IWLA has been working with others in the Device Distribution Group to develop uniform licensing of 3PLs in the medical device supply chain. This legislation is designed to mirror the Drug Quality Security Act, in establishing a federal licensing standard and guidance of tracking and tracing medical devices through the distribution process.
Similar to how they view pharmaceuticals, states have regulated medical device distribution practices in varying ways. These are often inconsistent with other states and federal regulations. Third-party warehouses are left to navigate these muddy waters on a case-by-case basis—leaving their operations and systems in constant jeopardy and/or in non-compliance.
A uniform code would force warehouses to adopt a consistent process that can produce a safer and more efficient medical device supply chain.
So far, the Device Distribution Group has drafted considerations for this legislation to bring the idea to congressional staffers. And if DQSA is any indication, there is a long way to go yet. For those who are handling medical devices, please send your request to IWLA Washington Representative Pat O’Connor to view the considerations that the group has outlined and to provide your feedback and suggestions.