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From an Associated Press article titled "Patients shocked, burned by device touted to treat pain" (emphasis added):

The investigation also found that the FDA — considered by other countries to be the gold standard in medical device oversight — puts people at risk by pushing devices through an abbreviated approval process, then responds slowly when it comes to forcing companies to correct sometimes life-threatening products.

Devices are rarely pulled from the market, even when major problems emerge.

  1. Are devices "rarely pulled from the market, even when major problems emerge?"

  2. Does the FDA respond "slowly when it comes to forcing companies to correct sometimes life-threatening" devices?

I have only found one specific seizure of a device (the date is 07/27/2010). Here is an example of FDA seizure of "human and animal food products, over-the-counter (OTC) drugs, cosmetic products and medical devices" in a grocery warehouse with "widespread insanitary conditions."

  • Please suggest improvements, thanks! I have tried to make the question as simple as possible. I honestly think it should be possible to easily show the claim to be false, so the definitions aren't necessary. – Barry Harrison May 5 at 4:47
  • 1
    Generally we reject the definitions provided by the questioner. It isn't Barry's understanding of the claim that is relevant. It is the claimant's understanding of the claim; we should look for context of the statement for the likely meaning. (Caveat: If the claimant's definition is likely to be different to the reader's definition, an answer should take the effort to explain this. (e.g. a claim that is technically correct, but misleading to a lay audience.) – Oddthinking May 5 at 16:03
  • @Oddthinking Definitions deleted, thanks for the suggestion! I completely misunderstood the "unclear what you're asking" flag and thought the definitions prevent it. I will stop providing definitions in the future. – Barry Harrison May 5 at 18:19
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Summary

The FDA does not issue recalls quickly, because it is not the FDA's responsibility to issue recalls quickly; that is the manufacturer's responsibility. The FDA generally only issues recalls when the manufacturer fails to do so in a timely manner.

How does the abbreviated approval work?

Device manufacturers may choose to submit an Abbreviated [Approval] 510(k) when:

  • a guidance documents exists,
  • a special control has been established, or
  • FDA has recognized a relevant consensus standard.

[...]

An Abbreviated 510(k) that relies on a guidance document should include a summary report that describes adherence to the relevant guidance document and how the guidance document was used during device development and testing. The summary report should include information regarding the manufacturer's efforts to conform with the guidance document and should outline any deviations.

[...]

In an Abbreviated 510(k) submission, manufacturers elect to provide summary reports on the use of guidance documents and/or special controls, or declarations of conformity to recognized standards, to expedite the review of a submission.

[...]

An Abbreviated 510(k) that relies on a recognized standard must include a Declaration of Conformity to the recognized standard. Under certain conditions, conformance test data are not required to be submitted in the 510(k).

(Source, emphasis added)

In short: A manufacturer of a new medical device can refer to studies, standards and even approved medical devices of another manufacturer and claim the same effectiveness and safety for their own new device (that's based on the same technology) without having to repeat clinical studies. The reasoning behind that is that if someone else proved that X-ray is a valid technology to diagnose bone fractures, the manufacturer of an X-ray device doesn't have to prove the same facts again.

All you have to submit to the FDA is a huge amount of documentation claiming that you (the manufacturer) follow all the guidelines and standards that should result in the production of safe medical devices. The FDA trusts that if you follow all the guidelines, you create safe products. It is possible to modify and fake the documentation in a way that it obscures small deviations on your part.

If you chose not to adhere to the given standards and guidelines (maybe because you want to cut costs and decrease the diameter of an implanted electrode), all you have to do is a risk-benefit-analysis showing that the added risk of this measure does not outweight the benefit. If the electrode breaks due to the decreased diameter, you can get away with claiming coincidental failures or temporary deviations in the manufacturing process for a long time.

What the FDA does not do (and is not qualified to do) is testing the safety and effectiveness of a medical device itself. It solely relies on documentation by the manufacturer to approve a device for the US market.

How are medical devices pulled from the market?

First and foremost, the manufacturer of a faulty medical device is supposed to recall such devices. See the list of medical device recalls. Any respectable manufacturer recalls devices after receiving an unusual high number of incident reports, but this is still a voluntary action most of the time and seldom forced by the FDA (see below).

If a manufacturer fails to recall devices on their own, the FDA has the authority to issue a warning letter, force a recall, and take more severe legal actions. The FDA Enforcement Statistic of the Fiscal Year 2017 lists the following types of inforcements:

| Seizures                   |      3 |
| Injunctions                |     12 |
| Warning Letters            | 15,318 |
| Recall Events              |  2,945 |
| Recalled Products          |  9,199 |
| Drug Product Debarments    |      5 |
| Food ImportationDebarments |      0 |

As you can see, the number of recall events is only 1/5th of the number of warning letters issued and the statistic doesn't even distinguish between voluntary recalls by the manufacturers and recalls forced by the FDA.

The openFDA API is an interface to query the publicly available FDA database. A query of all mandatory vs. voluntary recalls ever yields:

| Voluntary: Firm Initiated | 18,943 |
| FDA Mandated              |     94 |
| Voluntary: FDA Requested  |      8 |

(Source; the query used is: https://api.fda.gov/device/enforcement.json?count=voluntary_mandated.exact)

How fast does the FDA respond?

This is where it gets blurry. I haven't found any practical means to compare the date of the first incident report of a product to the issue date of the recall. But realistically we have to assume:

  • Incident reports for medical devices are a quite common occurance, since manufacturers and users of such devices are supposed to report any problems with the usage, effectiveness, documentation and marketing of it.
  • Single reports do not warrant any action from the FDA. There has to be a significant number of reports or at least a significant trend in numbers to warrant any action from the FDA.
  • The FDA mostly relies on the good will of manufacturers to recall their own products and will only take legal actions after the manufacturer failed to react on its own.

When FDA finds that a manufacturer has significantly violated FDA regulations, FDA notifies the manufacturer. This notification is often in the form of a Warning Letter. The Warning Letter identifies the violation, such as poor manufacturing practices, problems with claims for what a product can do, or incorrect directions for use. The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction. FDA then checks to ensure that the company’s corrections are adequate.

(Source, emphasis added by me)

This adds another, undefined period of time to the time frame between the first occurance of a fault and the correction or recall.

Why does it take so long?

In the comments the question arised why the FDA takes so long to take actions against unsafe medical devices.

If you look at it from the FDA's perspective, they take actions before any unsafe products can even do harm to people, meaning they do not approve products for the US market if there are doubts about the quality of the product or production process. But all they have to make this assessment is a huge documentation (easily hundrets of pages). Manufacturers who care more about money than safety can fake and manipulate documents to a certain degree to push products on the market or they can simply do sloppy work and not be aware of the risks and faults of their own product.

Once a product is approved, there is quite a lot of trust implied. This trust is hard earned (FDA does have one of the strictest medical device oversights globally) and is equally hard to lose.

If you read a story about a man crippled by a malfunctioning medical device, you feel sorry and maybe enraged. If the FDA gets one incident report, it's no big deal. Medical devices are used to treat or cure patients who are ill or injured to begin with. If one of them dies it's always hard to tell if they wouldn't have died without the device just the same. Who is to blame? Did the device itself malfunction? Was the manual unclear and lead the surgeon or even the patient use the device in an inappropriate way? Did anyone even read the manual? Did someone conciously use the device in an inappropriate way?

Immagine reading that 60% of patients treated with SecretDevice X died immediately during treatment. Sounds severe, right? Now immagine that SecretDevice X is a defibrillator. Without this device probably 90% of patients in the same situation would have died, but no one would connect their deaths to any medical device. That's why it's so difficult to tell from incident reports alone whether a device is unsafe.

  • +1 Thanks for answering! In your last blockquote you bolded "The letter also makes clear that the company must correct the problem and provides directions and a timeframe for the company to inform FDA of its plans for correction." Could I ask what a typical timeframe is or what a range of timeframes are? Thanks again! – Barry Harrison May 5 at 18:40
  • @BarryHarrison Sorry, I have no first hand experience with FDA warnings or given time frames. Maybe there is something in the FDA regulation but I cannot find it. Realistically, though, I assume manufacturers have a very short time (like a few days) to plan any corrections in reaction to the warning letter, but then a much longer time (probably months) to actually implement those corrections. If they chose to immediately recall the device, that's good for the patients. The statistics imply that the FDA doesn't immediately mandate a recall even in severe adverse events (like death). – Elmy May 5 at 19:03
  • This is some really nice research. Could I ask how you started? The FDA has a database for warning letters as well, and I picked one at random. Basically, the device manufacturers didn't comply with the terms of the PMA. The manufacturers were supposed to perform a study and follow-up at years 2, 5, 8, and 10. However, the 3 year follow-up was lower than the target follow-up rate. 3 years would have been May 29, 2015. The letter was sent March 18, 2019. – Barry Harrison May 5 at 19:19
  • Then, I could argue the FDA took 4 years to respond. Is that correct, for this particular case? – Barry Harrison May 5 at 19:19
  • @BarryHarrison The FDA isn't omniscient and doesn't have the resources to check the entire documentation constantly. The initial check for approval is very thorough, each yearly check concentrates on only parts of the documentation. It's not unusual that transgressions like that stay hidden for years. Then keep in mind that there are humans involved who might make mistakes or be unmotivated enough to overlook a single number of participants in hudred pages of documentation. – Elmy May 5 at 20:37
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Not a complete answer. News sources that show public perception of device issues and the FDA response may better answer the question.

FDA recalls for medical devices are available here.

Picking two random Class I recalls in 2015 (I am not affiliated, past or present, with any of the companies used as examples):

Boston Scientific Corporation, Chariot Guiding Sheath May Break off During the Procedure:

The distribution date was from "June 6, 2015 to November 17, 2015." The recall date was December 15, 2015.

Reason for recall: "Boston Scientific has received fourteen complaints of the shaft of the device separating."

Insulet Corporation OmniPod Insulin Management System: Needle May Fail to Deliver Insulin:

The distribution date was from "09/2015 To 09/2015." The recall date was November 2, 2015.

Reason for recall: "The firm has received 10 cases where the malfunction occurred. No serious injuries or deaths have been reported in patients using OmniPod devices from the affected lots."

I cannot determine how dangerous the defects were, so cannot determine if the response time was reasonable. Your answer should provide a better analysis of this.

Regarding implanted spinal cord devices specifically (which was the example used by the Associated Press), I believe there have been 45 recalls. See the recall database here with product code LGW. However, I can't see when the devices were distributed, so cannot determine the response time.

Note: "[A] Class I recall [is] the most serious type of recall. Use of these devices may cause serious injuries or death."

  • I will not be accepting this answer, unless it has been significantly revised. – Barry Harrison May 5 at 7:39

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