Keep Your Products off the 2009 Recall List

In late December, Stryker announced that its Custom Cranial Implant Kits from its craniomaxillofacial (CMF) business unit were subject to a Class I recall. The company had originally initiated a voluntary recall in October after determining that the sterilization validation of the product was not performed according to appropriate standards, Stryker CMF reported on its Web site. The kits “could pose an imminent hazard to health,” the firm reported. “Because the company could not assure the sterility of the product, implantation could result in serious health problems including infection (e.g., meningitis), intracranial abscess, wound infection, sepsis. . . . Death can occur if an infection is not diagnosed quickly.”

These frightening scenarios brought to mind some conversations I had last year. A few industry experts worried aloud that some medical device manufacturers (MDMs) may not be doing all they should to validate their packaging and processes, let alone their package testing methods.

Granted, Stryker’s situation involved sterilization, not packaging validation. But given the crucial role of a primary package—i.e., the sterile barrier system—couldn’t inadequate packaging validations pose similar health risks?

I asked PMP News editorial advisory board member Tim Early, who spent 24 years working for MDMs and now provides packaging consultation and testing services, to describe package validation activity in the industry. Early is the director of business development for Packaging MD (, a division of Atlas Box & Crating (Sutton, MA). Early did not want to reveal any company names, but he did say that in many small- to medium-sized MDMs, packaging is not a core competency. “An R&D or manufacturing engineer is balancing packaging duties with other responsibilities. Companies that treat packaging as a core competency and have integrated packaging design, development, and validation into their product development process are in the minority,” Early says.

Corners may be cut when it comes to ISO 11607 compliance. Calling the standard comprehensive, Early says it details “all the requirements necessary to provide a validated sterile barrier system. No longer can a company simply seal, sterilize, and ship with no testing because they have been doing so for years with no history of complaints,” he says.

The risk these companies take is significant. Questionably sterile packages risk product safety and efficacy and patient health. “Also, when FDA issues a regulatory warning letter, it takes a few years before the MDM obtains clearance that the quality system’s deficiencies have been addressed and they can then move PMA submissions forward. Often, the time frame required to adequately address these issues results in product launch delays that cripple even the largest firms,” says Early.

In an era when Medicare is eliminating coverage of most hospital-acquired infections, perhaps the importance of the sterile barrier system—and validating that system—will take center stage in your company. If you can force packaging into the spotlight, you could keep your company from issuing packaging-related recalls, saving lives and money.

Daphne Allen

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