When a product recall occurs, typically there are complaints that can be traced back to trending issues with the specific device. During the process of assessing whether a correction or removal must take place, a company should be conducting a health hazard evaluation (HHE) to determine whether a violation has occurred. Several considerations come into…
Trading the potential health risk to a few patients versus the collective good of all patients is never acceptable. Even the experts are voicing concerns over the effectiveness of duodenoscope reprocessing.
From ensuring patient safety to protecting a company’s reputation, the product recall process starts with putting together the right team of qualified individuals.
If all goes as planned, patients who suffer from life threatening or irreversible debilitating conditions will have faster access to new technologies.
With decreasing prices and increasing regulation, many UK medical device businesses are looking to emerging markets for growth. However, compliance issues are also problematic in those territories, according to a recent study from life science consulting firm Maetrics.
The new recommendations are outlined in a final industry guidance aimed at helping device manufacturers develop safer reusable devices, especially those devices that pose a greater risk of infection.
The most important part to remember about this recommendation document for unannounced audits is that it not only applies to medical device manufacturers, but also significantly includes their suppliers and subcontractors.
A recent report describes an ambitious national medical device monitoring system that harnesses novel data sources, modern analytical techniques and the participation of all stakeholders to optimize patient care.
Mandatory revalidation may not be mandatory when a material change occurs; however, such changes need to be appropriately evaluated. When in doubt, repeat packaging validation. Or, if you believe the scientific evidence/rationale is adequate, then write a robust rationale as to why repeating packaging validation is not required.
The biological safety of a device is established for both short-term (acute) and longtime (chronic) safety risks to patients and device users. Medical device manufacturers must investigate their devices thoroughly to meet these expectations to receive approval to market their devices.
