Medical Device Re-work Manual
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Medical Device Re-work Manual

Medical Device Re-work Manual


Published: April 22, 2019 0 0 111
By: Andres Bergsneider, Cal Poly San Luis Obispo
Category: Engineering
Hashtags: #Engineering #fresenius #Medical #Teamwork

Fresenius is a German company specialized in the development of medical equipment and world leader of renal dialysis equipment defining the highest standard for treating patients with kidney failure by helping them have a better life style. Fresenius, Concord is where the Hemodialysis and Peritoneal Dialysis machines are manufactured. Under the same roof we can find a wide range of different teams from marketing through research and development through manufacturing engineers and production technicians where it’s easy to see the full development of a medical equipment.

At the production line there are multiple stages that the peritoneal dialysis machine; the Liberty Cycler undergoes. This path is similar in about 90% from a NEW machine to a Refurbished one. Throughout the entirety of its production a “Rework” line has been established to address different issues and non-compliance specifications the machine may encounter at the production line (see figure 1). The Rework line technicians are required to follow two main documents to be under compliance with Fresenius and FDA standards. These documents are the “Rework Manual” and the “Troubleshooting Guide”, aiding them on resolving issues the machines may have.

These 2 manuals included multiple procedures to address and resolve an issue with the cycler, but technicians were commonly misled into a procedure that was not comprehensive and may not resolve the cause of the machine being sent to the Rework line. The current documents appeared to be made by engineers for engineers, making some of its content irrelevant to technicians and other non-engineer personnel. These were some of the issues encountered at the rework line which, in the long term caused the cycler to be sent back to the rework production line due to ineffective previous rework.

My goal as a Manufacturing Engineering Intern was to create an all new document/manual that would replace the Rework Manual and Troubleshooting guide. The new document developed a comprehensive, clear and concise method of troubleshooting and fixing fallouts. The use of current Fresenius procedures, documents, and a wide range of engineers and technicians aided the research and development of this new manual.

The final document was reviewed by a group of engineers and technicians to help ensure our procedure met compliance and company standards. A final, polished document was provided by the end of the internship ready for implementation at the production line.