In clinical trials, compliance and good clinical practice are necessities to success, and patient safety is always paramount. Every detail is important, including the technical task of managing lot and expiry. Some think lot and expiry are important only when it comes to medication. Not so! Lot tracking and product expiry management of medical ancillary devices and disposables are critical — and of course, helps safeguard patients.
The truth is, many companies or organizations fail to accurately track medical ancillary devices in regards to lot and expiry as well as equipment serial numbers and calibration/preventative maintenance data. This can lead to compliance issues and patient safety concerns. The FDA has mandated that:
“Manufacturers are required to track certain devices from their manufacture through the distribution chain when they receive an order from the Food and Drug Administration (FDA) to implement a tracking system for a certain type of device. The purpose of device tracking is to ensure that manufacturers of certain devices establish tracking systems that will enable them to promptly locate devices in commercial distribution. Tracking information may be used to facilitate notifications and recalls ordered by FDA in the case of serious risks to health presented by the devices.”
Managing lot and expiry is an important job and not an easy one so here are some tips:
- Always use FEFO – (First Expiry/First Out). That means always check stock to verify that you are pulling the first item that will expire. Rearrange product as needed to be in the order of expiry. This will reduce waste and save time going forward.
- Always be on the lookout for recalls and safety notices. Do not ignore this task, as it is paramount for patient safety and compliance. Always address recalls and notices ASAP.
- Actively manage inventory. Rotate stock, do cycle counts, verify expiry, and on-hand inventory counts. This can be done as frequently as necessary to ensure compliance. Consider using point-of-use tracking software.
- Monitor active inventory. Check product expiry on open boxes or currently in-use stock. Do not just check stocked boxes. Make sure staff is trained appropriately and that everyone understands the importance or expiry management.
- Quantify losses associated with not tracking expired goods. This includes financial loss to the organization and how it contributes to the waste in the industry as a whole.
While these tips are useful, implementing a full program to manage medical ancillary devices, lot and expiry requires commitment and skill. Feel free to call on us at Imperial if you would like some expertise in getting started, or in improving your present process.