Maintenance and Repair of Medical Devices Key Terms

Learn about maintenance and repair standards for medical devices

Medical devices are intricate pieces of equipment that work to repair the human body. Many medical devices are only used once, but others require extensive storage and maintenance since they will be used multiple times. Companies that repair  medical equipment strive to meet the high standards of the original manufacturer. This helps to maintain a standard of quality throughout the industry.

 

Quality System Requirements

Quality System Requirements are rules set forth by the Food and Drug Administration (FDA) that help to regulate the production of new medical devices and also help to set standards for maintenance and repair of these devices.
Try: The Food and Drug Administration outlines its Quality System Requirements in its Medical Device Quality Systems Manual.

Original equipment manufacturer (OEM)

The original equipment manufacturer is the manufacturer that built and sold the medical device. Companies strive to meet the same OEM standards of production when maintaining or replacing parts on medical devices.
Try: Reference for Business provides an overview of OEMs and how these manufacturers set standards in production.

Replacement parts

Replacement parts are new parts that can be used on medical devices when a specific part has worn out. Replacement parts help to sustain the life of the equipment and provide a cost-saving option for medical facilities.
Try: ipFrontline provides the guidelines for using replacement parts on medical devices that are patented.

International Organization for Standardization (ISO) registered facility

The International Organization for Standardization works to set standards for regulation in a number of industries. An ISO registered facility is one that complies with a specific set of standards.
Try: The International Organization for Standardization provides facility registration for manufacturers that meet quality and environmental management standards.

Steam sterilization monitoring

Steam sterilization monitoring is a maintenance technique used to monitor all types of machines that use steam sterilization to clean medical devices.
Try: Infection Control Today provides information on the different types of steam sterilization monitoring processes.

Medical vacuum sealer

A medical vacuum sealer is a piece of equipment used to maintain medical devices that are sensitive to oxygen and moisture levels. The vacuum sealer provides a controlled barrier environment for those medical devices.
Try: Van Der Stahl Scientific provides information on a medical vacuum sealer, one of many maintenance tools used for medical devices.

Copyright © 2011 Business.com, Inc. All Rights Reserved.

---