AAMI News November 2017

News in Brief

ST79Updated Steam Sterilization Standard Now Available

The long-awaited update to AAMI’s influential steam sterilization standard is now available for purchase.

ANSI/AAMI ST79, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, provides essential guidance for all personnel who use steam for sterilization at their healthcare facility regardless of size. ST79 was last updated in 2010.

The 2017 edition of the standard includes major updates to temperature and humidity settings and the selection of sterilization cycles. It incorporates an entirely new format to improve readability and ease of use for sterile processing professionals.

“Readers will find the third edition of ST79 to be more user-friendly and useful as a tool to support best practice and provide a rationale for why they process as they do,” said consultant Cynthia Spry, who co-chaired the committee tasked with the revision. ANSI/AAMI ST79:2017 is available for purchase at www.aami.org/store.

China Releases New Medical Device Classification Catalogue

The China Food and Drug Administration announced revisions to its Medical Device Classification Catalogue, an essential document for regulating China’s medical device industry that was first introduced in 2002. The changes, which take effect on Aug. 1, 2018, will impact how medical device companies register, manufacture, and distribute their devices in China.

The new catalogue overhauls how devices are categorized and assessed for risk using a three-tiered structure, beginning with the broad categories of surgical instruments, devices with electronics (active), devices without electronics (passive), devices by clinical departments, and others. The number of device categories was reduced from 43 to 22, which further break down to 206 primary product types (from 260) and then 1,157 product subtypes.

In addition, the risk classes for 40 devices were downgraded and more than 5,000 additional product name examples and more detailed descriptions were added.

Connected Patient Challenge Seeks Next Great IoT Idea

You don’t need a company, a university affiliation, or a lot of funding to get a good idea off the ground. Boston Scientific and Google are seeking the next big idea for the Internet of Things (IoT) that could improve the fields of neuromodulation, rhythm management, cardiology, peripheral interventions, endoscopy, urology/pelvic health, or oncology as part of the third annual Connected Patient Challenge.

Six finalists will be selected by Boston Scientific, a panel of three official judges, and crowd-sourced online votes to pitch their idea live before the judges in a “Shark Tank” style event on March 1, 2018. The winners will receive up to $50,000 to put toward making their ideas a reality. Individuals over the age of 18, early-stage companies, or mature startups are encouraged to submit their ideas or vote on submissions at www.medstro.com.

AAMI’s Horizons Supplement Highlights Healthcare Technology Cybersecurity

In the face of increasingly aggressive cyberattacks on protected health information, as well as the threat of medical devices being hacked by cybercriminals, AAMI is focusing on defending healthcare technology in the fall 2017 issue of its award-winning, peer-reviewed publication, Horizons.

Horizons is the twice-yearly supplement to AAMI’s peer-reviewed journal, BI&T. This issue presents best practices from leading experts to help healthcare technology management professionals and health IT professionals lock down sensitive data, devices, and systems.

AAMI members and BI&T subscribers can expect the cybersecurity issue of Horizons in their mailboxes beginning in mid-November. The issue will also be available online at www.aami.org/Horizons.

Race Car Technology Adapted to Protect Newborns during Emergency Transport

The Baby Pod 20
The Baby Pod 20 is designed to be light, strong, and easily accessible.

Formula One race cars can reach speeds of more than 200 mph. Even with extreme forces at play, they’re designed to give the driver a good chance of survival in the event of a high-speed crash. The Baby Pod 20, designed by U.K.-based Williams Advanced Engineering (derived from the Williams racing team) and manufacturer Advanced Healthcare Technology, uses the same principles to protect infants and newborns during emergency transport in an ambulance or helicopter.

“The parallels between a Formula One car and transport device for babies may not be immediately apparent, but both demand a lightweight and strong structure that keeps the occupant safe in the event of an accident,” said Craig Wilson, managing director of Williams Advanced Engineering, in a press release.

The Baby Pod 20 updates a heavier Baby Pod II design. It gets its strength from a carbonfiber shell—the same lightweight material used to build F1 cars. The infant is protected by a shock-absorbing foam interior, vibration-absorbing gel warming mattress, and the same strapping system used to secure race car drivers. The pods are being used by the Children’s Acute Transport Service in the U.K.

FDA Issues Final Guidance on Interoperable Devices

The Food and Drug Administration (FDA) has issued final guidance describing design considerations and premarket submission recommendations for interoperable medical devices. The guidance provides manufacturers with the functional, performance, and interface requirements so interoperable devices can communicate with one another safely, accurately, and fully.

The guidance recommends that manufacturers design devices with interoperability as an objective; conduct verification, validation, and risk management activities; and provide the information necessary for other devices to safely trade information with it.