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Healthcare Blog
They didn't. They didn't have Unique Device Identifiers (UDIs) in place to do a recall pilot. In fact, 2014 was when class III devices were registered and UDI compliant. In September 2015, the devices, licensing, licensing supporting and implants under the FDASIA regulations were made compliant, so there wasn't a base of devices available to do a recall pilot. USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.
The traceability should really start at the receiving dock so what's going to be a change within the provider is going to be when the sales reps bring in product and a provider takes it directly to the Operating Room or to the Cath-lab, there's going to be a little bit of a change there. That information really needs to be captured at the point of receipts and I know that's going to be difficult especially during off hours because we typically don't have somebody in receiving 24/7, but that's going to be again, looking at this as a program.…
There is not a requirement for full traceability like you will see in pharmaceuticals. There is a requirement for full identification through plan of use at the healthcare institutions. The distributors really don't have a traceability responsibility, they have a responsibility to ensure that only properly identified medical devices, as required by law, are continued through the supply chain. There are specific requirements that manufacturers legislation mandates manufacturers be compliant by a certain date and those dates are already under way. For class 3 - September 2014, for class 2 and class 1 that are regulated by the sedation regulation…
A pharmaceutical must have the ability to be traced back to the manufacturer.  For example, authorized distributors must have information on the TH (what is TH?) TH links the product back to the manufacturer.  If there is a change of ownership between the manufacturer and the authorized distributor, the manufacturer must appear on the TH. USDM Life Sciences offers healthcare a comprehensive assessment, strategy and solutions to implement end to end traceability of pharmaceutical and medical devices from point of receipt through to the electronic health record.
There are Drug Supply Chain Security Act (DSCSA) solutions built on the EPCIS set of messaging standards being used in production. An Internet search for EPCIS will help you locate EPCIS vendors. This is not a concept that is future state. There are companies using this method every day, including some with serialized products. Most vendors can handle EDI and EPCIS, but keep in mind the limiting factor for any of the technologies you select is whether your customer can receive the data format. According to the FDA guidance on the DSCSA, trading partners need to be interoperable – meaning…
Grant Hodgkins, Vice President of Track and Trace Services and Solutions at USDM Life Sciences says it’s unclear how this is going to work with the barcode rule intact.  At the moment, if you have a drug package that is two levels (for example, a blister pack going inside a carton dispensed at a pharmacy), the linear would continue to go on the carton as well as a data matrix.  Hodgkins says there are all kinds of variances for this particular situation and the FDA will need to clarify the requirement for this type of situation. USDM Life Sciences offers…
The Drug Supply Chain Security Act (DSCSA) states pharmaceutical trading partners must include product transaction information in an electronic or paper record every time ownership is transferred starting January 1, 2015.  In November 2017, product transaction information in paper form will no longer be acceptable.  Many wholesale distributors are insisting on electronic records starting on January 1, 2015.  For large wholesalers, it is very difficult to deal with paper records because of the many possible places the product and the associated paper record could be.  While in the possession of a wholesaler, a product and paper record could be at…
Food and Drug Administration (FDA) is working very closely with all of the medical device manufacturers so there should be few problems with UDI Final Rule compliance. Some of the manufacturers have requested extensions of 30, 60, or 90 days for various reasons but not for extended time frames. All class III packages should now be received with Unique Device Identification (UDI). Devices within the supply chain before September 24, 2014 are not required to be re-labeled. There are also exemptions from UDI for kit and non-sterile devices, as well as individually requested exemptions by companies. An assessment of devices…
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