With the increased control of implants and thus also of the implanting institutions, the new regulation for medical devices aims to increase patient safety. This results mainly from the serious problems with defective silicone breast implants and other high-risk products such as hip prostheses and HIV tests.
The control process starts with unannounced quality controls of clinical evidence of the safety of medical devices at the manufacturers and more stringent controls of the testing organizations. Furthermore, with the help of a paper-based implant passport, patient and physician can check exactly which product (type, model, serial number) has been implanted and whether a public warning might be issued.
Electronic implant ID card: patient and doctor can store information, personal patient data can be called up in the operating room.
Clinic's own implant register: enables, among other things, possible recall actions.
Centrally provided patient information: necessary behavioral instructions and information on necessary check-ups.
Due to the electronic administration of implant ID cards, the corresponding clinical implant registers and the prescribed (written) patient information, data can be transmitted and checked at any time.
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Your BESTMINDS Team
Source: DeviceMed
