Change Of Tissue Sampling Device Regulation And The Tissue Bank Regulation

Original Language Title: Änderung der Gewebeentnahmeeinrichtungsverordnung und der Gewebebankenverordnung

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87. Ordinance of the Federal Minister of Health, with which the tissue collection regulation and the tissue bank regulation will be amended

On the basis of § § 7 and 30 of the tissue safety law-GSG, BGBl. I n ° 49/2008, in the version of the Federal Law BGBl. I No 162/2013, shall be assigned:

Article I

Amendment of the tissue collection regulation

The Tissue Collection Regulation-GEEVO, BGBl. II No 191/2008, shall be amended as follows:

1. § 1 together with the title is:

" Scope and definitions

§ 1. (1) This Regulation shall apply to the operation of removal devices according to § 2 Z 14 of the tissue safety law (GSG), BGBl. I n ° 49/2008, as amended.

(2) The definitions of § 2 of the tissue safety law shall also apply to this Regulation.

(3) In addition, the following means:

1.

Direct use: any process in which cells are donated and used without being included in a tissue bank;

2.

germ cells: all tissues and cells intended for use in medically assisted reproduction;

3.

Developable cells: fertilized egg cells and cells developed therefrom;

4.

Partner donation: the donation of germ cells of persons of different sex who live in a marriage or a life community;

5.

Standard work instruction (SOP): a written instruction to describe the individual steps of a specific procedure, including the materials and methods to be used, and the expected end product. "

2. § 2 together with the title is:

" Qualification

§ 2. (1) Pick-up facilities shall ensure that any collection of cells or tissues shall be carried out by persons who have sufficient clinical experience and have successfully completed a training programme which is carried out by a Withdrawal team, which has sufficient clinical experience with regard to the type of tissue to be removed, in accordance with the state of the art and technology.

(2) Pick-up facilities shall keep records of all training measures, including the date, duration, location, content, and all the participants and participants. The implementation of each training event shall be confirmed by the signature of the participant and the participant. "

3. § 4 (1) Z 1 reads:

" 1.

AIDS/HIV infection: HIV antibody determination in accordance with the regulation on quality control and quality assurance in HIV diagnostics and the procedure to be followed in the taking of HIV tests, BGBl. No 772/1994, as amended, '

4. According to Article 4 (2), the following paragraph 2a is inserted:

" (2a) On the basis of a written risk assessment, a written assessment shall be made, taking into account accepted scientific principles and requirements, in writing for which donations which are subject to microbiological testing are required. "

5. In § 4 (3), the word "Incidenz" by the word "Prevalence" replaced.

6. § 4 (15) reads:

"(15) In the withdrawal of bone marrow and peripheral blood stem cells, the blood samples are to be taken within 30 days before the donation to the test, the test result being to be found before the donation."

7. § 4 (17) reads:

" (17) Each sampling device shall define in advance-based on a risk assessment-whether and in what quantity to apply recovery samples of appropriate body fluids or tissues and cells of the donor in order to ensure that: it is possible to repeat, at least twice, the laboratory tests that are relevant to the release of the release. The rehearsals shall be transmitted to the respective tissue bank. "

8. § 6 para. 2 Z 6 reads:

" 6.

in the case of deceased donor/donor, place and time of death and description of the conditions under which the body is stored: chilled (or not), time of commencement and end of cooling, "

9. At the end of § 6 para. 2 Z 7, the word "and" replaced by a dash; at the end of Section 6 (2) (8), the point shall be replaced by the word "and" shall be added and the following Z 9 shall be added:

" 9.

where sperm cells are obtained outside of a withdrawal device, this shall be indicated in the removal report, which shall contain in this case the date and time of the donation. "

10. In § 10 (2), the word order shall be "to the clinical team responsible for their use" through the phrase "to the user responsible/responsible for their use/user" replaced.

11. § 11 (2) reads:

" (2) In the case of partner donations not intended for direct use, the conditions laid down in paragraphs 3 to 9 must be met. § 4 (17) does not apply. "

12. § 11 (4) to (9) reads:

" (4) The following laboratory tests shall be carried out in order to determine whether there is a risk of cross-contamination:

1.

HIV 1 and 2: Anti-HIV-1,2,

2.

Hepatitis B: HBsAg and anti-HBc,

3.

Hepatitis C: Anti-HCV-Ab and

4.

Syphilis.

In addition, in the case of donors/donors of germ cells, urine samples have a negative reaction to the test on chlamydia by means of nucleic acid amplification methods (NAT).

(5) HTLV-I antibody tests shall be carried out in the case of donors who live in or come from areas of high prevalence or whose sexual partners or parents come from such areas.

(6) Depending on the history of the donor and the characteristics of the donated tissues or cells, additional tests shall be carried out on the basis of a risk assessment of donors.

(7) The blood samples for the test shall be taken within three months before the first donation, the test result being to be found before the donation. Further blood samples for the performance of the laboratory tests referred to in paragraph 4 shall be taken at the latest 24 months after the previous sampling.

(8) In the case of sperm cells which are processed and not stored for the intrauterine semen transmission, and provided that the tissue bank can demonstrate that the risk of cross-contamination and the exposure of the personnel by the use of validated procedures has been met, a laboratory examination is not required.

(9) If the results of the laboratory tests in accordance with paragraph 4 are positive, no results are available or a risk of infection of the donor is known, the donation must be stored separately in order to avoid any risk of cross-contamination with other Avoid transplants and/or contamination with Adventiv agents and/or confusion. "

13. In § 11, the previous paragraph 8 receives the sales designation "(10)" , in Z 3 of this paragraph, the word shall be: "Incidenz" by the word "Prevalence" shall be added and the following Z 5 shall be added:

" 5.

The serum or plasma samples shall be taken at the time of each donation. "

14. In accordance with § 11, the following § 11a is inserted:

" § 11a. § 9 of the German Reproductive Medicine Act (FMedG), BGBl, applies to the use of developable cells. No 275/1992, as amended. '

15. § 12 together with headline reads:

" Reference to acts of the European Union

§ 12. The following acts of the European Union shall be implemented by this Regulation:

1.

Directive 2006 /17/EC on the implementation of Directive 2004 /23/EC as regards technical requirements for the donation, procurement and testing of human tissues and cells, OJ L 175, 5.7.2006, p. No. OJ L 38, 09.02.2006 p. 40,

2.

Directive 2012/39/EU amending Directive 2006 /17/EC as regards certain technical requirements for the testing of human tissues and cells, OJ L 175, 5.7.2006, p. No. OJ L 327, 26.11.2012 p. 24.

Article II

Amendment of the tissue banking regulation

The Tissue Bank Ordinance-GBVO, BGBl. II No 192/2008, shall be amended as follows:

1. § 1 (3) reads:

" (3) The definitions of § 2 of the Tissue Safety Act (GSG), BGBl. I n ° 49/2008, and § 1 of the tissue collection regulation, BGBl. II No 191/2008, as amended, shall also apply to this Regulation. '

2. § 3 (2) reads:

" (2) The staff must be trained before the start of the activity, as well as in the event of changes in procedures or new scientific knowledge, and must be given sufficient opportunities for the appropriate professional development. The training programmes must ensure that all staff are competent in carrying out the tasks assigned to them, and that they have sufficient knowledge and understanding of the scientific/technical procedures and procedures, and They shall have principles relevant to the tasks assigned to them, the organisational framework, the quality system and the health and safety requirements of the institution in which they work, and shall be sufficiently informed of the other ethical and legal aspects of their work. The training measures shall include records in which, in particular, the date, duration, location and content, as well as all the participants and the participants, are listed. The implementation of each training event is to be confirmed by the signature of the person who has been given and the participant. The staff of the staff shall be regularly evaluated within the framework of the quality system. "

Section 9 (5) reads as follows:

"(5) Restoring rehearsals from donors shall be kept for the period laid down by the tissue bank based on a risk assessment."

Stöger