1. Buffalo Filter
To comply all of Buffalo Filter’s class II medical devices with UDI requirements in
order to be FDA approved through the creation of label designs, verification of
the new barcodes to ensure functionality, and the submission of device
identification information to the GUDID website by September 24, 2016
Gantt Chart:
• Constructed assuming 100% work is dedicated to the project and that no
resource unit is over-allocated based on work hours in order to avoid
bottlenecking.
• Provides completed tasks in the past involving training and procedures that
have been timed from start to completion taking into consideration the part-
time worker’s hours and a learning curve effect
• Provides future schedule of labels to be redesigned and verified for
procedural completing based on timed procedures for a realistic outcome
taking into consideration a full-time work schedule which will replace the
part-time worker and assuming no learning curve effect and 100% work.
• Project is desired and estimated to end sooner than the UDI deadline, by
August 1, 2016, for additional procedures that must be completed post-
project.
Buffalo Filter develops a standardized procedure and label design template for
compliance with FDA standards through the use of human factors design
principles, project managements methods, and the creation of standard
operating procedures. After the implementation of these methods, 13% of
products are registered by the FDA and 60% of the label designs are completed
and need verification of usability. The status of progress is correspondent with
the progression presented on the Gantt chart.
United States of America. U.S. Food and Drug Administration. Unique Device
Identification. 9 Feb. 2016.
Design Principles:
• Visibility – All of the important and necessary information is present on the
label
• Consistency – All labels are designed to have the same layout of
components to minimize the usage of the working memory.
• Error Prevention – In order to scan the barcodes successfully, there must be
a tolerance of white space on the left and right sides of the barcodes and
also placed apart from another.
• Recognition – ISO symbolism/abbreviations are universal and the user will
understand the meanings
Design Constraints:
• Size of CE mark must be 5 mm tall and distinctly positioned with a certain
amount of white space tolerance surrounding the symbol
• Barcodes must be of a certain height and have enough white space on the
left and right sides in order to be scanned properly
• There must be 11 translations which are of varying lengths for each product
• Label must be oriented in a landscape, rounded corner template in order for
barcodes to be printed clearly
Translations
UDI Barcode
Name & Description
Required ISO Symbols
Company Logo & Address
Catalog & Quantity # Part Number
A Park
Medical Device Product Label Design and Compliance
Standard Operating Procedure:
• SOP created in order to create a clear and thorough procedure for a user to
understand and learn the process of product label design and compliance.
• Clear explanation of roles and responsibilities, terminologies, step-by-step
procedure
Fig 2. Portion of Gantt Chart of UDI label procedure in order to schedule work and estimate end
date (Left); Resource usage of worker 1 and worker 2 (Right)
Fig 1. Standardized label template for all product labels
Buffalo Filter is an organization part of Filtration Group Corporation Life Sciences
Group which is located in Lancaster, NY. This organization specializes in creating
medical devices that are designed to enhance the safety for surgeons, nurses,
and other specialists involved with surgical procedures by minimizing the
hazards of being exposed to smoke plume.
On January 14, 2015, the FDA implemented Unique Device Identification (UDI)
which requires all medical devices to possess a UDI, a code on labels for medical
devices that are both human and machine readable. All labelers, those who
label and intend to commercially distribute their medical devices, require
selecting an FDA-accredited issuing agency who will develop unique labeler
codes for use in UDI which is in compliance to ISO 15459. Once all medical
devices and packaging acquire a UDI, all key data must be stored into the GUDID
(Global Unique Device Identification Database) which is an online directory of
important device identification information.
Fig 3. SOP for Product Label Design and Compliance procedures