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Recent reports of potentially fatal infections related to inadequate reprocessing of medical devices has resulted in the Food and Drug Administration (FDA) imposing more stringent regulations for reprocessing of medical devices in healthcare settings. In March 2015, a detailed guidance document addressing validation methods and labeling was published for the benefit of industry and FDA staff.

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The FDA is mandating more stringent processes, including validation of effective cleaning, disinfection and/or sterilization of medical equipment and devices. This has resulted in several companies scrambling to develop more detailed and applicable instructions or directions for use. Companies are faced with challenges due to complex design of equipment and devices as well as ensuring multiple products on the market always have the proper instructions for compliant cleaning, disinfecting and sterilization.

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The Ledoza Group assists medical equipment and device companies with reprocessing by offering the following services:

 

• Review of reprocessing procedures

• Revision of current reprocessing procedures

• Development of reprocessing procedures

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​If you are interested in improving your processes and procedures and would like to learn how Ledoza can help, please contact us for a complimentary telephone consultation.

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