When medical professionals treat a patient they design a plan. If the plan requires a medical device, some patients may require surgery depending on where that device needs to be installed.
Medical devices have been a life-saving treatment option and have a huge success rate for many health problems, however, it is not uncommon for medical devices to malfunction or have defects. When an instance like this occurs it is documented and if it’s due to a bad batch or manufacturing error the device will be recalled.
Medical recalls Are Not Immediately Pulled
Medical devices that are found defective or dangerous are not immediately pulled. Doctors will first look to see if the device can be fixed without having to surgically remove it. If that is not the case, then the medical team will calculate the risk of removing it with the consequence of leaving it in.
It is not uncommon for recalled devices to be left in the patient. And it is left to the medical staff to determine if the device poses a threat to the patient life. If the consequence for keeping a recalled device installed is not severe enough the device usually remains untouched
Yes, you heard that right. – Patents are to carry in life with a potentially defective device in their body.
An example of how this can be bad is the 2020 infusion pump recall which severely injured 55 patients with 1 death. And what’s even more shocking is that these devices could still be in the hospital’s inventory just waiting to be installed.
Recalled Medical Devices Not Being Removed From Inventory
Recall on medical devices happen quite often and is nearly impossible for health providers to track due to a poor database system between providers, manufacturers, and distributors. While are there are companies out there that offer an integrated platform for medical device recalls, many providers still use an outdated system for handling recalls.
Here are 3 reasons why the old method of handling recalls is such a problem.
Lot Numbers Are Missing
Health providers do not always purchase medical devices straight from the manufacturer but sometimes buy from distributors and lot numbers are often misplaced. When a device is recalled, it’s difficult which patients had that device installed from a particular lot.
Reliant on Hospitals to Adjust the Database
The database that hospitals use to track recalls is updated by the health providers and not the manufacturers. This is because there is poor communication between manufacturers and distributors and while lot numbers often go missing it can be difficult for hospitals to be accurate update the system.
Real-Time Visibility
Without having an integrated platform between all the providers, manufacturers, and distributors, it can take a long time for information to be relayed. This complicates the process of handling any discrepancies with medical devices.
Conclusion
Medical device recalls remain a problem to public health due to a lack of real-time visibility, a reliable database, and misplaced lot numbers. While there are some 3rd party platforms that offer great solutions, these platforms are not utilized by all healthcare providers. It can take years to get a recalled device off the market, and in some cases, not all recalls are removed from inventory.