FDA Truisms Part 1: Documentation Lesson from “Spirit in the Sky"
When working with our clients, I always find a place for this slide in our discussions. A truism is defined as “a statement that is obviously true and says nothing new or interesting.“ It may seem odd to put so much importance on statements that are obviously true. However, we find that in the day to day, sometime frenzied environment that those developing and manufacturing medical products find themselves in, it is important to remind ourselves of what is always true when working on products regulated by the US FDA.
In this series of blog entries, I’m going to discuss each of these truisms and how important they are to our work.
“If it isn’t documented, it wasn’t done.”
Everyone in the medical products field has likely heard some version of this truism. Another popular version is “If it isn’t documented, it didn’t happen.” Either version gets across the point that documentation is important within the context of designing, building, and distributing medical products.
The reason I like the version that ends with “…it wasn’t done” is that often people do the right thing but don’t properly document it. By phrasing it like this, it acknowledges that a task may have been performed but it is not finished until it is properly documented. This is especially true since having an ability to replicate our work is often essential to maintaining its quality and safety. Imagine a chemist who has just perfected a formula for a critical component of an in vitro diagnostics sensor but failed to write down the exact parameters.
An example of the perils of poor documentation comes from the world of classic rock. In 1968 Norman Greenbaum recorded the hit song Spirit in the Sky. The song’s introduction includes an iconic guitar riff that is unique to that song. If you know the song, you can recall the deep, gravely syncopated guitar rhythm at the beginning. If you don’t know the song, here is a YouTube link: https://www.youtube.com/watch?v=AZQxH_8raCI
In fact, that opening guitar riff is so unique, it apparently was never reproduced again even by Greenbaum himself. According to curator of rock and roll history, Adam Reader (aka Professor of Rock) the settings that Greenbaum used on his guitar and distortion amp were never properly documented when the recording was made. For decades, Norman Greenbaum has never been able to replicate it. Apparently, he has tried in vain using the same or similar equipment and adjusting the settings over and over to try to get it right. Several other artists have also tried to replicate the effect but none have succeeded. As it turns out the sound of the opening riff of Spirit in the Sky will be forever relegated to that one recording. (Link to Adam Reader's Spirit in the Sky video: https://www.youtube.com/watch?v=Ac5c1Ns-Bng)
Fortunately, Greenbaum was not designing or producing a medical product. Of course, in our industry, losing such a formula could be catastrophic or even deadly. As such we have strict standard for documentation and the FDA holds us to those standards.
The purpose for this truism is to remind everyone in our industry that documentation regarding the tasks they are performing is always necessary. This may come up during an FDA inspection or during an ISO 13485 audit and producing the documentation can save the company from getting a 483 (FDA observation letter) or an ISO audit finding. It may also come up during an investigation of a medical device report (MDR) or complaint to the FDA which may have been the result of an Adverse Event or a Serious Adverse Event. Having been part of these investigations, I can say that any lack of documentation is extremely frustrating and stressful. More likely though the documentation is simply necessary for the company to manage its day-to-day tasks. Colleagues often use documentation from each other to coordinate efforts and communicate more effectively.
I counsel our clients to think of documentation as an integral part of their business processes. As with any business process, one should endeavor to make the documentation effort as quick and efficient as possible while maintaining accuracy and completeness. One should try to avoid overly burdensome processes which present a barrier to proper documentation. If done properly, employees at all levels will begin to think about how best to document their work every day.
As a scientist and engineer, I have always felt that designing and building medical products that save patients’ lives, improve clinicians’ ability to work, and increase efficiency and affordability of high quality medical care is an honor and privilege. I accept that part of performing this duty is proper documentation which is intended to maintain quality and thus prevent issues in the future. We should all get onboard with wanting the products we work on to be safe and effective for the patients and the clinical users.
If that isn’t enough, we should all think about Norman Greenbaum and the iconic sound of Spirit in the Sky. It must have been very difficult for him to not be able to replicate the deep, raspy sound exactly as it was for the original recording. Image losing such a formula for a life-saving device.
FDA Jargon found in this post
United States Food and Drug Administration. The US FDA receives its authority from a series of laws passed by the US congress during the first half of the 20th century. Most significant among these laws was The Food, Drug, and Cosmetic Act signed by President Franklin Roosevelt in 1938. Also known as "The Agency".
International Standard for Medical Device Quality Management Systems and recognized by the US FDA. Last updated in 2016.
Report issued to management following FDA inspection documenting potential violation of the Food Drug and Cosmetic Act. Usually just called a "483".
Medical Device Reporting regarding suspected device-associated deaths, serious injuries and malfunctions. MDRs may be reported directly to The Agency by the public or may be voluntarily reported by the company themselves.
Adverse Event (AE)
Any undesirable experience associated with the use of a medical product with a patient or the user of the product (clinician). Adverse Events are common in clinical studies and do not necessarily mean the device being studied is unsafe.
Serious Adverse Event (SAE)
An adverse event is considered serious when the patient outcome is death, life-threatening injury, hospitalization or other similar outcomes. Serious Adverse Events must be reported to the FDA.