Medical device recalls are rising at astonishing rates due to software failures and safety protocol checks – But the major problem with medical device recalls is not that defects have gone up. The problem is that most medical devices selected for recall are not immediately being pulled from the shelf.
Yes! You heard that correctly. Medical devices selected for recall are still being used on patients.
Here are 4 reasons why medical devices with recalls are not being pulled before they are used on patients.
1. Communication On Recalls
It can often take months for medical recalls to be communicated to the right person. When a manufacturer decides to recall a medical device, they must communicate that information to the right person that has the authority to pull the item off the shelf.
Often times communicating this information has to go through multiple people, which can make it difficult to get the information to the right person. The current process of relaying information through the current communication channels is quite ineffective.
2. Hospital Lack Recall Information
Hospitals don’t always purchase medical devices from manufacturers where lot numbers are provided on the outside of the packaging. A lot number is an identification number assigned to a quantity or batch of devices produced. When hospitals purchase medical devices from distributors or vendors, these lot numbers are not always provided.
Without a lot number, hospitals find it difficult to know if a medical device is from a defective batch that has been recalled. Unfortunately, these medical devices will go to patients. It isn’t until later that doctors find out about the recalled device and they are forced to make a calculated risk to whether or not the device should be taken out of their patient.
3. Reliant on Hospitals to Adjust Databases.
The database that hospitals use to check for recalls for medical devices is not always up to date. This is because these databases are updated by hospitals when a recall or defect emerges and needs to be communicated to the rest of the industry. There is poor communication between manufacturers and distributors, and if you add in the missing lot numbers, the database doesn’t always display which medical devices have a problem.
Unfortunately, there is no fully integrated system between manufacturers, supplies, and hospitals that would fully prevent recall devices from being sold to patients. However, there is medical recall software that can be utilized in making the process less complex and much easier for providers. Not all hospitals have begun to use these types of software because they are still reliant on their old outdated methods.
4. Lack of Real-Time Data Within The Medical Industry
The number one problem with recalls on medical devices is the lack of real-time data. The process is just too inefficient and time-consuming, and with the lack of communication with recalls, it can take years to fully get a defective batch of medical equipment off the market.
With the growing number of recalls, it can be a struggle for any healthcare provider to keep track of the medical devices that currently still have recalls.
Patients are at health risks due to medical devices with recalls on them still being sold to the market. This is due to lack of communication, missing lot numbers (tracking ID) on devices, databases not being updated with needed information, and above all, the lengthy process it takes for devices to be recalled. The process is beyond tedious since there is no full integration for communication channels between all the departments involved. While there is software that can be utilized to manage these recalls, most healthcare providers still use outdated methods in handling recalls.