Mammography systems operating in the U.S. must meet stiffer performance regulations beginning Oct. 28, 2002. If they don’t, the FDA will shut them down as part of the mandate contained in the Mammography Quality Standards Act (MQSA).The
Mammography systems operating in the U.S. must meet stiffer performance regulations beginning Oct. 28, 2002. If they don’t, the FDA will shut them down as part of the mandate contained in the Mammography Quality Standards Act (MQSA).
The requirements, which address radiation output, compression force, and other technical aspects of breast imaging, will pertain to an estimated 10,000 centers that provide mammography in the U.S. Administrators at these centers have known about the deadline for years, and nearly all will be in compliance, the FDA predicted.
“Our evidence indicates it won’t be a big issue,” said Charles Finder, associate director for policy and clinical affairs with the FDA’s Division of Mammography Quality and Radiation Programs. “There probably will be a couple older units out there that won’t meet the requirements, but the vast majority of machines shouldn’t have any problems.”
The reason most facilities will breeze through the deadline without incident is that they will have bought new systems or upgraded old ones, according to industry sources.
“There was quite a spike in 1999,” said Jack Cumming, president of Lorad. “That first wave took out of circulation a significant number of systems that did not meet the requirements. The rest will be taken out in 2002. We’re anticipating a very healthy increase in our sales because of this.”
The initial surge came shortly after the FDA issued a guidance in April 1999 clarifying MQSA rules. Neither Cumming nor others interviewed would say how many additional systems the industry might sell as a result of next year’s deadline for final compliance, but there is general agreement that the increase will be short-lived.
“We anticipate a bubble of purchases, similar to the effect seen in 1999,” said Samantha Allison, general manager of women’s healthcare business for GE Medical Systems. “Customers are either purchasing equipment today that conforms with pending regulations, or they are seeking our assistance in budgeting for purchases over the coming year.”
Allison added that GE is offering aggressive trade-in programs so that customers can acquire equipment that conforms - or even consider making the transition to GE’s full-field digital mammography system.
Siemens Medical also expects an increase in sales, one that may be felt industry-wide over the next 18 months.
“There will have to be an upswing, because there are a number of older systems out there,” said Joanne Scott-Santos, women’s health product manager for Siemens. “I think we all anticipate some increased volume. I’ve noticed many more inquiries from customers regarding the new regulations. The industry is getting ready, as are consumers.”
Instrumentarium also finds reason to be optimistic.
“Interestingly, I’ve seen evidence of radiology departments using those regulations as leverage to replace mammography systems when they may have trouble justifying it otherwise,” said Donald Blomstrom, vice president of mammography in the U.S. for Instrumentarium.