A new AAMI TIR38, “Medical device safety assurance case report guidance,” has just been released. It provides you with information on how to meet the new additional FDA pre-market requirements for infusion pumps. However, it can be widely applied to any medical device safety program. You can get your copy now from Document Center in paper format, for pdf download or as part of our multi-user Standards Online subscription service.
The 65-page document is a Technical Information Report. AAMI releases these TIR’s because of critical need within the medical device industry. So a TIR does not go through the same adoption process as an AAMI standard would. However, these publications can provide invaluable assistance when new issues face the industry.
In this case, the TIR was developed specifically to address the issue of developing safety cases for drug delivery systems (like infusion devices, etc.) But the protocol and information can be used for any medical device and its design story.
Safety cases are an adjunct to risk management. The concept stems from the nuclear industry, where failure is to be avoided at all costs. In this application, it represents the totality of the documented information and arguments to prove that a nuclear facility is safe. Additionally, it provides a written demonstration that all applicable standards have been met and that risks have been reduced as far as is reasonably practicable.
Now we’re starting to see the expansion of usage of this tool for medical device safety support. This means a safety case can be used to provide a structured argument, supported by a body of evidence, that there is a compelling, comprehensible and valid case that a particular medical device is safe for its intended use.
The AAMI TIR38 provides you with a safety case development reference you can use for in this application. It’s kind of a framework for distillating the experience and insight that went into your device’s design. And it provides a way to systematically assure and document the safety that’s embedded in that design. Further, it is intended for products that are already in existence and well understood. You would not use this methodology for “new-to-the-world” products.
AAMI TIR38 has a strong tie to the ISO 14971 standard on medical device risk management. Information that you generate for ISO 14971 compliance can be part of the data for your safety case.
Not only will you get a tutorial on the subject, but there’s also a number of Annexes that provide you with examples, tool selection considerations, and even lessons learned.
If you’re looking for additional tools to support your risk management efforts or want to meet emerging regulatory requirements, you’ll want a copy of the AAMI TIR38. Head to the Document Center webstore at www.document-center.com to order your copy online. Or contact our staff by phone (650-591-7600), fax (650-591-7617) or email (info@document-center.com). We’re here to support your compliance program with standards and standards services. Make us your Standards Experts!
