AAMI News December 2017
2017—The Year in Review
From hurricanes to hackers, servicing to sterilization standards, AAMI News looks back at the stories that helped shape 2017.
Hurricanes Disrupt Healthcare Delivery, Manufacturing
Many healthcare delivery organizations (HDOs) and medical device manufacturers are still trying to recover from one of the most destructive hurricane seasons on record. The epic flooding in southeastern Texas, spawned by Hurricane Harvey’s landfall in late August, tested HDOs’ ability to effectively function during a natural disaster and underscored the importance of preparing for such nightmare scenarios.
Just a few weeks later, Hurricane Maria swept across Puerto Rico, leaving the island’s more than 50 medical device manufacturing plants (and 3.4 million residents) without power. Device manufacturers in Puerto Rico produce everything from pacemakers to advanced cancer diagnostics, prompting fears of medical device shortages in the United States.
In the wake of that storm, Food and Drug Administration (FDA) Commissioner Scott Gottlieb released a statement acknowledging that “it will likely be months before power is fully restored and medical product manufacturing returns to pre-hurricane levels.”
Cybersecurity Vulnerabilities Affect Patient Care
In May, the WannaCry ransomware burst into the global spotlight, crippling computers in more than 150 countries, including those in Britain’s National Health Service.
“This ransomware is a wake-up call for the few people still in denial,” said Kevin Fu, chief scientist of Virta Labs, Inc. “Patients were denied scheduled heart surgeries. Ambulances were in disarray.”
On the heels of this widespread attack came Petya/NotPetya, which seriously affected at least three U.S. hospitals. Both pieces of malware exploited known vulnerabilities and highlighted the importance of patch management in the healthcare technology sector.
In the face of these increasingly aggressive cyberattacks, AAMI focused on ways to defend healthcare technology in the fall 2017 issue of its peer-reviewed journal supplement, Horizons, www.aami.org/Horizons. This issue presents best practices from leading experts to help healthcare technology management (HTM) and health IT professionals lock down sensitive data, devices, and systems.
AAMI Celebrates ’50 Years of Building Tomorrows’
Half a century ago, a group of pioneering medical device makers, physicians, and innovators came together to guide the development of healthcare technology. In 2017, AAMI—the result of their vision—celebrated the contributions of its founders, members, and volunteers in multiple ways, including the creation of an anniversary website (www.aami.org/50) and video (www.aami.org/50th_Video), the publication of a series of essays about healthcare technology, and the hosting of festivities throughout the year.
“This anniversary was really about recognizing the extraordinary talents of our members and partners who have committed themselves to improving healthcare technology, supporting patient safety every step of the way,” said AAMI President and CEO Robert Jensen. “As healthcare technology evolves ever faster, AAMI is poised to have an even bigger role in shaping that evolution—through its standards; training, certification, and education programs; resource development; and its many patient safety initiatives.”
AAMI’s plans for the future are outlined in a new strategic plan, details of which can be found in this related story.
Device Service Debate Intensifies
Tensions among original equipment manufacturers (OEMs), independent service organizations (ISOs), and HTM professionals have been mounting over who can and should service medical devices, as well as whether OEMs should be required to provide access to service manuals, replacement parts, training, and diagnostic tools.
This summer, Congress dove into this debate when lawmakers considered a bill that would have required third-party service providers to register with the FDA, maintain a complaint handling system, and submit adverse event reports. While those requirements were ultimately dropped, lawmakers did use the FDA Reauthorization Act of 2017 to call on the agency to produce a report that addresses “the continued quality, safety, and effectiveness of devices … with respect to servicing.”
Around the same time, The Joint Commission (TJC) announced it would add a new element of performance (EP) in January 2018 that requires HTM departments to have a “library of information regarding inspection, testing, and maintenance of its equipment and systems.” This EP was intended “to provide something that HTM can point to when requesting information that historically was not readily available,” according to George Mills, TJC’s former director of engineering.
These developments sparked sometimes heated debate and tough questions, a point noted by Jensen. “During such moments, we sometimes are asked why AAMI does not advocate or lobby for one community over another,” he wrote on the AAMIBlog. “No one camp has all the answers, nor would it be helpful to assert that any one group could—or should—be the sole provider of medical device service.”
AAMI Publishes New Sterilization Standards
Sterile processing is all that stands between patients and potential exposure to dirty medical instruments. To help support this vital—and often complex—function, AAMI published two important new standards this year that focus on medical device processing.
The first, ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, is an update to a widely used standard. Reformatted and reorganized to make it easier to use, this resources includes fresh guidance applicable to all healthcare personnel who use steam for sterilization, regardless of the size of the sterilizer or the type of facility. Using ST79 could help sterile processing departments stay in compliance with accrediting bodies.
The second standard, ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing, is a new document that specifies the minimum requirements for a quality management system that can be used by healthcare organizations that process medical devices. It was developed to help facilities more effectively, efficiently, and consistently reprocess (clean, decontaminate, disinfect, and sterilize) medical devices in order to prevent infections, pyrogenic reactions, and other adverse events.
TJC Raises the Bar with New PM Requirements
Since the beginning of the year, TJC has expected hospital HTM departments to complete all planned maintenance activities in line with the manufacturer’s recommendations or an alternative equipment management (AEM) program 100% of the time. Previously, the accrediting body had drawn a distinction between high-risk and non–high-risk equipment in terms of the 100% rule.
HTM departments still have leeway when it comes to crafting an AEM program and departmental policies, as well as in determining the frequency of maintenance activities.
To help HTM professionals better understand and develop an AEM program, AAMI has published a new AEM Program Guide. Written by consultant Matthew Baretich, this resource seeks to address AEM-related terminology, offer ideas for practical implementation, and explain how to remain compliant with applicable standards and regulations.
FDA Looks to Speed Up Device Approvals
When it took effect on Oct. 1, the fourth iteration of the Medical Device User Fee Amendments to the FDA Reauthorization Act increased the fees device manufacturers must pay by more than $320 million over the next five years. The additional funds are intended to help pay for resources that would reduce the average total time to decisions for premarket applications and 510(k) submissions, among other provisions.
To speed up review times, the FDA is developing a number of new programs, including a software precertification pilot program that focuses on assessing the makers of the software, not the product itself. This approach should reduce the time and money it takes for developers who “reliably manufacture high-quality, safe, and effective digital health devices” to enter the market, according to the FDA.
For more traditional medical devices, the FDA issued draft guidance in late October that outlined a new Breakthrough Devices Program. This program is intended to provide patients with more timely access to technologies that provide more effective treatment or diagnosis for serious or life-threatening diseases. See related story in this issue.
Annual Conference Sets New Record
It seems everything really is bigger in Texas. With more than 2,600 registered attendees, the AAMI 2017 Conference & Expo in Austin was the largest ever and marked the first time attendance at this event has surpassed 2,500 in the association’s 50-year history.
During the conference, which ran June 9–12, leading healthcare technology experts addressed some of the biggest challenges facing the field: “big data,” which offers enormous potential to help patients heal and save costs, while also tasking stakeholders with new responsibilities; increasing pressure to bring down healthcare costs; and ransomware and other cyberthreats.
AAMI Foundation Launches New Initiatives
In April, the AAMI Foundation launched a new coalition tasked with overcoming the challenges presented by the burgeoning development and use of complex healthcare technology. Over the next two years, the National Coalition to Promote the Safe Use of Complex Healthcare Technology aims to build a body of best practices to guide healthcare facilities and clinicians in the procurement and use of technology, as well as user training.
In July, the Foundation named the first recipients of funding from the Mary K. Logan Research Awards Program. The two grants, worth a total of $80,000, went to researchers at Cincinnati Children’s Hospital in Ohio and Saint Alphonsus Regional Medical Center in Boise, ID, part of the Trinity Health System, who are focusing on ways to enhance the safe use of healthcare technology.