FDA staff tours UNMC’s orthopaedic implant lab

Ten implant reviewer experts from the FDA’s Center for Devices and Radiological Health (CDRH) visited Omaha Dec. 6-7 to study the orthopaedic implant testing techniques and innovative developments at UNMC’s Biomechanics and Advanced Surgical Technologies Laboratory.

The group included reviewers and supervisors for hip, knee, shoulder, ankle, joint replacement and spinal devices.

Ten FDA staffers visit UNMC to study orthopaedic implant testing techniques and developments. They are pictured with Hani Haider, Ph.D., professor and lab director, center, and Joel Weisenburger, research engineer, left.

“We work hard to develop new testing methods for regulatory purposes and we work with the FDA and the orthopaedic industry for these to become industry standards,” said Hani Haider, Ph.D., professor and lab director. “The FDA could have gone anywhere, but chose our lab for this topic because of UNMC’s area of excellence. We help shape how the world pre-clinically tests implants.”

In Omaha, the FDA had six one-hour lecture/seminars delivered by Dr. Haider and approximately 10 practical lab demonstrations on various aspects of cutting-edge technology and procedures for implant wear testing.

The FDA group also met with Orthopaedic Department adult reconstruction, shoulder and spine surgeons to exchange ideas on the clinical perspective of implant longevity and regulatory procedures for patient safety.

“The FDA experts who visited Nebraska represent the best that our federal government offers,” said Dr. Haider. “They are the guardians to screen for badly designed implants, and their excellent work helps most joint replacement patients today enjoy a renewed pain-free life.”

One of the world’s largest academic, non-profit, industry-neutral facilities for orthopaedic implant wear testing, the lab occupies 4,400-sq. ft. of space directly adjacent to UNMC’s Orthopaedic Surgery Department. On a non-profit basis, the lab has conducted more than 75 orthopaedic implant testing contracts for more than 26 different orthopaedic companies and university labs in the U.S. and internationally.

Knee and hip simulators developed by Dr. Haider allow the lab to perform in vitro implant tests, mimicking lifelike complex forces and motions of the human body, to investigate the function and longevity of artificial joints.

“Our work has firmly engraved the name of Nebraska as a haven for innovative excellence in the world of orthopaedic implant technology testing,” Dr. Haider said. “Year after year, I see the rest of the world’s regulatory authorities from China to Brazil emulating how the U.S. FDA screens implants for their own patients. This helps the U.S. to cement its categorical lead in this arena, helps the U.S. economy, and, most importantly, helps patients worldwide.”