China
Africa
Explore chapters and articles related to this topic
Singapore: Medical Device Regulatory Syste
Published in Jack Wong, Raymond K. Y. Tong, Handbook of Medical Device Regulatory Affairs in Asia, 2018
Post-market surveillance ensures that an approved medical device in use continues to be safe and effective. It facilitates early detection of product design and/or usage problems and allows timely intervention to prevent further harm. Post-market surveillance serves to compliment pre-market review and may drive the manufacturers to further improve its processes and/or product design.
Fully Incorporating Risk Management
Published in William I. White, Excellence Beyond Compliance, 2018
There are several aspects of dealing with issues postproduction where risk management principles need to be incorporated into the “how-to” of various required actions: The risk management file provides guidance on which reporting deadline applies to a particular event. For example, it helps to assess whether the event represents an immediate threat to public health. Such a situation in most jurisdictions has a very short reporting time requirement, and the risk management file facilitates a quick decision.The risk management file assists with preparing a Health Hazard Analysis for Medical Device Reporting in the United States.Complaint records must be analyzed to ensure that observed problems are consistent with information in the risk management file. If new hazards are identified, the risk management file must be updated.In the case of in vitro diagnostics (IVDs), there can arise changes in the pathogen or markers that affect test performance; this will also require changes in the risk management file.In extreme cases, it can happen that a risk previously identified as acceptable would become unacceptable. This would mean serious consequences for the product.13Periodic assessments based on post-market surveillance should be carried out to verify that products continue to meet “state-of-the-art” requirements for product safety that are explicit in some jurisdictions and implicit in others. As a general rule, it is prudent for managers and other employees to consider each process for the role that product risk management should play in that process, and then take steps to ensure that those principles are fully implemented in the process.
Transcatheter aortic valve replacement: clinical safety and performance data
Published in Expert Review of Medical Devices, 2019
Jantine W. P. M van Baal, Boris Roszek, Merel van Elk, Robert E. Geertsma
A heart team is in charge of selecting the most suitable treatment option (SAVR or TAVR and which THV) for each patient. This team is critical to ensure the best outcome for a patient. In order to select the most suitable THV for each individual patient, it is important to consider all relevant factors. In addition to patient specific characteristics, these include the TAVR and THV specific characteristics, like THV design, access route or delivery system. Therefore, it is important to increase the evidence, the amount of literature and data on THVs. This review can provide valuable input for the selection process. In addition, this review also provides important information for ethics committees, regulators, patient associations and manufacturers. Ethics committees can use the data when evaluating a proposed clinical study on TAVR. Patient associations can use them to provide detailed information on THVs to their members. Manufacturers are required to perform post market surveillance of their products. Under the recently published new medical device regulations in Europe, this includes a comparison with similar devices available on the market [28]. Regulators can use the information to guide their market surveillance activities. For all of them, it is important that articles report outcomes in a standardized method based on VARC-2 definitions to provide a clear overview and to make comparisons possible.