The effort to reclassify bone growth stimulators (BGSs), undertaken last month by RS Medical (Vancouver, Washington), seemed to progress fairly well despite a large party in opposition at the June 2 meeting of the orthopedic and rehabilitation devices panel of the Center for Devices and Radiological Health. The first round of voting by the panel seemed to favor the petitioner’s position, albeit by a narrow margin, but in the end, differences of opinion on engineering between an FDA engineering expert and two orthopedic surgeons on the panel derailed the effort. And that left the makers of this class of devices in need of a pre-market application approval to get a new machine to market, regardless of any similarities with existing technology.
The effort to reclassify bone growth stimulators included only two modes of field generation, namely capacitive coupling (CC) and pulse electromagnetic field (PEMF). At present, the five PMAs in existence for these machines cover both these technologies as well as a combination configuration known as CMF. The two indications applied for were treatment of established, non-union fracture secondary to trauma and as an adjunct to lumbar spine fusion surgery. The five existing PMAs cover both these indications along with treatment of congenital pseudoarthrosis and as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
The opposition to reclassification included officials from Healthonics (Bethesda, Maryland) and dj Orthopedics (now DJO; San Diego). Both firms manufacture bone growth stimulators.
Representing dj Orthopedics, Gary Friedlaender, MD, professor of orthopedics at Yale University School of Medicine (New Haven, Connecticut), said that the proposed reclassification of BGS machines was “unwarranted, potentially problematic and risky” because the 510(k) process was inadequate to deal with risk when a “direct biological effect was involved.”
Barbara Boyan, PhD, a professor of biomedical engineering at Emory University (Atlanta) and a co-founder of OsteoBiologics (San Antonio), also advocated against reclassifying BGSs, insisting that the petition “does not meet FDA’s regulatory requirements” in part because the petition covers two modalities and two indications.
James Ryaby, PhD, vice president of Orthologic and an adjunct professor of tissue engineering at Arizona State University (both of Tempe) argued that the application did not fulfill FDA’s request for “a range of technical specifications and that “seemingly minor changes to these waveforms” can have meaningful impacts. He said that the difference between a wave generated with 14 and 15 hertz could influence calcium uptake and that there exists “no adequate public database” defining the required signal to achieve the desired effect.
In rebuttal, Robert Sheridan of Sheridan Consulting (Wilmington, North Carolina) answered one of Ryaby’s complaints by noting that FDA does not require the kind of device specifications Ryaby discussed if the devices “do not differ significantly in purpose.” Sheridan pointed out that FDA had not required new clinical trials for the reclassification of pedicle screws, which also are used for spinal fusion, and that the agency had already concluded that bone-growth stimulators employing CC and PEMF sources “do not differ significantly” as they employ “essentially the same mode of action” and “the same risk.”
Sheridan said that the petitioner recognizes that a change in signal can impact the process of bone healing, but insisted that the review process under 510(k) would ensure that “the public will not be exposed” to unsafe devices because of design specification re-quirements under quality systems regulations.
Edmund Frank, MD, a professor in the neurological surgery department at Oregon Health & Science University (Portland) said that the petition included 41 studies for a total of 6,500 subjects and that 28 of those were prospective studies, a feature that the opponents of classification claimed was wanting. Of the non-union studies, outcome measures were said to have included radiological and clinical definitions of union, and some of the studies included controls as treated by sham devices.
Frank said that the 29 clinical studies for treatment of non-union fractures included more than 5,300 subjects and that 19 of those were prospective studies.
Christine Brauer, PhD, of Brauer Device Consultants (Bethesda, Maryland), speaking for the petitioner, argued that risks associated with BGMs are “typically transient” in reference to the risks of electrical shock, burn and skin irritation/allergic reaction. She added that general controls for devices, such as design validation and specific inputs and outputs generated by a specific design were sufficient to deal with many of the concerns associated with the 510(k) review process.
Michael Janda of the orthopedic devices branch at CDRH addressed a number of issues in connection with current BGS devices, including adverse events. These included two reports of death in connection with BGSs, both of which involved patients with implanted cardioverter defibrillators. No causal connection was made between the BGS and these two deaths, however.
Sheridan told Biomedical Business & Technology that while “it would have helped” to have had more corporate backing for the reclassification effort, he nonetheless was of the opinion the principal problem was not that of sufficient industry interest in reclassification. “I don’t think the panel understood” that a clinical trail would have been more than adequate to deal with the concerns raised by the opponents of reclassification, Sheridan said.
Guidant’s more pointed warning letter never mailed
Boston Scientific (Natick, Massachusetts) took on the potential for large legal liability fees when it acquired Guidant (Indianapolis) this past spring. And those costs may have ballooned considerably in early June with the forced release of company documents indicating that it had composed a letter warning physicians concerning malfunctions of its implantable defibrillator devices but then didn’t put that letter in the mail.
The unmailed letter was among documents in the case unsealed – over the company’s objection – in relation to a product liability lawsuit in Texas. The letter is being interpreted as the company’s acknowledgement that the company was aware of the malfunctions but had decided to send only a standard warning to doctors that encouraged only increased monitoring of patients implanted with the devices.
The letter it did send constituted a routine “product update,” coming after the company learned of a short-circuiting problem that had occurred in some units of two defibrillator models and is being linked to a variety of malfunctions and, in some cases, deaths.
The unsealed documents indicate that the rationale by Guidant executives not to issue a more pointed and aggressive warning about the malfunctions was that they feared creating “undue alarm” about the problem and that it would lead to a flood of surgeries to remove the devices – surgeries which themselves carry a considerable risk. That choice appears to leave the company more susceptible to the allegations made by plaintiffs that it continued to sell the potentially malfunctioning devices that it had in inventory.
The details of what the company knew about the malfunctions, when the problems were known, the timeline and contents of notices issued by Guidant and the timelines employed in the withdrawal of the defective line of products clearly will provide a variety of much hair-splitting debate in upcoming legal actions. These actions include various individual liability lawsuits, dozens of class-action suits, as well as ongoing investigations by the Department of Justice and the FDA.
The unsent warning letter was one of 22 documents order unsealed by Judge Jack Hunter in Corpus Christi Texas, overruling the contention by Guidant that the documents contained trade secrets. Paul Donovan, spokesman for Boston Sci, confirmed that the warning letter drafted was never sent.
The documents unsealed and yet to be released related to a liability case set to go to trial Sept. 18 in Neuces County District Court in Corpus Christi, Texas. It is the first such case and was brought by Louis Motal and Beatrice Hinojosa, two patients implanted with Guidant’s Ventak Prizm 2 defibrillators. They allege Guidant knew the devices might fail but didn’t warn patients.
HIMSS, AFEHCT merge for broader impact
The Healthcare Information and Management Systems Society (HIMSS; Chicago) and the Association for Electronic Health Care Transactions (AFEHCT; Washington) last month reported plans to merge, the new entity to be known as the HIMSS AFEHCT Business Information Systems Initiative. According to a press statement unveiling the link-up, the merger combines the “subject matter expertise of AFEHCT with the organizational strength of HIMSS” to maximize their influence on policy affecting e-commerce, healthcare transactions and clinical information systems.
HIMSS, founded in 1961, has roughly 17,000 members representing more than 275 member firms that employ more than a million people. AFECHT came into being 31 years later, in 1992, formed by software vendors and other business entities largely in response to the passage of a number of bills that affected clinical data processing systems. (This data coming from the announcement of the merger.)
Steve Lieber, president and CEO of HIMSS, told BB&T that the merger between the groups took shape fairly rapidly. “The first conversation [on the merger] would have been in mid-January,” he said, adding that the fusion of the two groups “speaks to the commonalities” they share regarding the increasing overlap between information technology and healthcare.
The toughest part of this marriage, he said, was “being respectful of history and volunteer roles” at AFEHCT. Thus, the new organization has set about ensuring that HIMSS does not entirely “swallow up” the smaller AFEHCT and “make it disappear.”
dj Orthopedics renamed DJO
dj Orthopedics (San Diego), a provider of products and services that promote musculoskeletal health, said it has changed its name to DJO to better reflect the diversification of its business beyond the original DonJoy brand. In connection with the name change, the company also launched an enhanced corporate web site at www.djortho.com.