Dealing with rising medical device recalls

Recently another class 1 medical device recall has surfaced involving cardiovascular products from St. Jude Medical.  As class 1 recalls are reserved for cases with a “reasonable probability that use of the product will cause serious adverse health consequences or death“ it is certainly a priority for healthcare providers to be able to locate and remove these items from their shelves immediately.  Even more important is quickly identifying any patients that may have received the device and taking the appropriate next steps to mitigate safety concerns.

While this type of recall notification is concerning, unfortunately it is not surprising.  The trend of increasing device recalls seems to be skyrocketing upwards in the past few years.  According to the  ECRI Institute, in 2009 alone the FDA recalled over 2,000 devices with potential safety defects and the number of yearly recalls has grown by nearly 400% since 2001.

While the rising number of recalls is a concern, an equally pressing issue is many hospitals’ inability to efficiently find and remove the defective units from their shelves before being used.  Secondly, devices are often implanted in patients before a recall occurs or the provider is made aware of the recall thus making it the hospital’s responsibility to notify the patient that a faulty product was used.

Studies have shown that manual documentation and procedure logging practices pose severe risks to quality and safety of care in the event of a recall.  With as many as 10% of recalled products overlooked and left on shelves, many hospitals are turning to information technology to more accurately track these devices.  A great white paper further details the safety issues and excessive labor costs created as a result of manual practices for the locating and removing of recalled medical devices.

Specifically, RFID based storage and tracking systems such as Mobile Aspects iRISupply are well suited to overcome these challenges.  By capturing item level information with each product including the exact location of the product as well as automatically associating the device to the patient who received it, device recalls no longer need to be inaccurate and time consuming processes.

The continued adoption of HIT systems is more apparent than ever as care providers struggle to keep pace with the rising number of recalls and procedures involving new implantable technologies.