not in condition
  to carry out its stated mission.

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TERMS AND DEFINITIONS

• Maintainability function. This is a plot of the
  probability of repair within a time stated on the
  vertical axis vs. maintenance time on the
  horizontal axis. It is extremely useful to
  predict the probability that repair will be
  completed in a specified time.
• Maintenance plan. This is a document that
  outlines the management and technical approach to
  be employed to maintain an equipment or item.

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TERMS AND DEFINITIONS

• Maintainability parameters. This is a class of
  factors or human, environmental, and design
  features that influence the carrying out of
  maintenance on product or equipment.
• Maintainability demonstration. This is the joint
  manufacturer and customer effort to determine
  whether stated maintainability goals have been
  satisfied.

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REPAIR AND MAINTENANCE INDICES

• the Association for the Advancement of
  Medical Instrumentation (AAMI) conducted a pilot
  study(????) to help medical technology managers
  reduce repair and maintenance costs and enhance
  the effectiveness of repair/maintenance services.
  This was achieved by developing common,
  standardized cost and quality metrics or indices
  so that repair and maintenance services could be
  compared among organizations involved with
  medical equipment.

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REPAIR AND MAINTENANCE INDICES

• The AAMI study focused on three metrics or
  indices one cost and two quality.

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Cost Index

• CR is the cost ratio.
• SC is the service cost or the total of all
  labor, parts, and material costs for
  scheduled and unscheduled service, including
  in-house, vendor, prepaid contracts, and
  maintenance insurance.
• AC is the acquisition cost or the cost at the
  time of purchase of equipment.

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Medical Equipment Classification and Indices for
Repair and Maintenance
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A Range of Values of CR and Its Average Value for
Various Classifications of Medical Equipment

• 
  CR Values
• No. Medical Equipment Classification Range
  () Average ()
• 1 Laboratory apparatus
  1.9-8.6 5.1
• 2 Imaging and radiation therapy 1.0-6.7
  5.6
• 3 Patient diagnostic
  1.7-3.8 2.6
• 4 Life support and therapeutic
  2.3-5.3 3.5
• 5 Patient environmental and transport
  1.4--8.5 4.4
• 6 Miscellaneous medical equipment
  1.6-3.9 2.6

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Quality index I

• This index provides repair requests completed per
  device thus it is analogous to equipment repair
  rate.
• RR is the number of repair requests completed
  per device.
• NRRC is the total number of repair requests.
• is the number of devices or pieces of equipment.
• In the survey, the value of RR ranged from
  0.3 to 2.0, with a mean of 0.8.

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Quality index II

• This index gives average turnaround time per
  repair thus it measures how much time elapses
  from a customer request until the failed device
  or equipment is repaired and put back in service.
  
• ATAT is the average turnaround time per repair.
• TTAT is the total turnaround time.
• is the total number of work orders or repairs.
  
• Only five hospitals provided data for
  turnaround times, and the average value of ATAT
  was 79.5 hours. However, among these hospitals,
  the turnaround time per repair ranged from 35.4
  to 135 hours.

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COMPUTERIZED MAINTENANCE MANAGEMENT SYSTEM FOR
MEDICAL EQUIPMENT AND DEVICES AND ITS SELECTION

• Clinical engineering departments in hospitals use
  Computerized Maintenance Management Systems
  (CMMS) to collect, store, analyze, and report
  data on the repair and maintenance performed on
  medical equipment and devices.
• In turn, these data are used for various
  purposes, including work order control, equipment
  man-agement, cost control, quality improvement
  activities, and reliability and maintain-ability
  studies.

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Pre-Purchase Evaluation of CMMS

• Define the problem scope.
• Evaluate the current system being used.
• Perform a preliminary study of commercially
  available systems.
• Perform a comprehensive study of the chosen CMMS.
• Discuss potential performance issues related to
  the selected CMMS.
• Examine CMMS support issues.
• Examine CMMS cost.

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Ventilator Maintenance and Field Performance

• The material presented in this section is the
  result of a U.K. study of 11 lung ventilators
  used in the Intensive Care Unit of the Wakefield
  General Hospital. TM At the time of the study,
  the hospital had the planned preventive
  maintenance (PPM) system under which all the
  ventilators underwent maintenance every six
  weeks, half yearly, and at yearly intervals.

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Ventilator Maintenance and Field Performance

• The history record sheets of the ventilators
  contained information such as the following
• Type of service or repair
• Date of service or repair
• Service/repair time
• Description of repair parts used
• Part and labor costs

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Ventilator Maintenance and Field Performance

• In addition, all ventilators were installed with
  running/frequency meters to deter-mine their
  utilization. The study concluded factors such as
  these
• A total of 131 faults occurred during the period
  of 14.066 calendar operating days for all
  ventilators.
• On average, 16 hours were spent annually (per
  ventilator) for maintenance, out of which only
  12.3 accounted for breakdown maintenance.
• Statistically one in every 240 ventilators is not
  available for service either due to breakdowns or
  maintenance.
• The potential risk of death due to faulty
  ventilators is one in every 75,000 patients.
• The efficiency of the PPM is around 65, i.e.,
  PPM helped to remove 65 of the potential faults
  that otherwise would have resulted in a failure.

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Example

• MarCal Medical, Inc.
• 1114 Benfield Blvd, Suite H
• Millersville, MD 21108

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Repair Capabilities
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• Pumps are a major investment for
  healthcare facilities, so you need them to last a
  long time. MarCal can support your efforts to
  maximize the service life of your infusion pumps
  through a variety of services. We understand the
  need for quick and reliable delivery of the best
  products, clinically trained people who can
  answer questions and provide hands-on training,
  and responsiveness to your overall business
  needs.
• To best support our customers, we provide
• 24-hour LIVE Support
• Equipment Repair
• Preventive Maintenance
• Resmed II

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24-Hour LIVE Support

• Along with excellent technical capabilities,
  service support must be available 24 hours a day.
  MarCal Medical offers this support. Whether it is
  a question about equipment operations, how to
  clean a pump, or getting your device repaired,
  our technical staff is always available day or
  night.  You are only a phone call away from total
  customer support. We can answer your questions,
  solve your programming problems and provide
  next-day turnaround service when needed. We even
  have loaner pumps(??) available when you need
  them. This is the kind of product support you
  should be receiving when you purchase specialty
  medical products. Contact MarCal for more details
  at 1-800-628-9214.

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Equipment Repair

• You can trust MarCal to be your
  responsive, reliable partner in repairing your
  vital equipment. High-quality repairs completed
  by trained technicians eliminate the high expense
  of purchasing new products. Our quick turnaround
  on repairs and convenient loaner program keep
  your downtime to a minimum, reduce your need for
  additional back-up units, and ensure that your
  department is operating at the highest levels of
  efficiency.

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Preventive Maintenance

• Your biomedical equipment needs a checkup
  on a regular basis to minimize downtime and
  maximize productivity and profitability within
  your organization. MarCals Preventive
  Maintenance is a proactive maintenance program
  designed to prevent system problems. This is
  different from diagnostic or corrective
  maintenance, which is performed to correct an
  existing problem. By preventing problems from
  occurring, you may lower your need to spend money
  on costly repair jobs. Our goal is to create
  long-term value with customers by managing
  equipment needs rather than reacting to them.

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• After evaluating biomedical equipment,
  well suggest an appropriate maintenance and
  inspection schedule designed to help lower the
  cost of maintaining patient care equipment.
  Preventive Maintenance of your equipment,
  performed by a biomedical technician, may
  include interior and exterior cleaning,
  lubrication, alignment and adjustment,
  calibration, inspection and replacement, in
  accordance with the applicable federal, state and
  local regulations with emphasis on JCAHO and OSHA
  patient care equipment standards.

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