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ARZNEIMITTEL oder
MEDIZINPRODUKT?
Wissenswertes
für die lokale
Wundbehandlung
Definition:
Was ist ein
Arzneimittel?
∗ ...Stoffe,
∗ Die zur Heilung oder Verhütung
von Krankheiten bestimmt sind,
oder
∗ die verabreicht werden, um
physiologische Funktionen durch
eine pharmakologische,
immunologische oder
metabolische Wirkung
wiederherzustellen...
∗
Kennzeichnung von
Arzneimitteln
In der Europäischen Union:
∗ Name des Arzneimittels
∗ Stärke
∗ Darreichungsform
∗ Name Pharmaunternehmen
∗ Packungsgröße
∗ Verfalldatum
∗ Chargennummer
∗ Zulassungsnummer (Z.Nr.)
In Deutschland:
∗ Pharmazentralnummer (PZN)
Definition:
Was ist ein
Medizinprodukt?
∗ …Instrumente, Apparate,
Vorrichtungen, etc…
∗ …mit der medizinischen
Zweckbestimmung:
∗ - Erkennen, überwachen,
behandeln von Krankheiten,
Verletzungen,…
∗ - Untersuchen, ersetzen,
verändern des anatom. Aufbaus
od. physiolog. Vorganges
∗ - Empfängnisregelung
∗Überwiegend physikalische /
mechanische Wirkung!
Wirkung Medizinprodukt:
Abhängig vom Gefahrenpotential f. d. menschl. Körper
Klasse l: Applikationshilfen, Gehhilfen,
Krankenhausbett,…
Klasse ll a: OP-Handschuhe, Katheter, RR,…
Klasse ll b: Alginate, HCV, Schaumverband,…
Klasse lll: - implantierbare MP mit langer
Verweildauer im Körper, z.B.
Endoprothesen.
- MP tierischen Ursprungs, z.B.
Kollagen, Hyaluronsäure.
4 Risikoklassen
Anwendungsdauer:
∗ Vorübergehend: <60 Minuten
∗ Kurzzeitig: bis 30 Tage
∗ Z.B. Wundauflagen
∗ Langzeitig: >30 Tage
∗ Z.B. Implantate
Parameter – 4 Risikoklassen
Anwendungsort:
- Nicht invasiv z.B. Wundauflagen
- Invasiv z.B. Nasenspray
- Chirurg. Invasiv z.B. PEG Sonde
- Implantierbar
Parameter – 4 Risikoklassen
Parameter – 4 Risikoklassen
Produkte in Verbindung mit
Arzneimitteln
z.B. Biatain Ibu
Produkte aus tierischem
Gewebe
z.B. Kollagen,
Hyaluronsäure
∗ Medicalprodukte = nicht aktive MP
z.B. Verbandmittel, Implantate, OP- Materialien,
…
∗ Elektromedizinische Geräte
z.B. Beatmungsgeräte,…
∗ Aktive, implantierbare medizinische Geräte
z.B. Herzschrittmacher,…
Arten von MP
∗ Medizintechnische Instrumente und Produkte
z.B. Skalpelle, Brillen, Rollstühle,…
∗ Dentalprodukte
∗ In-vitro-Diagnostika und In-vitro-Geräte
∗ Produkte zur Empfängnisregelung
Arten von MP
∗ Arzneimittel…
wenn pharmakologische Wirkung der Hauptzweck
des MP ist.
z.B. Ibuprofen
∗ Medizinprodukt Klasse 3…
wenn die arzneiliche Wirkung den Hauptzweck
des Produktes lediglich unterstützt.
z.B. Silberwundauflagen
Kombination: MP oder AM
Kennzeichnung
Medizinprodukt
Kennzeichnung MP
Dekontamination –
Wundantiseptik
Beispiel:
Dekontamination
Wundantiseptik
Produkte: Dekontamination -
Wundantiseptik
Medizinprodukte
zur Wundspülung:
Prontosan
Lavasorb
Octenilin
Arzneimittel zur
Desinfektion:
Octenisept
Betaisodona Lsg.
Lavasept
Medizinprodukte-
betreiberverordnung
Gemäß §2 MPBetreibV
dürfen MP „nur ihrer
Zweckbestimmung
entsprechend betrieben
und angewendet
werden.“
MP dürfen nur von
Personen betrieben
werden, die dafür die
erforderliche
Ausbildung oder
Kenntnis/Erfahrung
haben.
MPBetreibVO
Der Anwender hat sich
vor der Anwendung
eines MP von dem
ordnungsgemäßen
Zustand zu überzeugen
und die
Gebrauchsanweisung
zu beachten.
Es muss ein Gerätebuch
geführt werden.
∗Betreiber, die MP mit nicht
nachweislich kompatiblen Zubehör
kombinieren, tragen allein die
haftungsrechtliche Verantwortung
für die Sicherheit der
Produktkombination!!!
Anforderungen an Betrieb und
Anwendung
Danke
für die
Aufmerksamkeit!!!

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Arzneimittel oder Medizinprodukt?