Following a string of high-profile cyberattacks, one U.S. senator said that industry itself has failed to adequately address the problem and has proposed legislation to shore up medical device cybersecurity.

Sen. Richard Blumenthal (D-CT) has introduced the Medical Device Cybersecurity Act of 2017 (S. 1656), which, if passed, would require devices to come with a “cyber report card,” mandate testing prior to sale, bolster remote access protections, ensure that cybersecurity updates and patches are free, provide guidance for end-of-life devices, and expand the responsibilities of the Industrial Control Systems Cyber Emergency Response Team.

“My bill will strengthen the entire healthcare network against the ubiquitous threat of cyberattacks,” Blumenthal said in a statement. “Without this legislation, insecure and easily exploitable medical devices will continue to put Americans' health and confidential personal information at risk.”

The bill has garnered the support of the College of Healthcare Information Management Executives and the Association for Executives in Healthcare Information Security. However, it faces a tough road to passage, according to bill analyzer GovTrack.us.

A cross section of grass fibers used to transport ions in the biocompatible battery design.

A cross section of grass fibers used to transport ions in the biocompatible battery design.

Engineers at the University of Maryland (UMD) have designed a new type of battery that uses the same means of producing electrical energy as biological systems. This biocompatible battery uses blades of Kentucky bluegrass soaked in a lithium salt solution as cables to move ions, rather than electrons as in a traditional battery. The human body utilizes a similar system to produce current by moving ions of sodium, potassium, and other electrolytes.

“My intention is for ionic systems to interface with human systems,” said team leader Liangbing Hu, professor of materials science at UMD. “In our reverse design, a traditional battery is electronically shorted. Then ions have to flow through the outside ionic cables. In this case, the ions in the ionic cable—here, grass fibers—can interface with living systems.”

UMD's biocompatible battery design eventually could be used to develop medical devices that manipulate neuronal activities, as well as for other biocompatible applications, according to a news release. The battery was described in a July article published in Nature Communications.

Risk management is more than just checking boxes or filling out forms to satisfy regulatory requirements. Rather, it is an essential part of the design process, according to a new guide for startups and other manufacturers new to the healthcare arena titled Premarket Risk Management for New Medical Device Companies.

This practical “how to” resource describes the contents of a risk management file and outlines the activities and documents that go into its creation, such as hazard identification and risk assessment and control. The book also includes useful templates for developing a risk management plan and other necessary documents, as well as a risk management report checklist.

The new guide helps nascent medical device companies navigate the world of risk management.

The new guide helps nascent medical device companies navigate the world of risk management.

“Startups usually know they need to do something about risk management, but they often think brainstorming a big risk assessment matrix is the heart of the work when that's not a good approach at all,” said author Tom Shoup. “I hope risk management owners in startups will say ‘I get it’ after reading this book and will know how to create a premarket risk management file for their first product.”

Premarket Risk Management for New Medical Device Companies is available for purchase in the AAMI Store at www.aami.org/store.

Two of AAMI's flagship publications have been recognized with an APEX Award for Publication Excellence. This annual awards program, which drew nearly 1,400 entries in 2017, honors excellence in publishing by professional communicators.

AAMI News earned an Award of Excellence in the category of a newsletter produced by no more than two people, while Horizons, the twice-yearly supplement to BI&T, won an Award of Excellence for “one-of-a-kind publications (health and medical)” for the spring 2016 issue focusing on the sterilization and reprocessing of medical devices.

Sean Loughlin, AAMI vice president of communications, said the honors speak to the dedication of staff editors as well as the volunteer authors who contribute to AAMI's publications.

“We're fortunate to have editors who care deeply about the quality of our editorial content,” he said. “And our publications would be far thinner without the volunteers who submit articles and ideas about the trends, challenges, and solutions in healthcare technology. Working with them, our editors are able to give readers the news and information they want and need to be able to succeed in their field and support safe, high-quality patient care.”

The Food and Drug Administration (FDA) has given 501(k) premarket clearance to the Embrace Neonatal Magnetic Resonance Imaging (MRI) System. This MRI device, developed by Aspect Imaging in Tel Aviv, Israel, is the first MRI designed specifically to provide neonatal brain and head imaging in a neonatal intensive care unit (NICU).

“It is now possible to routinely scan premature babies in the NICU, almost immediately after birth, helping to increase the quality of life and improve care for newborns by assisting in the early detection of health issues, enabling at-risk babies to grow into healthy children,” said Uri Rapoport, CEO and founder of Aspect Imaging, in a press release.

The Embrace Neonatal Magnetic Resonance Imaging (MRI) System allows premature babies to receive MRI scans while remaining in the neonatal intensive care unit.

The Embrace Neonatal Magnetic Resonance Imaging (MRI) System allows premature babies to receive MRI scans while remaining in the neonatal intensive care unit.

The Embrace system accommodates infants who weigh 1 to 4.5 kg and whose head circumference is up to 38 cm. The device includes an incubator to control the child's temperature. The fully enclosed system does not require shielding and can be used in the NICU near other medical devices. However, the system is not recommended for infants who have a metallic or electronically active implant.

The FDA's first advisory committee dedicated solely to patient-related issues is set to address common clinical trial challenges, including “inconsistent or minimal participation,” according to a blog post by Kathryn O'Callaghan, assistant director for strategic programs in the FDA's Center for Devices and Radiological Health (CDRH), and CDRH Director Jeffrey Shuren.

The first meeting of the new Patient Engagement Advisory Committee, which is intended to be “a forum for the voice of patients,” will take place Oct. 11–12 at the Hilton Washington DC North/Gaithersburg. Attendees will discuss issues related to clinical trial design, conduct, and reporting.

Although patient representatives currently participate in many FDA advisory committee meetings, the agency has never had a committee specifically dedicated to addressing patients' needs, views, and concerns related to medical devices. More information about meeting content and times is available in the Federal Register.

The AAMI Standards Board approved five new or revised standards and two updated technical information reports (TIRs) during a June meeting in Austin, TX, clearing the way for their publication. These guidance documents focus on an array of important topics, including the sterilization and reprocessing of medical devices, the safety and performance of in vitro diagnostics and high-frequency surgical equipment, the biological evaluation of devices, and systems used to forecast remaining battery service life in pacemakers:

  • ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities

  • ANSI/AAMI ST90, Processing of health care products—Quality management systems for reprocessing

  • ANSI/AAMI/ISO 10993-16, Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables

  • ANSI/AAMI/ISO 16142-2, Medical devices—Recognized essential principles of safety and performance of medical devices—Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards

  • ANSI/AAMI/IEC 60601-2-2, Medical electrical equipment—Part 2-2: Particular requirements for basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

  • AAMI TIR17, Compatibility of materials subject to sterilization

  • AAMI TIR21, Systems used to forecast remaining pacemaker battery service life

AAMI has published a free resource to help healthcare delivery organizations reduce the risk of transmitting healthcare-associated infections (HAIs). Checklists for Preventing Healthcare-Associated Infections: Key Considerations for the Purchase and Use of Reusable Medical Devices includes recommended steps when purchasing a new medical device, training considerations, and stakeholder-specific checklists for sterile processing, infection prevention, environmental services, and healthcare technology management professionals.

This tool draws from the lessons learned during AAMI's 2016 HAI forum, in which AAMI and its partners met with more than 100 stakeholders concerned about the safety of reusable medical devices (e.g., healthcare administrators, clinicians, researchers, instrument processing personnel, device manufacturers) to explore how and why device- and equipment-associated infection transmissions occur and to identify solutions to the problem.

The checklists are designed to be filled out electronically or printed out and completed by hand. Download them at www.aami.org/HAI_Checklists.

The nonprofit Medical Device Innovation, Safety and Security Consortium (MDISS) has launched a worldwide network of security “proving grounds” specifically designed to test the security of medical devices, identify vulnerabilities, and develop solutions.

The MDISS World Health Information Security Testing Lab (WHISTL) includes healthcare delivery organizations, medical device manufacturers, academic institutions, and technology companies. WHISTL will utilize both the ANSI/AAMI/IEC 80001 and UL 2900 series of standards when testing the cybersecurity of medical devices.

“MDISS WHISTL facilities will dramatically improve access to device security know-how while protecting patient privacy and stakeholder intellectual property,” said Dale Nordenberg, executive director of MDISS, in a news release.

In addition to identifying vulnerabilities, the WHISTL initiative encourages worldwide collaboration. By the end of the year, facilities will open in California, Indiana, New York, and Tennessee, as well as the United Kingdom, Israel, Finland, and Singapore. Security vulnerabilities will be reported to collaborators and medical device manufacturers using a database maintained by MDISS and the National Health Information Sharing and Analysis Center.

AAMI has revised its steam sterilization standards for the first time since 2010. ANSI/AAMI ST79:2017, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, covers all steam sterilization activities in healthcare facilities, regardless of the size of the sterilizer or the size of the facility, and provides guidance to all healthcare personnel who use steam for sterilization.

The updated edition of ST79 is easier to reference, as it's been reorganized into topical groupings and provides the flexibility for facilities to determine certain criteria based on their concerns. Other changes include new guidance on heating, ventilation, and air conditioning systems as they relate to the well-being of sterile processing personnel, as well as revised guidance on the placement of instruments.

For more information on ANSI/AAMI ST70:2017 and to purchase, visit www.aami.org/ST79.

President Donald Trump has signed The FDA Reauthorization Act of 2017, a bill that is poised to affect the healthcare technology community in two significant ways: through the renewal of the “user fees” imposed on medical device manufacturers and with a call for a report that will dive into the hot issue of medical device service, especially by third parties.

This legislation will allow the FDA to collect more than $320 million in user fees from medical device manufacturers over the next five years to fund the agency's regulatory activities. It also includes a provision requiring the FDA to produce a report that addresses “the continued quality, safety, and effectiveness of devices … with respect to servicing” within 270 days of being signed into law.

The bill defines servicing as “refurbishing, reconditioning, rebuilding, remarketing, repairing, remanufacturing, or other servicing of the device.” The Medical Imaging & Technology Alliance applauded the president for signing the Medical Device User Fee Amendments, one aspect of the overall reauthorization act.

The AAMI Board of Directors will host a special business meeting on Nov. 3 to vote on two proposed amendments to the association's bylaws. The first amendment would allow the Board to determine when AAMI's fiscal year begins and ends. The second amendment would allow bylaw changes to be considered at any meeting of the association, not just during the Annual Conference & Expo, as long as a quorum was present and notice of the proposed changes had been sent in writing to voting members.

All AAMI members should cast their vote on these proposed amendments by completing the form at www.aami.org/proxy. The deadline is Oct. 6.