AAMI Reviews the News of 2014

This past year was full of surprises for members of the healthcare technology world. Big announcements from federal agencies made for head-turning headlines, and a deadly virus reaching the United States from Africa riveted the healthcare community. Meanwhile, the sweeping Patient Protection and Affordable Care Act continued to make its presence felt for employers, health insurance companies, and healthcare facilities. Here's a look at what's on AAMI's top 10 list of healthcare technology stories and initiatives for 2014:

CMS Makes Waves

The Centers for Medicare & Medicaid Services (CMS) made a couple of important announcements that affect how healthcare facilities conduct their daily routines. The first actually came in late December 2013, but its impact was felt this year. The agency gave hospitals some latitude in setting their maintenance activities for medical equipment. That move revised an earlier stance that manufacturers' recommendations must be followed in almost all cases—something that caused consternation in the field.

The second headline came in late September, when the agency issued a memorandum that gives hospitals more leeway for using power strips, or relocatable power taps (RPTs), in patient care areas. CMS acknowledged that, although it had a longstanding policy against RPT use in these areas, the rule would cause an undue burden on facilities. The change was greeted with cheers by many members of the healthcare technology community.

S3 Challenge Makes Debut

After 23 years, AAMI retired the format of the annual AAMI/FDA International Conference on Medical Device Standards and Regulation. Instead, it went with a revamped style that put an emphasis on standards, synthesis, and solutions, dubbing it the S3 Challenge. The inaugural two-day event in March drew praise for allowing audience members to interact with one another, rather than featuring traditional presentations followed by short Q&A sessions.

The first S3 Challenge focused on biocompatibility, risk management, and sterility. The 2015 event already has been scheduled for April 1-2, 2015, in Herndon, Va, with fresh topics (see related story).

Government Signals Intentions on Health IT

As the health information technology (IT) space gets increasingly crowded, the question of regulation on that front is a sensitive subject. So, in April, when the U.S. Food and Drug Administration, Office of the Coordinator for Health IT, and the Federal Communications Commission unveiled the eagerly anticipated plan to regulate health IT products, people took notice.

The draft framework identified three categories of health IT products based on the potential risk to patient safety: administrative, health management, and medical device health IT. The first two categories pose little or no risks to patients, so the FDA will not regulate them so aggressively. Meanwhile, the latter will be more closely regulated, as these products can have an adverse impact on patient safety.

Stakeholders have had mixed views on the plan. AAMI, like other organizations, called on the government to clarify certain aspects of the plan. "Clarity in this area is urgently needed—the difficulty in knowing what health IT products are subject to which regulation creates chaos for health IT developers and producers, inhibits investment in the field, and hinders the advancement of technology," AAMI said in comments to the framework.

PCAST Report on Systems Engineering

For years, forward-thinking leaders have touted the value of adopting systems thinking in healthcare. A presidential body apparently agrees with this sentiment.

In May, the President's Council of Advisors on Science and Technology (PCAST) unveiled a report promoting the need for systems engineering in healthcare. Adopting these practices could go far toward improving the quality and affordability of care.

AAMI and the International Council on Systems Engineering subsequently sent a joint letter to President Obama, offering their help and expertise in improving the delivery of healthcare in the United States through a systems engineering approach to big technology challenges.

Ebola Comes to the United States

With the virus killing thousands in three West African countries, healthcare professionals and the public were alarmed when the first patient was reported in the United States. The sterilization community in particular had many questions about the handling of biohazardous waste contaminated by the virus. To provide some answers, AAMI joined with the Association for periOperative Registered Nurses, Association for Professionals in Infection Control and Epidemiology, Association of Surgical Technologists, and the International Association of Healthcare Central Service Materiel Management to draft and issue a statement providing guidance to personnel and healthcare organizations for handling biohazardous medical waste. The statement can be found on a special Ebola resources page that AAMI created on its website.

AAMI also loomed large in the media coverage about the protective gear that healthcare workers should wear when treating Ebola patients. In a new protocol, the American College of Surgeons recommended that surgeons and healthcare workers wear "AAMI Level 4" surgical gowns and drapes when operating on these patients. The protocol adapted relevant recommendations made by the Centers for Disease Control and Prevention and applies them to the operating room environment.

M&A Mania

Multibillion dollar mergers and acquisition (M&A) deals dominated the news in both the healthcare and medical device worlds this year.

The $42.9 billion merger between Medtronic and Covidien was the largest, but the $12.2 billion Becton, Dickinson/CareFusion deal also caught analyst attention.

Hospital mergers have grabbed the headlines as well. For example, the Federal Trade Commission (FTC) has been using its authority to halt those deals that it thinks will harm competition. In 2011, the FTC blocked the merger of ProMedica Health System and St. Luke's Hospital in Lucas County, Ohio, a ruling upheld in the U.S. Court of Appeals for the 6th Circuit this year.

Launch of AAMI University

Over the summer, AAMI unveiled an ambitious learning program that promises to revamp training related to the development and use of medical devices and technologies.

AAMI University offers a diverse lineup of live and on-demand courses, covering software validation, quality systems, the role of human factors, management skills, industrial sterilization, and other topics of interest to the medical device industry. Training programs for professionals in healthcare delivery organizations also are available. "AAMI provides many great education opportunities, and we want to make it easier for professionals to find them," says Deborah Reuter, AAMI's senior vice president of education. "AAMI University will serve as a convenient place for busy professionals to keep current with industry issues."

Cybersecurity Guidance

In early October, the FDA unveiled hotly anticipated final guidance on assessing cybersecurity in premarket submissions.

The document addresses such vulnerabilities as malware infections, the unsecured or uncontrolled distribution of passwords, failure to provide software updates and patches to medical devices and networks, and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access.

HTSI Advances Patient Safety

The AAMI Foundation's Healthcare Technology Safety Institute (HTSI) launched two big initiatives in 2014.

In April, close to 100 clinicians, healthcare technology experts, regulators, patiet safety advocates, researchers, and leaders in the medical device industry met to kick off a two-year initiative known as the National Coalition for Alarm Management Safety.

The goals of the coalition are to have leading hospitals in alarm management and other members share resources and success stories and then disseminate what they learn to healthcare organizations across the country. The coalition hopes these actions help move the country to some standardization of alarm systems, where possible.

Last month, HTSI kicked off another initiative, The National Coalition to Promote Continuous Monitoring of Patients on Opioids. One crucial aspect of this effort is to establish the business case for continuous electronic monitoring of these patients. Some patients on opioids have suffered respiratory depression, even death, leading to this campaign. The first meeting of the coalition, held in Chicago, featured powerful stories from families whose loved ones died as a result of respiratory depression while on opioids.

A Swath of New Resources

Are you considering a career in the HTM field, or are you a manager who wants to take his or her department to the next level? AAMI released a number of free educational materials in 2014 to help you meet your goals.

At the AAMI 2014 Conference & Expo in Philadelphia, the association debuted a video with Karen Waninger and Barrett Franklin of AAMI's Technology Management Council. They discussed opportunities offered by a career in the field.

Also at AAMI 2014, the association introduced a guide to help HTM departments assess the value they provide to their organizations, as well as to identify what they might consider adding to their scope of services. The HTM Levels Guide groups departments into three categories—essential, progressive, and advanced—and includes a checklist of key characteristics that define each level. The guide is available for free download at www.aami.org/tmc/levels.html.

Finally, AAMI entered new territory this year with its podcast series. The popular new resource, which is produced with Healthcare Tech Talk, has featured episodes on ventilator technology, sterilization, and building stronger HTM departments. The free series is available at www.aami.org/news/podcast.html.

Source: Association for the Advancement of Medical Instrumentation (AAMI)

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