In the lower left-hand corner of most FDA web pages is a date given as “page last updated.” The straightforward understanding of this would be that either the whole page or something substantive on the page was changed on that date. In some cases, there is no other date associated with the information provided so it is not possible to determine when the information first appeared or what exactly has been updated.
For example, there is a posted safety communication entitled Positive Displacement Needleless Connectors and Bloodstream Infections: Initial Communication. This notice has an internal date of Aug. 11, 2010 and a “page last updated” of May 12, 2015. Was the 2010 letter first posted in 2015? Had it been there before May 2015 but something on the page was then changed? There is no way to tell.
There is a link to another page entitled Letter to Infection Control Practitioners Regarding Positive Displacement Needleless Connectors. This letter has no internal date, although we can surmise from the link from the previous page that it had to be at least earlier than or simultaneous with Aug. 11, 2010. But in a search related to needleless connectors, I had previously found my way directly to this letter via Google. Therefore, I didn’t then have the 2010 framework, and I could not determine the date of this information. As with the communication mentioned above, the “page last updated” date is May 12, 2015. This fact might suggest the letter had been issued in 2015, which, of course, is not the case. The posting has an email address for an FDA contact person, but that email address is now rejected. Perhaps since 2010 (or 2015) that person has left the agency. The letter references orders for postmarket surveillance studies. Six years later, those studies should have been completed (or, as it turns out for some, the product withdrawn from the market), but there is no link to the studies or the current status of the affected products, showing that an updated page is not necessarily up to date.
There are other examples of this date confusion. The oldest FDA CDRH draft guidance document I found that has a web page is entitled Implementation of the Biomaterials Access Assurance Act of 1998. This draft was issued in April 2001. The page says that it was last updated in May 2015, but what, if anything, was changed on that date?
The second-oldest draft with a web page is entitled Premarket Notification [510(k)] Submissions for Medical Sterilization Packaging Systems in Health Care Facilities, and it is dated March 7, 2002. This page was last updated in September 2015. One problem here is that last update event may have nothing to do with the actual content. If you can remember the last major FDA web site redesign, every page was shown as updated on the roll-out date even though the content had not changed, only the appearance and the many of the URLs and links had changed.
Surely, maintaining a comprehensive website is a challenging task, but it should be routine that all pages have a clear date that reflects when the information on that page was actually generated. And if there really were changes made, what were they?
William Hyman, ScD, is professor emeritus of biomedical engineering at Texas A&M University. He now lives in New York where he is a consultant and adjunct professor of biomedical engineering at The Cooper Union.