FAQ's medical device operators
The Federal Office for Safety in Health Care (BASG) / AGES Medizinmarktaufsicht is bound by the General Administrative Procedure Act (AVG) with its procedures. Persons with party status are informed of the outcome of the investigations. Stakeholders, for example reporters, have no party status and cannot be informed of the outcome of investigations.
The operator must carry out an incoming inspection of all medical devices in accordance with Annex 1 MPBV before the first use at the operating site. The scope of the incoming inspection is based on that of the periodic safety inspection. If a detailed manufacturer or vendor measurement log is included in the delivery, the incoming inspection can be limited to a visual inspection for transport damage. The tested medical devices must be marked with the date of the next test (month, year) after successful testing. This is also in line with a protective idea that all equipment subject to inspection is labelled in such a way that the time of the next inspection is clearly identifiable. For better documentation, a record of the visual inspection should also be drawn up so that such an execution is clearly recognisable and comprehensible.
Apart from inspection and maintenance, repair is a part of maintenance. Maintenance must be carried out in accordance with the manufacturer's instructions and may only be carried out by suitable persons. For the repair either original parts, original aids or materials (e.g. also glue) must be used or equivalent spare parts, aids or materials must be used. If a company or a customer does not comply with 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 repair does not correspond to a repair according to the Austrian Medical Device Act.
The purpose of the implant register according to MPBV is to enable the implanting health care institution to quickly and accurately identify the implanted and unimplanted implants as well as the affected patient in order to avert or reduce risks in the event of a corrective measure. This register must be kept by the operator and must include all implant types listed in the Medical Device Operator Ordinance.
Annex 5 of the MPBV defines product categories subject to registration. The enumeration of these product categories is to be regarded as an exhaustive list. Medical devices which cannot be classified in this list do not have to be entered in an implant register according to MPBV. Products such as screws, plates, nails, wires, tympanic tubes, implantable spirals, tracheostomata, urether stents, cerclage pessaries are not covered by the MPBV.
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 Z 1 MPBV explicitly mentions implantable accessories for AIMDs - this addition is missing in Z 2. It can therefore be assumed that the legislator's intention is to record the main implant - in the case of a hip joint implant, for example, this would be the acetabular cup, possibly the acetabular cup insert, as well as the head and stem (possibly also with modular extension components). Separate recording of support components not involved in the primary function (screws, etc.) would not be necessary.