Radio Check, Good Buddy?
New Telemetry Rules Forcing Healthcare to Grow Up
Healthcare is getting a home of it’s own in the radio frequency spectrum (see July/August, page 7), but with ownership comes added responsibility, so the FDA issued a public health advisory to hospitals and nursing homes on July 10, warning they could lose their current borrowed bandwidth very, very soon.

“We recommend that you determine if your wireless medical telemetry systems are at risk of electromagnetic interference and take the appropriate action if necessary,” reads the advisory. “In doing this, we recommend that you consult with the telemetry equipment manufacturer. This action should include, at a minimum, determining at which frequencies your telemetry systems are currently operating and comparing that data with the frequencies allocated to digital television in your area and the PLMRS [Private Land Mobile Radio Service] band.”

TV gets the most press, but the biggest problem lies in the popular 450-470 MHz range where the presence of medical telemetry prevented the primary users of the spectrum, the PLMRS (two-way business radio), from expanding. Now that telemetry enjoys designated bands, the FCC will lift the five-year-old freeze on new two-way frequency assignments. Medical telemetry systems that interfere with business users must clear the air. The FCC will begin accepting operating license applications for PLMRS users in the 450-460 MHz telemetry band on Jan. 29, 2001, and applications for the remaining 460-470 MHz. region three years later.

Older equipment has a mixed fate. The FCC’s Hugh Van Tuyl explained, “We set a deadline of two years, after which we will no longer issue equipment approvals for medical telemetry equipment operating in the TV or the Private Land Mobile Radio Service (PLMRS) bands. Equipment approved in those bands before the deadline may be manufactured, sold and operated indefinitely.”

So older designs may remain on the market and it will be up to the customer to determine if that equipment is safe from interference and appropriate for use. The FCC isn’t forcing hospitals to replace working equipment.

The FDA recommends moving to new telemetry frequencies if a spectrum audit reveals conflicting TV or two-way allocations, and the FDA suggests using equipment designed to operate in the newly designated telemetry bands when possible.

For the purpose of regulation, the FCC considers the new Wireless Medical Telemetry Service to be an extension of the notorious Citizen’s Band. Facilities that meet the strict FCC definition for healthcare telemetry can operate on the new frequencies without a license. Instead, facilities must register with a private “Frequency Coordinator.” The Coordinator has not been crowned, but it will be free to set its own fees for telemetry registration. Equipment operating under the previous rules will not need registration.

Verdict Validates Indie Software Service
A six-year battle between a vendor of mainframe business software and the company contracted by customers to make it work ended when a jury found in favor of Grace Consulting Inc. of Parsippany, N.J. on June 2.

Grace started an alternative maintenance program for accounting and payroll products sold by Dun & Bradstreet Software. Grace said its service attempted to make D&B’s COBOL application more compatible with customers’ systems. D&B fired off a suit in 1995 that claimed Grace violated copyright laws by altering source code.

Dun & Bradstreet Software was acquired by Geac Computer Systems Services Inc. (Toronto) in 1996 and Geac continued the case. Geac is estimated to hold 70 percent of its segment of the accounting and payroll market.

Grace accused Geac of using copyright law to monopolize service. “Most of Geac’s revenue from its products is derived from maintenance payments,” argued Grace. “Its base of legacy customers is decreasing, creating pressure to generate additional revenue from its existing base of customers.”

Geac countered that Grace violated copyright law by writing fixes for 2,000 Geac customers that allowed the COBOL apps to be used after Y2k.

The Federal Court jury in New Jersey returned a unanimous verdict in favor of Grace.

Said Grace, “The verdict confirms the recognized computer industry custom and practice that licensees may obtain third-party assistance in using and maintaining their licensed software. This will allow further compensation for software maintenance and will likely result in lower prices by providing customers with alternative sources of maintenance.”

Trex Medical
Hologic ended months of speculation and offered to buy much-troubled imaging manufacturer Trex Medical from its parent Thermo Electron for approximately $55 million.

Trex has two major sites which will remain in their current locations: Danbury, Ct., for mammography systems and Littleton, Mass. for general radiography. The proposed acquisition does not include Trex’s dental imaging business.

Hologic CEO and chairman David Ellenbogen said he’s been courting Trex for three years. “Trex’s mammography products go well with our bone densitometry product line and clearly puts us in a commanding position worldwide in the field of capital equipment for women’s health.”

Ellenbogen said Trex’s investment in digital mammography will be scrapped in favor of technology developed by another Hologic acquisition, Direct Radiography Corp.

“We’re viewing this as starting the process from scratch,” he said. “This acquisition fits beautifully with the one we made a year ago with DRC … What we’ll try to do is accelerate the availability of the amorphous selenium plate from DRC and use that in a PMA submission.”

Ellenbogen said Hologic expects to show digital mammography at the Radiological Society of North America meeting in November and tentatively plans to submit for pre-market approval from the FDA in 18 to 24 months.

d01b.jpg (7764 bytes)Brotherly Links

The crabby crawler gets miffed when a site takes minutes to load and produces nothing but outdated information and unlinkable links. Sure, it takes effort to keep a site up to date, but the whole point of the Web is providing timely information in a user-friendly format.

The Philadelphia Area Medical Instrumentation Association (PAMIA) does it right. The scrolling surfer was pleased to find PAMIA’s easy to navigate home page with no banner ads and some very useful hotlinks. “Now we’re getting somewhere,” thought our cyber scavenger.

There’s a calendar of PAMIA meetings, an employment section for Keystone-state specialties, and the tech tips section holds the composite cleverness of PAMIA members. And it’s current — including a hotlink to the FCC’s site on medical telemetry.

Eschewing fancy graphics and slick images, PAMIA gave our cyber chomper a mouthful of useful, timely and easy to find information.



d01c.jpg (10579 bytes)Recovering the satellites
Iridium was created with a grand multibillion-dollar plan to provide world-wide telephone coverage using a majestic constellation of low-orbiting satellites, and it worked — except there wasn’t enough customers willing to pay $9.00 a minute for an Iridium call. The company filed for bankruptcy in August 1999 and after a year of near-saves, Motorola, which had been operating the satellites for Iridium, announced it is shutting down the service and reprogramming the spacecraft to "deorbit" — the politically correct way of saying Iridium is about to become the biggest bombardment from the heavens since the War of the Worlds.

It will take nine months and $30-50 million of Motorola’s money to alter software controlling the thrusters on Iridium satellites so they will fire and gradually lower the constellation into Earth’s atmosphere where it will burn-up over the course of two years.

Deorbitting is not altogether unusual and Motorola originally planned to bring down Iridium spacecraft at the end of their eight-year operational life.The U.S. Space Command and amateur satellite spotters say 14 Iridium satellites cannot be controlled and may remain in orbit for hundreds of years. As the other 76 space orphans plummet to a fiery funeral, a few chunks are bound to get through with unpredictable results. "Once an object enters the atmosphere," Space Command’s Major Perry Nouis told the BBC, "depending on the aerodynamics it can go off in different directions."

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d01e.jpg (7532 bytes)NEW ZEALAND
It’s a good time for in-house in New Zealand. There aren’t enough qualified biomeds to fill field service vacancies, so in-house groups are winning local and national contracts to support private hospitals and equipment suppliers.

Murray John, a biomed manager for Auckland Healthcare Services, explained, “The major in-house groups provide a comprehensive and wide-ranging service and, in reality, due to the remoteness of New Zealand from the international OEMs, these groups have filled the role of efficient and cost-effective multivendor service providers for many years.”

There is only one domestic medical device manufacturer in the country, so most service calls require dispatching a tech from Australia — or occasionally even the U.S.A. — and Kiwi service groups rely on overseas manufacturers for test equipment and spare parts. This has inspired the exploration of alternatives, such as using a second source when local equipment agents do not keep a required part in stock.

Electrical power in New Zealand is typically 230 VAC at 50 Hz.

John said the composition of an in-house biomed department depends on the individual facility. For example, in Auckland there are facilities with 40 biomeds on staff, while smaller operations may combine a limited in-house team with a mix of manufacturer and third-party service.

The majority of New Zealand’s hospitals are government-support through the Health Funding Authority (HFA) and there are private hospitals funded by private medical insurance. The number of private community-based medical centers is increasing, and the public institutions have seen a great deal of effort over the 5-8 years to adopt successful commercial practices.

New Zealand has produced a plethora of great distance runners, but biomed is facing a hurdle that gets harder to jump every day. As international manufacturers consolidate, local reps are eliminated, and biomeds must learn to “do-it-yourself” according to John. So far, manufacturers have not seriously attempted to market multivendor service.

Hospitals in this nation of islands are working towards international accreditation. For example, in-house groups in Auckland and Christchurch are ISO 9002 registered. Many Kiwi biomeds get their training in the military, and although there is no national organization to representing biomed techs, clinical and biomedical engineers can join the Australasian College of Physical Scientists in Medicine.