vossenkuhl@endocenter.de At the request of Members Dr. Marlies Volkmer is expressed for the first time a representative of the Federal Health Ministry on Arthroplasty.
Printed Matter:
Printed Matter 17/2963
49th Members
Dr. Marlies Volkmer
(SPD)
What are reasons it has rejected the Federal Government
far, initiate the establishment of a
arthroplasty and / or to promote
that, according to the German Society for Orthopaedics and Orthopaedic
Surgery (opinion of
July 28, 2010 at the presentation of
BARMER GEK Hospital Reports 2010)
to improve the quality of care and also help
could realize a savings of over 40 million
€?
response to the Parliamentary Secretary
Annette Widmann-Mauz
of 17 September 2010
From the perspective of the federal government can fulfill a variety of Arthroplasty
functions. Its introduction has to be agreed with the existing regulations
security in the field of medical devices
and the measures of quality assurance.
In this sense, it must be noted that to ensure the European
and the German medical device monitoring system already
today that incidents are recorded (eg fractures of hip implants)
. In the Germany for the risk assessment of medical devices
responsible Federal Institute for Drugs and Medical Devices
(BfArM) evaluates the data centrally from
and can respond immediately to protect all patients.
is in the European and national legislation in this regard regulated
that information in the event of a recall or exchange of a product, the manufacturer
the affected health facilities
and possibly the patients about it. The replacement program
the manufacturer and the operators is controlled by the
competent state authorities. In § 16 paragraph 2 of the Medical Devices Regulation
Security Plan provides that the clinics
for special implants (eg pacemakers, hip prostheses)
have to conduct its own documentation, which allows the quick identification of data
patients and / or
of the product. For this, the hospitals also use
register. A nationwide implants register would have would be minimized over
these existing arrangements with regard to the prevention
of incidents with medical devices and an increase
the safety of products may be the advantage that the
suspected currently unknown number of unreported incidents
.
experience Scandinavia with the implants in the registry show
also held that a positive assessment of the expenses and benefits
is very difficult to reach. In the Scandinavian registers
therefore is not only the question of the duration of the function
products at the center of the register. Rather, it is much
also to improve the supply, which in Germany is currently
with other measures of quality tracked.
Printed Matter 17/2963 - 32 - German Bundestag - 17 Term
The Federal Joint Committee (G-BA) are responsible for the
mandatory quality assurance measures set
(§ 135a ff SGB V) added. This also allows the decision to introduce an arthroplasty
. One function of such a register could include
be that a striking accumulation
example of necessary revision operations
evidence of poor quality of medical care in certain
could give hospitals. The survey of service quality
the use of implants for years but is an essential part of
stationary cross-institutional audits,
initiated by the G-BA and guidance.
by comparing the results (quality indicators) in such interventions
Qualitative vulnerabilities of supply in the hospital and discovered
improved or even stopped.
has to ensure the necessary experience and expertise
a hospital in the use of total knee
the G-BA also stipulates a minimum amount of annual 50 total knee
. There are already so far-reaching measures for quality assurance in
endoprosthetic treatment taken.
Given the demonstrated complexity of the issues raised
the decision to introduce an additional
arthroplasty should be carefully considered. The G-BA has
with this issue and the possible Embodiment of such a register
deal of work. Also because of the transfer of tasks
the national office Quality Assurance (BQS) to the
AQUA-Institut (§ 137a SGB V), these discussions are not concluded yet
. However, it is intended that the G-BA
still in 2010 a further decision on quality assurance
"endoprosthesis" sums.
50th Seconded
Dr. Marlies Volkmer
(SPD)
What draws conclusions from the federal government
in the "Frankfurter Allgemeine Zeitung" of 11 August 2010
(S, N 2) documented announcement of the German Society for Orthopedics and
Orthopaedic Surgery
establishing an arthroplasty, the financial support from the manufacturers of implants
to do?
response to the Parliamentary Secretary
Annette Widmann-Mauz
of 17 September 2010
As a possible added value of an arthroplasty
will see the answer to question 49th All efforts to improve patient safety
are nonetheless worthy of support.
would therefore appreciate the federal government if
the activities of the G-BA for quality assurance in endoprosthetic
care and the question raised in the initiative
in the direction of a register would be pooled and coordinated
.
Nachlesbar at the following link .
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