We just added 32 AAMI TIR Reprints into our database and we know it’s sure to cause some confusion. After all, usually AAMI (the Association for the Advancement of Medical Instrumentation) updates include important changes to technical data that the medical device industry relies on. However, these reprints represent an administrative change which has little to no bearing on the use of these publications. So here’s what! Let’s take a look at these reprints and learn what it all means.
First of all, we need a quick review of what an AAMI TIR (Technical Information Report) is. Unlike AAMI standards and recommended practices, these documents do not go through the usual rigorous development process as required by ANSI (the American National Standards Institute) for adoption. They are created specifically to meet a critical industry need. In particular, the requirement for review every 5 years for either reapproval or updating is not mandatory for TIR’s. They may be left in place if the authoring committee deems the information either to still be valid or to be of historial value.
So, all the documents that have been issued as reprints are actually adoptions of ISO/TR or IEC/TR publications. AAMI has the right to republish these Technical Reports (TRs) because of its participation in international standards development at the behest of ANSI. However, at the International level, similarly to the TIR, the TR is not subject to the same rigorous review process as the other publications. This means they do not meet ANSI administrative process requirements that are critical to release as an ANSI adopted document.
When the 32 AAMI TIRs were originally published, they were given a numerical designation that included “ANSI” in the number. However, as you can see above, these reports didn’t actually meet the criteria needed for ANSI approval. This error in numbering has been brought to AAMI’s attention and has just now been fixed. Thus, the 32 reprints!
And the changes are (administrative only):
- “ANSI” was removed from the designation of all 32, including in the footer
- The title page of each has been updated to read “Registered” by ANSI, rather than “Approved”
- The text before the table of contents has been revised
There is no change to the guidance within the documents or the page counts at all.
Do you need to purchase these reprints? The AAMI TIR reprints are administrative in nature. There is no change to the technical content. So getting a copy of the reprint is not necessary if you are interested in technical changes only. However, in cases like this where the document has some type of physical change (for example, reprints with reapproval dates only), some auditors do require companies to have the most current information. You should review the situation with your company’s compliance staff if you are uncertain how to proceed.
In the meantime, you’ll want to purchase your copies from an authorized AAMI distributor like Document Center Inc. You can search for and order all the standards you need at our webstore, www.document-center.com. An easy way to check which items have been revised is to search for “AAMI/IEC TIR” and/or “AAMI/ISO TIR”. And if you’ve purchased copies of any of these 32 recently reprinted TIR’s from Document Center Inc., you’ll soon get your notification(s).
Need more information? Want to order directly from Document Center Inc.? Just contact our staff by phone (650-591-7600) or email (info@document-center.com). We’ve been working with standards since 1982 and have the knowledge you need to make the most of this type of compliance documentation. Make us your Standards Experts!