WO2019170945A1 - Élément pré-identifié d'administration de substances médicamenteuses - Google Patents

Élément pré-identifié d'administration de substances médicamenteuses Download PDF

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Publication number
WO2019170945A1
WO2019170945A1 PCT/ES2019/070127 ES2019070127W WO2019170945A1 WO 2019170945 A1 WO2019170945 A1 WO 2019170945A1 ES 2019070127 W ES2019070127 W ES 2019070127W WO 2019170945 A1 WO2019170945 A1 WO 2019170945A1
Authority
WO
WIPO (PCT)
Prior art keywords
administration
identified element
color
identified
substances
Prior art date
Application number
PCT/ES2019/070127
Other languages
English (en)
Spanish (es)
Inventor
Mónica Rubio Soliva
María Cristina Fernández Barreto
Original Assignee
Rubio Soliva Monica
Fernandez Barreto Maria Cristina
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Rubio Soliva Monica, Fernandez Barreto Maria Cristina filed Critical Rubio Soliva Monica
Priority to ES202090015U priority Critical patent/ES1257216Y/es
Publication of WO2019170945A1 publication Critical patent/WO2019170945A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65C—LABELLING OR TAGGING MACHINES, APPARATUS, OR PROCESSES
    • B65C3/00—Labelling other than flat surfaces
    • B65C3/02—Affixing labels to elongated objects, e.g. wires, cables, bars, tubes

Definitions

  • the present invention belongs to the field of medical devices for administering drug substances.
  • the device of the invention refers to a pre-identified element comprising an administration element, intended to administer liquid or fluid medicament substances to a patient, for example, by infusion, infusion, drip or injection, in the that a label, adhesive, a color, label, alphanumeric characters, symbols, codes, reliefs, images or any other characteristic that the element carries is identifying the route of administration to which said element should be applied.
  • the identification protocol developed by the Ministry of Health of the Community of Madrid also contemplates identifying the different routes of administration, with a series of standardized legends. More particularly, said identification protocol of the Ministry of Health of the Community of Madrid uses the following legends and background colors:
  • identification labels of predetermined colors have begun to be marketed, which conform to the criteria of the identification protocol of the Community of Madrid.
  • Said labels have adhesive on at least one of their faces and are rolled into elongated protective strips, forming rolls. The rolls are introduced, in turn, inside dispensers, which facilitate the removal of the labels.
  • dispensers which facilitate the removal of the labels.
  • an element for administering drug substances to a patient is placed, said element must be subsequently identified with the corresponding label.
  • the form of administration is, for example, of the central intravenous type
  • the healthcare personnel must choose a blue label (Pantone code 2945C), remove it from the corresponding dispenser and paste it on the element. of administration to identify it.
  • the procedure for removing the identification labels of the dispensers is sometimes difficult to perform especially, for example, if the medical personnel wear gloves, which is common due to prophylaxis.
  • identifying labels are broken when removed, they are attached to the gloves of the healthcare professional and / or the ends of said labels are glued together, being rendered useless. This also translates into an increase in the consumption of these identifying labels, with the consequent economic and time expenditure.
  • administration element refers interchangeably, both to the routes of administration of drug substances, and to the lines of administration of substances.
  • route of administration of medicament substances designates any device for administration of medicament substances intended to be introduced - totally or partially - into a blood duct, blood vessel, organ or cavity of a patient.
  • drug administration routes are, therefore, catheters, cannulas, and needles.
  • drug substance administration line refers to any device for administering drug substances that is not intended to be introduced into a patient's bloodstream, blood vessel, organ or cavity, but to transport the medicinal substances from a reservoir (bag or container) that contains it and already coupled to a route to introduce said medicament substance into the body of a patient.
  • drug substance administration lines are, therefore, lights, lumens, extensions, probes, connectors, infusion equipment and infusion equipment.
  • distal end of an administration element is that closest to the patient, while the “proximal end” of an administration element is that furthest from said patient.
  • patient designates a human or animal being, to whom a drug substance is administered.
  • fusion refers to the administration of a drug substance by injection into the patient's circulatory system.
  • perfusion refers -in the present specification- to the administration of a drug substance by introducing it, gradually, continuously and / or intermittently into the circulatory or lymphatic system of a patient, by for example, by gravity drip from a perforated bag and coupled to the administration element.
  • pre-identified element means that said element has been previously identified, at some stage of its manufacturing or obtaining process, including packaging or packaging thereof. That is to say, the element supplied, according to the invention, to be used by the sanitary personnel, already carries the factory labels and / or inside the package, where appropriate, or will be determined by colors, labels, text, acronyms, reliefs, image, code, silkscreen, adhesive or any other feature that helps to recognize and make the application of the element. Not being necessary by the staff that will use it, identify it before use when it comes already pre-identified.
  • the adjective "medicated” is used to designate -in this specification- any fluid substance, preferably liquid, used in the treatment or prevention of diseases.
  • They are medicinal substances, for example and without limitation, injectable drugs, anesthetic or sedative substances, blood, plasma, blood products, saline solutions and serums, as well as food substances, nutrients and vitamin complexes supplied to a patient. , for example, by a nasogastric tube.
  • the present invention is intended to address the problems and disadvantages of the prior art indicated above, providing a pre-identified element of administration of drug substances; characterized in that said element is provided with one or more identifying characteristics, which ensure the specific form of administration of the drug substances through said element, from among a set of possible forms of administration.
  • the administration elements according to the present invention are therefore pre-identified. In this way, the risk of error in administration is limited and the need to affix labels to the elements is eliminated, once said elements have been prepared for administration to a patient, in order to identify what the specific form is of administration of drug substances through each of them (central intravenous, peripheral intravenous, subcutaneous, epidural, intrathecal / intradural, intraarterial, oral / enteral, etc.).
  • the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol.
  • the modalities pre-identify the administration form of the drug substances, according to a standardized identification protocol, which associates a specific color with each possible administration form.
  • the methods of pre-identification of use in the present invention may have a predetermined color, depending on the specific form of administration, as provided by the Identification Protocol of the Ministry of Health of the Community of Madrid .
  • the pre-identification modalities in addition to being of a predetermined color - which varies depending on the specific form of administration - also contain a legend that describes what said form of administration is in one or more item locations.
  • the standardized identification protocol associates with the "central intravenous” administration the color blue, the "peripheral intravenous” the light blue color, the “subcutaneous” the light orange color, a the “epidural” the yellow color, the “intrathecal / intradural” the yellow color, the “intra-arterial” the red color, and the “oral / enteral” the purple / violet color.
  • the administration element is provided with a first identification, arranged in its proximal region and a second identification, arranged in its distal region.
  • the pre-identified element according to the invention is a route of administration of medicament substances.
  • the pre-identified administration element according to the invention is a drug substance administration line.
  • the pre-identified drug substance administration element is contained in a packaging wrapper, preferably, bag or blister type.
  • the pre-identified drug substance administration element is also pre-packaged or pre-packaged.
  • the pre-identified element of administration of pre-packaged or pre-packaged drug substances, as a whole, is sterilized.
  • Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1G are schematic views of a first pre-identified element, in accordance with the present invention, in the form of a drug substance delivery line.
  • An example of a pre-identified element provided with the packaging wrap is shown in Fig. 1A, while in Fig. 1 B, 1 C, 1 D, 1 E, 1 F and 1G, said packaging wrappers have been removed, in order to be able to better appreciate the rest of the components of the pre-identified drug administration element according to the invention.
  • Fig. 2A is a schematic view of a second example of a pre-identified element, in accordance with the present invention, in the form of a drug delivery route, provided with a blister packaging package.
  • Figures 1A, 1 B, 1 C, 1 D, 1 E, 1 F and 1 G show pre-identified elements for administering drug substances according to the invention, which is - in this embodiment of the invention - a line ( 20) administration of medicinal substances.
  • Said line (20) is arranged inside a wrapper (10) of bag-type packaging.
  • the proximal area of the line (20) is provided with a first identifying tag (30), while the distal area of the line (20) is provided with a second identifying tag (35) .
  • Each of the labels (30) and (35) is formed, in this specific embodiment of the invention, by two symmetrical parts 40 mm in length, joined by a 20 mm length and 10 mm width.
  • the obverse of the labels (30) and (35) is formed by a light blue material (Pantone code 297C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a peripheral intravenous administration line. Also, the back of labels (30) and (35) is provided with an adhesive, which allows its adhesion to line 20.
  • a light blue material Pantone code 297C
  • each of said labels (30) and (35) embraces line 20, the two parts that compose them being arranged as a flag.
  • a legend (40) is provided that specifies that the form of administration is, in this particular case, peripheral intravenous.
  • a legend (45) is provided that specifies that the form of administration is, in this case, peripheral intravenous.
  • Legends (40) and (45) use an 8-point straight Arial font.
  • the pre-identification is given by colors (50) and (50 ' ), adhesives, symbols or specific codes (60) and (60 ' ) in the different fluid management elements: the dropper, the system, the three-step key and the extension.
  • FIG. 2A Another embodiment of the invention is shown in Figure 2A in which the pre-identified element of administration of drug substances is a route (20 ' ) of administration of drug substances.
  • the obverse of the label (35) is formed by a light orange material (Pantone code 164C) which is, according to the Identification Protocol of the Ministry of Health of the Community of Madrid, the corresponding color to a subcutaneous route of administration.
  • the label (35) is also provided with a legend (45) that specifies that the form of administration is, in this particular case, subcutaneous.
  • the track (20 ' ) is arranged inside a blister-type packaging (10 ' ).
  • FIG. 2B Another specific embodiment of the invention is shown in Figure 2B in which the pre-identification is given by colors (50) and (50 ' ), codes or symbols (60) specific to the different fluid and catheter administration elements.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Veterinary Medicine (AREA)
  • Anesthesiology (AREA)
  • Public Health (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un élément pré-identifié d'administration de substances médicamenteuses caractérisé en ce qu'il est pourvu d'une ou de plusieurs étiquettes d'identification. L'élément peut être une voie, par ex. une canule, ou un conduit, par ex. une lumière, une sonde.
PCT/ES2019/070127 2018-03-08 2019-03-04 Élément pré-identifié d'administration de substances médicamenteuses WO2019170945A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
ES202090015U ES1257216Y (es) 2018-03-08 2019-03-04 Elemento pre-identificado de administración de sustancias medicamentosas

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ESU201830311 2018-03-08
ES201830311U ES1209214Y (es) 2018-03-08 2018-03-08 Elemento pre-etiquetado de administración de sustancias medicamentosas

Publications (1)

Publication Number Publication Date
WO2019170945A1 true WO2019170945A1 (fr) 2019-09-12

Family

ID=61802398

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/ES2019/070127 WO2019170945A1 (fr) 2018-03-08 2019-03-04 Élément pré-identifié d'administration de substances médicamenteuses

Country Status (2)

Country Link
ES (2) ES1209214Y (fr)
WO (1) WO2019170945A1 (fr)

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013142211A1 (fr) * 2012-03-23 2013-09-26 C. R. Bard, Inc. Signes informant des caractéristiques de dispositifs médicaux insérables

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013142211A1 (fr) * 2012-03-23 2013-09-26 C. R. Bard, Inc. Signes informant des caractéristiques de dispositifs médicaux insérables

Also Published As

Publication number Publication date
ES1257216Y (es) 2021-02-17
ES1209214Y (es) 2018-07-03
ES1209214U (es) 2018-04-09
ES1257216U (es) 2020-11-27

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