[Meh] Medical Device Regulations

[Honor and Glory]

Items of laboratory equipment are not, in any sense of the phrase, considered medical devices. Just because they are used in a medical testing laboratory instead of a pharmaceutical production laboratory, or a food testing laboratory, does not mean they must meet a higher standard than exists for other laboratory equipment.

Those technical instruments which come in contact with or act physically upon the human body, e.g. scopes, dialysis machines, hearing aids, Goa'uld healing devices -- er, never mind that last bit -- are medical devices.

"I believe I understand your point now. Perhaps the quality and standards for laboratory equipment should be handled outside of this proposal, if they need to be handled by the WA at all. May harmony find you."

[The Dark Star Republic]

"So, I've asked Ms Chinmusic to come up with some different versions of the definition:

For the purposes of this Resolution, "medical device" is defined as...
...a technical instrument...
...a piece of technical equipment...
...a technical device...
...a physical element...
...a tool, machine, device or prosthesis...
or, simply
...one...
...
...used for medical purposes...
...used for the diagnosis, prevention or treatment of a malady...
...used for the diagnosis, prevention or treatment of a medical condition...
...

...that acts through a physical effect;
...that acts through a physical effect on or within the body;
...whose effect is achieved through a physical interaction with the body;
...that interacts with the body without meeting the definition of a drug;

"I do think this is one example of where a definition is needed, so any help in achieving a proper wording would be gratefully received."

~ Vice-Colonel Truculent Bilgewater

[Wrapper]

Ambasador Trucky -- you don't mind if we call you that, do you? If so, eh, it will be hard to think of you as anything else -- anyway, before we talk definitions, we need to clarify what you are trying to regulate. Is your intent to include or exclude smaller, non-mechanical items that still interact with the body, like syringes and catheters? Obviously pharmaceuticals and the like are excluded, but what about radioactive tracers like barium (which in our nation are regulated as pharmaceuticals anyway, even though they are diagnostic tools)? Also, while both ocular and cochlear implants are generally included in the definition of "medical device", in our nation so are hearing aids, while eyeglasses are not. Yes, terribly inconsistent, isn't it? Not saying our way is right or wrong, just saying, need clarification first.

In any case, we prefer the wording "medical condition" to "malady", which implies an illness. In our opinion, deafness, for example, would be considered a medical condition, but there are some who would object to referring to it as a malady.

[The Dark Star Republic]

"It's better than Bilgey, at least...

we need to clarify what you are trying to regulate. Is your intent to include or exclude smaller, non-mechanical items that still interact with the body, like syringes and catheters?

"Unless doing so produces a definition that is simply unworkable, I don't necessarily see why not. But a defective syringe poses a health risk just as does a defective pacemaker.

In any case, we prefer the wording "medical condition" to "malady", which implies an illness.

"I agree; I'm going to change the preamble, regardless of the definition."

~ Vice-Colonel Truculent Bilgewater

[The Dark Star Republic]

(Bump in case anyone else has thoughts on the definition)

[Sciongrad]

Hmmm... a medical device is used for medical purposes... this seems a little redundant. Perhaps your clause in the preamble should be integrated into your definition: "'medical device' is defined as a technical instrument used to diagnose, prevent or treat a malady" etc. May need further clarification, to prevent the inclusion of items like centrifuges, autoclaves, chromatographs, etc., in medical test laboratories, which assist in diagnosis.

"I'm not sure what the most honorable vice-admiral's intentions are, but devices used for diagnosis are typically included under the umbrella of 'medical devices.' I see no reason why devices use to assist in diagnosis shouldn't be included, either. Regarding the definition, how's this: 'medical device is defined as a technical instrument used in the diagnosis, prevention, mitigation, or treatment of disease or similar conditions that acts through a physical effect.' That removes the redundant 'medical purposes' bit."

"This also might be a bit pedantic, but what type of 'standards' do you want the WHA to set in this clause: 'create and maintain a set of universal standards for medical devices?'"

[Ardchoille]

Because this is a new category and this proposal may become a reference, step-by-step explanations of your thinking on why you included or excluded stuff would be helpful, even if it's only one word changed. I'll do the same, as needed.

I've just made the following change in the description of the Biotethics sub-category (because I was checking to see if the draft met the category requirements):

I say it's the free individual's civil rights freedoms being chipped away by the nanny state!

[The Dark Star Republic]

OOC: Putting it in Bioethics is at this stage fairly notional - you can see from this thread just how hard making any sort of progress on the actual substance of a proposal is. Articles 2 and 3 are meant to be the justification, as they impose regulations on medical practices: medical practitioners have to use, by implication, only approved devices, rather than just anything. The regulatory aspect means there has to be some Healthcare spending, and for that reason I preferred Bioethics to Moral Decency (which could apply to the restrictions, but not the health spending).

[Ardchoille]

Thanks, that's exactly the sort of commentary I was looking for.

[Bears Armed]

OOC: Would the WHA's authority extend only to those items that are actually being sold/issued specifically for use within the nation concerned as medical devices, or would it also cover any devices of types that are used for medical purposes in some other nations but that are only used for some alternative purpose instead in the nation where they're being sold/issued?

[The Dark Star Republic]

(bump)

OOC: Would the WHA's authority extend only to those items that are actually being sold/issued specifically for use within the nation concerned as medical devices, or would it also cover any devices of types that are used for medical purposes in some other nations but that are only used for some alternative purpose instead in the nation where they're being sold/issued?

OOC: The WHA doesn't really have any authority in this resolution. It is still up to the nations to decide whether to implement the WHA's list of standards; the only mandatory element is that they have to permit legitimate and prohibit illegitimate use of the WHA marking. So, I'm not sure how to answer. If the device were being sold for some alternate reason, then I doubt anyone would care whether or not it had a WHA-approved marking.

[Bears Armed]

Fair enough. I somehow missed the fact that use of the standards wasn't actually required. Oops!
No further questions, yet.

[Mesogiria]

Question?

3. All nations shall maintain a licensing authority with responsibility for ensuring such standards are met, or where multiple such licensing authorities operate within their jurisdiction shall maintain a single point of contact for liaison with them;

Under this wording, would 'maintain' allow a nation to utilize a private, non-governmental entity or entities as the "licensing authority"?

OOC: I am thinking of how Underwriters Laboratories is approved by OSHA in the United States to conduct safety testing, but is a private not-for-profit company.

[The Dark Star Republic]

Question?

3. All nations shall maintain a licensing authority with responsibility for ensuring such standards are met, or where multiple such licensing authorities operate within their jurisdiction shall maintain a single point of contact for liaison with them;

Under this wording, would 'maintain' allow a nation to utilize a private, non-governmental entity or entities as the "licensing authority"?

"Yes, I can't see any reason why not. How a nation meets the requirements of a resolution is up to that nation. If a nation grants private non-governmental/quasi-non-governmental authorities the right to act as a licensing agency, that's up to that nation."

~ Daisy Chinmusic
Legislative Intern to the Dark Star WA Office

[The Dark Star Republic]

(bump)

[The Dark Star Republic]

(Bump?)

[The Dark Star Republic]

There really hasn't been very much progress on this at all. This is one of those moments where I really wish players were less snooty about not drafting on the forums, so I could just go ahead and write it myself; otherwise, I'm really not sure what to do. Bump, I guess.

[The Dark Star Republic]

As there hasn't been enough comment, but equally there clearly isn't going to be any more comment, I guess this has to be abandoned.