THE ASAHI SHIMBUN
April 18, 2025 at 16:08 JST
Unqualified sales employees of a U.S.-affiliated medical device manufacturer operated X-ray machines during surgeries in violation of the law, The Asahi Shimbun has learned.
NuVasive Japan said four employees operated the machines at five medical institutions in the Kanto and Kansai regions during orthopedic surgeries between April and November of 2024.
The company, which makes and sells devices used to stabilize spines during surgeries, told the newspaper that the acts violated the Radiology Technicians Law.
The law allows only doctors and other qualified personnel to operate X-ray machines because X-rays can adversely affect thyroid glands, eyes and other body parts.
It is extremely rare for people who do not work at medical institutions to be found to have used the machines in operating rooms.
The health ministry suspects that the acts by NuVasive employees also violated the Medical Practitioners Law, which prohibits anyone other than medical professionals from providing health care services.
The employees were present at surgeries where NuVasive’s spinal implants were used.
“Sales employees provided services to accommodate doctors in the hopes that our company’s medical devices would be purchased,” a company source said.
The Asahi Shimbun obtained multiple videos and photographs showing NuVasive employees in radiation protective clothing pressing buttons on X-ray machines and taking spinal implants out of bags in operating rooms.
The employees told NuVasive officials that a sufficient number of personnel had not been available in the operating rooms but that the surgeries could not be suspended midway through.
The employees operated X-ray machines to irradiate patients continuously throughout orthopedic surgeries, which last for several hours, to allow doctors to see conditions inside the patients’ bodies in real time.
The large machines require sophisticated adjustments, such as fine-tuning irradiation levels, to ensure the safety of patients.
NuVasive reported the case to the health ministry and other authorities in early April after The Asahi Shimbun sent an inquiry to the company.
The company said it is carrying out a questionnaire survey covering all sales employees and interviews and has also asked outside lawyers to conduct an investigation.
NuVasive told The Asahi Shimbun that it has not found any systematic issues involved, such as directives from senior company officials.
“We have taken the incident seriously and feel sorry for failing to prevent it,” the company said.
NuVasive Japan, based in Tokyo’s Chuo Ward, was founded in May 2009. It had 160 employees as of March. Domestic sales totaled about 13.3 billion yen ($93 million) in 2024.
(This article was written by Nobuya Sawa, a senior staff writer, and Yosuke Takashima.)
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A NuVasive Japan employee operates an X-ray machine in an operating room of a university hospital in the Kansai region in 2024. (Provided by a source)
