There is no question that the 1996 publication of the Quality System Regulation (QS Regulation) clarified medical device manufacturers’ responsibilities when it came to package development and validation. I write “clarify,” though, because the responsibility to ensure that medical device packaging is adequate has been in place since the 1978 regulation that promulgated Good Manufacturing Practices for the manufacture, packing, storage, and installation of medical devices.
For instance, 21 CFR Part 820.130 in the original regulation states that “each manufacturer shall ensure that device packaging and shipping containers are designed and constructed to protect the device from alteration or damage during the customary conditions of processing, storage, handling, and distribution.”
The 1996 QS Regulation did not change this requirement, but it did “improve the regulation with the inclusion of design controls for packaging,” states Patrick Weixel, postmarket team leader, Center for Devices and Radiological Health (CDRH). “It stated that packaging must be considered early on in the product design process.”
For instance, the definition for “design output” in 21 CFR 820.3(g) includes packaging: “The total finished design output consists of the device, its packaging and labeling, and the device master record.”
And in the QS Regulation’s “Medical Device Quality Systems Manual,” FDA states that “package design should be an integral part of the product development program. Waiting until the end of the development process to design packaging can result in severe delays in getting the product into distribution. . . . Defective packaging and seals have been a major cause of medical device recalls. This type of recall can often be avoided by correct package design including validation of the packaging and sealing processes.”
Weixel, who has recently been studying the causes of medical device recalls, says that products are recalled because of package design issues. “If packaging is not evaluated during the product design phase, then there is the potential of transferring an inadequate packaging process to production, resulting in inadequate packaging in the field,” he says.
When I asked Weixel whether FDA was becoming more vigilant in terms of packaging reviews, he said it would be “hard to say.” However, he did say: “I hope that investigators are auditing processes involving sterile barrier systems. The recall data shows that packaging is the main reason the sterile barrier is compromised.” During a recent presentation to ASTM Committee F02, Weixel said that there were 230 recalls due to problems with the sterile barrier system, 79 of which were associated with design control issues.
Interestingly, 63 recalls in 2011 were associated with supplier issues, and 62 were associated with production processes.
Under 21 CFR Part 820.50 on purchasing controls, which was added as part of the QS Regulation, manufacturers are required to “establish and maintain the requirements, including quality requirements, . . . [are] met by suppliers, contractors, and consultants.”
Weixel says validation requirements extend to contract packagers. “Device manufacturers must demonstrate that the processes used by their contract packagers have been validated. Sometimes we have no evidence that the packaging process has been validated.”
Manufacturers also must ensure that the equipment software used in the packaging process has been validated for its intended use, says Weixel. This requirement is included in 21 CFR 870.70(i).
I asked Weixel whether he had a sense of how the current number of recalls compared to the number 20 years ago, but he said the data wasn’t available in time for our article. In the meantime, Weixel hopes sharing current recall data can help prevent future problems. “I like to give industry and investigators information on what is occurring in the field so manufacturers can look at their own processes to ensure they won’t repeat the same errors,” he says. For instance, errors from 2011 that Weixel categorized under “design control issues” include burrs or sharp edges puncturing sterile barrier systems and over-stressed trays due to a change in the protective packaging, leading to cracking. Errors categorized under “production process issues” included the wrong parameters being used during sealing and changes made to the packaging processes that weren’t validated.
For our look back at the last 20 years in sterile medical packaging, please see our feature . If you would like to share your own experiences, please let me know! We’ve got more anniversary coverage planned throughout the year!
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