The Roundup

Abstract

A recently organized consortium wants to focus more attention on the vulnerabilities of medical devices to cyberthreats and security breaches.The Medical Device Innovation, Safety and Security Consortium was founded earlier this year to find collaborative solutions to protecting medical devices and electronic health records from hackers, viruses, and other hazards.Some of the challenges identified by the consortium include:The consortium's membership includes payers, device manufacturers, component manufacturers, information technology providers, pharmaceutical companies, research organizations, associations, and advocacy groups.For more information on MDISS, visit www.mdiss.org.Studies show that more patients are being overexposed to radiation from medical imaging scans, leaving regulators and the imaging industry scrambling to find ways to tackle the problem.The American College of Radiology (ACR) hopes that a new Dose Index Registry (DIR) will become an effective tool in addressing that challenge.The registry, according to a press release from the group, allows participating imaging facilities to submit anonymous dose information for computed tomography (CT) exams and compare that dose information to those from other facilities of a similar size or geographic area and to national benchmarks.Those facilities and departments that participate will be provided with software that receives the dose information from the CT scanner or the picture, archiving, and communications system for every CT exam that is performed.“Right now, many facilities may know their dose levels, but not how those relate to other practices or national benchmarks,” said John A. Patti, MD, chair of the ACR Board of Chancellors in the press release. “The DIR helps imaging providers gauge how effective their dose optimization efforts are by continuously supplying measurement of their dose over time. At the national level, it provides a big picture view of how dose reduction policies are working in the clinical setting.”That headline isn't a typo.Device manufacturer Medtronic and car maker Ford may not seem like the likeliest of partners, but the two are working together to help drivers manage their diabetes on the go.Under the prototype they have developed, Ford's SYNC, an in-car communications system, connects to Medtronic's continuous glucose monitor with the help of Bluetooth technology. The device will share glucose levels and trends through a display screen on the dashboard, and provide alerts if the levels get too low, according to a press release from Ford.“Diabetes in particular is a chronic disease where frequent monitoring of blood glucose levels throughout the day is critical,” said James Dallas, senior vice president of Medtronic. “By utilizing information technology and consumer electronic devices, we can help patients actively manage their health via access to real-time data on phones, hand-held devices, or even in their cars.”Kelvin Knight and Scott Skinner have been itching to find ways to help the healthcare technology management profession. They now have a new way to achieve their goals, having been selected to serve on AAMI's Technology Management Council (TMC).They will serve a three-year term on the 24-member council, which advances the interests of clinical engineers and biomedical equipment technicians (BMETs).Knight, director of biomedical engineering for Children's Hospital of Alabama in Birmingham, AL, says he would like to focus on career resources. “I would also like to help with the efforts to promote communications with the C-Suite.”Skinner says he wants to help promote the collaboration of clinical engineering (CE) and information technology (IT). “I want to see the TMC continue to advance CE-IT integration and build best practices around what that collaboration looks like,” says Skinner, director of clinical engineering for Norton Healthcare in Louisville, KY.Knight and Skinner replace Ray Laxton and Chris Abe, whose terms expire this year.For more information on the TMC, visit www.aami.org/tmcconnect.An article in the Chicago Tribune suggesting conflicts of interest with doctors who put their own inventions to use caught the attention of the medical device industry and patients alike.The May 22 article cast an unflattering light on what it called a “tangled web of interests,” focusing on one surgeon, Patrick McCarthy, who had implanted a medical device he had invented into a patient to fix her leaky heart valve.Stephen J. Ubl, president and CEO of AdvaMed (Advanced Medical Technology Association), wrote the newspaper, saying it had mischaracterized the review process by the U.S. Food and Drug Administration (FDA). And Daniel Renaud, another patient of the surgeon's, also wrote, taking issue with the article: “I thought who better to operate on me than an experienced and skilled surgeon who actually invented some of the procedures and devices to be used!”AAMI's Clinical Engineering Management Committee (CEMC) has two new members.Dave Dickey, corporate director of McLaren Clinical Engineering Services with McLaren Health Care in Flint, MI, and Paul Miklovich, administrative director of clinical engineering at the Cleveland Clinic Foundation in Cleveland, OH, have been tapped to join the committee.“I am hoping that my 30-plus years of experience—and current position as a director of a large, multihospital clinical engineering program—will be of value to the committee,” says Dickey.The 20-member CEMC works to advance the professional interests of clinical engineers, promote the field, and support numerous member benefits.One CEMC project was the creation of the Medical Equipment Management Manual, which provides guidance to clinical engineering departments on complying with Joint Commission requirements. The committee is also developing a new book about biomed staffing.For additional information about the CEMC, visit www.aami.org/cemc.AAMI hopes to give clinical engineering departments all the information they are looking for —and without a trip to Google—with a new edition of its comprehensive Clinical Engineering Collection CD. The 2011 edition includes a myriad of resources, standards, guidance documents, and publications in a convenient, searchable, and easy-to-use CD.The CD is for clinical engineers, biomedical equipment technicians (BMETs), and other medical technology professionals.Additions to the collection include:The Clinical Engineering Collection is available at $450 for AAMI members and $650 for non-members. To order, call (877) 826-8226, or visit the Marketplace at http://marketplace.aami.org. The order code is CEC.You've heard of interns, but what about an extern?That will be the focal point of a new partnership between GE Healthcare and the 807th Medical Command—which manages the deployment of all Army Reserve field medical units from Ohio to California—to form a joint “externship” pilot program to provide training and workplace preparation for biomedical equipment specialists.The program will provide training and career development to soldiers wanting to become biomedical equipment specialists either in the private sector or within the Command. The one-year program will ensure the soldiers obtain professional qualifications for both military and civilian standards, according to a press release on the partnership.“With the leaps and bounds made in technological science, medical technologies have become an essential and integral part of modern medicine. This collaboration will provide streamlined and relevant hands-on training with a variety of medical technologies for soldiers to contribute to their military training requirements,” said Maj. Gen. L.P. Chang, commander of the 807th Medical Command.It isn't too often you are recognized for how you celebrate something, but that's the case with the University of Vermont Technical Services Partnership.The partnership, which provides clinical engineering services to healthcare facilities in Burlington, VT, was recognized as the group that best celebrated National Biomedical/Clinical Engineering Appreciation Week, which was held May 22–28.The UVM technical services team sent each chief executive officer and other important contacts in the UVM system a letter with the official 2011 proclamation of the week. They also distributed copies of AAMI's new C-Suite brochure, and hung posters about the department throughout the facility.The team also set up a table where all UVM staff could get information about the profession, and even enter a “Biomed Bowl” raffle for a chance to win a University of Vermont hat.There were two runners-up in this contest—Spectrum Health of Grand Rapids, MI, and Hays Medical Center of Hays, KS.The word “epidemic” is usually reserved for widespread outbreaks of disease. One security expert is now using it in a different context as it relates to healthcare: data breaches.Mahmood Sher-Jan, senior director of product management at ID Experts, a Portland, OR firm which specializes in preventing security breaches, told Healthcare IT News that when he read that breaches of healthcare records had surpassed 10 million, “the word epidemic immediately hit me.”“Hidden in the daily barrage of reported data breaches is the risk that consumers will become fatigued and desensitized to the issue. When faced with such information and sensory overload, it is useful to use known analogies or references to help us quickly process the information to gain a better understanding of its merits.”Sher-Jan gave five reasons why security breaches of healthcare information are like an epidemic:It's not exactly Cannes, but nearly 40 original infection prevention videos made their debut as part of a film festival at the annual conference of the Association for Professionals in Infection Control and Epidemiology (APIC) in June.The videos focused on the impact of healthcare-associated infections and how healthcare personnel can help protect patients. “Received from APIC's members in the U.S. and around the globe, the films use music, drama, dance, humor, animation, and numerous references to popular culture to promote adherence to best practices that save lives and improve healthcare quality,” according to a press release from the association.To watch the videos, visit APIC's Youtube site at www.youtube.com/user/APICInc. Or maybe they're coming soon to a hospital near you?The federal government wants to put more power in the hands of healthcare users to help protect their privacy when it comes to electronic health records.The U.S. Department of Health and Human Services wants to change part of the Health Insurance Portability and Accountability Act Privacy Rule to allow people the right to get a report on who has electronically accessed their protected health information, according to a release on the rule change.“This proposed rule represents an important step in our continued efforts to promote accountability across the healthcare system, ensuring that providers properly safeguard private health information,” said Georgina Verdugo, director of the U.S. Office of Civil Rights. “We need to protect peoples' rights so that they know how their health information has been used or disclosed.”The proposed rule change would allow people to obtain a report that will document who electronically accessed and viewed their health information.Healthcare facilities already have to track this information, but they aren't required to share it with people, the release reads.For more information on the rule, visit www.regulations.gov and search for “Proposed Rule.”Hospitals and healthcare facilities know the score. Times are tough and many facilities are under enormous pressure to contain costs while addressing the need for new medical equipment.In the face of this challenge, some healthcare facilities may be tempted to buy lower-quality devices, a short-term solution which can morph into long-term problems.A new study published in the Journal of Medical Marketing details the problems with these procurement practices, and offers five principles to help prevent negative consequences.The study, called Global best practices in medical device procurement—A road map to system success, examined medical device spending in the United States, United Kingdom, Sweden, Taiwan, Germany, Singapore, Canada, Hong Kong, Norway, and China.It found that hospitals purchased less expensive products to get immediate savings, but “the use of lower-quality products can have the opposite effect, ultimately leading to reduced patient care and higher long-term costs—thereby negating the advantage of a product's lower initial procurement price.”The study outlined “five principles for success.” They are:The research firm Thomson Reuters put out its list of the 10 top healthcare systems in the U.S. based on healthcare quality and patient satisfaction. The firm's picks are:The results are part of the research firm's 100 Top Hospitals program, which analyzed the performance of 285 health systems. The systems were evaluated on eight metrics, including in-hospital mortality, medical complications, average length of stay, and adherence to clinical standards of care.“To produce consistent, strong performance across multiple hospitals, health system leaders must be providing crystal clear goals and communication as well as the means for staff to execute effectively,” said Jean Chenoweth, senior vice president for performance improvement and 100 Top Hospitals programs at Thomson Reuters, in a press release. “These systems are positioned to continue performing well as we move further into the era of healthcare reform.”For more information on the results, visit www.100tophospitals.com.Medical device manufacturers and their allies in Congress are keeping the pressure on the U .S. Food and Drug Administration (FDA) for what they feel is a stifling and confusing review process for new products.FDA officials stress they're making improvements to the 510(k) program, but can't take shortcuts when it comes to patient safety. And they say at least part of the problem rests with manufacturers who don't provide all the information they need when filling out applications.In May, manufacturers rallied around a Northwestern University study which found that most device makers say Europe has a more “predictable” system and, as such, they're inclined to introduce new products there—as opposed to the United States. On Capitol Hill, lawmakers are issuing sharp statements. For example, Sen. Orrin Hatch, R-Utah, says the regulatory process is “fraught with uncertainty” and impeding innovation.At a recent press conference, Jeffrey Shuren, director of FDA's Center for Devices and Radiological Health, said changes are already in the works for the 510(k) program to provide more clarity and transparency to the review process. “The 510(k) program has to adjust, but it has to adjust properly,” he said.The U.S. Veterans Administration (VA) has spent billions over the past few years to manage and secure its information technology (IT), but, according to a key government agency, there are still some problems.The U.S. General Accountability Office (GAO) says that two VA systems development projects have yielded mixed results. One project was for outpatient appointment scheduling which cost an estimated $127 million over nine years but never came to fruition.The reason? Weaknesses in “acquisition, planning, requirements analysis, testing, progress reporting, risk management, and oversight,” the GAO report reads.The VA also faces significant barriers to establishing a shared electronic health record (EHR) system with the U.S. Department of Defense (DOD). Both departments weren't able to create plans, goals, and time frames for jointly addressing “the health IT requirements common to both departments' EHR systems,” the report reads.The GAO recommended that the VA improve the two projects, strengthen information security practices, and ensure that security issues are adequately addressed.The departments concurred with the recommendations and the secretaries of both the VA and DOD agreed this spring to pursue joint development and acquisition of integrated EHR capabilities.It has been three years since former president and selfdescribed cowboy George W. Bush rode off into the sunset after two terms in the Oval Office. But the former commander-in-chief will soon make his way back to Washington, D.C. to pay a visit to the annual conference of the Advanced Medical Technology Association.Bush will deliver his keynote address and participate in a moderated question-andanswer forum on Sept. 27.Since leaving office, Bush has kept a relatively low profile, focusing mainly on developing the George W. Bush Presidential Center at Southern Methodist University in Dallas, TX. For more information about the conference, which runs Sept. 26–28 in Washington, D.C., visit www.advamed2011.com.