Briefing (medical technology)

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In medical technology, an instruction refers to training in the operation of medical products . The applicable provisions are based on the classification of these products, a distinction is made between the products contained in Appendix 1 of the Medical Devices Operator Ordinance (MPBetreibV) and those that are not listed in this directory. In addition, there is a directory for old devices in accordance with the Medical Devices Ordinance (MedGV), which has not been in force since 2002 .

The special care required when complying with the provisions results from the fact that the improper use of medical products can easily endanger the persons handling and treating them.

Instruction for medical devices contained in Appendix 1 of the Medical Device Operator Ordinance

Section 10 (1) MPBetreibV obliges the operator of the medical device that the device is only put into operation after a functional test at the place of use. In addition, the operating personnel must be instructed in the operation of the device itself and in the use of the device together with other approved devices and accessories on the basis of the instructions for use and the associated safety-related supplements. These instructions must be carried out by the manufacturer of the product or a person acting in agreement with the manufacturer (authorized person).

The operator of the medical device (e.g. a hospital) appoints authorized persons for all device types and requests the manufacturer or an authorized person to carry out instructions for the authorized persons. The authorized persons in turn pass these instructions on to the users (medical personnel) before they are allowed to use the devices and products.

All instructions must be documented in accordance with Section 10 (3) MPBetreibV (instruction documentation). This can be done either in the medical device book or elsewhere (e.g. in a personnel file, in software), in which case there must be a corresponding reference to the documentation in the medical device book.

Instruction in identical devices that serve the same purpose and have identical instructions for use only needs to be given once. However, if new software is installed, for example, a new briefing must be given.

Briefing documentation

With the instruction documentation, an operator of medical devices fulfills his obligation to provide evidence for the necessary instruction of authorized persons and users. The obligation to provide evidence is regulated in the Medical Devices Act (MPG), which is part of the Medical Devices Operator Ordinance (MPBetreibV). Regulations for the construction, operation, use and maintenance of medical devices according to § 3 MPG apply to all medical devices with the exception of those for clinical testing or performance evaluation testing. Products and devices that are not used for commercial purposes or where no workers are employed in the hazardous area are exempt from the documentation requirement.

The principle according to the MPG is: A user may only use an Annex 1 medical product if he has received instruction in the use of the product and can substantiate this accordingly. The documentation includes a record of the instruction chain from the manufacturer to the end user.

According to § 12 MPBetreibV, such a document is the medical product book, which must be kept by operators of medical devices and contains information on the medical devices in use. The following instruction data must be recorded:

  • Name of the person carrying out the briefing
  • Authorizations of the instructor (manufacturer, authorized person or authorized person)
  • Names of the instructed persons of the operator
  • Information on the device (designation, type, manufacturer)
  • Time of instruction

Manufacturers and authorized persons may instruct both authorized persons and users, while authorized persons may only instruct users and not other authorized persons.

The proof is usually authenticated by the handwritten signature of all those involved. This recording is the actual "documentation of the briefing".

For the type of written documentation, the legislature allows all types of media, i. H. In addition to recording on paper, qualified recording using software is also an option. An entry in the medical device book remains necessary in any case. If the data on instructions are not stored there directly, a corresponding reference to the recording location must be created.

For active non-implantable medical devices, documentation of the instruction has been mandatory since January 1, 2017 ( Section 4 of the Medical Device Operator Ordinance).

Briefing documentation in practice

In practice, due to high staff turnover, both within a facility and between different employers, it is a major challenge to keep track of the training needs of employees. Particularly in larger organizations, the still frequently used paper form of evidence in the device log or instruction book can only be searched and evaluated with great effort. A possible solution could be to use computerized systems. A database for device and personnel data can help the operator to keep track of who needs which instructions or who has already received which instructions when internal or external staff changes. Compared to paper recording, the required information can be found more quickly, and the systems can usually also create device and instruction passes. However, the note that such an EDP solution only supports the fulfillment of the legal requirements and the actual proof of instruction (with signatures) always belongs in the corresponding medical device book applies here as well.

On a voluntary basis, the employee can be provided with a so-called equipment pass or equipment driver's license. This document, for which forms are available from various publishers, remains with the employee and records the devices, the time of all personal instructions and the names of the instructing persons. So far, this type of documentation has not yet been anchored in law, but is widely used in practice because it offers some advantages in providing evidence. In particular, the legal requirement for the instruction documentation to be accessible at all times can often not be fully met with the medical device book. Again, it should be noted that a device pass is only an addition to the medical device book and is not valid alone.

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Individual evidence