[Meh] Medical Device Regulations

[The Dark Star Republic]

Medical Device Regulations
Category: Health | Area of Effect: Bioethics(?)

Description: The World Assembly,

Aware that medical devices are commonly used in medicine to diagnose, prevent and treat medical conditions,

Recognising that WA Resolution #82, "Universal Clinical Trials Act", has previously addressed clinical trials of drugs to ensure universal standards,

Believing that creating a universal standard for efficacy of medical devices will create a significant incentive to conform with such standards,

Seeking to remain respectful of national jurisdiction in medical matters,

Declares:

1. For the purposes of this Resolution, "medical device" is defined as a technical instrument used for medical purposes that acts through a physical effect;
2. All nations shall enact and enforce minimum standards of safety, functionality and cleanliness for all medical devices produced, sold or used within their jurisdiction;
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;
4. The World Health Authority shall:
   
   • create and maintain a set of universal standards for medical devices,
   • create a single universal marking signifying compliance with such standards,
   • monitor ongoing developments in the field of development of medical devices to keep such standards relevant and updated,
   • coordinate and facilitate research and innovation in the field of development of medical devices;
5. All nations shall authorise use of the single universal marking on medical devices complying with the necessary standards, and similarly prohibit false or unauthorised use of the single universal marking and enforce this restriction through legal means, within their jurisdiction;
6. Nothing in this Resolution affects each nation's sovereign right to determine the legality of specific medical devices or of their application within their jurisdiction.

"Very rough draft, but given the great importance placed on presenting drafts before the Assembly we're obviously extremely confident of gaining useful feedback - otherwise doing so would be rather pointless, haha!"

~ Vice-Colonel Truculent Bilgewater
Ambassador to the WA

[Bears Armed]

"Believing that the use of unsuitable medical devices potentially poses an extreme hazard to national populations"?

[Louisistan]

"Believing that the use of unsuitable medical devices potentially poses an extreme hazard to national populations"?

Indeed. Glad to see this is slowly catching on!

[The Dark Star Republic]

"Believing that the use of unsuitable medical devices potentially poses an extreme hazard to national populations"?

Indeed. Glad to see this is slowly catching on!

OOC: I'm not sure why you think it's "catching on" when it's been absolutely explicitly ruled that such language is not necessary.

As to whether the preamble as written meets the standards of NEF I couldn't guess, as that ruling is too subjective, but if it's ruled not to I'll just go to thesaurus.com and throw in random adjectives until it does.

[Araraukar]

Recognising that WA Resolution #82, "Universal Clincial Trials Act", has previously addressed clinical trials of drugs to ensure universal standards,

...am I missing something on how this wouldn't count as HoC violation?

[The Dark Star Republic]

Recognising that WA Resolution #82, "Universal Clincial Trials Act", has previously addressed clinical trials of drugs to ensure universal standards,

...am I missing something on how this wouldn't count as HoC violation?

OOC: How would it? It doesn't "build on" the previous resolution, it just happens to mention it, and one single reference doesn't seem like "excessive back-referencing".

[Separatist Peoples]

...am I missing something on how this wouldn't count as HoC violation?

OOC: How would it? It doesn't "build on" the previous resolution, it just happens to mention it, and one single reference doesn't seem like "excessive back-referencing".

OOC: I remember that being enough to scuttle proposals in the past, as a heads up. I don't have a ruling to that effect, but you know better then anybody how inconsistent rulings are these days. /$.02

[The Dark Star Republic]

OOC: I don't see how that at all reflects the House of Cards rule or how it has been applied in the past, but I was actually posting this proposal in the hope of moving past the dense legality squabbles that have occupied me of late and getting back to talking about policy. My friend came round this morning to watch the cricket and we were talking about the EU mark on her hearing aid, which made me think about whether we had anything similar in the WA. For once, no sinister plans lurking in the background.

[Araraukar]

OOC: For once, no sinister plans lurking in the background.

OOC: That's all fine and dandy, but seeing how mentioning extant resolution works on the Silly/Illegal thread as a clear illegality, I'd be leery of putting it in a not-trying-to-challenge-the-mods-for-once proposal.

[Sciongrad]

OOC: For once, no sinister plans lurking in the background.

OOC: That's all fine and dandy, but seeing how mentioning extant resolution works on the Silly/Illegal thread as a clear illegality, I'd be leery of putting it in a not-trying-to-challenge-the-mods-for-once proposal.

A Proposal must be able to stand on its own even if all referenced Resolutions were struck from existence...

OOC: This seems to indicate that referencing past resolutions is fine as long as the proposal referencing those past resolution can exist independently of those references, which this one does.

[Ardchoille]

A Proposal must be able to stand on its own even if all referenced Resolutions were struck from existence...

OOC: This seems to indicate that referencing past resolutions is fine as long as the proposal referencing those past resolution can exist independently of those references <snip>

That's how I interpret that rule, too.

(Note: it's too early in drafting for mods to be ruling on the proposal text. I'm just clarifying the rule.)

BTW, typo: ... WA Resolution #82, "Universal Clincial Trials Act" ...

[Defwa]

It was my understanding during the bodily integrity act development that references to other resolutions would essentially be gibberish if the target resolution is repealed. As if the text of the resolution never existed

[The Dark Star Republic]

All OOC, again.

OOC: This seems to indicate that referencing past resolutions is fine as long as the proposal referencing those past resolution can exist independently of those references <snip>

That's how I interpret that rule, too.

Me three.

It was my understanding during the bodily integrity act development that references to other resolutions would essentially be gibberish if the target resolution is repealed. As if the text of the resolution never existed

Lol, what? That's the first I've heard of that. Do our Ambassadors receive Men In Black memory wipes every time a repeal passes? Or is it more like 1984, a big incinerator destroying all evidence that Max Barry Day ever existed?

[Araraukar]

OOC: This seems to indicate that referencing past resolutions is fine as long as the proposal referencing those past resolution can exist independently of those references <snip>

That's how I interpret that rule, too.

OOC: Well, that's a new approach, then.

[The Dark Star Republic]

That's how I interpret that rule, too.

OOC: Well, that's a new approach, then.

OOC: Not a new approach. If it's been the case that the House of Cards rule was interpreted as banning literally any mention of a previous resolution, then that was the new approach. That TMGH's concern with the rule was to stop the technical House of Cards issue and excessive back-referencing as a format issue only can be seen from the original discussion of the rule.

Anyway, for now I'll leave the reference in. Any chance, at all, that anyone might be interested in moving on to the substance of the proposal?

[Wrapper]

Anyway, for now I'll leave the reference in. Any chance, at all, that anyone might be interested in moving on to the substance of the proposal?

OOC: Chances are getting better all the time.

IC: Ah, a new proposal, and one that doesn't make the gag reflex engage and the eyes bleed! Let's have a look, shall we?

Aware that medical devices are commonly used in medicine to diagnose, prevent and treat maladies
...
For the purposes of this Resolution, "medical device" is defined as a technical instrument used for medical purposes that acts through a physical effect

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.

All nations shall enact and enforce minimum standards of safety, functionality and cleanliness for all medical devices produced, sold and used within their jurisdiction;

Loophole: The "and" should be an "or". If we produce a device but export it to another nation, it's not "produced, sold, and used within our jurisdiction", yet we should ensure it meets minimum safety standards, yes? Same if we import it. Or donate it instead of selling it. Or if it's produced by the same people who use it, therefore it isn't sold. Or one of our citizens uses it in another jurisdiction via the Licensed Medical Professionals Without Borderlines program. Etc.

Nothing glaring in the rest of it, though we're sure we'll come up with something after we read it a few more times. We shall keep an eye on your progress.

[Honor and Glory]

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.

"Ambassador Wad, as the scope of this proposal is to ensure that devices in medical field are all held to a standard, would it not make sense to included devices like centrifuges, autoclaves. to me, it makes little sense to me to hold a needle used to draw blood is held to high standard to prevent contamination if the devices used to actual test the blood are falling apart or dirty. Your thoughts?"

[Separatist Peoples]

Seeking to remain respectful of national jurisdiction in medical matters,

“Much appreciated!”

For the purposes of this Resolution, "medical device" is defined as a technical instrument used for medical purposes that acts through a physical effect;

“Vague, I know, but I think this should be fleshed out a bit more. Its…well, a Patient History Form would fall under this definition, in a most technical sense. I believe the Wads have tendered a superior option.”

All nations shall enact and enforce minimum standards of safety, functionality and cleanliness for all medical devices produced, sold and used within their jurisdiction;

“I’m a bit torn on this option, Colonel. On one hand, you make a valid point that medical equipment should work and be clean. On the other hand, this ends up including a few facets of medical equipment that would make me, at least, uncomfortable at having international regulation on. I understand, and accept, that we would want functional, clean scalpels, catheters, dialysis machines, medical tricorders, and pacemakers, but this definition would preclude certain tools that wouldn’t necessarily be found in hospitals and medical offices. Snakebite venom extractors, for example, come to mind. Useless fucking things…I digress. I understand the international importance of shipping sub-par medical equipment, and even using dirty equipment domestically, but this clause toes a little bit into the realm of national consumer safety policy. It seems a national issue, rather than international, to determine how much adhesive is insufficient before a band-aid isn’t officially functional any longer.
“Might I suggest splitting this into two clauses, one on the safety,cleanliness and functionality of all international exports and imports of medical equipment, and one on just the safety and cleanliness of those domestic products? Its nitpicky of me, but you did want feedback.”

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;

“A single point of contact being one agency, or one individual? One individual seems insufficient for such a task. Please, correct me if I’m wrong.”

The World Health Authority shall:
create and maintain a set of universal standards for medical devices,
create a single universal marking signifying compliance with such standards,
monitor ongoing developments in the field of develoPment of medical devices to keep such standards relevant and updated,
coordinate and facilitate research and innovation in the field of development of medical devices;

“No complaints here, or in the rest of the text. Minor spelling error addressed. That’s just what comes to mind for now. I’ll let this percolate for a while before coming back with anything else. It’s certainly not offensive. I rather like the concept.”

[Wrapper]

"Ambassador Wad, as the scope of this proposal is to ensure that devices in medical field are all held to a standard, would it not make sense to included devices like centrifuges, autoclaves. to me, it makes little sense to me to hold a needle used to draw blood is held to high standard to prevent contamination if the devices used to actual test the blood are falling apart or dirty. Your thoughts?"

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.

[Bears Armed]

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.

"Ahem!"

[Louisistan]

Deputy Ambassador Roland Schulz: "Well, 'National Economic Freedoms' come to mind. But putting that aside for the moment - be forewarned, we will revisit this - the content per se is fine with us. We are especially pleased that the actual licensing will not be performed b the WA gnomes, but by our own errm... trusted people."

[The Dark Star Republic]

"Thanks for the comments. Minor SPAG updates made.

"On the definition, we definitely agree it could be refined more. The main point is to exclude drugs, to avoid conflict with previous resolutions on the subject. So if 'through a physical interaction with the body' would resolve that without introducing any new problems, then we'll rewrite it.

"On Article 2, it was never the intention to write an absolutely watertight line here. The clause is mainly a process one, to ensure the resolution matches the category and doesn't fall afoul of a committee-only violation. The presence of loopholes is, if anything, intentional.

"On Article 3, we simply want to ensure other nations have a single point of contact. If a producer of medical devices in The Dark Star Republic wants to try selling them in another nation that has multiple different licensing authorities, it could be very confusing - and potentially dangerous. So while having multiple authorities with overlapping jurisdiction may be necessary, there should still be a single centralised point to check that such products would meet the required standards. It's not a big deal, though, if it's considered to be overly intrusive for the WA to meddle with.

"We're also considering adding a clause prohibit knowingly exporting medical devices that do not meet the required standards of the importing nation, but we're not sure if this is necessary."

~ Vice-Colonel Truculent Bilgewater

[Louisistan]

It's not a big deal, though, if it's considered to be overly intrusive for the WA to meddle with.

It is a big deal and it absolutely must stay! There are countries where the authority to license these things is transferred to private corporations or foundations. Having a single point of contact would actually help trading in that aspect!

OOC: RL example of transferring such things would be in Germany, where cars must be checked every two years to ensure they're still safe to use. These checks are (of course) not done by the state (which wouldn't have the know-how), but rather by private corporations such as TÜV or DEKRA which have in turn be licensed by the state to perform these checks.

[Wrapper]

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.

"Ahem!"

**Sigh**. I know, I know. The usual penalty?

Ari hands over two sticks of honey flavored chewing gum.

[Bears Armed]

"Ahem!"

**Sigh**. I know, I know. The usual penalty?

Ari hands over two sticks of honey flavored chewing gum.

"Thank you."