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Sources for Obtaining Medical Equipment Reliability-Related Data

There are many organizations in the United States from which failure data directly or indirectly concerned with medical equipment can be obtained. Some of these organizations are as follows: [1]

  • • Government Industry Data Exchange Program (GIDEP) GIDEP Operations Center, Fleet Missile Systems, Analysis, and Evaluation Group, Department of Navy, Corona, CA 91720, USA
  • • National Technical Information Service, 5285 Port Royal Road, Springfield, VA 22161, USA
  • • Reliability Analysis Center (RAC), Rome Air Development Center (RADC), Griffis Air Force Base, Department of Defense, Rome, NY 13441, USA

Some of the data banks and documents considered quite useful for obtaining failure data concerning medical equipment are as follows:

  • Medical Device Reporting System (MDRS). This system was developed by Center for Devices and Radiological Health (CDRH), Food and Drug Administration (FDA), 1390 Piccard Drive, Rockville, MD 20850, USA.
  • Universal Medical Device Registration and Regulatory Management System (UMDRMS). This system was developed by Emergency Care Research Institute (ECRI), 5200 Butler Parkway, Plymouth Meeting, PA 19462, USA.
  • Hospital Equipment Control System (HECS). This system was developed in 1985 by Emergency Care Research Institute (ECRI), 5200 Butler Parkway, Plymouth Meeting, PA 19462, USA.
  • NUREG/CR-1278. Handbook of Human Reliability analysis with Emphasis on Nuclear Power Plant Applications, U.S. Nuclear Regulatory Commission, Washington, DC, USA.
  • MIL-HDBK-217. Reliability Prediction of Electronic Equipment, Department of Defense, Washington, DC, USA.

Useful Guidelines for Healthcare and Reliability Professionals for Improving Medical Equipment Reliability

There are a large number of professionals involved in the design, manufacture, and use of various types of medical equipment/devices. Reliability engineers and analysts are one of them. Nonetheless, some of the guidelines considered quite useful for reliability and other professionals for improving medical equipment reliability are as follows [26,42]: [2]

  • • Use methods such as FMEA, qualitative FTA, design review, and parts review for obtaining immediate results.
  • Other professionals
  • • Keep in mind that the application of reliability principles have quite successfully improved the reliability of systems used in the aerospace sector, and their proper applications to medical equipment/devices can generate quite similar dividends.
  • • Recognize that failures are the cause of poor medical equipment/device reliability, and positive thinking and measures can be quite useful for improving medical equipment/device reliability.
  • • Compare human body and medical equipment/device failures. Both of them need appropriate measures from reliability professionals and doctors for enhancing equipment/device reliability and extending human life, respectively.
  • • For the total success in regard to equipment/device reliability, both manufacturers and users must accept clearly their share of related responsibilities.
  • • Remember that the cost of failures is probably the largest single expense in a business organization. These failures could be associated with equipment, business systems, people, etc., and reduction in these failures can reduce the cost of business quite significantly.

Problems

  • 1. List at least six facts and figures concerned, directly or indirectly, with medical equipment/devices reliability.
  • 2. Discuss the main classifications of electronic equipment/devices used in the health care system.
  • 2. Compare FTA with FMEA with respect to medical equipment/devices.
  • 4. Describe the parts count method.
  • 5. List at least eight important operator errors that occur during medical equipment/device operation or maintenance.
  • 6. List at least 15 medical devices with high incidence of human error.
  • 7. Assume that the repair time of a medical equipment/system are exponentially distributed with a mean value (mean time to repair) of 8 hours. Calculate the probability that a repair will be completed in 20 hours.
  • 8. Define medical equipment maintainability and list at least 8 frequently addressed maintainability design factors with respect to medical equipment.
  • 9. Discuss classifications of medical equipment with respect to maintenance and repair.
  • 10. List at least eight good sources for obtaining medical equipment/device reliability-related data.

  • [1] Emergency Care Research Institute (ECRI), 5200 Butler Parkway, PlymouthMeeting, PA 19462, USA • Center for Devices and Radiological Health (CDRH), Food and DrugAdministration (FDA), 1390 Piccard Drive. Rockville, MD 20850, USA • Parts Reliability Information Center (PRINCE) Reliability Office, GeorgeC. Marshall Space Flight Center, National Aeronautics and Space Administration(NASA), Huntsville. AL 35812, USA
  • [2] Reliability Professionals • Always focus on critical failures as not all device/equipment failures areequally important. • Keep in mind that manufacturers are totally responsible for reliability duringthe equipment/device design and manufacturing phase, and during its operational phase it is basically the responsibility of users. • Focus on cost effectiveness and always keep in mind that some reliability-related improvement decisions need very little or no additional expenditure. • Aim to use simple and straight forward reliability methods as much as possible instead of some sophisticated approaches used in the aerospace industrial sector.
 
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