Many computer users may have avoided the dreaded Conficker worm, but now comes news that it has infected medical devices at dozens of hospitals around the world. About a month ago, worm watchdogs observed an imaging machine accessing the Internet for instructions, likely from the Conficker creators. The researchers eventually found that more than 300 medical devices had been compromised. The machines all had several things in common: first, they were not supposed to be connected to the Internet, but somehow they were. Also, they were running unpatched versions of Microsoft Windows.
The typical solution would be to install a patch from Microsoft, but the device makers said that FDA rules prevent them from patching machines without 90-day notice. One wonders if FDA plans to make exceptions.
UPDATE: FDA’s John Murray says that FDA rules do not generally prevent the installation of software patches. See question 7 in the Cybersecurity for Networked Medical Devices Containing Off-the-Shelf (OTS) Software guidance.
Joining the chorus of many organizations, the Institute of Medicine has called on doctors to stop accepting gifts from drug companies and device makers. The Institute released a report, Conflict of Interest in Medical Research, Education, and Practice, that says Congress should pass legislation requiring device makers to publicly disclose all payments made to doctors, according to the New York Times. Such legislation has already been proposed by Senators Grassley and Kohl.
Additionally, the report recommends that device makers should lessen their influence by eliminating their financing of refresher courses for doctors. However, Jack Lewin, MD, chief executive of the American College of Cardiology, tells the Times that without the financing, it may be difficult for doctors to keep up with the pace of scientific progress. “I think industry has some responsibility toward education,†he says.
Both industry organization AdvaMed and the state of Massachusetts have been at the forefront of this movement. AdvaMed recently amended its code of ethics to discourage gifts from industry to healthcare professionals, while Massachusetts passed legislation that requires gifts of more than $50 to any doctor to be disclosed.
According to the Hartford Business Journal, Connecticut is also considering adopting the gift laws enacted by its New England neighbor.
There will be no time for Kansas governor Kathleen Sebelius to celebrate her confirmation as HHS secretary. The Democrats urged a quick vote on the nominee, according to the Kansas City Star, so that she can immediately address the swine flu emergency.
Although many Republicans disagree with Sebelius’ proabortion stance, the governor managed to capture 65 votes from the 100-seat Senate, the Star says.
Stephen J. Ubl, president and CEO of AdvaMed, issued a statement congratulating Sebelius. He says, “Her experience as Kansas’ chief executive, where she has earned a well-deserved reputation for bipartisanship, and her 8 years as that state’s insurance commissioner, will serve her well as she assumes a crucial role in the President’s efforts to improve the U.S. health care system.”
The US-China Joint Commission on Commerce and Trade’s (JCCT) Pharmaceuticals and Medical Devices subgroup recently met to discuss medical devices, reports AdvaMed.
Officials of the U.S. Department of Commerce and China’s State Food and Drug Administration (SFDA) have agreed to harmonize standards for medical devices being developed, so that China can become a more successful player in the medtech sector.
In the talks, the two parties discussed ways to further streamline China’s device registration process. China’s SFDA delegates explained their country’s new adverse event reporting regulation.
A French company is designing an innovative artificial larynx made of porous titanium and is preparing for its first in man trial. ProTip SAS, based in Strasbourg, has just raised $1 million euros in funding from angel investors and entrepreneurs. The financing will go toward finishing the development of the artificial larynx and the trial. According to the company, the implant is a breakthrough product, because there’s no such prosthesis available today. So far, ProTip has validated the biocompatibility and cell colonization of the porous titanium used in the implant. It also recently started marketing a thyroplasty prosthesis for laryngeal surgery and is in the final design phase of its phonatory implant. In addition to throat applications, ProTip is developing porous titanium implants and prosthesis for the ear and nose.
Complications that arise during implantable cardioverter-defibrillator (ICD) procedures may have something to do with the type of doctor that implants the device. A study published in JAMA finds that when a nonelectrophysiologist implants a defibrillator, procedural complications are more likely to occur. This is troubling giving that a significant number of these procedures are done by noneletrophysiologists. Out of the 111,293 ICD procedures examined in the JAMA study, 21.9% were performed by nonelectrophysiologist cardiologists, 1.7% by thoracic surgeons, and 5.5% by other specialists.
The JAMA study found another strike against nonelectrophysiologists. Based on its sample of procedures, It concluded that those doctors were less likely to give qualified patients cardiac resynchronization therapy (CRT-D) than electrophysiologists.
Criminal investigators with the Defense Department are searching the U.S. headquarters of Siemens Medical Solutions in Malvern, PA. The action could be linked to the company’s recent contracts with the military. In recent weeks, Siemens received a Defense Department contract worth up to $267 million to sell medical imaging equipment to the military.
FDA has scheduled an internal meeting today to discuss the next steps for handling device controversies within CDRH. Donna-Bea Tillman, who is director of the Office of Device Evaluation (and who was also selected as one of MD&DI’s 100 Notable People last year), sent an e-mail two weeks ago that announced an “all-hands meeting†to discuss the strategic direction of the device center. Two unnamed FDA officials said that such a broad meeting of ODE staff—including all scientists within the office—has not been held for years.
It’s a good bet that the meeting will at least touch on the recent brouhaha about dissident staff members and their accusations of a corrupt device approval process. The dissidents have also sent several e-mails to acting FDA chief Joshua Sharfstein asking for his intervention. Regardless, this meeting may have ripple effects across the device industry if the agency decides on a course of action.
A 20-patient study is under way in the United States to explore the efficacy of C-Pulse heart assist system implants. The system, manufactured by Sunshine Heart is designed to increase blood flow to the body and to the heart muscle, thereby improving quality of life for patients with moderate heart failure. The device is implanted with minimally invasive techniques and does not come into contact with blood. A simulation video of the device is available at the company’s Web site.
The company has already conducted clinical studies in New Zealand and Australia. The latest FDA-approved feasibility clinical trial is being undertaken at six U.S. medical institutions: Northwestern Memorial Hospital; The Ohio State Medical Center; Jewish Hospital University (University of Louisville); Hershey Medical Center of the Pennsylvania State University; University of Florida School of Medicine; and University of Alabama, Birmingham Medical Center.
Following the trial’s successful completion, Sunshine Heart will request a CE mark to begin marketing in Europe. In addition, it says it will seek FDA approval for a larger randomized U.S. pivotal study to support the submission of a marketing application for C-Pulse in the United States.
Since his arrival in 2003, ATS Medical (Plymouth, MN) president Michael Dale has helped push the company from one that was losing money into a diversified business that achieved a 33% rise in revenue last year. One year before Dale joined ATS, the company revenue had dropped to $13 million, with just 28 employees. In 2008, employee count reached 200 in Minnesota and more than 300 globally. Its share of the worldwide mechanical valve market rose 14% last year as well. Although Dale isn’t one to take credit for the comeback, he saw the company through a difficult contract dispute (it began before he started at ATS) and mobilized a strategy to diversify product line. The business strategy has added tissue heart valves, valve repair technology, and cryoablation products, and Dale believes this move will help push sales to more than $100 million.
