Among the more thoughtful letters we’ve received recently is one that comes from Curtis Larsen, a principal in Spartan Design Group, an engineering consultant firm specializing in medical products packaging. He astutely observed that features editor Jim Butschli erred in his description of the impact a proposed FDA guidance draft will have. Because Larsen’s letter has at its core an important reminder of how important it is to maintain a separation between drugs, biologics, and medical device packaging, we felt it appropriate to include his letter here. To say that we value the input of such engaged readers would be a gross understatement.
In Packaging World’s August 2009 page 61 article, “Insights into FDA’s process validation guidance draft,” a reference to medical device makers could cause a bit of concern and/or confusion.
Specifically, in the first full paragraph on page 62, you questioned the impact the proposed guidance will have on “drug and device makers.” It is my understanding that this guidance is not for device makers and their packaging. Mr. D’Eramo did not refer to devices anywhere in the article. Device packaging requirements are very different than those of drugs, biologics, and in some cases, combination products. We in the device packaging world do not want to be held to the same requirements as those addressed in the article. Your inference that the new document included devices was (as I understand its scope) incorrect. We have tried very hard to write and adopt a global standard for medical device packaging—it’s called ISO11607, both parts 1 & 2. In the U.S., we are fortunate to have a companion document to help interpret those ISO Standards, AAMI TIR 22.
Uninformed readers could certainly interpret that the new guidance did include devices if they went no further than your article. This is where the confusion lies. It’s increasingly important that we maintain this separation between drugs, biologics, and device packaging; the FDA is confusing enough without confusion of this nature. In this vein, I especially enjoyed the last two paragraphs where Mr. D’Eramo addressed the confusion with terminology within the FDA. I totally agree! Confusion is rampant throughout the entire device industry as well; validation, qualification, verification, design verification studies—what do they all mean?
Good article, by the way. Thanks for listening.
Curtis L. Larsen
CPP, Fellow, Principal
Spartan Design Group, LLC