Implantation card

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An implantation ID card (also: implant ID card or implant passport ) is issued by health institutions that use medical implants for patients . The implantation card contains z. B. Information about the person who received an implant, about the implant and the manufacturer of the implant.

The implantation ID is used to improve patient safety when using implants, since crucial information is available more quickly.

history

The regulations on medical devices were required at European level to ensure the free movement of such medical devices in the common market . One of the reasons for an expansion and more precise regulations through the European Medical Device Regulation was also the scandal surrounding the company Poly Implant Prothèse ( France ), which is said to have filled breast implants with cheap industrial silicone , among other things.

Since October 1, 2015, an implantation ID must be issued in Germany for certain implants.

purpose

The implantation pass serves several purposes. In the event of a defective product, the manufacturer can carry out a targeted recall campaign. With the help of the ID card, patients and doctors can easily check whether the patient has been implanted with an affected device. During an examination, for. B. MRI may not be performed on a patient with certain metal implants. The implantation card provides the radiologist with information about any risks and precautions to be taken. During security checks at an airport , the implantation ID can be useful if a metal detector reacts to the implant.

Legal basis

Product implantation ID

According to Article 18 Paragraph 1 of the European Medical Device Regulation . the manufacturer of implants must provide the following information in an implantation card that is supplied with the product:

  1. Information to identify the product including the product name, the serial number, the lot number, the Unique Device Identification (UDI), the product model and the name, address and website of the manufacturer;
  2. any warnings and precautions or precautions to be taken by the patient or health professional regarding interactions with reasonably foreseeable external agents, medical examinations, or environmental conditions;
  3. Information on the expected service life of the product and the necessary follow-up measures;
  4. any further information to ensure the safe use of the device by the patient, including all qualitative and quantitative information on the materials and substances with which the patient may come into contact (Annex I, Section 23.4, letter u).

Implantation card for the patient

According to Article 18 (2) of the European Medical Device Regulation, healthcare facilities in the Union member states and Liechtenstein , Iceland , Norway ( EEA member states ) are obliged to provide patients who have been implanted with a product,

  • Information that identifies the product, including the product name,
  • a serial number,
  • a ticket number,
  • the UDI,
  • Product model as well
  • the name, address and website of the manufacturer

in an implantation card that contains information about their identity. An implantation card is to be issued for (examples):

In accordance with Article 18 (3) of the European Medical Device Regulation, no implantation ID has to be issued for the following implants: sutures, brackets, dental fillings, braces, dental crowns, screws, wedges, dental or bone plates, wires, pins, clamps and connectors. However, the European Commission can adopt delegated acts to adapt this list by adding other types of implants or deleting implants. However, it is left to the EEA member states to decide on a case-by-case basis whether a product falls within the scope of the EU Medical Device Regulation or not, provided the European Commission has not yet made a decision.

Entry in other identification documents

According to § 6a of the Austrian Passport Ordinance, medical implants can be entered in the passport. See also Article 7, Paragraph 2 of the Liechtenstein Local Register Ordinance (HSchV) of September 28, 2011 in conjunction with Article 16, Paragraph 4 of the Local History Act (HSchG) of December 18, 1985. In Switzerland , an implant can be entered in the passport on request.

Operation pass

According to the Austrian Federal Act on the Performance of Aesthetic Treatments and Operations, in accordance with Section 9, an operation passport must be created for each patient on whom one or more aesthetic operations are or have been performed as part of the first medical consultation.

The operation pass must contain the following information in particular:

  • First name and surname, date of birth and, if applicable, social security number of the patient,
  • Name and qualification of the treating doctor,
  • Date and reason for the first and all subsequent medical consultations and, if necessary, the clarification,
  • Date of aesthetic surgery,
  • Type of aesthetic surgery and
  • If applicable, name, type and type, lot code or serial number of the implant including the name and address of the manufacturer and the distributor.

costs

In principle, there are no additional costs for the implant ID for patients. This must be issued by the treating healthcare facility. This has to include the costs and the corresponding documentation effort in the total costs of the intervention.

Registration

The information in the implantation card is stored in one or more registers, the implant register. This is structured differently depending on the EEA member state and can also be carried out electronically.

Influence on the ability to drive

Persons who have had an organ transplant or who have received an implant may, if this may affect their ability to drive, in accordance with Section 16 (1) of the Austrian Driving License Act Health Ordinance, a driving license only after a favorable opinion from a specialist doctor and, if necessary, medical check-ups granted or left.

See also Annex 1 (Minimum Medical Requirements) to the Swiss or Liechtenstein Traffic Licensing Ordinance (VZV) of August 1, 1978.

Web links

See also

Individual evidence

  1. ↑ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83 / EC, Regulation (EC) No. 178/2002 and Regulation (EC) No. 1223/2009 and repealing Council Directives 90/385 / EEC and 93/42 / EEC, ABl. L 117/1.
  2. ↑ Unique Device Identification system - system for the traceability of products based on the unique product identifier.
  3. ↑ See e.g. B. for Germany: § 10 Paragraph 1 No. 2 and § 15 MPBetreiberVO and for Austria § 81 Paragraph 2 Medical Devices Act, Federal Law Gazette No. 657/1996.
  4. ↑ For Austria see z. E.g .: Annex 5 of the Medical Device Operator Ordinance, Federal Law Gazette II No. 70/2007.
  5. ↑ Recital 8 of the EU Medical Device Regulation.
  6. ↑ Federal Law Gazette No. 861/1995.
  7. ↑ LGBl. 453/2011.
  8. ↑ LGBl. 27/1986.
  9. ↑ Federal Act on Identity Cards for Swiss Citizens (Identity Card Act, AwG) of June 22, 2001, BBl 2001, 2921.
  10. ↑ Federal law on the implementation of aesthetic treatments and operations, Federal Law Gazette I No. 80/2012.
  11. ↑ For Austria see z. B. Section 73a (1) of the Medical Devices Act, Federal Law Gazette No. 657/1996.
  12. ↑ Federal Law Gazette II No. 322/1997
  13. ↑ LGBl 20/1978.