Leading medical device original equipment manufacturers (OEMs) have launched a new MedAccred critical process focus area for Labeling, Printing, and Unique Device Identifier (UDI). The goal of the new program is to ensure that medical device information provided to medical staff and patients is reliable, accurate, complies with regulatory requirements and, most importantly, improves patient safety.
Paweena Limjaroen, PhD, senior director, Global Labeling and Packaging, Edwards Lifesciences, is chairing the new MedAccred Labeling, Printing and UDI Task Group, which will develop the industry MedAccred audit criteria, select subject matter expert auditors and determine which companies meet the rigorous industry requirements to provide oversight for this critical process area.
The new assessments will help the medical device industry avoid costly warning letters and recalls by driving the adoption of stringent manufacturing process controls. It comes in response to changing and increasingly complex global requirements, which place extra burdens on content management, product labeling, promotional material and UDI.
“In today’s ever-changing medical device-labeling landscape, it is more important now than ever to ensure labeling documentation is regulatory compliant. The MedAccred Labeling, Printing and UDI Task Group’s role is to provide medical device companies with structure and requirements to assist in identifying and implementing industry best practices for global market compliance,” said Limjaroen.
The focus of the new MedAccred Labeling, Printing, and UDI Accreditation is on systems compliance and includes:
- Data Management
- Hardware Systems Management
- Software Systems Management
- Translation Management
- Documentation and Training
The MedAccred Labeling, Printing, and UDI Task Group is open to participation from suppliers and other OEMs within the industry. Companies currently subscribing to the MedAccred program are Bausch Health, Baxter, Becton Dickinson, Boston Scientific, Edwards Lifesciences, Johnson & Johnson, Medtronic, Philips Healthcare, Roche Diagnostics and Stryker.
“This new focus area for MedAccred Accreditation will add to the current areas of accreditation. MedAccred continues to add up to two critical processes per year to support the medical device industry’s drive to improve product quality and enhance patient safety,” said Connie Conboy, director, MedAccred.
MedAccred is a medical device industry-managed, critical process supply chain oversight program that reduces risk to patient safety, assures quality products and verifies compliance with requirements. The program is administered by the Performance Review Institute (PRI), a not-for-profit trade association. PRI is a global administrator of industry-managed critical process accreditation programs focused on improving process and product quality with collaboration among stakeholders in industries where safety and quality are shared goals.