• Risks Digest 32.33 (2/2)

    From RISKS List Owner@21:1/5 to All on Sun Oct 25 00:59:11 2020
    [continued from previous message]

    linked to the TPLC Patient Problem tabulations are extracted from FDAs MAUDE platform. Refer to the MAUDE page for significant disclaimers about MDRs @ https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm.

    An MDR can be filed for a benign reasons: a chipped knob, worn package
    label, or blurred device marking, etc. MDRs usually originate from patient-device interactions that may result for an EVENT TYPE: Injury, Malfunction, or Death. An EVENT TYPE for "Other" is allocated for device
    EVENT TYPE that neither cause injury or death or from malfunction. MAUDE
    also sponsors an EVENT TYPE for "No Answer Provided" category.

    For example, https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/results.cfm?start_search=1&searchyear=&productcode=MCM&productproblem=2993&devicename=&knumber=k&pmanumber=p&manufacturer=&brandname=&eventtype=&reportdatefrom=01/1/2015&reportdateto=&pagenum=10
    gives an TPLC URL that says "Adverse Event Without Identified Device or Use Problem (2993)." Accessing that link shows all (up to 500) contributing
    MAUDE MDRs to the TPLC device problem category.

    What did the patient experience with this device to merit an MDR submission? For an example, see https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=10609891&pc=MCM.
    Observe this MDR text: Patient Problem Therapeutic Response, Decreased
    (2271), and then read the Event Type (Malfunction) and Event Description.

    MDRs are often, but not exclusively, written by manufacturer representatives consulting with the physician who performed the implant procedure and/or reported the patient event. MDR content can be challenging to interpret: significant medical and device subject matter expertise are often required.

    Consider a consumer who might become a patient/device recipient. Before surgery, they may desire to know which device will likely yield the best outcome, and satisfy their quality of life expectations.

    How can a consumer make a good choice, other than considering the price tag
    of the device implant, procedure expense, convalescent period, etc. if they can't understand what the device has or hasn't achieved based on historical outcomes? There's no "Consumer Reports" article to study on cochlear or bone conduction implants.

    One wonders if physicians read, or are required to read, the historical
    MAUDE MDRs before deciding on what device to consider. What motivates their device selection? What weight do physicians allocate to device track record?

    https://www.nidcd.nih.gov/health/statistics/hearing-charts-tables#hearing-aids-adults
    reveals several charts on hearing impairment by population segments: loss of hearing in adults by age and gender, cochlear implants by 1,000 population
    and age, etc.

    Using https://www.healthypeople.gov/2020/data/Chart/4410?category=1&by=Total&fips=-1, for people aged 70+ in the calendar year 2013, the rate of cochlear implant
    per 1,000 population is 323. That's ~32% of that cohort.

    The US Census 2019 estimated total for persons aged 70-85+ years is
    35.431M: https://www2.census.gov/programs-surveys/demo/tables/age-and-sex/2019/age-sex-composition/2019gender_table1.xlsx

    The estimated number of cochlear implants in this cohort, using 2013 NIH implant data, is 0.323*35.431M ~= 11.44M.

    SUMMARY

    The tabulations indicate, given the comparatively low device problem report
    and MDR densities in light of eligible recipient population, that the
    devices in these product codes appear broadly successful.

    Recipients that experience an unfortunate device problem may require
    additional medical care to ameliorate these unfortunate outcomes. It is
    these untoward and often unexpected events, though proportionately rare,
    which device suppliers must minimize to reduce frequency.

    DEVICE PROBLEM AND PATIENT PROBLEM TABULATIONS

    For product code MCM, from 01JAN2015 to 30SEP2020 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=1694&min_report_year=2015,
    the Top-10 TPLC Device Problems (in CSV format):

    Device Problems,MDRs with this Device Problem,Events in those MDRs
    Appropriate Term/Code Not Available,5444,5444
    Device Operates Differently Than Expected,3297,3297
    Output Problem,2264,2264
    Adverse Event Without Identified Device or Use Problem,1530,1530
    Receiver Stimulator Unit,1255,1255
    No Device Output,1220,1220
    Insufficient Information,1083,1083
    Migration or Expulsion of Device,745,745
    Electrode,731,731
    Migration,510,510

    The same report yields medical device reports (MDR) originating with
    patients. Here's the Top-10:

    Patient Problems,MDRs with this Patient Problem,Events in those MDRs
    Failure of Implant,4495,4495
    No Code Available,2830,2830
    Hearing Impairment,2660,2660
    No Known Impact Or Consequence To Patient,1496,1496
    Unspecified Infection,1319,1319
    Pain,1252,1252
    No Information,1031,1031
    Patient Problem/Medical Problem,668,668
    Bacterial Infection,666,666
    Deafness,543,543

    For product code MCM, from 01JAN2015 to 30SEP2020 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=1640&min_report_year=2015,
    the Top-10 TPLC Device Problems (in CSV format):

    Device Problems,MDRs with this Device Problem,Events in those MDRs
    Appropriate Term/Code Not Available,1593,1593
    Loss of Osseointegration,434,434
    Failure to Osseointegrate,394,394
    Adverse Event Without Identified Device or Use Problem,274,274
    Insufficient Information,39,39
    Osseointegration Problem,17,17
    Extrusion,9,9
    Patient-Device Incompatibility,7,7
    Biocompatibility,6,6
    Loosening of Implant Not Related to Bone-Ingrowth,6,6

    The same report yields medical device reports (MDR) originating with
    patients. Here's the Top-10:

    Patient Problems,MDRs with this Patient Problem,Events in those MDRs Unspecified Infection,525,525
    No Code Available,522,522
    Host-Tissue Reaction,399,399
    Bacterial Infection,382,382
    Inadequate Osseointegration,373,373
    Patient Problem/Medical Problem,309,309
    Pain,206,206
    Head Injury,71,71
    Inflammation,64,64
    Skin Irritation,55,55
    Swelling,53,53

    For product code LXB, from 01JAN2015 to 30SEP2020 https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTPLC/tplc.cfm?id=1635&min_report_year=2015,
    the Top-10 TPLC Device Problems (in CSV format):

    Device Problems,MDRs with this Device Problem,Events in those MDRs
    Appropriate Term/Code Not Available,2157,2157
    Loss of Osseointegration,505,505
    Adverse Event Without Identified Device or Use Problem,185,185
    Insufficient Information,124,124
    Failure to Osseointegrate,34,34
    Magnet,31,31
    Patient Device Interaction Problem,22,22
    Biocompatibility,20,20
    Extrusion,17,17
    Patient-Device Incompatibility,17,17
    Osseointegration Problem,10,10

    The same report yields medical device reports (MDR) originating with
    patients. Here's the Top-10:

    Patient Problems,MDRs with this Patient Problem,Events in those MDRs
    No Code Available,671,671
    Unspecified Infection,458,458
    Bacterial Infection,455,455
    No Information,371,371
    Patient Problem/Medical Problem,359,359
    Pain,304,304
    Host-Tissue Reaction,240,240
    Hearing Impairment,104,104
    Swelling,75,75
    Head Injury,65,65

    ------------------------------

    Date: Fri, 16 Oct 2020 14:59:16 -0400
    From: Gabe Goldberg <gabe@gabegold.com>
    Subject: 'E.T.' 1982 Atari Game: The True Story Behind the Worst Video Game
    Ever (MelMagazine)x

    Atari's 1982 E.T. game was so disastrous it's been blamed for the company's downfall and the crash of the entire industry. The man responsible for the game, however, has taken it surprisingly well. [...]

    Warshaw agrees that the pits were a problem he didn't foresee.
    Unfortunately, he was in such a rush to finish the game he never got to the *first playable* stage, which is when a game is tested by users to work out
    any design kinks and flaws.

    https://melmagazine.com/en-us/story/et-1982-atari-game

    What could go wrong with toxic compressed schedule without time for testing?

    ------------------------------

    Date: Fri, 16 Oct 2020 10:47:57 +0800
    From: Richard Stein <rmstein@ieee.org>
    Subject: Re: Fifth of countries at risk of ecosystem collapse (RISKS-32.32)

    With ecosystems at risk globally, economies will also experience knock-on effects.

    Corbin Hiar, Natural Disasters May Push Global Finances to the Brink,
    concisely summarizes anthropogenic climate forcing impact on sovereign economies. https://www.scientificamerican.com/article/natural-disasters-may-push-global-finances-to-the-brink/

    See "Climate Change and Sovereign Risk": https://www.eenews.net/assets/2020/10/13/document_cw_01.pdf for details.

    ------------------------------

    Date: Fri, 16 Oct 2020 09:52:34 +0100
    From: Wols Lists <antlists@youngman.org.uk>
    Subject: Re: Why cars are more "fragile": more technology has reduced
    robustness (Drewe, RISKS-32.32)

    aiui, UK law defines a "historic vehicle" as one over 25 years old (it was originally one made before a certain date, but that was never updated as the years went by).

    That explains the surge in old vehicles on UK roads, as these cars are
    exempt from tax, they're now exempt from the MOT, and I believe they are
    also exempt from the congestion charge and low emission zones.

    ------------------------------

    Date: Fri, 16 Oct 2020 13:16:09 +0100 (BST)
    From: David Alexander <davidalexander440@btinternet.com>
    Subject: Re: SpaceX Is Building a Military Rocket to Ship Weapons
    Anywhere in the World in 1 hour (RISKS-32.32)

    The SpaceX initiative to build a rocket to deliver good anywhere in the
    world in less than an hour is not a novel idea.

    In January 1956 the (UK) BBC radio comedy The Goons had a show on this very subject, called the Jet-propelled NAAFI <https://www.youtube.com/watch?v=tmCZ9BIeX5c>

    ------------------------------

    Date: Fri, 16 Oct 2020 21:10:04 +0200
    From: Erling Kristiansen <erling.kristiansen@xs4all.nl>
    Subject: Re: SpaceX Is Building a Military Rocket to Ship Weapons Anywhere
    in the World, in 1 hour (RISKS-32.32)

    The distance from the launch site to its antipode (the point on the Earth exactly opposite) is roughly 20,000 km or 12,500 miles. At 7,500 mph that
    will take 1 hour 40 minutes. And you have to add the extra time spent in the acceleration and deceleration phases where the speed is a lot lower. So something like 2 1/2 to 3 hours is probably about the best one can dream of doing.

    And what about the time to fuel the rocket and prepare it for launch?
    Typically takes days if everything goes smoothly.

    ------------------------------

    Date: 16 Oct 2020 13:40:42 -0400
    From: "John Levine" <johnl@iecc.com>
    Subject: Re: A different way the news is dividing America (Stein, RISKS-31.32)

    While it is absolutely true that we have a crisis in the news business,
    calling it "redlining" is gratuitous and pretty offensive.

    Actual redlining was a policy of not selling real estate to minorities, regardless of their income or ability to pay. Newspaper web sites don't
    charge because they want to keep poor people out, they charge because print advertising has collapsed, online advertising pays very little*, and they
    have to pay the reporters and keep the lights on. As I'm sure we all
    remember, they tried free web sites with online ads and it didn't
    work. Where is all this high quality free news supposed to come from?

    For a much better analysis, see "Ghosting the News: Local Journalism and the Crisis of American Democracy" by Margaret Sullivan, published in August by Columbia Global Reports. She looks primarily at the growing local news
    deserts and the not great options for fixing them.

    https://globalreports.columbia.edu/books/ghosting-the-news/

    * -- unless you are gatekeeper Google or Facebook.

    ------------------------------

    Date: Sun, 18 Oct 2020 11:29:59 +0800
    From: Richard Stein <rmstein@ieee.org>
    Subject: Re: A different way the news is dividing America (Levine,
    RISKS-32.32)

    John -- Thank you for a civil critique and rebuttal. It was not my intent to promote offense.

    What word might best encapsulate societal division based on preference to consume freely available, misleading and false news reports versus those who purchase professionally authored, edited, and published news reports? Infolining? No such word exists.

    The definition of redlining @
    https://www.merriam-webster.com/legal/redlining states, "the illegal
    practice of refusing to offer credit or insurance in a particular community
    on a discriminatory basis (as because of the race or ethnicity of its residents)." The definition does not incorporate poverty or encompass affordable access to information or news.

    As you note, government policies/regulations have promoted business
    redlining policies and practices, an immoral betrayal of the democratic idea that "all men are created equal." See https://www.nytimes.com/2020/01/20/opinion/fair-housing-act-trump.html, for
    a historical perspective.

    Choosing to believe that fictional news stories are real and merit re-circulation confounds explanation. A captive audience that endorses falsehoods and conspiracy theories characterizes the allure and
    effectiveness of weaponized free speech. https://www.nytimes.com/2020/10/13/magazine/free-speech.html

    I certainly agree that professional news writing, editing, and reporting requires revenue that funds deserving publication businesses. The access
    price to premium factual information is exclusionary: disposable income is needed to procure this modest, daily essential.

    Viable reporting holds governments accountable, and promotes economy development, public health, education, civil discourse, and enriches culture
    -- all subjects of historical and immediate social merit.

    "News is the first rough draft of history" per Philip Graham (https://www.forbes.com/quotes/7446/). Mr. Graham's quote applies to factual and meretricious news, not the pink stuff.

    ------------------------------

    Date: 18 Oct 2020 11:31:25 -0400
    From: "John R. Levine" <johnl@iecc.com>
    Subject: Re: A different way the news is dividing America (RISKS-32.32)

    Infolining? No such word exists. ...

    The phrase people use is "news desert" but that is more for places with no newspapers at all, not ones that people can't afford. It's news as luxury good, not the snappiest of terms.

    But that's not at issue -- what I object to is the misuse of the term redlining, and the author's airy assertion that if the greedy capitalists
    would just tear down the paywalls everything would be fine. The particular evil of redlining was that it was pure bigotry with no economic rationale -- real estate agents sell property and banks make loans the same way they
    always had, only now to the full set of buyers rather than just to one race. This is nothing like that.

    For several centuries the news business had an economic model where
    advertisers paid to have their messages included with the news, first in newspapers, then magazines, then radio, then TV. This let the publishers provide the news below cost, for a few cents for newspapers and free for
    radio and TV. The Internet totally destroyed that economic model. The
    costs of distribution dropped and are shared with consumers, which allowed competing marketplaces to handle ads for cheap, or as at Craigslist mostly
    for free. Advertising revenue isn't going back to newsrooms, reporters have
    to eat, and saying everyone should have a pony doesn't help.

    [PS: Insert obvious snark here about an academic who never had to worry about
    where his next paycheck was coming from.]

    ------------------------------

    Date: Fri, 23 Oct 2020 16:35:45 +0000 (UTC)
    From: Steve Bacher <sebmb1@verizon.net>
    Subject: Re: A different way the news is dividing America (RISKS-32.32)

    This article seems somewhat specious to me. If putting the content of some news sources behind a paywall constitutes creating an "information have"
    vs. "information have-not" class system, then in the pre-Internet world
    where people had to actually purchase papers, was there a divide between
    those who could afford the handful of change for the day's news vs. those
    who couldn't? Or between those who went to the trouble of subscribing and those who just dug into their pockets each day?

    And FWIW, there are numerous ways to access content from most of those
    online journalistic sites while bypassing the paywalls.

    ------------------------------

    Date: Mon, 19 Oct 2020 09:18:40 +0800
    From: Richard Stein <rmstein@ieee.org>
    Subject: Re: Continuous glucose monitoring/insulin dosing systems
    (RISKS-32.32)

    FOLLOW UP FROM ADA

    I received this email message in response to my inquiry on glucose monitoring/insulin dosing device deployment from a representative of the American Diabetes Association:

    "Hi Richard;

    "I assume you mean traditional insulin pumps and CGMs, not implantable.
    There are no implanted pumps on the market, and just one CGM that's
    implanted subcutaneously, with what I assume is a very small share of the
    market.

    "Regardless, unfortunately, ADA doesn't have any data other than what one
    can find by googling for the results. The companies are guarded with their
    sales and usage data, and what I find online is both speculative and
    dated. I wish I could give a more substantive answer--this is a question I
    get a lot and I never have a very good answer."

    Matt Petersen
    Vice President, Medical Information and Professional Engagement
    2451 Crystal Dr. | Arlington | VA | 22202
    Phone: +1 (703) 299-2071
    diabetes.org
    1-800-DIABETES (800-342-2383)

    ------------------------------

    Date: Mon, 1 Aug 2020 11:11:11 -0800
    From: RISKS-request@csl.sri.com
    Subject: Abridged info on RISKS (comp.risks)

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    End of RISKS-FORUM Digest 32.33
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