CONFIRMED: BMEBT Master's of Science Thesis Proposal Michael Callahan
Master's Thesis Proposal Contact: mcallahan10@umassd.edu Location: Textiles 219/Remote Via Microsoft Teams Microsoft Teams: https://teams.microsoft.com/l/meetup-join/19%3ameeting_YmYzNTkzZWQtOTVkZS00MTJmLWFhMmEtZmNjNzQxYWFkMjFh%40thread.v2/0?context=%7b%22Tid%22%3a%22328d6c0d-0f2f-4b76-9310-9762ba1c3e2d%22%2c%22Oid%22%3a%223d47b535-80e5-4a3c-9a07-e54b59a72428%22%7d Title: Fiber Laser Marking Unique Device Identifiers (UDIs) onto Surgical Steel Medical Devices, and Subsequent Citric Acid Passivation, Novel Method to Predict Parameter Viability Abstract: The European Union regulates that a Unique Device Identifier be directly marked onto all reusable medical devices, Class III devices by May 2023, Class II by May 2025 and Class 1 devices by May 2027, MDR Article 123(3)(g), Article 27(4). Stainless steel is an indispensable material for medical device design, used to produce some of the first implants, now ideal for low cost, temporary contact devices. The material is ubiquitous in the medical setting and thereby it is necessary to investigate viable methods of marking the UDI onto steel. The UDI is typically represented as either barcode or data matrix, allowing a scanner to read data, such as lot number, into a database. Laser Marking of the annealing type has emerged in the medical device industry as a solution to marking Steel, which with proper process parameters allow high contrast marks and last the devices lifespan. Improper parameters however result in marks that may, create habitat where pathogens survive sanitization, fade completely, or are initiation sites of corrosion. Further ideal parameter selection is application specific, largely dependent on laser absorbance and heat dissipation of the sample's marking area. Citric Acid Passivation is prevalent in the medical device industry, and used to rebuild the passive layer of stainless steel and is necessary to ensure the laser marked steel is suitably corrosion resistant, yet extended baths will fade the mark. To address the need for UDI marking of stainless steel and the requirement to identify viable laser mark parameters for UDI marking which often are application specific a rapid and flexible method to predict viable laser mark parameters for a given application is desirable. This novel approach utilizes the fading produced by citric acid immersion across a designed test mark. This produces measurable bands, and the measurements of known samples allow the creation of a calibration curve which unknown samples can be fit into, allowing prediction of viable parameters for the unknown sample. Further Pass/Fail marks can be developed where fading indicates acceptable passivation. This novel method enables reduction of sample size through high resolution measurement providing statistical power, tunable to an institution's workflow, and measurements can be preformed inexpensively with little expertise. Advisor: Dr. Tracie Ferreira Committee Members: Dr. Christopher Brigham, Christina Easterbrooks Johnson and Johnson Principle UDI Engineer, Joseph Mayer Johnson and Johnson Senior Quality Engineer All BMEBT graduate students are encouraged to attend, and all interested parties are invited.
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