Sweeping medical reforms proposed

DOWNTOWN — Proposed federal safety controls meant to reduce patient overexposure to radiation would bring sweeping reforms to the medical imaging industry, a local hospital official said.

Proposed requirements for medical imaging device manufacturers include developing safer technologies, proper training for health-care professionals who use the machines and increasing awareness of radiation exposure, according to the U.S. Food and Drug Administration.

“One of the things we have not had in place is any of those developed standards, so one of the questions that we honestly had is ‘OK, what is the appropriate dosage?’” said Warren Tetz, Glendale Adventist Medical Center’s chief operating officer. “And honestly, those standards have not never been fully developed, so to have them be developed and be available for all facilities to us would be a tremendous leap forward.”

Glendale Adventist was one of several hospitals, including Cedars-Sinai Medical Center in Los Angeles and Providence St. Joseph’s Medical Center in Burbank, that overexposed patients to radiation during medical imaging procedures.

Ten Glendale Adventist stroke patients received three to four times the normal dose of radiation during a triple-imaging brain exam using a General Electric-manufactured CT scan machine from January to November last year, hospital officials said.

Officials at St. Joseph’s have said 34 patients received excessive radiation over a 20-month period ending in October last year.

Representatives for the hospital did not return calls seeking comment on the FDA proposal.

At Glendale Adventist and Cedars-Sinai, radiation overdoses began after the hospitals reprogrammed machines to use a new protocol to control the scans, according to the FDA.

Glendale Adventist officials said the new protocol combined three types of brain-imaging procedures for a simultaneous scan.

CT, or computed tomography, nuclear medicine and fluoroscopy pose serious risks to patients and can increase the chance of cancer, according to the FDA. Other drawbacks to accidental exposure to ionizing radiation is hair loss, skin burns and cataracts.

In response to the overdoses, the agency Tuesday unveiled an initiative that calls for “appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.”

Medical imaging machines are challenging to use because the devices don’t always provide a clear picture of what is happening during a procedure, Tetz said.

Glendale Adventist’s X-ray technicians keep logs of every procedure performed, he said. And any initiative that wouldn’t require less manual logging and set off automatic alerts would help the technicians, Tetz said.

Federal officials are also considering creating patient medical imaging history cards that would be accessed through a website and allow patients to review their imaging history.

The FDA will hold a public meeting in Washington, D.C., March 30 and 31 for input about the types of requirements needed.