As we all heard back in September, the U.S. Food and Drug Administration issued a ruling requiring that most medical devices sold in the U.S. include tracking codes known as unique device identifiers (UDIs). These UDIs, which need to identify the product make, manufacture date and lot number, will allow federal health regulators to track medical devices and monitor them for safety. But, what does this ruling mean for medical device companies?
1) Rising Costs of Manufacturing
Adding this extra step to the manufacturing process will be costly. The implementation of adding the UDIs in the products and the process of testing such codes so they work accurately will be one of the biggest challenges. In preparation to make UDIs fulfill their function, there will have to be plenty of trial and error before the cataloguing of all medical devices is accurate. Additional costs will also come from training medical staff on how to use the new system and modifying device labels. However, these increased costs should return benefits in the long-run.
2) Public and Easy Access to a Catalog
Because the FDA is currently missing a database where to track faulty medical devices, this new ruling will bring a most-needed solution to federal health regulators, doctors and even patients. The FDA plans to add each device UDI in a public database where everyone will have access to a medical device’s information and be able to identify the quality of said device. Doctors, hospitals and insurers will be able to take advantage of their access to this database by adding the UDIs to a patient’s medical records, which will be useful in identifying patients who have been affected by faulty devices.
3) Monitor Device Safety
The biggest benefit of this ruling is the ability to determine which devices are safe for patients to use. The UDI system seeks to resolve many of the issues the medical industry has faced over the years regarding medical device recalls. Some of the highest recalls involved defibrillators, artificial hips and drug pumps. The implementation of UDIs will not only result in increased trust in the medical device industry, but also in increased patient safety.
The new system will begin to take effect in early 2014 starting with high-risk devices such as defibrillators and heart stents. As process of implementing this system is tailored appropriately, the UDIs will begin to be added to moderate-risk devices such as X-ray systems and power wheelchairs.
Can you think of other ways the new tracking codes will affect the medical industry?
What does the #FDA‘s ruling for tracking codes in #meddevices mean for the medical device Industry? http://t.co/aNNNk4aE3r
— Hospital Overstock (@HospitalSurplus) November 21, 2013
Want to discuss the article? Connect with us on:
Need surgical supplies?
Check out our store page for the same name-brands you require, but for less.