ADAC documentation undergoes review prior to resumption of nuc med shipments

Voluntary suspension should end in early 2002

As 2001 drew to a close, ADAC staff were reviewing documentation involving manufacture of the company's nuclear medicine equipment. Completing the review will be a major milestone on the way to resuming shipping of ADAC equipment. The future of this equipment has been in limbo since ADAC's parent company, Philips Medical Systems, declared a voluntary suspension in late November. Philips executives believe shipments will begin moving again in January.

"We are not going to release the products until we feel we've done a thorough assessment of the quality system records for each product and resolved any issues about which the FDA may be concerned," said Jeffrey W. Nelson, general manager for nuclear medicine at Philips. "We believe we are very close to achieving that."

According to Philips, the agency is allowing the company six months to review its internal verification and validation processes and correct any deficiencies. Philips is going a step further, however, and is reviewing ADAC's entire quality system, said John Allison, vice president of regulatory affairs. Philips plans to contact the FDA when the company is ready for a follow-up inspection. Shipments will likely begin, however, long before this inspection is completed.

Philips voluntarily stopped shipping nuclear medicine equipment from its Milpitas, CA, facility Nov. 12, after the company was informed that FDA field investigators had identified deficiencies in ADAC's internal verification and validation processes. The deficiencies were identified during a regularly scheduled facility inspection.

"Our customer service philosophy since then has been, 'We understand there's a problem that's caused an inconvenience for you. What can we do to alleviate the current situation?'" Nelson said.

Since the voluntary shutdown began, Philips has tried to keep prospective customers happy by offering them an array of alternatives. In most cases, these efforts have been successful, according to Nelson. More than 95% of prospective ADAC customers have chosen to continue working with Philips during the voluntary suspension.

Most simply chose to wait for the products they originally ordered, according to the company. Others, who needed equipment immediately, were offered loaners, usually manufactured by the Marconi component of Philips, which was acquired in November. Some of these have since opted to keep the Marconi equipment, finding that these systems meet their needs, said Josh Gurewitz, Philips' senior director of marketing for nuclear medicine and PET. In a few cases, Philips sold customers Marconi equipment from the get-go.

In some cases, no substitution has been possible. There are no commercially available systems comparable to the ceiling-mounted, open-style Skylight, for example. Thus, no Marconi camera can replace this system, which has been the most popular of all ADAC cameras ordered since the voluntary suspension began. ADAC's dual-head Forte and Vertex cameras have also been popular, but the Marconi Axis is a viable substitute for those, Gurewitz said.

Gurewitz, formerly an executive in Marconi's nuc med business unit, scoffed at calling the Marconi line a "compromise." Rather, he said, the equipment fills a variety of niches that capture between 10% and 12% of the market.

When the dust clears, everyone involved may benefit: ADAC, whose voluntary suspension was at least a good public relations move; Marconi, whose products have received added exposure as loaners to ADAC customers; and Philips, which owns both companies and has proved the merits of having a broad-based product line.

The ADAC hiatus has proved that Philips' purchase of ADAC and Marconi gives it considerable flexibility in meeting customer demand. It has also provided Philips a chance to evaluate ways to integrate its newly acquired nuc med products.