Medical device manufacturers appear to be spared from a proposed rule that would require bar codes on medications and blood products used in the hospital setting at least for now. That's because the FDA is still accepting comments regarding section 301 of the Medical Device User Fee and Modernization Act (MDUFMA) of 2002. That section of the act requires devices "to bear the manufacturer's name, abbreviation or symbol."
The proposed bar code rule, published in the March 13 Federal Register, is intended to improve patient safety by reducing medication errors and by quickly identifying potential errors that could occur, according to the Department of Health and Human Services (HHS; Washington). The rules are part of the FDA's strategic initiative to reduce adverse events involving regulated products, said HHS Secretary Tommy Thompson in describing the requirements. "These proposals are key steps in reducing medication problems through using state-of-the-art technology," he said.
The rule would apply to all prescription drug products, including biological products and vaccines, and over-the-counter drugs commonly used in hospitals and dispensed in the hospital with a physician order. Samples dispensed in physician offices would be exempt. The bar code would contain the National Drug Code number unique identifying information about the drug in a linear bar code as part of the drug's label. Manufacturers would be allowed to include additional information, Thompson said. When used with bar code scanners and computerized patient information systems, bar code technology could prevent medication errors, Thompson said.
FDA Commissioner Mark McClellan, MD, welcomed the proposed rule. "[These] actions are the start of a comprehensive strategy to build a medical patient protection system for the 21st century," he said. A related proposal published in the Federal Register the same day would revamp the safety reporting requirements for drugs and biologics. Under the changes, companies would have to submit to the FDA within 15 calendar days any reports of actual or potential medication errors occurring in the U.S.
For devices, the labeling issues are a bit different. In a March 11 letter to the FDA regarding section 301 of MDUFMA, the Advanced Medical Technology Association (AdvaMed; Washington) outlined areas that it said the agency should consider. AdvaMed's primary concern over labeling deals with reprocessed single-use devices and logistical issues for small devices. AdvaMed would like the FDA to amend section 301 to apply the requirements only to single-use devices that are reprocessed, Janet Trunzo, vice president of technology and regulatory affairs for AdvaMed, said in a 12-page letter. Current regulations require single-use devices to be conspicuously labeled, and "there is no evidence to suggest that these current labeling requirements are inadequate or that end-users are confused or unable to identify the person responsible for the device for single use devices that are not reprocessed," Trunzo wrote.
Additionally, some devices are physically too small to carry the name, abbreviation or symbol of the manufacturer, according to the association, and surface properties of some devices often do not allow for legible printing, such as fabric-covered devices, meshes, sponges and resins or bone fillers. AdvaMed outlined a partial list of devices that should be exempt from labeling, ranging from anesthesiology to cardiovascular to general hospital and personal-use devices.
AdvaMed also requested in its letter that the FDA extend the implementation deadline from the current April 2004 timeframe. "Manufacturers will need at least a 12-month extension beyond the current deadline to address the requirement for the many different device types that are affected," Trunzo wrote. She also requested that companies be allowed to exhaust existing inventory and require the provision only to devices manufactured after the effective date and not to devices made prior to the effective date.
Intuitive, Computer Motion end robotics wars
In a deal that will serve to end more than two years of fierce patent infighting and put a cap on the resultant mounting legal fees the two major players in the surgical robotics sector last month said that they will combine their efforts via a stock-for-stock merger. Intuitive Surgical (Sunnyvale, California) and Computer Motion (Goleta, California) are the leaders in the development of robotics-driven technologies supporting minimally invasive systems in the OR, and they have been entangled in a series of patent suits and counter-suits that had threatened to drag on interminably. Instead, the two companies will consolidate this market, merging their complementary technologies.
Larry Haimovitch, president of Haimovitch Medical Technologies Consultants (Mill Valley, California) and an observer of this sector, said the companies had made "an incredibly great decision to stop the war and make peace. This is really fantastic for the companies and [their] shareholders." While the combination is a positive for both firms, it might best benefit Computer Motion, he told The BBI Newsletter. Computer Motion had been living "hand to mouth" and would have had to raise additional funds to get through the current year, according to Haimovitch.
Intuitive is the developer of the da Vinci system and reports its use in 100 hospitals. Computer Motion has developed the Zeus family of products, the Hermes Control Center, the Aesop Robotic Endoscope Positioner and the Socrates Telecollaboration System, and says its products are used by 900 customers in 32 countries. The merged company will be traded on Nasdaq under a symbol to be determined. It will be headquartered in Sunnyvale, with operations in both Sunnyvale and Goleta. Lonnie Smith, president and chief executive officer of Intuitive, will serve as president and CEO of the merged firm. Robert Duggan, chairman and CEO of Computer Motion, will serve on the board of the combined company.
In a conference call, Smith said he did not see any reasons why regulators would have reason to block the merger, even though the two firms dominate the surgical robotics space. Both he and Duggan stressed that their competition was not other robotics firms but rather "open surgery," and that the combined firm could now put its resources into growing this technological space. "All legal disputes and court action are stayed, pending closer of the merger transaction," Smith said at the opening of the conference call," as if to emphasize the importance of getting rid of this distraction.
Smith emphasized that what the companies would now save on legal fees would likely be enough to offset the charges that will result from integrating the two companies. That integration is expected by June, he said, but both Smith and Duggan fended off a variety of questions concerning the total valuation of the combined company and the exact positioning of the combined product lines, saying that it was too early to know some of these specifics or to disclose them.
Mark Smillie, an analyst with The Seidler Companies (Irvine, California), emphasized the over-arching importance of putting to rest the continuing litigation. "It reduces all the uncertainty out there that overhang is now gone," he said. "From the marketplace's perspective, this [merger] is great. The company can go out and compete with open surgery but more importantly focus their energies on letting the market decide whether this technology survives or not," Smillie said. He added, "I think it will survive." Comments from physicians are that guys in medical school are being taught this as standard technology. Now the companies can focus on getting the technology adopted rather than focusing on litigation."
Smith was clearly intent on not claiming the merger as a victory for either company. "Both companies have made tremendous contributions to the field by creating and delivering innovative products representing the next generation in innovative surgery," he said. And he pointed to "significant synergies via products and people. By combining the outstanding talents of our respective organizations, the respective technical sales and marketing staffs, we will provide the best possible suite of products and support to serve patients needs."
Under the terms of the definitive merger agreement, Intuitive's shareholders would receive 68% of the combined company on a fully diluted basis and Computer Motion's equity holders would receive 32%. The merger agreement exchange ratio formula anticipates that each outstanding share of Computer Motion common stock would be converted into approximately 0.52 shares of Intuitive common stock. In the event that Computer Motion's common stock trades at an average of less than $1.86 a share before the merger, the exchange ratio will be reduced, but, the companies said in a joint statement, that it "shall in no event be less than approximately 0.48."
Lifting devices key to ergonomics rules
Use of mechanical devices to lift residents in nursing homes is just one of the recommendations the government offers in its new ergonomic guidelines released last month. The U.S. Department of Labor's Occupational Safety & Health Administration (OSHA; Washington) published the first in a series of industry-specific guidelines designed to prevent musculoskeletal disorders in the workplace.
"Less than a year ago, we announced that we would work with the nursing home industry and workers to develop guidelines to reduce ergonomic-related injuries in their industry," said John Henshaw, OSHA administrator. That early collaboration is being praised by two nursing home-related organizations, The American Health Care Association (AHCA; Washington) and the American Association of Homes and Services for the Aging (AAHSA; Washington). The voluntary guidelines acknowledge the "indelible connection" between patient-handling tasks and clinical care by recommending the use of the minimum data set to assess resident handling tasks, said AHCA President and CEO Charles Roadman II, MD. The minimum data set is a federal patient assessment document required for reimbursement for Medicare patients.
"Nursing home professionals are in the business of caring for the frail, elderly and disabled," said Roadman. "When we talk about ergonomic safety for our staff, we aren't talking about moving boxes. We are talking about moving real people. We cannot ignore the clinical needs of our patients when discussing employee safety, and the OSHA guidelines recognize this."