21 CFR Part 11 Helps to Ensure Medical Devices are Safe and Reliable

by Maureen Perroni, on May 6, 2016

Screen_Shot_2016-05-05_at_3.22.49_PM.pngMedical errors are silent killers. When people think about the leading causes of death in the United States, they typically cite heart disease or cancer. While it is true that these are the two factors most responsible for deaths in this country, fewer people realize that medical errors are now in third place - and may be getting even more common.

There are many reasons why patients are experiencing a growing number of potentially fatal medical mistakes, and it's possible that medical devices are part of the problem.

According to a survey of 526 nurses conducted by Harris Poll, half said they had witnessed a medical error due to lack of coordination among medical devices. In addition, many such devices may have safety problems that are not being identified, the New York Times reports. The Times noted that while medical device manufacturers and hospitals are required to notify the U.S. Food and Drug Administration about potential issues, health care professionals are not. This leads to crucial gaps in important safety data.

Thus, the burden falls more heavily on manufacturers to ensure that their medical devices are safe and reliable. Regulations such as the 21 CFR Part 11 rule require manufacturers to preserve records of systems used during production. Proper labeling of these products is critical to making sure that any problems detected can be quickly tracked to the source so they can be addressed before the devices are delivered to care providers.

An Enterprise Labeling Solution helps medical device manufacturers meet complex regulatory requirements, such as 21 CFR Part 11, while still integrating seamlessly within an existing business framework.

For more information download our brochure on medical device labeling.

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Topics:Medical DevicesRegulatory