Medical Device Maintenance and Maintainability

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.

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().

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.

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.

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.

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.

REPAIR AND MAINTENANCE INDICES

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

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.

SC CR AC

Medical Equipment Classification and Indices for Repair and Maintenance

FIGURE 3.1 Medical equipment classification for the purpose of repair and maintenance.

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

Quality index I

RR

NRRC

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.

Quality index II

ATAT

TTAT

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.

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 management, cost control, quality improvement activities, and reliability and maintain-ability studies.

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.

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

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.

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 http://www.marcalmedical.com/Superior%20Service.htm needs rather than reacting to them.

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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