Bruce Youngman Interesting to see how this turns out. I am not sure the current definition of a medical device from 93-42-EEC would call a dog a medical device unless they stretched the definition of "other article".

Karen Boyd, ASQ CQA That is interesting... I've heard that dogs can sense cancer or potentially be early warning indicators of diseases.
Of course, the snouts or extreme olfactory sensors of some dog breeds have been utilized for decades to search for missing persons, cadavers, drugs, etc..
I'm all for harnessing these canine "superpowers" for the greater good of human health. However, can a living being actually be considered a "device" or a "biologic"? Perhaps dogs would be a delivery system or vehicle where they serve as a mode to process and transfer an input to an output?

They would make for interesting clinical trials, I'll give you that.

John G. Caruso How about medical provider? I think military dogs are NCO's and their trainers are considered specialists. Using that model, the dogs could be "Canine Clinical Assistants". Therapeutic and diagnostic at the same time. There could be a new specialty field in nursing for the trainer as well.

Interesting!

Stephane Morvan A dog could be a fast and inexpensive pre-screening aid. Any positive flagged by the dog would warrant much more detailed lab work, imaging etc...

False negative could be mitigated by with random tests.

Ashley Smith The person who set up the charity that trains the dogs has described them as "biodetectors" not sure this does them justice though - https://www.whitehalltraining.com/blog/cancer-detection-by-dog

Ricardo Deus Well, it sure works through a non-pharmacological, non-immunological and non-metabolic mechanism. If they found enough clinical evidence on that, I see no reason so it can not be...

Leonel Graça I have trained my dog for sports, obedience and also in Search&Rescue. And I have attended several veterinary and dog sport seminars and congresses.
Lately there is also a very unregulated trend to introduce dogs for assisting in therapies.
Problem is, some charities are run by psychologists using positive reinforcement, while others are run by wannabe dog trainers that were merely glorified ex military dog handlers used to negative reinforcement training on dogs .
Just because you register a so called "dog therapy association" does not turn you into a specialist and misleads the general public and Medical Sector.
On one hand, same way that some EU countries regulate a specific training for handling "Potentially dangerous dog breeds", it should regulate these nose dogs.
On the other hand, same as for many other activities (drug and explosive detection) both the handler and the dog need to be certified via a practical test.

As for regulations, problem is scale. (TBC)

Leonel Graça (continuation)
Scale issue is a problem. For instance there are allegedly less then 5 dogs in the world certified for entering Correction Facilities. Here the FB page of the head of the Corrective Special Operations:
https://www.facebook.com/STL-Joseph-Garcia-393921155117/

In Portugal, only military and authorities can train detection dogs for drugs, while in UK there are civilians being certified. EU should level this.

If someone would bother to do this, it should be on a EU and USA level, with a world organization, similar to IRCA for auditors.

Problem in the Dog world is to have people agreeing. There is a say, that two dog trainers only agree about badmouthing a third.

Root cause for this is that similarly to 30 years ago in footbal/soccer/baseball coaches were illiterate people most with good will but poor social skills. Nowadays, most dog trainers are in the same level: great tech skills, poor social and management skills that a University degree facilitates.

Ricardo Deus I see your point Leonel Graça: How could we actually validate that training (manufacturing process)...?

Leonel Graça Ricardo Deus, in the end, it can be quite simple. Just same way as you validate any other "scent detection dog".

Instead of detecting money, drugs, explosive, living people, cadavers etc, they can detect the scent of cancer.

They validate the results of the training by testing the dog and handlers aptitude and attitude on a practical test. And this is done several times, yearly, for consistency.

It needs to ensure there is no bias in age, gender. Many variables can happen and need to be anticipated, or lessons learned and shared in congresses.

For instance, we train Search dogs to find people staying still, lost children or elderly. Finding people that are confused or mentally disturbed ads variables and once an old person (afraid of him) shouted the dog to "go away!". And the dog moved on ruling him out. Now we include that at the training.

In medical, will be hard to anticipate if other substances, other diseases, anything, could trigger on/off a wrong response.

IVD of course!

Now that dogs have been shown to be able to sniff out cancer, is this the end for the cat scan?

Somashekar BV It will have to start with the re-defining of the medical device. Certain worms are used in cases of severe gangrene. Are they the next on the cards too ... It won't be too far to then say that a doctor is also a type of a medical device.
So the next obvious question is faith. Faith heals ~~~~~

Karen Boyd, ASQ CQA Good to see all points of view on this topic! :)

Joe McMenamin Sorry to be a contrarian, but I don't think the dog qualifies, at least under US law. First, a dog is an organism, and it's debatable whether as such it can be characterized as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article."

Second, I do not believe dogs are recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them.

Third, although in this context the dog does indeed seem to be "intended for use in the diagnosis of disease," and although the effectiveness of the dog as a diagnostic aid "is not dependent upon" the DOG's "being metabolized," it clearly requires metabolic activity to do its job. But for metabolism, the dog would be dead, and it appears only living dogs offer efficacy here. Moreover, the sense of smell itself requires a complex and rather elegant physiology. See, e.g., http://www.utmb.edu/otoref/Grnds/smell-2012-01/smell-pic-2012-0130.pd

Brian Matthews From a purely practical point of view, a dog cannot be a medical device in the EU since viable animal organisms are excluded.

Stuart Engelking If it means not having a prostate exam with a metal object, who cares what they call it??

Henry Sibun Brian is right - you would have to render the dog non-viable....not very effective afterwards! and certainly unethical

As a living organism wouldn't that be contrary to classification as a device? I think Joe made this point earlier in greater detail. We are not talking about enhancing a dog with a mechanical scent detection apparatus are we?

An interesting debate ;-)

Clearly it would be a biologic and not a medical device. I suppose if it had a leash it could be a combination product, but the primary mode of action would clearly be the biologic.

Karen D. We have dogs here in the USA categorized as "seeing eye dogs" for the blind. But I don't think they are listed as a med.device.

Potato, patahto, it doesn't matter what the nomenclature is. I bet it is a lot less expensive to use the dog than bringing in equipment, training, maintenance, etc.

It would be good to get more data on the accuracy using the dog to detect this disease and compare it to the results from current technology in use.