Risk Assessment and Legal Requirements
Über den Vortrag
Der Vortrag „Risk Assessment and Legal Requirements“ von Hans-Jörg Gröber ist Bestandteil des Kurses „Instruction for Medical Product Consultants (EN)“.
Quiz zum Vortrag
Who belongs to the professional circles that receive advice? (Multiple answers are correct)
- Medical professionals
- Users and operators of medical products who have the required technical and specialist knowledge
- Informed patients
- Assessors who specialise in medical technology
- Anyone who asks for information about the medical product, beyond the purely technical basic data (price, performance, dimensions)
A cardiological rehabilitation centre purchases simple exercise bikes (cycle ergometers) from you. They do not have medical product approval and are labelled "not for medical purposes". What are your responsibilities and obligations as a Medical Product Consultant if you find out that the equipment will be used for therapeutic purposes? (Multiple answers are correct)
- Only approved medical products may be used for therapeutic applications in a medical facility. You inform the user/operator that they areviolating the Operator Ordinance (MPBetreibV) and is fully liable in case of damages. For your own protection, you submit a report to the person responsible at your customer’'s facility, detailing the notification of the user/operator.
- According to the new European MDR, as the distributor, you are jointly responsible, and liable for ensuring that only approved medical products are used for medical applications. You must therefore obtain an explicit disclaimer/waiver of liability in writing from the user/operator.
- You suspend the use of the devices and report the matter to the appropriate authority.
- You advise the user/operator that the area of use is clearly indicated for exercise only, or as a non-medical apparatus, so as to avoid any problems with regard to liability.
- You obtain confirmation from the client that they will only use the equipment for non-medical exercising purposes.
An endoscope breaks off when inserted into the patient’'s body; however, it does not cause any harm to the patient. Must this be reported as an incident?
- Yes, most definitely. It indicates a technical fault.
- No. You presume that it was not operated correctly, and give the physician another briefing on the correct use.
- Since the patient was not harmed in any way, the incident does not have to be reported.
- The physician themselves must report the matter directly to the authorities.
A user informs you that a medical product that you gave a briefing on, is becoming significantly less efficient. As a Medical Product Consultant, how should you react? (Multiple answers are correct)
- In the context of your duty of post-market surveillance of a medical product that has been supplied, you record this information and report it to the person responsible at the supplier’s facility immediately, in order for them to react appropriately.
- In consultation with the user/operator and the manufacturer of the medical product, check whether the device is defective, whether it is being operated correctly, or whether there is a problem with the system, then implement appropriate countermeasures.
- You ignore this information and do not pass it on.
- You explain to the user/operator that this is just part of the normal aging process.
- You presume that it involves an incorrect operation, and explain the operation of the product to the user/operator again.
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Dozent des Vortrages Risk Assessment and Legal Requirements
Hans-Jörg Gröber
Hans-Joerg Groeber, Sportlehrer und Physiotherapeut (1988), Fachlehrer Physiotherapie für physikalische Therapie, Biomechanik, Trainingslehre (seit 1996), eigenes Medizintechnik-Unternehmen mit Muskelstimulation bei Querschnittlähmung und neurologischen Indikationen, seit 1990 medizinischer Fachberater national/international für Medizintechnik-Unternehmen mit den Aufgabenbereichen Produktentwicklung, Anwendungsberatung, Fachvorträge, Marketing und Präsentation.Hans-Joerg Groeber (*1961), Sports Instructor & Physiotherapist (1988), Specialist Lecturer in Physiotherapy for Physical Therapy, Biomechanics, Training Theory (since 1996). He has his own medical technology company, where he offers muscle stimulation for paraplegia and neurological indications, and since 1990, he has been a specialist medical consultant both nationally/internationally for medical technology companies, in the areas of product development, advice on applications, specialist lectures, marketing, and presentation.
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