Welcome to Part 1 of the four part series on making the transition from LDT to IVD. This week’s episode will focus on taking the first steps into the big scary world of regulated IVD devices. And of course, there will be some analogies to my favorite gaming franchise turned hit television series, Fallout.
I know what you’re thinking…”How far is he going to carry this theme?” Well, you’re talking to someone that braved the Glowing Sea, battling Deathclaws and Radscorpions (hate those things) along the way. So yeah, pretty darn far. Now let’s open that big lead-lined door and head out into the world of IVDs!
The first phase of the FDA rollout of LDT regulation involves starting the post-market surveillance process, often referred to as medical device reporting. Most labs have some sort of customer support system in place, fielding questions and comments from patients, physicians, insurers, etc. So the concept shouldn’t be a foreign one.
But in medical device regulation, it gets pushed a bit farther. Here’s a brief primer.
Let’s say you get a complaint about your test, in this example a false negative. In the complaint, there’s a claim by the customer that the test isn’t performing as it should. You’ll need to collect as much information from the customer as possible about what happened. How do they know it’s a false negative (clinical outcome, other test result, etc.)? If it seems like a real complaint (as opposed to “I hate the new box colors”), it gets passed along to quality assurance for further evaluation.
Here’s where you’ll need to up your complaint handling game. Quality will need to evaluate the complaint and determine if it should get elevated to Reg Affairs for further review. For example, if the customer claims the false negative test result landed them in the ER, that’s a potential adverse event. Regulatory will need to assess whether the complaint needs to be reported to regulators like the FDA. There’s a narrow window on this, since adverse events need to be assessed and reported to the FDA in 5 days if they’re really serious and could happen again. Because of this, it’s probably best in the beginning to err on the side of caution and elevate anything that seems off. Trust me, RA will tell you when you’re taking it too far.
But even if it’s not reportable, you still need to log the complaint into a system where it can be tracked and trended with other similar events. Let’s say based on your development data, you’d expect a false negative result 5% of the time. But over the last couple of months, you’ve seen more like 8%. That could mean your test is out of specification, and that you might need to do a market correction. Market corrections can be anything from initiating a CAPA, issuing a customer notification, or even a full device recall. But the severity can only be determined if Quality is trending the complaint data and alerting Regulatory on any potential performance issues.
By now it should be clear that you at the very least will need to beef up your quality system around complaint handling, CAPA and medical device reporting. But there are some other systems that might need a bit of an upgrade as well. Take your CRM system. Is it up to date with customer contact information? If you’re using it to collect complaints or other customer inquiries, how easy is it to pull and analyze the data for trends.
You’ll also need to look at training. Make sure that everyone interacting with customers knows all about medical device reporting requirements. That’s not just the folks answering the phone, but also anyone attending trade shows, monitoring social media, etc. Complaints can come from a lot of places, and they need to be logged and handled appropriately.
Now you’re probably thinking, “gee whiz, that’s a lot of work”. It can be, depending on the systems you already have in place. But most established labs will find that with some training, a few good procedures, and an honest evaluation of the gaps in your current process, it could just be an incremental increase in workload from what you’re already doing.
I could go on, but you get the point. Yes it seems daunting, but keep in mind that you don’t need a fully compliant quality system in the first year. The FDA is asking labs to make sure that their current CAP/CLIA complaint handling process is up to the level required for medical device reporting. So, go grab yourself an ice-cold Nuka Cola, and maybe some delicious Blamco Mac and Cheese, and get started on that gap assessment!