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Category: Legal aspects

CE marking or norm in relation to components for prosthetic arms

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - CE marking or norm in relation to components for prosthetic arms; published December 25, 2018, 15:20; URL: https://www.swisswuff.ch/tech/?p=7749.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - CE marking or norm in relation to components for prosthetic arms}}, month = {December},year = {2018}, url = {https://www.swisswuff.ch/tech/?p=7749}}


CE-marking or norm

The CE-marking establishes that a particular item or product conform to European product law in relation to health, safety, and environmental protection standards [link].

As this text is not public or may be hard to get into the public eye, why not just go ahead and drag it out. I started to be interested by the backgrounds of what our prosthetic limbs and their technical documentation ideally could be already a few years ago [link].  So, a few blog posts here do have a long history, longer than others, and were assembled over quite a period of time.

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Social ranking wins over function for "bionic" hands [this & that]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Social ranking wins over function for "bionic" hands [this & that]; published August 25, 2011, 17:40; URL: https://www.swisswuff.ch/tech/?p=475.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Social ranking wins over function for "bionic" hands [this & that]}}, month = {August},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=475}}


The actual and real performance of "bionic" hands (i.e., simple myoelectric hands that now offer what Becker hands offered since many decades, which is, an adaptive grip) is not anywhere near cool.

  • They are known to break, assumedly at first sight,
  • They suck out batteries within as little as a few hours of usage.
  • They do not offer anything close to a reasonable pinch force.
  • They are more heavy than useful.
  • Recent price estimates for a "bionic" arm range from 60'000 US$ do 120'000 US$.
  • Their marketing sucks up all company funds that would be far better invested in long-term prosthetic function such as better body powered technology. Instead, short lived gadgetry is marketed that is of extremely limited functional and otherwise probably no orthopedic help at all.

One may not even be able open a bag of popcorn and I would suggest it is quite correct to state that one might be at least as disabled with a "bionic" hand than without one - with the difference of all that money gone.

Hints for this being a rather correct assessment are out and about.

  • For example, the actor that demonstrated the Otto bock Michelangelo hand recently here in Zuerich [link] did not at all keep a symmetric posture, nor did he put that anchor to any use, before his show had started - instead he pulled up the shoulder of his amputated arm that had the Otto Bock Michelangelo hand on it, and he grabbed the cables he was about to plug into a computer into his own mouth. All nice and sweet but I can do that without "bionic" arm.
  • It has also been claimed several times now that an iLimb should be very useful to type or to "hold a bottle". For typing, what does count is a good symmetric back, neck and shoulder postur. But it is rather obvious that typing with an iLimb will cause painfully elevated shoulders and abnormally twisted elbows whereas typing with a prosthetic hook is far more relaxed, precise, fast and healthy. Facts are clear here, let there be no doubt [link, re-posted from link].

Given that these facts are sky clear and that I know of exactly no one who would ask for a "bionic" prosthesis from a functional view point, there are two very noteworthy recent stories to read and to learn from:

  • [1] A Florida judge of compensation claims ordered an employer to provide a worker with the i-LIMB hand prosthesis and therapy to assist him with the use of the prosthesis. [link] [link] [reference: Bond v. Superior Mulch, Inc., 18 FLWCLB 95 (Fla. JCC, West Palm Beach 2011)]
  • [2] 14-year-old Matthew James sent a tongue-in-cheek letter to the head of Mercedes' F1 team asking for £35,000 (~$57,000) for a bionic hand, which they could brand like an F1 car. Mercedes' response? They made him "the most advanced prosthetic hand in the world". [link] [link] [link] [link]

What do we learn from that?

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Prosthetic arms - components, price, price per month of service free operation, functional value [economical considerations]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Prosthetic arms - components, price, price per month of service free operation, functional value [economical considerations]; published July 10, 2011, 15:45; URL: https://www.swisswuff.ch/tech/?p=454.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Prosthetic arms - components, price, price per month of service free operation, functional value [economical considerations]}}, month = {July},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=454}}


1 Comment

In terms of prosthetic arms, long term costs are a real issue. If a prosthetic arm is built right, long term cost also means long term income.

However, there are some unidentified obstacles. As this is a biased website - I would like you to assume it just represents my personal views and opinions, and if you somehow believe that I share views with others you may well think that bu I would not really comment - I will not address all of the underlying real issues. There are very good reasons for that. But the cost - performance issue is an interesting problem anyone can sit down and study.

With that I am not just talking about long term costs of overuse. I recently learned that prosthetic component manufacturers usually are more than happy to have their clients suffer their prosthetic components - but if you do want to get rich you need to provide a minimal amount of true support.

Obviously that is mostly the case only in a very limited fashion. Most overpriced items - which include the whole myoelectric option as well as some other parts - are *particularly* un-functional. They are built to malfunction, they are built to frustrate, they are built to fail, they are even built to look weird.

My sharp eyes googling a pre-demo "performance" of a Michelangelo hand adds to that impression. How rigid and awkward any prosthetic arm - including the iLimb pulse - look, and how little the industry representative Bertolt Meyer actually acknowledges that, is shown in a recent panel discussion.

Price, performance and function do not add up. Market rules do not just not work within the extremely skewed market of prosthetic components - they are not even going anywhere, no, this is a completely reversed world.

And that then warrants the type of questions that are somewhat uncomfortable.

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Prosthetic arms, hands and hooks and other orthopedic technical products. Swiss Disability Insurance. Swiss import regulations.

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Prosthetic arms, hands and hooks and other orthopedic technical products. Swiss Disability Insurance. Swiss import regulations.; published July 4, 2011, 00:50; URL: https://www.swisswuff.ch/tech/?p=451.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Prosthetic arms, hands and hooks and other orthopedic technical products. Swiss Disability Insurance. Swiss import regulations.}}, month = {July},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=451}}


1 Comment

[->Artikel auf Deutsch]

Currently, orthopedic products for upper extremity amputees - prosthetic hands, hooks, cables, replacement parts, liners, silicone liners, cosmetic gloves and so on - as well as other stump wear such as stump socks are imported to Switzerland and re-sold through solitary exclusive corporate channels or company conglomerates.

People are often interested in how, exactly, prosthetic arms are evaluated and paid for in Switzerland. I mean, how, *exactly*. Particularly now, as there are an increasing choice of so-called "bionic" and sport supporting systems out, one might wonder what Swiss athletes, managers and other people actually do should they need a prosthetic item that is somewhat out of their reach or that they would like to see covered by insurance. As that is not being discussed in public, though, it is a matter of public interest to discuss import regulations.

If ever one tries to do a direct import to Switzerland, the usual answer of the company representative is for me to buy it through a Swiss orthopedic technician. That is where the product is sold at absolutely prime prices if at all the technician manages to fight through an English catalog. With not an inch better quality.

Turns out that forcing me to do that is illegal in Switzerland. Turns out that I (as customer) or my technician (as the one that buys the stuff) are perfectly entitled to directly import to Switzerland ourselves - and if you as manufacturer abroad believe you can coerce us to feed some of your friends by having them add howevermuch to that price you are selling it locally, you do infringe on Swiss law. Nikon tried to suppress direct import and was fined with 5 million CHF recently.

Still, as consumer and customer, it is currently almost impossible to buy orthopedic products - prosthetic parts, stump socks - anywhere else than at the orthopedic technicians' offices. Orthopedic technicians are always named as the one institution where I - as amputee - would be - in the view of manufacturers - entitled to buy.

Our state disability insurance / Invalidenversicherung (IV) restricts support to simple and effective technical means for work. All items for comfort, sports and play have to be paid for myself. The list contains stump socks, sports equipment, choices of hooks and other parts.

Along the trade and import relay stations, prosthetic and orthopedic products get a massive increase in price. That increase is paid for by (a) disabled consumers such as me or (b) insurances such as disability insurance / IV - Invalidenversicherung. Mostly, the ones that get screwed by this type of scam are insurances - so really, tax payers and insurance members are getting screwed. Because it is a scam. Import into Switzerland is not subject to any particular regulation or quality control. Prosthetic or orthopedic items such as prosthetic hands are absolutely equal to t-shirts, socks, shoes or trousers. In other words, current resale channels are enforce at the loss of the user, and without any increase in product quality.

In fact, a lot of prosthetic components are manufactured in a particularly cheap fashion. The discrepancy between miserable product quality and high price is huge. The assumption that in fact, orthopedic medical import companies are dealing with body parts, is not matched by trade law. There, they are dealing with items that legally are indistinguishable from cheap junk. Always instructive to check out photos of my cosmetic hand that is built with cheap wire and cheap mounting foam.

As dependency of amputees and insurance situations are exploited, these companies are actual social parasites: they ream off, and they do so sometimes even illegally, and consciously.

Swiss price surveillance office is not interested in the subject too much. However they point to the orthopedic support section of the disability insurance. There, at the Federal office of Social Insurances (Bundesamt fuer Sozialversicherungen BSV), I obtain confirmation that orthopedic and prosthetic products such as the ones mentioned above are not at all restricted, regulated or particularly inspected, controlled, checked or otherwise legally constrained. They are, in each and every aspect, similar to all kinds of consumer products such as shoes, socks or shirts.

And that means that (definitely since August 2009), companies must not restrict parallel imports to Switzerland. In other words, if Ossur (Sweden) does not sell to me directly (but to other customers in Switzerland), but restricts me to a Swiss or German reseller, they thereby restrict my right to conduct a parallel import. That, in Switzerland, is not allowed.

http://www.videoportal.sf.tv/video?id=0fc13161-b4eb-4ac8-a7c7-621974ccab1a;did=d-a57e717f-6566-471e-bab4-53012efb2e3e

As you can conclude from this (German) TV sequence, Swiss cartel commission (WeKo) invites submissions of problematic situations. They already fined Nikon with 5 Million CHF (currently about 6 Million US) for trying to block someone to do parallel imports to Switzerland. You could now very well assume that I will be more than happy to wait for someone to redirect me to my orthopedic technician, so I can then submit your company to that cartel commission and get you fined - but I could not possibly comment.

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Armprothese, orthopaedische Hilfsmittel und Import [Schweiz, Importbestimmungen, IV]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Armprothese, orthopaedische Hilfsmittel und Import [Schweiz, Importbestimmungen, IV]; published July 2, 2011, 13:36; URL: https://www.swisswuff.ch/tech/?p=449.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Armprothese, orthopaedische Hilfsmittel und Import [Schweiz, Importbestimmungen, IV]}}, month = {July},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=449}}


1 Comment

[->Article in English]

Aktuell werden in der Schweiz Bauteile fuer Armprothesen - Prothesen-Haende, Hooks, Kabel, Ersatzteile, Liner, Silikonliner, kosmetische Handschuhe, etc. - sowie weitere Produkte wie Stumpfsocken ueber sehr teure Firmenkanaele vertrieben.

Sicher besteht ein gewisses Interesse daran, offenzulegen, wie *ganz genau* in der Schweiz die Abklaerung und Bewilligung fuer Armprothesen laeuft. Dies besonders, da in letzter Zeit sogenannte "bionische" Protheseb oder auch Freizeit-Ausruestungen erhaeltlich geworden sind, die im Preis irgendwo zwischen teuer und absolut irrsinnig angesiedelt sind. Sicher liesse sich so eine Frage wohl irgendwie beantworten, aber dies ist ein Artikel zu einem anderen Thema. Derzeit ist vor allem von oeffentlichem Interesse, wie genau der Import von Prothesenteilen vonstatten geht bzw. gehen sollte.

Es ist als Endkunde daher praktisch derzeit kaum moeglich, Produkte ausserhalb der Orthopaedietechnik zu beziehen. Orthopaedietechniker werden von Herstellern und Wiederverkaeufern naemlich permanent als Endverkaeufer angegeben, als diejenigen Leute, an die ich - als Behinderter - mich zu wenden habe.

Da die Invalidenversicherung (IV) lediglich einen bestimmten - einfachen und zweckdienlichen, meist berufstaetigkeits-bezogenen - Anteil der orthopaedischen und prothetischen Hilfsmittel und Massnahmen bezahlt, bezahle ich als Kunde den Rest meines Bedarfs. Dazu gehoeren etwa Baumwollstumpfsocken, weitere Prothesenteile fuer Sport und Freizeit, und so weiter.

Vom Hersteller in die Schweiz werden bei jedem der Zwischenhaendler meist recht unverschaemte Margen draufgeschlagen, die von der IV oder mir als Endkunden letztlich mitbezahlt werden. Dabei unterliegen diese Produkte in der Schweiz keinerlei weiteren Pruefung oder Qualitaetskontrolle. Das merkt man auch, die Liste von klar erkennbaren Maengeln ist umfangreich. Es erfolgt also ein umfangreiches Mitverdienen an Produkten, deren Mehrwert oder Qualitaet dadurch keineswegs steigt.

Das Zeug ist vielmehr oft wirklich schweinebillig gemacht. Dem gegenueber steht der vorgeschobene Anspruch, dass es sich um Ersatzkoerperteile handeln soll - was aber weder aufgrund der Konstruktionen, den Fertigungsqualitaeten, oder den Regulierungen begruendet ist. Es handelt sich also um reine Einbildung. Wirklich ist z.B. eine Kosmetikhand allerbilligster Biegedraht und Montageschaum.

Da Abhaengigkeiten und Versicherungs-Situationen ausgenutzt werden, sind diese Firmen eigentliche Sozialschmarotzer.

Der Preisueberwacher der Schweiz interessiert sich fuer dieses Thema nicht. Man wird an die IV verwiesen. Die zustaendige Auskunftsperson bei der Hilfsmittelabteilung des Bundesamts fuer Sozialversicherungen (BSV) bestaetigt, dass diese Produkte in der Schweiz nicht reguliert sind, und dass ihr Handel vergleichbar mit T-Shirts oder Socken ist.

Das heisst aber auch, dass - spaetestens seit August 2009 - keine Firma mir, oder jedem Orthopaedietechniker, oder sonst jemandem, verbieten darf, vom Ausland parallel in die Schweiz zu importieren.

http://www.videoportal.sf.tv/video?id=0fc13161-b4eb-4ac8-a7c7-621974ccab1a;did=d-a57e717f-6566-471e-bab4-53012efb2e3e

Bei der WeKo ist die Sache klar: in einer analogen Situation, wo Nikon Parallelimporte zu vereiteln versuchte, musste diese Firma 5 Millionen CHF Busse bezahlen.

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Lawsuit against a prosthetic part manufacturer [rumor]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Lawsuit against a prosthetic part manufacturer [rumor]; published April 22, 2011, 23:21; URL: https://www.swisswuff.ch/tech/?p=402.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Lawsuit against a prosthetic part manufacturer [rumor]}}, month = {April},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=402}}


Lawsuits against a prosthetic part manufacturer are interesting in part because the market is tiny and because the products normally tend to be overpriced and not of particularly good quality. So why sue.

Word of mouth has it, that a relatively large prosthetic part manufacturer will have to face a lawsuit. An amputee who obviously was met with legally unacceptable issues now appears to strike back. It's a rumor though, so we'll keep the ball low.

But that is somewhat unheard of. Why?

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Orphan Disease - term, significance, consequence [statistics and insurance rant]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Orphan Disease - term, significance, consequence [statistics and insurance rant]; published March 23, 2011, 13:17; URL: https://www.swisswuff.ch/tech/?p=388.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Orphan Disease - term, significance, consequence [statistics and insurance rant]}}, month = {March},year = {2011}, url = {https://www.swisswuff.ch/tech/?p=388}}


1 Comment

There exists such an entity such as Orphan Disease or Rare Disease. These are defined based on their prevalence related to slightly differing numbers:

  • Prevalence of less than 1 in 1'500 people (USA; Rare Diseases Act 2002)
  • Prevalence of less than 1 in 2'000 people (European Union; EUROPEAN COMMISSION for HEALTH & CONSUMER PROTECTION DIRECTORATE-GENERAL  - Directorate C - Public Health and Risk - Assessment - C2 - Health information, PDF)
  • Prevalence of less than 1 in 2'500 people (Japan; Japanese law)

An estimate for our local prevalence can be assumed from a Norwegian study with upper limb amputees containing  11.1 persons per 100'000 population of which around 43% had a forearm amputation, effectively rendering prevalence estimates for below elbow amputees around 1 in 50'000 persons [1].

With that, below elbow amputation issues share some rather interesting characteristics with issues of other orphan diseases that I find worthwhile mentioning.

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Ruf nach Registrierung sämtlicher Produkteversager in der orthopädischen Prothetik [Prothetik allgemein]

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - Ruf nach Registrierung sämtlicher Produkteversager in der orthopädischen Prothetik [Prothetik allgemein]; published October 3, 2010, 12:39; URL: https://www.swisswuff.ch/tech/?p=356.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - Ruf nach Registrierung sämtlicher Produkteversager in der orthopädischen Prothetik [Prothetik allgemein]}}, month = {October},year = {2010}, url = {https://www.swisswuff.ch/tech/?p=356}}


Firmen, welche masslos überteuerte Billigware im Bereich der Prothetik sowohl für Gliedmassen- wie Gelenkersatz verkaufen, sind keineswegs Seltenheit sondern Alltag.

Dabei ist grundlegend festzuhalten, dass gerade in der Schweiz derartige Probleme nie irgendwo gemeldet und schon gar nicht erfasst werden. Dabei wäre es für unsere Kranken- und Unfallversicherungen sowie die SAHB oder die IV (Invalidenversicherung) ein einfaches, diese Daten laufend mitzuschreiben und alljährlich dazu detaillierte Statistiken zu veröffentlichen - sie erhalten ja Antrag auf Kostengutsprache und die Rechnung für den Aufwand. Dies insbesondere unter dem Aspekt, dass die Import-Handhabung durch Firmenkanaele teils Parallelimporte unterdrueckt, was in der Schweiz nicht erlaubt ist.

Meiner Ansicht nach wäre es auch die Pflicht der Krankenversicherungen, derartige Daten öffentlich zu machen. Denn die Wahl von Produkten soll sich auf Information stützen können, und wir alle bezahlen bei den Reparaturen, Nachbesserungen und immer wieder frühzeitigen Produktersatzteilen viel Geld mit - zu viel, um uninformiert zuzusehen.

Vorschlag:

- Unsere Kranken- und Sozialversicherungen sind im Bereich der orthopädischen Prothetik (Gliedmassenersatz, Gelenkprothetik) verpflichtet, detaillierte Statistiken und Fallberichte zu Anfertigung, Einbau, Ersatz, Entfernung, Revision, Komplikationen, Bauteilverschleiss, Bauteilersatz, verrechnte Kosten derselben sowie Hersteller- und Produktenachweis sowie allfällig bekannte Gründe für die vorgenommene Be-/Handlung jährlich zu veröffentlichen und diese Information zur öffentlichen elektronischen Abfrage (on-line) anzubieten.

CE-Richtlinien

Cite this article:
Wolf Schweitzer: Technical Below Elbow Amputee Issues - CE-Richtlinien; published July 9, 2010, 17:11; URL: https://www.swisswuff.ch/tech/?p=329.

BibTeX: @MISC{schweitzer_wolf_1573560010, author = {Wolf Schweitzer}, title = {{Technical Below Elbow Amputee Issues - CE-Richtlinien}}, month = {July},year = {2010}, url = {https://www.swisswuff.ch/tech/?p=329}}


Immer interessant: http://www.ce-richtlinien.eu/richtlinien/MedProd.html

Update Dezember 2018: Ich habe das Thema nun einige Jahre, nachdem ich begann, mich damit zu beschaeftigen, etwas aufgearbeitet: [link]

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