Jan Beckmann - becon GmbH

The ISO 80001 standard urges medical institutions such as hospitals and clinics to provide comprehensive documentation. And although this standard is not yet law, this can (and will) change in the future. That is why now is the right time to start.

i-doit, in combination with the MedTec add-on from our partner becon, offers ideal conditions. We spoke with Jan Beckmann from becon about the possibilities offered by the MedTec Add-on.

Pattrick Bluhm

Hello, Mr. Beckmann,
You work as an IT consultant at becon GmbH. What exactly do you do there, and in general, what is it that you do?

Jan Beckmann - becon GmbH

Hello, Mr Bluhm,
As a project manager and consultant, I am primarily responsible for planning and implementing documentation projects for companies and organisations at becon GmbH. The topic of IT documentation with i-doit is naturally in the foreground and forms the basis of my work. However, we have also developed appropriate solutions for requirements placed on medical facilities with the ISMS and MedTec add-on.

Pattrick Bluhm

Who sets the requirements for medical facilities and what exactly must be fulfilled? Which regulations and ISO standards must be observed?

Jan Beckmann - becon GmbH

Unfortunately, it is not possible to give a general answer to this question. The requirements depend on the size of the organisation and various other factors. Frequently, organisations fall under the regulation for operators of critical infrastructures (CRITIS) and must therefore provide evidence that they have taken appropriate organisational and technical precautions to prevent disruptions to the availability, integrity, authenticity and confidentiality of their information technology systems, components or processes. One possible proof is a certification according to ISO 27001. In this case, the establishment of an information security management system (ISMS) with the i-doit Pro ISMS add-on is recommended. This can be used to perform the entire risk analysis and assign technical and organisational measures.

Pattrick Bluhm

Well, not every institution is covered by the CRITIS regulation. What requirements are placed on small organisations and facilities?

Jan Beckmann - becon GmbH

That is correct. In addition, there is, for example, the Ordinance on the Installation, Operation and Use of Medical Devices (MPBetreibV). Here, among other things, evidence must be provided of when and by which employee someone was instructed on medical devices. In this context, not only the time is important, but also in particular by whom the instruction was given.

Pattrick Bluhm

This means that a whole range of devices must also be documented? Can the standard object types of i-doit be used for this purpose or do I have to create my own object types?

Jan Beckmann - becon GmbH

No, using the MedTec add-on adds many new object types for medical devices. These include:

Absorption meter, Alarm device, Analyser, Apheresis device, Ventilator, Computer tomograph, Defibrillator, Dilutor, Dispensor, Electroencephalograph, Flowmeter, Hemodialyser, Information system, Camera, Laser, Air purifier, Microscope, Monitor (med), Surface imaging system, surface coil, pump, resuscitator, recorder, rescue helicopter, X-ray imaging/fluoroscopy device, pacemaker, simulator, probe, spectrophotometer, steriliser, stimulator, ultrasound device, compressor, balance, washer, warming device, heat exchanger, xenon clearance, centrifuge.

Pattrick Bluhm

So practically everything you need for medical device documentation.

Jan Beckmann - becon GmbH

Exactly, but there are also non-active devices that can be detected. These include, for example, implants and surgical instruments. Of course, these should not be placed in an MRI scanner. But also dressing material and medical devices for in-vitro examinations such as blood sugar measuring strips and measuring devices. There is really a lot that should be considered in the documentation.

Pattrick Bluhm

That leaves practically nothing to be desired. How are the briefings of the employees currently recorded and documented?

Jan Beckmann - becon GmbH

This is done directly in the respective object type. There is another major advantage here. In the case of briefings on devices of the same model, the briefing is taken over for all devices of the corresponding type. The effort required for recording is thus reduced to an absolute minimum.

Pattrick Bluhm

Are there any fundamental differences that need to be taken into account during briefings?

Jan Beckmann - becon GmbH

Yes, there are indeed. Depending on by whom the instruction was carried out. If the instruction was given directly by the manufacturer, the person instructed is also qualified to instruct other employees. However, if the instruction was only given by a colleague, the person is not allowed to instruct other colleagues. In the MedTec add-on, the so-called instruction matrix shows exactly which employees have been instructed in the use of which devices.

Medtec-Add-on Dokumentation medizinischer Geräte Einweisungsmatrix

Using the instruction matrix, you can immediately see which employees have been instructed in the use of which devices and for how long they are still valid.

Pattrick Bluhm

However, it is not always possible to check the briefings of all employees. Is there a possibility to automate the check of the briefings in order to determine expiring briefings?

Jan Beckmann - becon GmbH

The MedTec add-on was developed according to the highest quality standards and integrates seamlessly into i-doit. Thus, all functions such as automatic notifications are also available. We often configure the automatic notifications in customer projects in such a way that once a month an overview of all soon to expire briefings is sent to the responsible personnel by email. Of course, the reports are also available on i-doit at any time.

Pattrick Bluhm

This evidence must certainly be kept for several years. Are the changes still traceable in the long term?

Jan Beckmann - becon GmbH

All changes are always stored in the i-doit logbook in an audit-proof manner. This means that every change is recorded, regardless of whether it is a change to a medical device or a briefing.

Pattrick Bluhm

The collection of devices is one thing, but how can all this information be effectively evaluated?

Jan Beckmann - becon GmbH

We have developed standardised reports for the MedTec add-on for evaluation. On the one hand, there is the medical device inventory. Here, all devices are listed with all attributes to be documented. In addition, there are two variable reports that have been integrated directly into the object types. The first variable report is the medical device inventory. This variable report displays the values that should be present in a medical device log in accordance with the MPBereibV. In the second variable report, all entries for instruction on medical devices are displayed. This is determined automatically via the manufacturer/model combination.

Pattrick Bluhm

Who can access the information? Does every employee just see everything?

Jan Beckmann - becon GmbH

This depends on the configuration. Since the MedTec add-on integrates seamlessly into i-doit, the very granular rights system can also be used. This allows you to control exactly who is allowed to see, change and delete information. A subdivision according to locations or user groups is also frequently used.

Pattrick Bluhm

In addition to static documentation, is there also the possibility to capture or complete information automatically?

Jan Beckmann - becon GmbH

This depends on which systems are already in use. We often implement a connection and synchronisation of data with the CAFM (Computer-Aided Facility Management) or HIS (Hospital Information System) via OpenCelium. It always depends on what information is needed, what information has been captured in third party tools and what interfaces they offer. With our developed API hub OpenCelium, we have a tool that can communicate with practically all systems and can distribute information to all connected systems bi-directionally via suitable interfaces.

Pattrick Bluhm

In which areas can becon GmbH support organisations and the operators of medical facilities?

Jan Beckmann - becon GmbH

Basically, in all areas related to documentation and risk management. From the analysis of requirements and infrastructure to the development of complete documentation. We take over the initial setup of the systems, develop interfaces, set up appropriate automations and create customised concepts for complex topics. In our training, we attach great importance to training users and administrators in a practice-orientated way. Of course, we also offer support in the event of malfunctions or questions arising for various use cases.

Pattrick Bluhm

Thank you very much for this comprehensive insight into the documentation of medical devices Mr. Beckmann!

 

MedTec add-on

 

  • Documentation of medical devices
  • Recording and control of briefings on medical equipment
  • Medical inventory
  • Audit-proof data storage
  • Reporting
  • ISO 80001

ISMS add-on

 

  • Risk analysis and an evaluation of the entire IT landscape
  • Recording and documentation of technical and organisational measures
  • Definition of responsibilities
  • Continuous improvement (CIP)
  • ISO 27001
Logo Becon

becon GmbH is an i-doit premium, development and support partner and supports you in the introduction, integration and operation of i-doit. In addition to connectors to Microsoft Azure and OTRS, it provides the following add-ons for you: The MedTec add-on enables documentation in the medical sector, with the add-ons for information security ISMS enables documentation according to ISO 27001 and VIVA2 enables implementation according to IT-Grundschutz of the BSI. The ScanIT add-on enables the import of data stored in barcodes via Android app. The open source API hub OpenCelium ensures communication and data exchange of third-party applications with i-doit.

Pattrick Bluhm - Mit-Autor des i-doit Blogs

The author

Pattrick Bluhm is a certified IT project manager in the field of ITSM, IT documentation and CMDB. He designs and implements documentation projects with i-doit for medium-sized companies in the DACH region. In 2020, he published the book entitled "IT-Dokumentation - Projekte erfolgreich umsetzen".