A patient at a veteran's hospital in the Bronx was killed Wednesday when a large piece of diagnostic equipment fell on him in what experts called a rare accident.
The 66-year-old victim was undergoing a procedure using a gamma camera at the James J. Peters VA Medical Center when the apparatus apparently collapsed and crushed him, officials said.
In a statement, a spokesman for the medical center said the camera was installed in 2006 and was maintained by its manufacturer. "This is a very tragic and unusual event and the details are still unfolding," said Jim Connell, a hospital spokesman.
He declined to identify the patient, citing privacy laws.
According to the New York Fire Department, a 911 call for an ambulance came from the hospital on West Kingsbridge Road at about 12:30 p.m. on Wednesday, but was quickly called off. A spokeswoman for the New York City Medical Examiner said an autopsy hadn't yet been completed and that the victim hasn't been formally identified by next of kin.
An official with knowledge of the matter said the camera was a Infinia Hawkeye 4 model, manufactured by General Electric Co. The Hawkeye line is one of the largest on the market and can weigh more than 5,000 pounds.
Mr. Connell said the camera had been used in diagnostic procedures "without incident."
"Our first concern is for our veteran patient and for their family," Mr. Connell said in the statement. " We are in the midst of conducting an investigation and when we have a conclusive report, we will provide more information."
GE Healthcare learned of the incident from the VA, and a company "team has responded and is supporting the ongoing investigation," said Benjamin Fox, a GE spokesman. He didn't respond to questions about whether the company had seen similar failures elsewhere.
Nuclear-medicine physicians use gamma cameras to scan organs such as the lungs and kidneys, and other tissue deep in the body. Doctors inject patients with radioactive fluids; the gamma camera tracks the location of those drugs within the anatomy by collecting radiation they emit from inside the body. By contrast, X-rays fire radiation at the body from the outside to create images. Virtually all major hospitals use gamma cameras, which are a staple of nuclear medicine departments, said Jamie Dildy, an analyst for MD Buyline, a health-care equipment and technology research firm. New models, manufactured by the health-care units of Siemens AG, General Electric and Philips Electronics NV,typically cost between $300,000 and $800,000, she said.
Gamma cameras, which have been in use since the 1960s, consist of large panels of crystal that convert the rays to light. The rest of the device takes a digital picture of the light, not unlike a traditional camera.
The panels, which are often designed to rotate around a prone patient, are generally insulated with thick layers of lead that focus the gamma rays. They weigh "hundreds and hundreds of pounds," said William Spies, a professor of radiology at Northwestern University Feinberg School of Medicine.
But accidents are unusual. "I've been doing nuclear medicine since 1974," Dr. Spies said. "I remember one other incident where a gamma camera fell on a patient." Even that was a long time ago, he said.
In the wake of a fatal accident in which a patient was crushed by one of its gamma cameras, GE Healthcare has advised users of many of its nuclear medicine systems to stop using the products until they have been inspected by GE service engineers.
The GE letter was accompanied by a July 3 notice from the U.S. Food and Drug Administration (FDA), advising U.S. healthcare sites that GE is "voluntarily recalling" the systems. "Serious injuries or deaths could occur due to the failure mode associated with this recall," states a copy of the recall letter obtained by AuntMinnie.com.
The recall follows an accident that occurred on June 5 at the James J. Peters Veterans Affairs Medical Center in New York City, when an Infinia Hawkeye 4 gamma camera collapsed and fellon a patient, killing him.
GE's investigation into the incident has determined that bolts securing the system's camera to its gantry were loose, "thereby stressing the support mechanism and resulting in the incident," according to the recall letter.
Because of the similarities in the design of support mechanisms across many GE products, the FDA has concluded that the following systems should be included in the recall:
- Infinia and Infinia Hawkeye nuclear medicine systems of all types and manufacturing dates
- VG and VG Hawkeye nuclear medicine systems of all types and manufacturing dates
- Helix nuclear medicine systems by Elscint of all types and manufacturing dates (GE acquired Elscint's nuclear medicine business in 1998)
- Brivo NM615, Discovery NM630, Optima NM/CT640, and Discovery NM/CT670 systems, which have been added to the recall "due to similarities in basic mechanical concepts between these devices and the Infinia systems," the FDA letter said
An FDA spokesperson estimated that about 3,400 systems are affected by the recall.
GE originally sent a letter on June 13, the week after the incident, recommending that "qualified service personnel" maintain the equipment and perform preventive maintenance procedures. It then updated that advice with a letter last week advising customers that "all sites cease use of their nuclear medicine system until GE Healthcare can complete an inspection of their individual equipment."
GE engineers will inspect systems to verify that the support mechanism fasteners are secured properly, and sites will be able to resume use of their devices if no issues are found with the support mechanism fasteners, according to Benjamin Fox, GE public relations manager for the U.S. and Canada.
If engineers find an issue with the support mechanism fasteners, GE field service engineers will coordinate the replacement of affected parts and ensure that the system meets all specifications. In these cases, customers should not resume using the camera until the problems have been corrected. GE will fix any affected systems at no cost to customers.
This week's recall is unrelated to a recall of some GE gamma cameras in April 2013. An FDA spokesperson did not have details on that recall as of press time.
The recall is causing a ripple effect internationally, as several regulatory bodies in other countries are advising healthcare providers about the issue. Regulatory authorities in Hong Kong and Australia have issued advisories about the recall.
