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January 29, 2020
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ANATOMY (1,478)
00 TISSUE / GENERAL (222)
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Latest News
EU intends to postpone medical devices regulation by one year
March 25, 2020
The new regulation on medical devices was supposed to come into force on 26.05.2020 this year. Among other things, it provides uniform and more stringent criteria for so-called notified bodies when approving medical devices and establishes the procedure for approving clinical trials of medical devices. EU Health Commissioner Stella Kyriakides said: “We must not lose a second in our fight against the coronavirus. With the measures taken, safe and vital medical devices and protective equipment such as masks and surgical gowns can reach the EU market much faster”. “That’s the right move. I will do my utmost to ensure that the European Parliament adopts the proposal as soon as possible,” he said. “We must now ensure that everyone who can do it manufactures ventilators, masks, tests and other medical devices and is not prevented from doing so.” In the corona crisis it is necessary to improvise, says Liese. “If, for example, a part is not available, you have to work with a replacement and this has to be done immediately and not after months of testing”. In addition, companies that had previously done something different would now also be involved in the production of the necessary equipment. “Here, it must be possible to check the most important things very quickly and unbureaucratically and then start production,” says Liese. Author(s) Source © fos/aerzteblatt.de aerzteblatt.de, 25.03.2020 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know...
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India To Regulate All Medical Devices
March 25, 2020
Until recently, Indian regulations covered only 15 “notified” categories, such as syringes, needles, stents, and orthopedic implants; the rest of the market has been largely unregulated. Rules released in 2017 explained that more categories would get notified over time and, indeed, the number of notified categories is being expanded to 37 by April 2021. Notified Device Categories 1. Disposable Hypodermic Syringes 2. Disposable Hypodermic Needles 3. Disposable Perfusion Sets 4. Substances used for in vitro diagnosis including Blood Grouping Sera 5. Cardiac Stents* 6. Drug Eluting Stents* 7. Catheters 8. Intra Ocular Lenses* 9. I.V. Cannulae 10. Bone Cements* 11. Heart Valves* 12. Scalp Vein Set 13. Orthopedic Implants* 14. Internal Prosthetic Replacements* 15. Ablation Devices 16. Ligatures, Sutures and Staplers 17. Intra Uterine Devices (Cu-T) 18. Condoms 19. Tubal Rings 20. Surgical Dressings 21. Umbilical tapes 22. Blood/Blood Component Bags 23. Organ Preservative Solution* 24. Nebulizer (effective from Jan. 1, 2021) 25. Blood Pressure Monitoring Device (effective from Jan. 1, 2021) 26. Glucometer (effective from Jan. 1, 2021) 27. Digital Thermometer (effective from Jan. 1, 2021) 28. All implantable medical devices Equipment (effective from April 1, 2021)* 29. CT Scan Equipment (effective from April 1, 2021) 30. MRI Equipment (effective from April 1, 2021) 31. Defibrillators (effective from April 1, 2021) 32. PET Equipment (effective from April 1, 2021) 33. X-Ray Machine (effective from April 1, 2021) 34. Dialysis Machine (effective from April 1, 2021) 35. Bone marrow cell separator (effective from April 1, 2021)* 36. Disinfectants and insecticide specified in Medical Devices Rules, 2017 37. Ultrasound equipment (effective from Nov. 1, 2020) *bold marking of implants through Implant-Register® Author(s) Source Bagla G, Rohatgi R MED DEVICE Online 25.03.2020 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know...
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Unintentional magnet reversion of an implanted cardiac defibrillator by an electronic cigarette
March 20, 2020
Electronic cigarettes, or e-cigarettes, are nicotine delivery systems initially thought be a safer alternative to cigarette smoking as well as useful adjuncts for smoking cessation. More recently, attention has been directed by the Centers for Disease Control and Prevention at serious pulmonary complications from e-cigarette use, raising important public health concerns. This has been echoed in the scientific literature by demands for stricter regulations for commercialization of these products. Cigarette smoking is a well-established risk factor for cardiovascular events and a sizeable fraction of patients with implanted cardiac devices are active smokers. Here, we report the first case of unintended temporary magnetic reversion of an implantable cardioverter-defibrillator (ICD) by an e-cigarette system. Implantable pulse generators have the potential to interact with many commonly used electronic devices. This case report illustrates a repetitive magnet interaction between an ICD and an electronic cigarette. It is incumbent on electrophysiologic practitioners to be aware of such device-device interactions to avoid potential negative outcomes in patients. While no serious injury was observed as a consequence of the magnet reversion and suspension of ICD therapies in this particular case, there is potential for unintentional temporary programming and arrhythmic complications when an electronic cigarette is placed in close proximity to an ICD or pacemaker. Author(s) Source Shea JB, Aquilar M, Sauer WH, Tedrow U HeartRhythmCaseReports, March 2020, Vol. 6, Issue 3, 121-123 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know...
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EU-Medizinprodukte-Verordnung – MDR 2020: Was erwartet Zahnärzte (Red.: Einführung auf 2021 verschoben) (german)
March 9, 2020
Seit der Verabschiedung der EU-Medizinprodukte-Verordnung am 5. April 2017 mussten rund 3000 Dentalprodukte hinsichtlich ihrer technischen Dokumentation überprüft und ggf. neu bewertet werden. Was will die EU mit der MDR erreichen? Die MDR zielt in erster Linie auf die Industrie: Die EU möchte damit das europäische Medizinprodukterecht vereinheitlichen und Patienten vor fehlerhaften oder risikobehafteten Medizinprodukten schützen, nachdem Skandale um mangelhafte Brustimplantate oder Hüftprothesen das Vertrauen von Ärzten und Patienten in die Sicherheit von Medizinprodukten erschüttert hatten. Das Regelwerk sieht dazu unter anderem unangemeldete Audits bei den Herstellern, zusätzliche Prüfverfahren und eine bessere Rückverfolgbarkeit von risikoreichen Produkten vor (Artikel 10 MDR). Neue Risikoeinstufung in der MDR 2020… Die finale MDR setzt ab 2020 zum Beispiel für alle Produkte, die Nanomaterialien enthalten – darunter etliche Dentalprodukte –, eine Beurteilung des sogenannten Expositionsrisikos voraus. Dieses schätzt ein, wie wahrscheinlich der menschliche Körper den im Produkt enthaltenen Stoffen ausgesetzt ist und wie wahrscheinlich daraus Folgen entstehen. Geprüft wird, in welche Risikoklasse die unterschiedlichen Medizinprodukte aufgrund ihres Potenzials für eine interne Exposition eingruppiert werden müssen: in Klasse IIa (vernachlässigbares Potenzial), in Klasse IIb (mittleres Potenzial) oder Klasse III (hohes Potenzial). Eudamed erst 2022 einsatzbereit Die Europäische Datenbank für Medizinprodukte (Eudamed) ist noch nicht voll einsatzbereit. In ihr sollen künftig alle Medizinprodukte, die herstellenden Unternehmen, Zertifikate samt den Benannten Stellen, die diese erteilt haben, Daten zu klinischen Prüfungen, schwerwiegende Ereignisse sowie behördliche Maßnahmen der Marktüberwachung gelistet werden. Übergangsregelung bis Mai 2024 Es gibt eine Übergangsregelung, um Engpässe auf dem Markt zu vermeiden (Artikel 120 MDR). Sie könnten entstehen, wenn die Produkte der Hersteller aufgrund der mangelnden Verfügbarkeit von Benannten Stellen nicht rechtzeitig nach dem neuen MDR-Regelwerk geprüft werden können. Der Gesetzgeber hat daher vorgesehen, dass alle Zertifikate, die die Hersteller schon besitzen, bis zu dem im Zertifikat genannten Ablaufdatum gelten. Bis zum 26.05.2020 ist zudem noch eine Zertifizierung nach geltendem Recht möglich, die maximal bis zum 26.05.2024 Gültigkeit behält. In die Übergangsregelung eingeschlossen hat die EU auch Produkte, die zurzeit noch in die Risikoklasse I fallen, aber von einer Höherstufung betroffen wären – etwa wiederverwendbare Instrumente oder auch Produkte, die Nanomaterial enthalten, z. B. Abformmaterialien. MDR: Konsequenzen für Zahnärzte ab Mai 2020 (geändert auf 2021, die Red.) Auch Zahnärzte sind von den strengeren Anforderungen der MDR betroffen. Vor allem Zahnmediziner, die in ihrer Praxis chairside Zahnersatz mittels CAD/CAM herstellen, stehen vor der Frage, ob sie mit ihren Erzeugnissen nun bereits als „Hersteller“ gelten oder ob ihre Arbeiten in die Kategorie der „Sonderanfertigungen“ fallen. Die MDR regele diesen Fall in Artikel 2, Absatz 3, erklärt VDDI-Vorstandsvorsitzender Pace: Sofern ein Medizinprodukt eigens für einen namentlich genannten Patienten geschaffen wird, spezifischen Auslegungsmerkmalen genügt und den angestrebten therapeutischen Nutzen entfaltet, gilt es als „Sonderanfertigung“. Wesentliches Merkmal einer Sonderanfertigung sei die Herstellung des Produkts aufgrund einer Verordnung von einem qualifizierten Berufsträger, z. B. einem Zahnarzt, so der Experte. Dabei sei es nicht von Belang, ob die Herstellung manuell oder mittels eines industriellen Verfahrens erfolgt. Zahnärzte müssen die in Anhang XIII der MDR angeführten Informationen zur Konformität der Sonderanfertigung beifügen. Informationen zur Konformität von Sonderanfertigungen beifügen Solange ein Zahnarzt also ausschließlich Sonderanfertigungen herstellt, ist er von einer CE-Kennzeichnungspflicht und damit auch von den Pflichten, die von Herstellern gefordert werden, befreit. Ganz losgelöst von Pflichten sind Zahnmediziner damit aber nicht: Sie müssen in jedem Fall ab Mai 2020 die in Anhang XIII der MDR angeführten Informationen zur Konformität der Sonderanfertigung beifügen. Aufatmen können Zahnärzte auch in der Frage der Weiterverwendung bereits gekaufter und in der Praxis gelagerter Produkte und Verbrauchsmaterialien. Alle Medizinprodukte, die Praxen und Labors bis zum 25. Mai 2025 erwerben, dürften gemäß Paragraf 120, Absatz 4 der Verordnung nach den Regeln sowohl der MDD als auch der MDR in Verkehr gebracht worden sein, erklärt der Wirtschaftsexperte. Erst Produkte, die Zahnärzte nach Ablauf dieser Frist kaufen, müssten entsprechend den MDR-Regularien in Verkehr gebracht worden sein. Author(s) Source Pace MS Dental Magazin, 09.03.2020 This is a post of a scientific or business information. The information given here is checked thoroughly by “Implant-Register”. However we can´t be responsible for the content. Contact the publisher, if you have questions. You may inform us about changes of the information to improve the Register. Comments: n/alet us know...
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New Implants
Straumann® BLX
February 20, 2020
BRIEF PROFILE reg.: n/aregister now⇒ profile ⇒ full 01 application dental implant, compensation of dental root 02 specific bone level X implant 03 company Straumann AG 04 illustration 05 material SLActive® surface 06 year of introduction n/a 07 approvals X CE-Label n/a FDA-approval n/a Other 08 last update 2019-12-21 this page is not approved by the provider Information given here are checked thoroughly by “Implant-Register”. However it cannot be given guarantee for any material or properties. Ask the manufacturer for such questions and give us the information to improve the Register....
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HeartMate 3™ LVAD system
November 29, 2019
BRIEF PROFILE reg.: n/aregister now⇒ profile ⇒ full 01 application LVAD therapy 02 specific the HeartMate 3 LVAD pump, a wearable external battery pack, the driveline, a pocket-sized controller, and the mobile power unit (MPU) 03 company Abbott 04 illustration system (by Abbott) 05 material n/a 06 approvals n/a CE-Marking X FDA-Approval n/a ISO n/a DIN 07 regional directions n/a 08 last update 2019-08-14 not registered / this page is not approved by the provider “Brief Profile” shows a nonregistered implant. Information given here are checked thoroughly by “Implant-Register”. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Ask the manufacturer for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. No comments yet....
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POLYTECH Breast Implant: B-Lite®
November 20, 2019
BRIEF PROFILE reg.: n/aregister now⇒ profile ⇒ full 01 application breast implant 02 specific lightweight 03 company POLYTECH Health & Aesthetics GmbH 04 illustration n/a n/a n/a implant surface X-ray 05 material silicone, enhanced with microspheres 06 approvals X CE-Marking n/a FDA-Approval n/a ISO n/a DIN Be sure to observe current national regulations regarding the approval of textured breast implants (e.g. Australia 2019-11). 07 regional directions n/a 08 last update 2019-12-18 not registered / this page is not approved by the provider “Brief Profile” shows a nonregistered implant. Information given here are checked thoroughly by “Implant-Register”. Illustrations refer to the company, if not shown differently. However we can not guarantee for any material or properties. Ask the manufacturer for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they are taken from the companies website. The publishing company may inform us to hide them. No comments yet....
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New Companies
Zircon Medical AG
April 7, 2020
reg.: n/aregister now IMPLANTS SWITZERLAND product group dental implant products Patent™ Standard Line One-Piece Implant Two-Piece Implant One-Piece Loc Implant Two-Piece Loc Implant Individualized Implant direction(s) n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them....
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H&R Medizintechnik GmbH & Co. KG
March 30, 2020
reg.: n/aregister now IMPLANTS GERMANY product group skeletal system products BONEHELIX® transverse and short oblique fractures of the humerus and tibia direction(s) n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them....
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Replication Medical Inc.
March 3, 2020
reg.: n/aregister now IMPLANTS U.S.A. product group skeletal system implant, spine products GelFix™ Interspinous Spacer GelStix™ Nucleus Augmentation Implant direction(s) n/a This is a post of a nonregistered company. Information given here is checked thoroughly by “Implant-Register”. However we can not guarantee for any material, property or completeness. Ask the company for such questions and give us the information to improve the Register. If there are pictures like logos or implants, they may be taken from the companies website. The publishing company may inform us to improve or hide them....
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