Questionnaire for the implementation of the Medical Device Operator V
According to § 68 of the Medical Devices Act (MPG), Federal Law Gazette No. 657/1996, last amended by Federal Law Gazette I No. 143/2009, the Federal Office for Safety in Health Care (BASG) is responsible, among other things, for monitoring the operation of medical devices in accordance with the Medical Device Operator Ordinance, Federal Law Gazette II No. 163/2007.
In cooperation with the public hospitals and the professional association of private hospitals and health spas, BASG has developed a questionnaire on the application of the Medical Device Operator Ordinance (title: "Implementation of the Requirements of the Medical Device Operator Ordinance (MPBV) in Health Care Facilities").
The questionnaire covers aspects of setting up, operating, using and maintaining medical devices in healthcare facilities in accordance with Sections 6 and 7, 67 to 74 and 80 to 92 of the MPG and the requirements of the Medical Device Operator Ordinance (MPBV), Federal Law Gazette II No. 70/2007, as last amended by Federal Law Gazette II No. 163/2007. It consists of a question section and an explanatory section in italics.
The questionnaire is intended as an aid to interpretation of the Medical Device Operator Ordinance and is intended to ensure uniform application of the Ordinance. At the same time, it will be used as a monitoring tool by the BASG.
This questionnaire is addressed to all health care facilities as defined in Section 2 (23) of the MPG: "any facility, office or institution in which medical devices are professionally operated or used by health care professionals or authorized tradespeople, including those facilities of the Austrian Armed Forces that serve to provide medical care", with the exception of places of practice of physicians or dentists.
As part of a self-evaluation, operators in healthcare facilities are requested to complete the questionnaire "Implementation of the requirements of the Medical Device Operator Ordinance (MPBV) in healthcare facilities" according to the circumstances in your facility. BASG will use the questionnaire to begin random audits of medical device operators starting in September 2010.
The questionnaire does not replace the requirements of the Medical Device Operator Ordinance, nor is it a substitute for BASG inspections as defined in Section 68 of the MPG.
Queries:
Institute Inspections, Medical Devices & Hemovigilance
DI Dr. Ronald Bauer
Phone: +43 (0) 50 555-36420E-mail: inspektionen@ages.at
