Archiv - Safety Officer: Definition, Tasks and Responsibility
Über den Vortrag
Der Vortrag „Archiv - Safety Officer: Definition, Tasks and Responsibility“ von Prof. Dr. Christian Johner ist Bestandteil des Kurses „Archiv - Medical Devices Act“. Der Vortrag ist dabei in folgende Kapitel unterteilt:
- Indroduction: Safety Officer
- German Medical Device Law
- Reporting to Authorities and Reports from Manufacturer
- Safety Officer: Assessment
- Response of the Safety Officers
- The Report
- Expertise of the Safety Officer
Quiz zum Vortrag
Which statement(s) is/are true?
- The medical device law requires every medical device manufacturer to appoint a safety officer.
- The medical device law requires every medical device manufacturer to report a safety officer.
- The medical device safety plan regulation requires every medical device manufacturer to appoint a safety officer.
- The medical device guideline requires every medical device manufacturer to report a safety officer.
What are safety officers legally required to do?
- Collect reports about risks in medical devices.
- Analyze reports about risks in medical devices.
- Coordinate necessary measures when risks in medical devices are reported.
- Take necessary measures when risks in medical devices are reported.
Which sources of information should a safety officer use?
- Reports from public authorities about risks in similar devices.
- Reports from medical device consultants.
- Information about problems with identical or similar components.
- Scientific publications on similar technology, processes, or devices.
- Sales figures (especially decreasing) of similar devices.
What is considered an incident?
- A mistake in the instruction manual almost causes the death of a patient.
- The bracket of the operating light is broken and severely injures the surgeon.
- The patient was on his way to the X-ray unit when he suddenly fell and was fatally injured.
What is considered a recall?
- For example, when the manufacturer modifies the instruction manual in order to minimize risks.
- For example, when the manufacturer takes back a component from the customer and exchanges it in order to minimize risks.
- For example, when the manufacturer sends a device back to the own workshop and has it modified there in order to minimize risks.
- For example, when the manufacturer changes the production process in order to minimize risks.
When does the manufacturer have to report to the public authorities?
- The manufacturer has to report all incidents to the public authorities.
- The manufacturer has to report all recalls to the public authorities.
- The manufacturer has to report all changes in the production to the public authorities (but only if they help minimize risks).
- The manufacturer has to report all corrective measures to the public authorities.
Which deadlines does the manufacturer have to meet when reporting to the public authorities?
- Incidents must be reported within 30 days if the danger is imminent.
- Recalls must be reported at the start of the corrective measures at the latest.
- Recalls must be reported within 30 days.
- The manufacturer sets deadlines according to the level of urgency.
Who of the following people has the legally required expertise to be a safety officer?
- Anka von Schulz is qualified as a medical technical assistant and during the last three years has assisted and filled in for the safety officer.
- Dr. med. Anita Tenhaaf worked as a physician for one year after obtaining her medical license, and has now been working at a medical device manufacturer for 15 months.
- Axel Vosshoff is a qualified toolmaker and practiced his craft for five years. He has been working at a medical device manufacturer for the first time for the past two weeks. Now, he wants to become the safety officer.
- Stefan Tenner has simultaneously studied physics and medicine, and now wants to begin his career as a safety officer at a medical device manufacturer.
Dozent des Vortrages Archiv - Safety Officer: Definition, Tasks and Responsibility
Prof. Dr. Christian Johner
Christian Johner ist Professor für Software-Architektur und Software-Engineering an der Hochschule Konstanz. Er ist (Co-)Autor der Bücher „Basiswissen medizinische Software“ und "Usability Engineering — Effizient IEC 62366- und FDA-konform dokumentieren“ sowie eine der treibenden Kräfte des Zertifizierungsprogramms „Certified Professional for Medical Software“. Als Inhaber der Johner Institut GmbH berät er gemeinsam mit seinem Team zahlreiche Medizintechnikhersteller in Europa und den USA bei der Entwicklung und Zulassung medizinischer Software, speziell dem Erstellen der „technischen Dokumentation“ und dem Aufbau von QM-Systemen. Er unterstützt und schult auch benannte Stellen, für die er einen Auditleitfaden entwickelt hat.Dr. Johner hat mit dem Auditgarant eine Plattform mit Videotrainings und Templates geschaffen, mit dem Medizinproduktehersteller in die Lage versetzt werden, eine gesetzeskonforme Produktakte zu erstellen und Audits sicher zu bestehen.
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