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Christine and Anne's 22-minute video

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here

1. How do you conduct your post-market surveillance? Regulators require surveillance of device-related adverse events, use errors, product quality issues, and device failures. But do you: Simply evaluate risks then reporting adverse events (event-driven surveillance) or evaluate all product experience and fold back into the product development lifecycle (review-driven surveillance). You know which one is better. 😉
2. Is risk management a 'new product thing' for you? If you consider risk management only when you change to the product, that's not going to cut it anymore. Anne reports, "Certain notified bodies no longer will accept your technical file without a post-market clinical follow-up plan."
3. What's a UEF? Christine advises you design a UEF (Usability Engineering File, a subset of your Design History File) to continuously monitor and address your usability issues. 62366-2 (the guidance that accompanies 62366-1) is a great roadmap for setting it up.
4. Wow. This is scary: Up to one-third of "device failures" are likely failures of device use rather than failure of the device itself, estimates FDA.Christine rattled off a lot of guidances you should know about (see slide 7).
5. Wow. Interesting. Clinicians think every failure that happens in a hospital is their fault. Your device has to shut down or smoke before they think it’s your fault. At most, 20% of incidents are reported, Christine says. Implications: Can you imagine what your complaint roster would look like if it were five times higher than it is today? 😰

In terms of really looking at what their post-market data is telling them, most companies are not there yet. And I think one of the reasons is the tools they’ve been using. Most companies have a tool, it’s for collecting customer service information. They had people who were paid not a whole lot more than minimum wage sitting and answering the phones and putting the most important information they’re getting into a free text field. So guess what happens? That gets dumped into a big file; and it gets sent over to complaints department; and they have to read through every single file; and they don’t have good buckets to put things into. So what they’re pulling out is MDRs. What they’re pulling out is obvious device failures. Beyond that, I think most companies are not doing a very good job getting their arms around this data.

Three weeks 'til 10x – $695 pricing (if you qualify)*

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 this post

Those wonderful devices you made, perfectly calibrated when customers opened the box, are still your responsibility once deployed.

This guest post, courtesy of Gregg Schaeppi, Director of Client Services for PK Calibration & Validation, taught me everything I know(!) about device calibration. He writes,

"With repeated use and over a period of time, all medical equipment degrades, which affects its accuracy and precision. In our industry, measurement drift is unacceptable, so regular service and measurement are required to keep our medical devices working optimally.

Patient health and safety are manufacturers' top priority, of course. To safeguard the public health, the medical device industry is regulated by strict standards including FDA's 21 CFR Parts 11 and 820, Quality System Regulation (QSR) and ISO 13485.

Title 21

Title 21 of the FDA Code of Federal Regulations defines equipment calibration requirements.

Section 820.72 declares manufacturers must inspect, measure, and test equipment to ensure it is suitable for its intended use and capable of providing valid results. Manufacturers must have provisions to handle, preserve, or store the equipment. These activities must be recorded and documented.

Designated staff must have access to national/international standard procedures to inspect, measure, and test for accuracy and precision. Errors must be corrected; adverse events, evaluated and documented.

1. Equipment calibration must be carried out routinely, per the company's written directions.
2. Calibration of every device requiring calibration must be documented.
3. Acceptable limits for accuracy and precision must be specified.
4. Calibration personnel must be trained.
5. Calibration standards must be traceable to the national standards, in-house standards (if necessary), or other acceptable standards.
6. Provisions must be made for evaluating adverse effects caused by the defective equipment, and corrective measures must be taken.

Calibration Requirements

1. Calibration. As per FDA's medical device calibration requirements, all medical device companies need to have procedures in place that include instructions and acceptable limits for accuracy and precision. If a medical device fails to meet these standards for precision and accuracy,
1. FDA will evaluate whether failing to meet the standards can have an adverse effect on the patient. If potential risks are discovered, then the manufacturer must calibrate the medical device to improve its quality until the standards are met and must document all procedures involved.
2. Standards. If the standards for calibrating a medical device are absent, FDA states that relevant national, international, state, or local standards need to be applied. If no standard exist, the manufacturer must form its own set of requirements, and the medical device must be calibrated to meet those requirements.
3. Documentation. Part 21 CFR 820.72 states that manufacturers must document all the points of calibration, including the following:
1. The date the device was picked up for calibration.
2. The name of the engineer who performed the calibration.
3. The date when the next calibration is due.
4. Accessibility. All records must be accessible to the designated personnel of the company. For an instrument calibration program to remain in compliance with FDA, it is important to maintain a calibration schedule. Missed calibration cycles can compromise the quality of the product, resulting in non-compliance.

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Editor's Note: Gregg and I didn't talk much but I'm comfortable guessing: If you need help with medical device calibration, Gregg can help. Just email him using this link.

Thank you, Gregg. I encourage group members to follow Gregg's example and write me with educational content to share with the group. As you can see, I'm too happy to let everyone know our readers are the real brains behind this operation. 😊

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Cancerous Conspiracy Theories

Well, good news and bad news. Good news: Debate is alive and well in our group. Bad news: Boy, did I get an earful last week!

I published the discussion starter, "Is Cancer Too Profitable To Cure?"

to:

and everything in between.

For the record, I didn't state my personal view in the commentary, but I will, here.

It's not outside the realm of the possible that greed and corruption, so evident in political, financial, and social arenas, could play a role in any and all aspects of human behavior.

Squash a cure for cancer? Reprehensible!

Patently impossible and the stuff of conspiracy theories? No, I don’t believe so. Which is why I felt this topic meaningful and appropriate for our group.

Five weeks until our annual meeting

On the fence for any reason? Email me for promotional pricing for which you may qualify.

You can download the brochure here.

Come a day early for intense three-hour work sessions and a complimentary consultation from MedWorld Advisors to evaluate the saleability of your company.

Almost forgot!

Here's the countdown-to-10x video-clip-between-sessions throwback of the week, this one from our third event back in 2015.

Thank you for being part of our Medical Devices Group community!

Make it a great week.

Joe Hage
Founding Principal,
Medical Devices Advisory Group

P.S. Help a guy out? Please  this post if your customers would value it.