FDA safety alert for Park cameras creates hardship for installed base

Warning could be windfall for other camera firms

Owners of gamma cameras manufactured by the defunct Park Medical Systems have yet another reason to fret after the Food and Drug Administration last month advised users of Park's Isocam II systems to take the cameras out of service. The FDA's safety alert was issued after the failure of an Isocam II system installed in the U.K. (SCAN 3/4/98).

Park went out of business last year after failing to generate enough sales for its variable-angle dual-head cameras. Although the company's technology was well regarded, Park encountered resistance from prospective customers who were reticent about buying expensive technology from a small firm, especially during a market slump such as that experienced in nuclear medicine in the mid-1990s.

Park's failure left its installed base in the lurch with respect to camera maintenance, but some facilities have been able to turn to multivendor service programs offered by other companies, such as ADAC Laboratories. The FDA's alert creates a whole new level of problems for Isocam II users, however.

In a letter to Isocam II owners released on March 12, the FDA cited a preliminary analysis of the U.K. incident conducted by the U.K. Medical Devices Agency and Park Medical Systems Ltd., a Park distributor in the U.K. that is no longer connected to the camera manufacturer. In the incident, a stainless steel plate from a harmonic drive motor on an Isocam II failed, causing an arm of the system to fall onto the camera's gantry housing. There was no patient in the camera at the time of the incident.

The MDA and Park U.K. have concluded that the Isocam II system is unsafe for clinical use and will require engineering modifications to render it safe, according to the FDA's letter. The FDA has been unable to obtain a copy of the incident report because Park U.K. does not conduct business in the U.S. In the absence of any other information about the incident, the FDA is recommending that Isocam II cameras be pulled from service until further notice, according to Larry Kessler, director of the FDA's Office of Surveillance and Biometrics.

Kessler said the FDA recognized that the alert is a hardship for Isocam II owners, but the agency was forced to act due to the potential for patient injury if a camera failed during an examination and the heavy detector-head arm fell on the patient table.

"We are putting hospitals in an untenable liability situation, because we're telling them (the cameras) are not safe," Kessler said. "A failure isn't likely to occur, but if it does occur, (patient) death is almost certain."

Under normal circumstances, the FDA would notify the manufacturer and order it to fix the problem. Because Park is no longer in operation, however, the burden of repairing the system falls to hospitals. Sixteen Isocam II cameras are installed in the U.S., Kessler said.

A crippled workhorse. One Isocam II is installed at Cedars-Sinai Medical Center in Los Angeles. Cedars-Sinai was one of the original Isocam II beta sites, and has had its system installed for over three years. The hospital decided to immediately pull the system from use once it received the FDA's letter, and is planning to acquire a new camera to replace it, according to Jim Bietendorf, manager of the hospital's nuclear medicine department.

The withdrawal of the system has caused considerable disruption in Cedars-Sinai's nuclear medicine department, Bietendorf said. The camera was a workhorse in the department, handling an average of 10 studies a day that now must be shifted to other systems. Fortunately, Cedars-Sinai operates eight other gamma cameras, enabling the facility to spread the load across many systems. Other Isocam II users with fewer total cameras may not be so lucky.

"We're not in such bad shape. If you had only two cameras, you've lost half your cameras," Bietendorf said. "For some people that was their only camera."

Rumors have been floating that Park's assets are about to be acquired by another vendor that could repair the cameras and put them back in service. Park's assets are being sold off by Ernst & Young of Montreal, Quebec, which is acting as trustee for the court in which Park filed for bankruptcy. An Ernst & Young spokesperson declined to comment on whether a sale is imminent, although he did confirm that the divestiture process is ongoing.

Cedars-Sinai has decided to acquire a new system rather than await this outcome. Bietendorf has received approval from hospital administration for an emergency purchase, and is soliciting bids from major gamma camera manufacturers for a new system. The hospital hopes to have a replacement installed in the next 60 to 90 days.

Other gamma camera companies may experience a small spurt in purchasing as other facilities replace their Isocam II systems. Any such boom is likely to be short-lived, however, as only 30 Isocam II units are estimated to be installed worldwide.

Ironically, Bietendorf and Cedars-Sinai had a positive experience with their Isocam II, despite the trials and tribulations experienced by the camera's manufacturer.

"They're good cameras," Bietendorf said. "Park made a good product."

The FDA's Kessler said that hospitals can get their Isocam II systems back into service by conducting an engineering analysis of the system's problems and developing a plan for fixing them. If the FDA accepts the engineering plan, the hospital would be able to put their Isocam II back into service after conducting the proposed modifications.

Like Cedars-Sinai, however, most hospitals seem to be planning to purchase new cameras rather than repair their Park units, according to Kessler.

"They're pretty upset," he said of the Isocam II owners. "This is pretty expensive stuff."