Medical Device Daily Washington Editor
WASHINGTON — New technology marches on, and it most often marches on and over old technology, as indicated by FDA's new report that it will issue a rule for alternatives to mercury and glass in temperature detection for some types of food processing.
The proposed rule — which was not posted by press time — will "benefit both consumers and the food industry by enabling manufacturers of heat-processed, low-acid canned foods to modernize their equipment by using alternative temperature-indicating devices," onto which the agency slapped the acronym of TID.
The statement notes that the alternatives to mercury-in-glass thermometers are "state-of-the-art equipment," and that the proposed rule would "clarify such requirements as record-keeping and the rules for measuring and recording temperatures during processing."
Robert Brackett, director of the Center for Food Safety and Nutrition at FDA, said the rule will get FDA out of the way of new technology but would "ensure that these devices are accurate."
Dan Farnan, the general manager of TipTemp Products (Burlington, New Jersey), told Medical Device Daily "there's a slew" of thermal sensing devices that would be new to food producers, some of which are also new technology.
Among the existing device types is the thermocouple, which relies on the tendency of metal to develop electrical imbalances when exposed to temperature variations. Though inexpensive, thermocouples do not detect variations of less than one degree Celsius with great precision.
Resistance temperature detectors (RTDs) "are the most accurate," Farnan said, but because the sensing component is usually made of platinum, they are not cheap.
RTDs operate on an electrical principal, by gauging electrical resistance to develop a temperature correlation with temperature. The device must expose the platinum to an electrical current in order to measure the resistance, but the highest temperature at which platinum resistance devices will work is generally about 600-degrees Celsius.
"New digital temperature sensors are coming to market," said Farnan, including semiconductor thermometers, usually manufactured as integrated circuits (ICs) and often quite small. The IC works as a thermometer because the electrical conduction of semiconductors is sensitive to changes in temperature. Many of these are accurate to within half a degree Celsius, and they can be easily mated with a display unit. Thanks to the modern computer and other electronic devices in general use, these circuits are not especially expensive.
FDA said comments will be accepted for 90 days. It will allow processors to change their thermometers immediately, provided the new devices are "consistent with the proposed rule."
Children's healthcare gets failing grade
An article appearing in the current edition of Health Affairs describes current U.S. pediatric care as "patchwork of disconnected programs, policies and funding" deficient in terms of "clear accountability or performance goals," in reference to the Children's Health Insurance Program (CHIP).
Neal Halfon, director of the Center for Healthier Children, Families and Communities at the UCLA School of Public Health, and co-authors note that childhood obesity rates have doubled since 1987 and the incidence of mental health and behavioral problems has risen to more than 20% of the current generation of minors, and that these are "chronic conditions that will impact them for the rest of their lives." They argue that "[t]hese emerging health needs are simply not being addressed."
The authors attribute the problem to a system that is designed to deal with the kinds of public health problems of the early 20th century, but the conquest of poliomyelitis and the whooping cough are yesterday's news."
The authors liken U.S. child care in the U.S. to a modern business "ignoring the Internet, Windows and new Pentium processors" and running operations on first-generation computers.
Budget problems on the state level are causing hand-wringing among legislators responsible for funding their share of state CHIPs (SCHIPS). And they recommend consolidation of the various pediatric programs into one program.
At present, Uncle Sam provides $5 billion a year for the SCHIPs. But the program is up for reauthorization, and legislators disagree about the merits of the approach advocated by the White House, which wants to take adults off the SCHIP rolls.
Up to 35 states will have to come up with more money for their programs by 2012 unless Congress provides added revenue. According to figures provided by the Congressional Budget Office, federal contributions will have to increase more than $13 billion over the next five years over current levels to avoid coverage reductions. The White House budget proposes an increase of $4.8 billion over five years.
SCHIPs are designed to provide coverage to children who are part of a family whose income is lower than 200% of the federal poverty level or 50% higher than that state's Medicaid eligibility threshold. Some states have expanded CHIP eligibility beyond the 200% FPL limit, and others are covering entire families and not just children.
Some congressional Democrats want to boost funding another $745 million beyond the White House's proposed budget for the current fiscal year by tagging a bill onto a bill for the Iraq war spending.
Max Baucus (D-Montana), who chairs the Senate Finance committee, recently said that he will seek to boost CHIP funding to $75 billion for the next five years, more than double the White House proposal.