Medical Device Operators
The Austrian Medical Devices Act (MPG) and the Medical Devices Operator Regulation (MPBV) regulate the operation of medical devices in health institutions.
The following requirements are covered:
- operation in general
- incoming inspection, commissioning, maintenance and application
- periodic safety inspections and metrological checks
- the instruction of the personnel
- the inventory and the device file
- the implant register
- the reprocessing of medical devices
Members of a health profession, persons with a trade licence who are professionally authorised to operate or use a medical device, and technical safety officers of hospitals are obliged to report incidents in accordance with § 70 MPG. In the case of hospitals, except in the case of other imminent danger, these must be carried out uniformly by the medical director.
Medical devices that are suspected of having caused damage to a patient must not be destroyed, but must be subjected to a cause analysis. It is the task of the user or the operator within the meaning of § 72 MPG to take measures to identify and assess risks and, if necessary, to carry out or arrange investigations. In this sense, it may be advisable to hand over a medical device to the manufacturer for a root cause analysis - also in the interest of the patient. Alternatively, in justified individual cases, own investigations can also be carried out or commissioned. It should also be noted that the medical device alone is often not meaningful for a complete root cause analysis and can only lead to a final root cause analysis together with, for example, the patient's medical history, x-rays, etc. The decision as to whether a medical device is to be examined by the hospital, the manufacturer or a third examination facility must be made in each individual case by the responsible physician or the operator. In this context, the health institution is obliged to safeguard the legal position of the patient or any surviving dependants with regard to the significance of the medical device for the enforcement of any liability claims.
In special circumstances, the Federal Office for Safety in Health Care (BASG) may authorise the use of a medical device for which the conformity assessment procedure has not been carried out. This authorisation is only valid in Austria.
The derogation may be granted only if the use of such devices is necessary in the interest of health protection and equivalent medical devices for which the conformity assessment procedure and the CE marking have already been carried out are not or not sufficiently available. An exemption may be limited in time and subject to conditions.
Applications shall contain the following information:
- The exact name and purpose of the required medical device, including any accessories.
- The justification to what extent the use of the medical device is necessary in the interest of health protection.
- Evidence of non-availability of equivalent medical devices for which the conformity assessment procedure and the CE marking have already been carried out.
- Confirmation of compliance with the essential requirements applicable to the medical device, taking into account its intended purpose. Where certain essential requirements are not fully satisfied, a detailed benefit/risk assessment showing that the use of the medical device is appropriate and that all necessary measures have been taken to protect patients, users and, where appropriate, third parties with regard to the requirements not fully satisfied.
- Statement on the intended conditions of use (indications envisaged, type and number of patients, health facilities, special precautions for use, number or duration of use).
- For requests to extend the deadline for derogations, the documents referred to in points 2 to 4 which show that the use of the medical device is still necessary in the interest of health protection.
An application for derogation is not required if a physician authorised to practise independently in Austria confirms that a medical device is required for a specific patient in order to avert a danger to life or serious impairment of health and that the treatment success with a medical device for which the conformity assessment procedure and the CE marking have already been carried out is unlikely to be achieved. If such medical devices are intended to be used in hospitals, the medical confirmation must be submitted in advance to the medical director.
Certificate of exemption for joint implants
With the validity of the Regulation for the Classification of Medical Devices, Federal Law Gazette II No. 136/2007, on 01.09.2007 (replaced by Federal Law Gazette II No. 143/2009 on 21.03.2010), in conjunction with the European Directive 2005/50/EC for the New Classification of Joint Replacements for Hips, Knees and Shoulders, it is no longer possible to place joint implants for the replacement of hips, knees or shoulder joints on the market for the first time as medical devices of Class IIb.
Some implant systems have not been placed on the market by the manufacturer any more and have therefore not been subject to a conformity assessment procedure for Class III medical devices.
For the revision of implanted Class IIb systems it may be necessary in the interest of health protection to use components, which were used originally, despite the fact that these components have not undergone a conformity assessment for Class III medical devices. In such cases, the total implant and the component now to be revised form a functional unit without the possibility of switching to (higher-classified) components of other implants of the manufacturer concerned or of other manufacturers. In such situations, it may seem medically unjustifiable and highly unethical to expose the patient to the risk of a total revision, although suitable (but unclassified) components are available for a much less stressful revision surgery.
Note: The hourly rate applicable to exceptions is specified in the current fee ordinance.
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.
Is it necessary to record all individual components for implants requiring registration?
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.