FAQ's medical device operators
The procedures of the Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht are bound by the General Administrative Procedure Act (AVG). Persons with party status are informed about the outcome of investigations. Parties involved, for example notifying parties, do not have party status and cannot be informed about the outcome of the investigations.
The operator must carry out an initial inspection of all medical devices in accordance with Annex 1 MPBV before they are used for the first time at the place of operation. The scope of the incoming inspection is based on that of the periodic safety inspection. If a detailed manufacturer or supplier measurement report is supplied, the incoming inspection can be limited to a visual inspection for transport damage. The inspected medical devices must be marked with the date of the next inspection (month, year) if the inspection was successful. This is also in line with a protection idea that all devices subject to testing are marked in such a way that the date of the next inspection can be clearly identified. For better documentation, a record should also be made of the visual inspection so that such an inspection can be clearly identified and traced.
Along with inspection and maintenance, repair is a part of maintenance. Maintenance work must be carried out in accordance with the manufacturer's instructions and may only be performed by suitable persons. During repair, either original parts, original auxiliary materials or substances (e.g. also adhesives) must be used or equivalent spare parts, auxiliary materials or substances must be used. If a company or a client does not adhere to the manufacturer's specifications when repairing medical devices or does not use original parts or equivalent spare parts or is not suitable to carry out repairs on the medical device, this does not correspond to proper repair in accordance with the Austrian Medical Devices Act.
The purpose of the implant register according to the Medical Devices Operator Ordinance (MPBV) is to enable the implanting healthcare institution to quickly and specifically identify the implanted implants, but also the implants that have not yet been implanted, as well as the affected patients in the event of corrective measures, in order to avert or reduce risks. The operator must keep this register and it must include all implant types listed in the MPBV. Annex 5 of the MPBV defines product categories that must be registered.
With regard to the recording of all individual components of implants subject to registration (e.g. a complete hip joint set), it should be noted that Annex 5 item 1 MPBV also explicitly mentions implantable accessories for AIMDs - this addition is missing in item 2. It can therefore be assumed that the intention of the legislator is to record the main implant - in the case of a hip joint implant, for example, this would be the cup, if applicable the cup insert, as well as the head and stem (if applicable also with modular extension components). Separate recording of support components not involved in the primary function (screws, etc.) would not be necessary.