How to Decrease Legal Risks in the Medical Supply Chain
Knowing where a package is at all times is a big concern for healthcare companies. In response to this market need, FedEx has developed innovative solutions dedicated to the healthcare industry such as Priority Alert and SenseAware. Priority Alert is a contract-based customized service that offers proactive monitoring and communication with a single point of contact.
SenseAware, a multi-sensor device powered by a FedEx platform for data and device management, is allowing companies to follow the journey of their shipment in near real time. In the medical field, knowing the identity of the person signing at the point of delivery is also critical. Recently, I participated in a regulatory seminar with attendees from various medical device companies and gained new insights into their efforts to control quality and to minimize legal and regulatory risks.
Class III medical device manufacturers (those with severe regulatory controls) rely on a vast network of sales professionals who receive expensive devices and tool kits at hospitals, assist with surgical procedures, and are often responsible for returning surgical tools to the original sender for sterilization.
When FedEx Express packages are delivered to a hospital, hospital representatives may sign for an incoming shipment whose named recipient is a medical sales professional. Unfortunately, traceability and tracking ends there on the FedEx side, making it impossible to track the contents within the hospital at this point. However, even though FedEx Express couriers do not deliver packages within hospitals, FedEx Custom Critical offers customized white glove services to deliver packages safely and securely to specific locations within large complexes such as hospitals
Manufacturers are constantly innovating and releasing medical products that were evaluated in accelerated testing but not necessarily in vivo over a long period of time. Clinical trials are not always required since modified versions of existing medical devices known as predicate devices can be accepted through the Food and Drug Administration (FDA) 510(k) clearance program.
Out of the roughly 4,000 devices approved annually through this 510(k) program, only a few generate problems. But once patient complaints can be traced to an implanted device, surgeons are typically making the decision to remove the device from the patient’s body and to return it to the manufacturer for further investigation. Such devices are referred to as adulterated products by the FDA and returns to the manufacturer’s site need to be closely monitored in these situations.
If a package containing an adulterated product is lost in transit, the medical device manufacturer may voluntarily decide to issue a general recall as a preventive measure, which could cause severe damage to the brand’s reputation. The risk of losing packages can be decreased by choosing specific FedEx Express monitoring services such as Priority Alert and SenseAware. However, the identity of the individual receiving the package with the adulterated product needs to be well-defined and documented in case of any legal pursuit. Delivery signature options are available for FedEx Express and FedEx Ground products for a modest additional surcharge.
FedEx is addressing challenges in the supply chain sector by working on new solutions to meet the changing demands of customers in the medical industry.
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March 29, 2016
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