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CAPT Stephen C. Smith

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Captain (CAPT) Stephen C. Smith retired with over 40 years of service progressing from E-2 to E-6 (enlisted), then O2 to O6 (officer), which in his words were all “good times!”.  The catalyst to his medical career occurred shortly after high school graduation, when he witnessed a fatal motor vehicle accident. Feeling helpless with no medical experience at all, he sought how to enter a medical career that led to an Air Force recruiters’ station in Vermont in March 1983. CAPT Smith, then Airman Smith, completed his special operations training course with a greater than 80% attrition rate and logged six years as an enlisted United States (U.S.) Air Force Special Forces Pararescueman stationed in Europe.  He added ten years in the U.S. Army National Guard as an enlisted field medic and then eventually enrolled in the Notre Dame Physician Assistant (PA) Studies Program, graduating in 2000. His goal was to begin a career in pain management, however an opportunity to work at the Federal Bureau of Prisons (BOP) Federal Medical Center Devens in Ayers, Massachusetts presented itself.  There he met a fellow PA who recruited him to the U.S. Public Health Service (PHS) for the remaining 23+ years.

CAPT Smith, then Lieutenant (LT) Smith, left the BOP for Washington, D.C., to become a training officer for National Disaster Medical System (NDMS). There he served as a head quarters program manager responsible for the evaluation and implementation of targeted trainings for 108 response teams (9000 members at the time) within NDMS. He returned to New England with the U.S. Food and Drug Administration (FDA) completing 16 years as a regional and international medical device investigator, 10 years overlapping as an instructor who trained new FDA investigators, and finally retiring in 2023 as an established subject matter expert protecting, promoting, and advancing the health and safety of the nation. The FDA Office of Regulatory Affairs (ORA) protects consumers and enhances public health by maximizing compliance of FDA regulated products and minimizing risk associated with those products. He maintained his PA clinical skills with local patient care, volunteer activities, and Commissioned Corps deployments. CAPT Smith was also the Team Leader of Regional Incident Response Team (RIST 1) for 10 years growing and training a team from six to 22 members where his team members were used regionally and nationally for disaster response.In addition to his Physician Assistance/Associates Master’s Degree, CAPT Smith’s educational background includes Survival and Rescue Operations from the Community College of the Air Force, and a Bachelor of Science in Business and Management from University of Maryland.

A few notable career accomplishments as a Medical Device Investigator:

  • Served as the Lead Investigator/SME for international duodenoscope manufacturer: Volunteered for a high-profile inspection in Japan due to complaints where two deaths occurred in U.S. hospitals as a result of improperly cleaned devices and determined the firm was out of compliance. As Team Leader/SME, his findings supported changes needed to improve quality and safety of all medical device firms that make duodenoscopes, as more than 500,000 procedures across the U.S. each year involve duodenoscopes. He received the FDA Commissioner Special Citation, the highest award the FDA bestows for the promotion of public health.
  • Served as the Lead investigator for manufacturer of insulin pumps that resulted in a Class I recall where 408,462 insulin pods were removed from distribution at a value of over $11 million dollars, potentially protecting the lives tens of thousands of users, both adults and children. Each pod is a disposable insulin pump that delivers up to three days of insulin and is shipped nationally and internationally for patients ages four and above. For patients with diabetes, failure to control glucose levels can result in life-threatening conditions such as blindness, nerve damage, and kidney damage.
  • Served as the Team Member/SME for an on-site high-profile Emergency Use Authorization review for the decontamination process of reusable N95 masks for health care systems as a collateral duty during the COVID-19 pandemic. His work supported necessary corrections to manufacturing processes to protect health care providers. At maximum capacity, 48 sites were operating nationally, authorized to decontaminate up to 10,000 N95s per chamber, with 1-4 chambers per site.

International travel for CAPT Smith included foreign duty service for S. Korea, China, Japan, Thailand, Australia, Mexico, Uruguay, Malaysia, and all over Europe, to list a few. He has been recognized with the Surgeon General’s Exemplary Medal, The FDA Leveraging/Collaboration Award, and numerous active-duty medals over the course of his career.

Family is extremely important to CAPT Smith. He and his wife of 27 years have lived in NH since 2007 and love traveling, working on their house, and especially spending time with their daughters and two grandchildren.  In his spare time, CAPT Smith has volunteered as an adaptive ski instructor, working with wounded soldiers and civilians after loss of limbs, paraplegia, post-traumatic stress syndrome, etc., and by helping neighbors install solar panels in his community.

At the moment, CAPT Smith is enjoying the newness of retirement, August 1, 2023. He may work with a medical device firm as an internal investigator for good manufacturing practices to protect patients. Over his career, he has never had to ask for a job so he will see.

Acknowledgments: This biography was written by CAPT Stephen Smith with the assistance of CAPT Robin Hunter-Buskey, DHSc, CPHP, CCHP, CDCES, PA-C. It was submitted to the Society on November 2023. Photographs are courtesy of CAPT Smith.

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