Unique Device Identification, also known as UDI, is coming in 2010. All manufacturers of medical devices will be required to comply with the new UDI methodology. The Everest software solution for customer complaints and corrective action tracking includes several features to help medical device manufacturers track a UDI as it relates to all types of medical device problems or defects including: 

• customer complaints
• return authorizations
• product defects
• adverse event – MDR

The FDA UDI Rule will establish a single device identification system that is consistent, unambiguous, standardized, and globally harmonized.

At the device level, marking procedures may include bar code, radio frequency identification (RFID) and direct part marking (DPM). At the organization level, the new UDI methodology offers opportunities for improvement in traceability, recalls, electronic records, materials management, defect analysis and problem resolution.

For FDA regulated medical device manufacturers, the Everest software solution is highly configurable for customer complaints, non-conforming product and corrective action tracking. Here are a few key Everest software features related to UDI…

Product Fields
“Based on a specific UDI, what are the product details related to the customer or patient concern?”

Shipped and Defective Quantities along with Serial Number, Lot Number and user defined fields for any other product details, including the UDI.

Product List
“Based on a specific UDI, how many other problems have been reported for the same type of device or related products?”

Everest includes a master product list based on; Product Id, Description, Product Group and Manufacturing Location. The product list can be imported from a spreadsheet template or updated systematically from a source database with the software’s automatic import program (sold separately).

Defect Codes
“Based on a specific UDI, what types of defects or reasons were attributed to the problem?”For each UDI entered, track results from root cause analysis with up to three levels of defect codes based on configurable terminology to define each; Source, Type, Reason. Everest defect codes enable point-and-click selection of multiple reason codes as needed to identify manufacturing, supplier quality, material non-conformances or other sources.

 Reports & Charts
“What type and volume of concerns are associated with the device and how does that compare with related products, different products and the reason codes?”

Standard reports and charts by Product Id or Product Group, plus a chart drill down feature to explore highest frequencies with drill down details for defect source, type and reason codes.

UDI provides an opportunity to improve patient care, increase efficiency and reduce costs. For manufacturers, a configurable database for tracking the UDI will provide the visibility that is essential to maintain high quality standards and superior customer service. The UDI enables early detection of defective devices to ultimately enhance patient safety and reduce medical errors.

For more information about UDI…

Global GS1 Contact and Website
Ulrike Kreysa, Director Healthcare, GS1 Global Office
ulrike.kreysa@gs1.org
GS1 Healthcare website:
http://www.gs1.org/healthcare

FDA
The FDA is taking the lead in the United States for UDI and will shortly begin developing draft regulations to implement requirements. For additional information about the regulations, visit the FDA website
http://www.fda.gov/cdrh/ocd/udi

UDI Conference – October 20-21, 2009 – Orlando, FL
Hilton Bonnet Creek, Orlando, FL
http://www.udiconference.com

Not that long ago customer complaints were viewed as, well, a nuisance. Then came the quality movement and we all realized that in order to improve we need to pay attention to what’s going wrong as well as what’s going right.  As we were adjusting our attitudes toward complaints and those who make them, A Complaint is a Gift came along. This refreshing book by Janelle Barlow and Claus Moller offered us a new way to look at complaints and serves as a reminder that feedback from customers, while sometimes hard to hear, is a growth opportunity.

The first edition of A Complaint is a Gift (1996) introduced the revolutionary notion that customer complaints are not annoyances to be dodged, denied or buried, but are instead valuable pieces of feedback that can be used to improve an organization’s products and services. The new edition (2008) has been thoroughly revised and updated. View the FREE excerpt here.

A Complaint is a Gift urges us to remember the following:

• Complaints are gold nuggets covered in dirt. Once you clean off the dirt (emotion and negativity) they can be used to strengthen the customer relationship and increase profit.
• Organizations receive the most honest and valuable feedback from complaints, which are way more valuable than costly market research.
• Customers either complain or go elsewhere. Those who complain are giving the organization another chance.
• Less is not more when it comes to complaints. Trying to lower the number of monthly complaints is missing the boat completely. It’s like telling a loved one to only communicate with you when their happy… No connection, no relationship.

Welcoming complaints and getting to the gold nugget with compassionate listening is a solid first step. Organizations that use this information to improve bring the complaint full circle by using a product like Everest to capture the information and use it to solve the root problem. Using customer feedback to drive improvement is the most effective way organizations can thrive. This approach not only provides the information needed to ensure quality products or services, it also provides an opportunity to build a lasting relationship with the customer. I think Barlow and Moller were on to something – a complaint truly is a gift.