Talk:Medical device

Wiki Education Foundation-supported course assignment
This article was the subject of a Wiki Education Foundation-supported course assignment, between 4 October 2021 and 9 December 2021. Further details are available on the course page. Student editor(s): Tzc0725.

Above undated message substituted from Template:Dashboard.wikiedu.org assignment by PrimeBOT (talk) 03:45, 17 January 2022 (UTC)

Where's Canada's medical devices???
I know Canada only has 1/10th the population of the United States of America, but usually I can depend on Wikipedia having information for us too. Usually we're included as a footnote after USA. I am surprised I could not find a single reference to the word Canada (or even North America) in the entire article. I came here looking for some information what is considered a medical device. For myself I'm seeking this definition for tax purposes, I want to see for what reason the government doesn't accept weights (used for exercise) as medical devices (which logically help you live longer, stronger, healthier). As many adjectives as I can use though, it doesn't matter I'm sure they'll still decline it if I submit that... Well maybe I'm not sure that's why I'm looking. Nastajus (talk) 18:27, 20 December 2007 (UTC)


 * Canada is now included in the discussion throughout this article. I will look into adding additional information.  Japan should also be added to the discussion (see below).Utahabl (talk) 03:10, 15 March 2019 (UTC)

Medical Devices and Technological Security Issues
I would like to add a paragraph about the risk of these devices being hacked.Cableknitpower (talk) 21:57, 28 October 2011 (UTC)


 * great idea, I've also added additional information on the topic.Utahabl (talk) 03:10, 15 March 2019 (UTC)

Medical devices vs. equipment vs. supplies vs. products
I would like to see a brief general discussion of the different broad terms commonly used for medical devices / equipment / supplies / products, etc., with an explanation of how they overlap and differ, a few good examples that illustrate the differences between these terms.Thomas.Hedden (talk) 16:16, 22 October 2008 (UTC)

Thomas: Only medical device is an official legally-defined term. The other words you list have dictionary definitions. I do not think any special discussion is necessary. --Zeamays (talk) 04:09, 3 April 2009 (UTC)
 * I agree with Thomas that it is worth it, coudl it be just to advise the layman that " Only medical device is an official legally-defined term"...--MarmotteiNoZ 06:53, 2 May 2012 (UTC)

Raise this issue again....
Since there is no academic publishing standard for me to track which is similar to ISO 13485, the sections of Academic resources and Industrial resources are only of my preferences. Welcome others to edit them to reach a consensus--222.67.216.32 (talk) 06:01, 10 April 2009 (UTC)
 * You might take a look at WP:AJ and ask for help on the talk page...not sure if it's what you're looking for. If not, you could also post a request at WP:RSN. Flowanda | Talk 02:37, 11 April 2009 (UTC)

It's interesting....
I'm interesting to know when ISO is doing tracking of my google search, as the return results are very different with the time within a day and the later result will always suit my needs and taste. Thanks ISO to treat me as a VIP, hey ~__^.--222.67.216.32 (talk) 09:53, 10 April 2009 (UTC)

Will this site (Wikipedia) be closed off according to .....
This guidance? ~__^

http://www.fda.gov/oc/op/goodreprint.html --222.67.202.23 (talk) 07:57, 26 April 2009 (UTC)

If so, wiki admin please provide us a backup site for downloading the articles generated by this site —Preceding unsigned comment added by 222.67.202.23 (talk) 08:00, 26 April 2009 (UTC)

Ansiscope
I removed the Ansiscope reference in the Class lists of devices as that is a brand-name of a device; not a type of device. [ref]http://www.dyansys.com/portable_ansiscope.php[/ref] 63.211.227.66 (talk) 15:54, 15 October 2009 (UTC)

what is medical instruments? —Preceding unsigned comment added by 218.208.91.248 (talk) 11:49, 19 November 2009 (UTC)

Related discussion at Electronic medical record
I've started a discussion at the electronic medical record page; please participate in the discussion there as the links being added here seem to be related and we can keep the discussion together. Thanks! Flowanda | Talk 20:55, 18 April 2010 (UTC)
 * As there has been no legitimate discussion or explanation about the dozens of edits adding multiple links to google search result pages, I am removing them here and elsewhere. Flowanda | Talk 11:04, 11 May 2010 (UTC)

https://en.wikipedia.org/wiki/Medical_device?wprov=sfla1 172.58.222.130 (talk) 14:38, 8 November 2021 (UTC)

Proposed restructuration of the article
If nobody reject this idea here, I intent to: Please comment --MarmotteiNoZ 07:13, 2 May 2012 (UTC)
 * Add an introductory section about the fact that medical devices are regulated in most if not all countries. I would reuse some of the contents which are now in the "Standardization and regulatory concerns" section
 * Merge together the Radio-frequency identification and Medical devices and technological security issues sections
 * remove the "Standardization and regulatory concerns" section which I believe contains too much anectodical contents


 * Sounds like a great idea. I have interest in the topic but sadly very little time at present. Looking forward to seeing your work; this article is in sore need of good content, formatting and sources. Wafflephile (talk) 16:50, 3 May 2012 (UTC)


 * I know this comment was a long time ago, sorry I'm late to the party. I'm good with that though, let me know if you would like me to help with the new structure.Utahabl (talk) 03:10, 15 March 2019 (UTC)

Source that might be useful on RFI
This source might be useful for improving this article - RADIOFREQUENCY INTERFERENCE WITH MEDICAL DEVICES http://ewh.ieee.org/soc/embs/comar/interfer.htm Has links to other sources in academic literature. 64.40.54.91 (talk) 06:50, 21 November 2012 (UTC)

RFI overkill?
Is there some reason for the inordinate amount of information about RFI in this article? Was this a notable advance in medical devices? It seems as though this information could be more usefully placed somewhere else such as in medical informatics. Any thoughts?Desoto10 (talk) 05:33, 6 February 2013 (UTC)


 * Hi! Thanks for your edits so far. In the RFI section, most likely an editor contributed what he/she could based on a single, limited source. I believe the content does belong in this article, but could use a bit of improvement: better sourcing if possible, less advice, more encyclopedic info, less verbosity, etc. Could possibly be merged with Medical device. Wafflephile (talk) 18:08, 7 February 2013 (UTC)


 * Hello Wafflephile, The first section on implantable RF devices is a word-for-word copy of the ref 14 (wtnews).  I assume that is a copyright violation, but, in any case, would like to trim it down to a couple of sentences.Desoto10 (talk) 06:04, 9 February 2013 (UTC)


 * Good catch! It is indeed a blatant case of copyright violation. For now I'll remove the entire section in anticipation of your edits. Wafflephile (talk) 18:11, 12 February 2013 (UTC)

Merger of Medical equipment here
I propose we merge (or simply redirect) the already weak and insubstantial Medical equipment article to here. Reasoning:

1. See the initial discussion of the differentiation of "medical device" from "medical equipment," etc. earlier in 2008 on this talk page. Medical device is the legal term.

2. The FDA defines a "medical device" as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is ... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals." The examples currently listed in "Medical equipment" would handily fit into this definition. Externally, this topic has been discussed on other venues such as Quoara. Lostraven (talk) 21:16, 22 February 2016 (UTC)


 * ✅The article is tiny and scatter all over the wiki, should be nice to seem more effective way to use the space. --- by phoenix --180.17.195.64 (talk) 08:03, 25 April 2016 (UTC)

medical technology equipments and service
Advanced equipment technology Wunderbar mte (talk) 17:19, 15 December 2017 (UTC)

2018 reform discussions
Just added a bit on the 2018 buzz. I'm surprised that this hadn't been mentioned yet. The Bleeding Edge also seems to be driving some conversations around policy change, but wasn't sure how to capture that so I omitted it for now. II | (t - c) 23:02, 8 December 2018 (UTC)

Japan
There's no mention of Japan in the article even though they are a market leader. I'll be adding that.Utahabl (talk) 21:03, 14 March 2019 (UTC)

Construction
Hi all, I would like to put this article "under construction" with the goal of improving the article grade by the related WikiProjects. Any thoughts? Utahabl (talk) 04:45, 15 March 2019 (UTC)

Cybersecurity
There is quite deep detail on cybersecurity as the article stands right now, would anyone be opposed to moving the majority of the text to the Medical software article and citing that as the main article under this article's cybersecurity heading? Utahabl (talk) 19:44, 16 March 2019 (UTC)

Technology vs Equipment
I think the decision to merge (redirect) Medical technology and Medical equipment is incorrect. Technology has far broader meaning than equipment. How does one now add thecnology issues to the list of equipment page? How to unmerge this? Does anybody know? I am inexperienced wikipedian.

Suggested Definition
All physical items used in the diagnosis, treatment, prevention or monitoring of a person can be described as medical devices. However, the term equipment usually is taken to be for powered, reusable, items requiring maintenance, calibration and occasionally repair. This tends to distinguish between items for single patient use and items that can be reused.

Durable
It is surprising there is not discussion of "Durable" Medical Equipment. It is a term probably familiar to many patients.--Poodleboy 19:43, 25 April 2006 (UTC)

Artificial Limbs
I just updated the article on artificial limbs and was hoping to get some feedback on the article. This is my first article I've written for wikipedia, so any help would be appreciated. Thanks: Nfk17 02:38, 21 February 2007 (UTC)

Good decision on the move / merge
Hi...coming back after a long time to check on a few articles, especially Medical instruments and implants. Great to know its still being looked after. The subsections need some expansion / correction. Can someone please fix the general template of these pages?

P.s. Good decision on the move / merge Sarindam7 17:07, 21 May 2011 (UTC)

Just added the Medical instruments and implants template / navigation box. It links to this page from its header link. Plus, it should be useful. Inputs? Sarindam7 18:31, 9 September 2012 (UTC)

Artificial Intelligence
Dear community. I am new to Wikipedia and I recently added the section "Artificial Intelligence" to the medical device article. After some feedback, I quickly learned how to improve my edits and proposed a revised a short paragraph that highlights the actual state of the discussion regarding artificial intelligence in the field of medical devices:

In recent years, there has been a surge of interest in artificial intelligence and machine learning (AI/ML)-based medical devices. A study by Benjamens et al. detected 64 AI/ML medical devices approved by the FDA between 2010 and 2020. . Between 2015 and 2020 a study by Muehlematter et al. detected 222 AI/ML-based medical devices approved by the FDA and 240 CE-marked AI/ML-based medical devices in Europe and a study by Wu et al. identified 130 FDA approved AI/ML-based medical devices. . This difference in reported number of AI/ML meidcal devices might be explained by different definition of AI/ML and different search strategies. Despite differences in number of identified AI/ML medical devices, studies agree that number of approved AI/ML-based medical device increased over the past years and that most of them focus upon Radiology. Currently, there is no specific regulatory pathway for AI/ML-based medical devices in the USA or Europe, despite reported limitations of the actual practice. . However, regulation of AI/ML-based medical devices is changing: in January 2021, the FDA published an “Artificial Intelligence and Machine Learning (AI/ML) Software as a Medical Device Action Plan” as a direct response to feedback to a proposed regulatory framework regarding AI/ML-based software as a medical device. . The EU Medical Device Regulation replacing the EU Medical Device Directive as of May 26, 2021 defines strict regulatory requirements for medical devices, including AI/ML software.
 * Specific text to be added:

Muhur (talk) 21:11, 12 April 2021 (UTC)
 * Reason for the change: see below, and also here
 * References supporting change:

Problem MrOllie undid most of my revision. Unfortunately, many questions regarding the reasoning remained open/unclear in this discussion.

Solution The Wikipedia help recommended to start a discussion here to see if getting more eyes on the problem leads to a solution.

Question: What is your opinion on the proposed paragraph above? Thank you for your opinions/contributions. Muhur (talk) 19:14, 11 April 2021 (UTC)
 * , You forgot to summarize your COI. MrOllie (talk) 19:49, 11 April 2021 (UTC)

My statement regarding COI can be found here.Muhur (talk) 20:08, 11 April 2021 (UTC)

MrOllie, you forgot to state your COI here, i moved it here. Muhur (talk) 19:59, 11 April 2021 (UTC) Unfortunately, people responded to this question with mockery. Muhur (talk) 21:24, 12 April 2021 (UTC)

MrOllie it would help the community if you found time to answer the open questions regarding your statements here.Muhur (talk) 20:08, 11 April 2021 (UTC)
 * , I prefer not to answer questions when they are served with a side of personal attacks. MrOllie (talk) 20:10, 11 April 2021 (UTC)

Please see my statement here. I could also argue that some of MrOllie's statements are personal attacks. However, I assume good faith and I think everything else will not help to resolve this issue. We should focus on the content. The content is interessting. Thank you. — Preceding unsigned comment added by Muhur (talk • contribs)


 * The content is a wordy tautology. We do not need a section that boils down to 'AI based devices are approved the same way anything else is', especially not one what over emphasizes primary sources because a COI editor would like them to be references. I'll leave the requested edit unanswered so another editor can weight in, though. - MrOllie (talk) 21:22, 12 April 2021 (UTC)

Thank you. It would help if you speficy the tautology you mentioned. The section boils down to informing people about current discussion regarding regulation of AI/ML-based devices that is supported by cited review articles from major medical journals (chronologically in a neutral encyclopedic way and without promoting particular research) and medical organisations. If editors think that this section is too wordy, I very well appreciate constructive inputs and changes. Muhur (talk) 21:56, 12 April 2021 (UTC)

Copyedit
Muhur, welcome to the English-language Wikipedia. I believe that, in the spirit of an encyclopedia being a concise summary of information, a more normal way to write this information might look a bit more like this: The number of approved medical devices using artificial intelligence or machine learning (AI/ML) is increasing. , there were several hundred AI/ML medical devices approved by the US FDA or CE-marked devices in Europe. Most AI/ML devices focus upon radiology. , there was no specific regulatory pathway for AI/ML-based medical devices in the US or Europe. However, in January 2021, the FDA published a proposed regulatory framework for AI/ML-based software, and the EU medical device regulation, which replaces the EU Medical Device Directive in May 2021, defines regulatory requirements for medical devices, including AI/ML software. I've kept all of your refs (the same numbers as the ones above, even though none of it shows in the list here), but it's less than half as many words. Did I get anything factually wrong here? WhatamIdoing (talk) 01:50, 13 April 2021 (UTC)

Dear WhatamIdoing. Thank you for your copyedit, you got it right. Thank you also for your kind advice regarding style, I very appreciate this. I think I would not have ended up at this point, if I ran into a patient editor at the first time. What is the way forward regarding the copyedit you made? Thank you. Muhur (talk) 09:15, 13 April 2021 (UTC)Muhur (talk) 02:05, 13 April 2021 (UTC)


 * ✅ WhatamIdoing (talk) 17:16, 11 May 2021 (UTC)

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