From my personal experience, many hospitals approach me very concerned – how can they cope in times of recall when they stand helpless against documentation which is partial, missing, sometimes manual, or not associated with any patient?
Earlier this week Intuitive Surgical has announced a recall on staples over manufacturing Violation, as posted on FDA News and other sources. “If an incomplete staple line is not identified and addressed immediately, the risk is dependent on the type of tissue being stapled. In rare situations, there is a theoretical possibility that this could potentially lead to an air leak or an anastomotic leak which may require an additional procedural intervention” according to the company’s urgent Field Safety Notice.
The statement also notes all *23 batch number* of the affected lots of staples used with its da Vinci Xi robot-assisted surgery device.
Intuitive Surgical requested from all her customers – hospitals, clinics, and other healthcare facilities, to immediately locate the affected lots and return them via the standard RMA process. A very complicated request for a hospital that does not automatically manage those medical devices and keeps a digital tracking of all stapler information: batch number, serial number, part number and expiry date.
How to cope in case of staples recall which is not recorded in the patient file at all?
In recent years, we at LogiTag have adopted artificial intelligence and machine learning technologies, designed to complement our solution line to hospitals and address the need of full usage reporting of medical devices like sutures, wax, threads, and staples- who are currently absent from implant’s documentation in surgery, despite their high cost.
In today’s age, it is not a request, but a regulatory requirement by the FDA. We provide the hospital with tools to handle such common cases, while meeting the regulatory requirements and, most importantly, saving lives. Yes, although our systems are not clinical, and cannot cure, yet by quickly and efficiently retrieving data, disasters can be prevented.