After two inspections in September and November, the FDA sent ConforMIS, Inc., a warning letter on December 10, 2019 concerning the number of sterilization cycle failures relating to Vaporized Hydrogen Peroxide (VHP) sterilizers that the company uses as a limited, alternative sterilization method for a small quantity of products. The letter did not question product sterility.
FDA Warns ConforMIS Over Sterilization Failures
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Secondary#conformis#itotal#warningletter
The company manufactures sterile orthopedic implants such as the iTotal posterior stabilized and iTotal cruciate retaining Knee Replacement Systems and iTotal Hip Replacement Systems at its Wilmington, Massachusetts, facility.
ConforMIS Reply
ConforMIS responded to the FDA in an initial September 20 Inspectional Observation (FDA 483) on October 8 and November 25, 2019.
In a December 17 SEC filing, the company stated, “Notwithstanding instances of cycle failures, the Company’s quality system ensures that the sterility of products leaving the Wilmington facility has not been compromised. And because the VHP sterilizers are only used as a secondary sterilization method in limited circumstances, the Company does not anticipate any interruption in manufacturing or distribution, or with respect to the Company’s current new product launch schedule.”
Additionally, the company stated it had been planning to decommission and replace the VHP sterilizers. The company has already procured and validated a new onsite sterilization unit and, in early December 2019, submitted a 510(k) premarket notification to the FDA for clearance of this new unit.
FDA Rejection
The FDA warning letter wasn’t buying the promise of new sterilizers.
The ConforMIS reply, stated the warning letter, did not address “the immediate concern that your firm continues to rely to assure sterility for product release instead of ensuring the process is operating under a validated state.” Moreover, the agency noted there is “no objective evidence” to support that sterilization is operating in a validated state. “It is expected your firm has objective evidence your sterilization process ensures products consistently meet the established sterility assurance level under routine operating conditions.”
The company said it “takes seriously the matters identified in the letter, has worked diligently to address the identified issues, and will respond to the FDA in a timely manner.”
You can read the FDA Warning Letter here.
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Discussion
This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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