Using Recalled Devices to Approve New Ones; Inpatient Safety

News

TTHealthWatch is a weekly podcast from Texas Tech. In it, Elizabeth Tracey, director of electronic media for Johns Hopkins Medicine in Baltimore, and Rick Lange, MD, president of the Texas Tech University Health Sciences Center in El Paso, look at the top medical stories of the week.

This week’s topics include the safety of inpatient care, using recalled devices to get new ones approved, hearing and dementia, and antibiotic use and inflammatory bowel disease.

Program notes:

0:30 Using recalled devices to approve new ones

1:30 Using class recalls, usually voluntary

2:30 Can’t tie to patient safety

3:12 Inpatient patient safety

4:13 Sample of 2,800-plus admissions

5:14 Higher levels of adverse events

6:16 Mechanisms now to decrease events

6:52 Early use of antibiotics and inflammatory bowel disease

7:53 Clear association found

8:53 Understanding the mechanism

9:03 Hearing loss and dementia prevalence

10:03 Used Medicare beneficiaries

11:03 Hearing aid use

12:32 End

Transcript:

Elizabeth: The safety of inpatient healthcare.

Rick: Using recalled devices to approve new devices.

Elizabeth: Hearing loss and dementia.

Rick: And does antibiotic use increase the risk for inflammatory bowel disease?

Elizabeth: That’s what we’re talking about this week on TTHealthWatch, your weekly look at the medical headlines from Texas Tech University Health Sciences Center in El Paso. I’m Elizabeth Tracey, a Baltimore-based medical journalist.

Rick: And I’m Rick Lange, president of Texas Tech University Health Sciences Center in El Paso where I’m also dean of the Paul L. Foster School of Medicine.

Elizabeth: Rick, how about if we turn right to JAMA? This is one of yours. It’s a study that you served up as using old approvals to approve new devices and that’s a soft toss in a way, because you’re on one of the FDA committees looking at cardiac devices.

Rick: This is a particular pathway called the 510(k) pathway. All manufacturers have to do is they have to demonstrate that their new device are [sic] substantially equivalent to already authorized devices, called predicate devices. That means they don’t have to do randomized controlled trials if you have a device that looks like another device. That’s predicated upon substantial equivalence between those two devices, as the predicates for these future devices are safe.

Well, how often are devices that are approved based upon devices that subsequently have been recalled, and does having a recalled device influence those subsequent lineage devices? They looked at all 510(k) devices subject to Class I recalls from January 2017 to 2021. By the way, these class recalls — I used to think that the FDA initiated most of these, but actually most recalls are voluntary. As a result, there is a loophole: if the FDA has a Class I recall, you don’t use that for subsequent device approval. But if the manufacturer voluntarily recalls it, then you can have other devices based upon that device.

They analyzed 150 cases of 510(k) authorized devices that had a Class I recall; 44% used predicates with Class I recalls, and 48% of these devices were subsequently used as predicates for other devices as well. They were 6.4 times more likely to be withdrawn from the market than devices that didn’t have a predicate Class I recall device.

So we need to strengthen our laws. We need to follow these Class I recalls more intently. We need to have better databases to analyze these — a lot of work to be done on this.

Elizabeth: Can you give me a specific example or some of the outcomes that are related to the use of these devices?

Rick: We can’t tie this specifically to patient safety, unfortunately, but I can tell you the following. The FDA determined cause for recall; a third of the time it was because of device or software design issues, about 16% because there was a process control issue, about 15% we don’t even know, and about 10% because the material or component was non-conforming. We’re talking about cardiovascular devices, anesthesia devices, general hospital devices, pumps, equipment, ventilators, and intra-aortic balloons. Those kinds of things.

Elizabeth: This sounds like something that’s been hiding in plain sight.

Rick: That’s a great description. We haven’t given the FDA the legislative power to actually look at this.

Elizabeth: Two studies by the way that are addressing virtually the same issue. Let’s turn to the New England Journal of Medicine. This was a special article and it was looking at the safety of inpatient healthcare.

This is kind of a redo, actually. In 1991, a Harvard Medical practice study documented this level of major causes of inpatient harm. They did a retrospective cohort study to look at frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during 2018. They tried among the hospitals to get representative ones — big academic medical centers and little community hospitals, and then they oversampled those in trying to make the data more representative in general.

They looked at adverse events assessed with the use of a trigger method. That’s when you look in the EHR [electronic health record] and you see something that was previously shown to be associated with adverse events. They had this sample of 2,800 plus admissions where at least one adverse event occurred in just shy of 24%. Of that number, 23% were judged to be preventable. Almost a third had a severity level of serious and that was something that resulted in substantial intervention or prolonged recovery, or higher. A preventable adverse event occurred in about 7% of all admissions and a preventable adverse event with a severity level of serious or higher in about 1%.

There were 7 deaths, one of which was deemed to be preventable. The most common of these were adverse drug events, almost 40% surgical or procedural events, falls, and pressure ulcers, and infections. When you compared the rate of adverse events per 100 admissions, their previous findings showed this adverse event rate of 3.7 events per 100. This study shows huge variability, but very much higher than that. Kind of concerning.

Rick: This is very difficult to compare to other studies, but in essence, as you described, there are preventable adverse events in approximately 7% of all admissions. Why is it difficult to compare this to previous studies? We shift a lot of care now to outpatient. Those are patients that are generally less likely to suffer an adverse event.

Secondly, we have different reporting mechanisms. It’s very difficult to say, “Are we getting better or worse?” But what it does tell us is that if 1 in 13 or 1 in 14 people have a preventable adverse event, we need to drill down and see what those are and how we can address them. As you noted, adverse drug events really are the most common type.

Elizabeth: It’s not surprising to me, though, at all that that would comprise the biggest category.

Rick: It’s interesting. They listed the adverse events as being hypotension, a mental status change, acute kidney injury, or all other. All other was the major category. Unfortunately, this study doesn’t give us particular information. We do have mechanisms now for decreasing adverse drug events. There is, as you mentioned, considerable variability. We need to look at that.

Elizabeth: I was a little disconcerted that the usual suspects were still the things that were present, though — specifically falls, pressure ulcers, and infections, which seemed like we ought to have gotten our arms around that a little bit better.

Rick: We’ve done things to address that. Nationally we monitor how many infections are due, for example, to putting in a central line, or how many were due to being on a respirator or a urinary tract. But it says that we have more to do. There is no question about it.

Elizabeth: Let us now turn to Gut, one of the BMJ journals.

Rick: There have been studies that have suggested that in kids, the early use of antibiotics is associated with a subsequent increase in inflammatory bowel disease. It’s thought that the change in microbiome or the change in bacterial composition of the gut caused by antibiotic usage in kids changes the immune status and makes them more predisposed.

We haven’t really done a good job of looking at that in adults. That’s what this study tried to do. It assessed the impact of both antibiotic exposure, dose response, timing, and antibiotic class on the risk of inflammatory bowel disease in individuals over the age of 10. They did this by using the Denmark Nationwide Registry — that’s over 6 million individuals — and they have got great follow-up on the diagnosis and also whether they ever received antibiotics, what kind of antibiotics, and how often they did.

Among those 6 million individuals identified, about 53,000 that had new cases of inflammatory bowel disease and they looked at their antibiotic exposure. What they discovered was that there was a clear association between antibiotic exposure and the increased risk of inflammatory bowel disease across all age groups, but particularly in those aged 40 to 60 and those more than 60 years of age. It increased the risk of inflammatory bowel disease about 50%.

There was a dose-response curve. The more antibiotics, the more likely the increased risk of inflammatory bowel disease. It usually occurred between 1 and 2 years after antibiotic usage. The highest incidence was with antibiotics that affect the gut flora more — medications like metronidazole or the fluoroquinolones. This is another reason why we need to be good stewards of antibiotics.

Elizabeth: I agree with that. It’s interesting to me, of course, we applaud these databases all the time, these huge national things that keep such robust records and that have resulted in a tremendous amount of information that’s been of benefit to all of us. Now that we’re studying intently the gut microbiome, I’m wondering if prophylactic administration of some kind of a microbiome cocktail during or after the time when somebody takes an antibiotic would be helpful.

Rick: Taking it to the next level, understanding the mechanism and then how we could interrupt that mechanism to lower the risk, so I’m glad you mentioned that.

Elizabeth: Let’s turn back to JAMA, then, for a research letter on hearing loss and dementia prevalence in older adults in the U.S. This has been undergoing a lot of scrutiny because now we have over-the-counter hearing aids that are less expensive and possibly more fashionable than the traditional ones. Maybe it’s going to overcome people’s resistance to using them.

This research letter starts with a really interesting statement. It says hearing loss accounts for 8% of global dementia cases, asserting right off the bat that hearing loss and dementia are inextricably linked, and that in fact it is an important cause of dementia. The authors put forward that hearing aid use may potentially lower dementia risk among older adults with hearing loss, but right now this evidence is both limited and mixed.

They estimated the cross-sectional association of audiometric hearing loss and hearing aid use with dementia among community-dwelling older adults using a nationally representative data set of U.S. Medicare beneficiaries. They had air-conduction, pure-tone audiometry using an electronic, tablet-based, portable audiometer for these folks and they used the pure-tone average in the better hearing ear that was calculated for this study. They also examined a number of covariance including age, sex, education, race and ethnicity, smoking history, and chronic medical conditions.

They had 2,413 participants. There was kind of a dose response. The prevalence of dementia overall was 10.27% and it increased with the increasing severity of hearing loss. Among those with normal hearing, it was 6.19%, with mild hearing loss 8.93%, and with moderate or severe 16.52%.

The question: if we give these folks hearing aids, what happens? Among the 853 participants with moderate to severe hearing loss, hearing aid use, which was about half of those folks, was associated with lower prevalence of dementia compared with no hearing aid use. I understand the case that they are trying to make here. I’m not sure that this proves it.

Rick: This is interesting baseline data that accentuates the fact that this is a huge problem. In this age group, a third of them had mild hearing loss, and a third had moderate to severe hearing loss. If there is an association with dementia, and it appears there is, that affects a lot of the U.S. population. Okay. If we give these people hearing aids, does it actually decrease the risk of dementia? This study doesn’t really prove that at all. The authors mentioned that. They did randomized trials to determine whether the hearing interventions actually reduced dementia and that’s the next step.

Elizabeth: That is actually a study that is underway. I guess one of my questions is who is going to want to be randomized to the no-hearing aid arm and then potentially increase their risk for developing dementia?

Rick: Well, Elizabeth, as you and I know, there are a lot of people that are just resistant to wearing hearing aids already. This not only has implications regarding dementia, but it also has profound cost implications. You wouldn’t want to apply an intervention if it’s not effective. I think this information is very important to discover.

Elizabeth: On that note then, that’s a look at this week’s medical headlines from Texas Tech. I’m Elizabeth Tracey.

Rick: And I’m Rick Lange. Y’all listen up — no pun intended — and make healthy choices.

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