The Evolution of Medical Device Package Testing

For many years, there were no set standards on medical device package testing. In fact, the main emphasis was on product testing. However, it’s extremely important for many products like catheters and implants to be sterile and remain sterile until they are used or installed. This is one reason why packaging is so important today, and thankfully, it is receiving more attention and testing. Here is a look at the process over the years.

20th Century

As the 20th Century dawned, the Pure Food and Drugs Act took effect, and it stopped the transporting of foods and drugs that were misbranded. During the early years of the Great Depression, the Food and Drug Administration came into existence. It originally was part of the Department of Agriculture’s testing division. However, very little was done to improve medical device package testing until the 1970s.

In 1976, the FDA began overseeing the manufacturing and packaging of medical devices, and at that time, a special amendment for medical devices was added to the Food, Drug, and Cosmetic Act.

Early Testing

Visual inspections were common, and there were some methods like porosity testing and tear testing, yet they were not mandatory. Over the next two decades, considerable changes occurred. However, two of the most important developments were seal strength and leak integrity testing. They were instrumental in creating major changes in the industry.

Physical Testing in the 1980s

Dye leak test and burst tests were developed, and the FDA finally recognized that medical device package testing was just as important as the devices. ASTM standards went into effect, and special packaging standards for sterilized medical devices came into existence.

The 90s and Beyond

The Health Industry Manufacturers Association introduced scientific testing methods. Several studies led to improved package testing. Finally, in the late 20th Century, ISO 11607 standards made it possible for standardized testing in the industry.

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