Significant FDA Medical Device Marketing Shift...

[MIREGMGR]

In this week's FDA Enforcement Actions Report, a Warning Letter issued to Hill-Rom is reported. In that Warning Letter, an apparent change to FDA enforcement policy with radical significance for medical device marketing is obliquely described. As far as I know, this is the first revelation by FDA of this regulatory interpretation.

Hill-Rom makes hospital beds, which normally are classifiable as Class I devices. In their apparently unremarkable marketing literature for those beds, Hill-Rom made the usual benefit claims for their products, i.e.

"Smart beds can give you visibility to your patient even when you are not in the room by automating documentation to reduce steps and time spent charting, providing numerous clinical data points including patient weight, head of bed angle and frequency of turns."
"The Total Care Connect bed can help decrease adverse events while helping to improve both patient and caregiver safety and satisfaction"
"Clear Lungs Program"
"The TotalCare Connect bed: as easy choice to help you reduce VAP (Ventilator Associated Pneumonia)"
"No Falls Program, Helping prevent patient falls in the ICU."

FDA determined in the Warning Letter that these benefit claims exceeded the language in 21CFR 880.5100:

An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

and therefore that the Hill-Rom products

(...)exceed the exemptions in sections 880.5100 and 880.5150, triggering the requirement for clearance under section 510(k).

So...those of you who make Class I products...what are your marketing claims, and do they exceed the plain language in 21CFR 880 for your Product Code?

 

[Bill Evans]

Re: Significant FDA Marketing Shift...

Are the beds really a Class 1? Sec. 880.5100 AC-powered adjustable hospital bed.
(a)Identification. An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails.

(b)Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 880.9.

[45 FR 69682-69737, Oct. 21, 1980, as amended at 63 FR 59229, Nov. 3, 1998]

 

[RA Guy]

Re: Significant FDA Marketing Shift...

Frankly after reading your post and looking at the brochure for these beds I am not surprised by the outcome. This product obvioulsy far exceeds the definition.
A hospital bed that fits this definition is a Class II, 510(k) exempt device per the reg. The speacial controls appear to address entrapment prevention.

Having worked in the area of patient monitoring devices (including critical care) in past positions, I would not have automatically equated this type of product with a more traditional electro-mechanical bed.
I don't think they helped themselves when they use wording like "safety" and "critical care decisions" in their public lit.

Not sure I understand your first paragraph. Can you clarify what you believe the "radical" departure from the past is? The fact that its in a warning letter. I've definitely witnessed the FDA question classification conclusions in pre-IDEs, trade complaint investigations, etc.

It is unclear the extend of the role this "bed" in a critical care monitoring situation, but the manufacturer when devising these claims needs to deterimne the impact of failure in their risk analysis. Adding the required software and firmware to this bed in order to make it part of a critical care system is certainly something I suspect FDA would want to review.

Last week I posted a response to a question on the need for an intended use statement for class i devices where I opined that it is a fundamental requirement in product development/modification not just because FDA expects it in post marketing activities, but because it tells you what the product regulatory landscape will look like and untimately drive design validation. This example of the bed could be a poster child for that postion.

 

[MIREGMGR]

RA Guy: to the best of my knowledge, this is the first time that the FDA has (de facto) re-classified a modern hospital bed into Class II non-exempt.

As far as I know, FDA until now has accepted "baseline feature creep" as an inherent and beneficial result of the advance of electronic controls in powered beds. This appears to me to be a reversal of that past practice.

I think it's very likely that the current Hill-Rom product is predicate-traceable through a long line of devices that have been considered Class I by both Hill-Rom and FDA, starting with 1950s electromechanical beds and adding a little more patient/caregiver-beneficial functionality with each generation. In particular, I'd bet that the immediately preceding Hill-Rom product generation was equally classified without FDA friction. Of course the usual disclaimers would apply from the FDA's side, but I think it's noteworthy that Hill-Rom is well known to the FDA...in my estimation, not because they are a "bad actor", but oppositely because they are known to FDA to have a relatively intensive corporate compliance commitment...and FDA chose them to apply this particular issue because of their visibility and regulatory ability to deal with it.

BCSnave: of course you're right and my terminology was imprecise, but the present discussion is only about premarket notification requirement exemption and that's often short-handed...even here...using the "Class I" and "Class II" descriptors when the more precise distinction is (arguably) not essential.

 

[yodon]

Interesting, indeed.

We've worked on some hospital beds and they're far more sophisticated than adjustability and side rails. I think I'd have to side with the FDA on this. If I'm relying on some of these sophisticated features, I would expect them to work. Failure could have some dire consequences. I realize that bumping the class doesn't guarantee things will work but it does push the required verification and validation.

I recall hearing of a similar case where after years of incremental changes / letters to file, the FDA finally said 'enough' and required another 510(k) (or PMA, I don't recall which). Seems like there's definitely a shift towards more post-market (change) scrutiny.

 

[MIREGMGR]

Certainly the 510(k) guidance indicates that a determination of 510(k) need should always be based on the original product, not an incrementally changed most recent version. My reason for pointing out this particular instance is that FDA seems to be de facto cancelling the 880.5100 product exemption (without benefit of formal legal process) since no mainstream products are made that way and only that way anymore. Instead, that entire range of products has been elevated to Class II non-exempt territory. Clearly an argument can be made that that makes sense. Nonetheless, I'm quite sure it comes as a shock to every one of the participants in the hospital bed market sector.

 

[Gert Sorensen]

It seems that the issue is more that they have started to make claims regarding the intended use of their product, and therefore comes into conflict with the criteria for their market clearance. FDA routinely issues warning letters based on review of web sites and marketing material, in which they state that companies have exceeded their basis for clearance by claiming additional or entirely new features.

All in all, the signal to industry is that we should make sure that our marketing personell are adequately trained in the regulation so as to make sure that they don't create compliance problems for us.

 

[MIREGMGR]

My reading of the unnumbered issue-section following section 14 of the Warning Letter is that Hill-Rom was gigged both:

1. For marketing a product with features/functions that exceed the limits of their relevant 510(k), which FDA is interpreting to be strictly bounded by the underlying regulation in regard to features/functions that can be present (in the fourth paragraph following the paragraph numbered 14).

2. For claims that naturally exceed that same 510(k) because they describe the exceeding product (in the third paragraph following the paragraph numbered 14).

I think it would be in error to focus only on item 2 above. The core problem that Hill-Rom and other bed makers have is that the regulation that exempts beds from premarket notification has become technically obsolete.

I posted the issue here because other product classes might also be affected by a similar gradual technological evolution beyond an exemption-regulation that was originally tailored to fit them.

 

[Ronen E]

...we should make sure that our marketing personell are adequately trained in the regulation so as to make sure that they don't create compliande problems for us.

...or create formal processes that ensure that marketing materials (including website content etc.) are reviewed and approved by competent personnel prior to their release for publishing.

The first approach ("TQM style") would be ideal but unfortunately the latter is more realistic and sustainable, I believe.

 

[Ronen E]

My reading of the unnumbered issue-section following section 14 of the Warning Letter is that Hill-Rom was gigged both:

1. For marketing a product with features/functions that exceed the limits of their relevant 510(k), which FDA is interpreting to be strictly bounded by the underlying regulation in regard to features/functions that can be present (in the fourth paragraph following the paragraph numbered 14).

2. For claims that naturally exceed that same 510(k) because they describe the exceeding product (in the third paragraph following the paragraph numbered 14).

I think it would be in error to focus only on item 2 above. The core problem that Hill-Rom and other bed makers have is that the regulation that exempts beds from premarket notification has become technically obsolete.

I posted the issue here because other product classes might also be affected by a similar gradual technological evolution beyond an exemption-regulation that was originally tailored to fit them.

Isn't there an established mechanism to pro-actively review and update classification regulation that has become outdated due to technological advancement? I'd tend to think that this would be highly desirable for a classification methodology such as that employed by the USA medical devices regulatory system.