FDA issues guidance updating Unique Device Identifi cation Compliance Policy

The U.S. Food and Drug Administration (FDA) released the guidance, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassi- fi ed Devices and Certain Devices Requiring Direct Marking,” which takes effect im- mediately.


End-users of computer technology, including healthcare professionals, were quizzed on their knowledge of the types of cybersecurity threats they are likely to face in their day-

to-day jobs and what they can do to protect themselves and their organizations. The

following percentages represent answers that were answered correctly or incorrectly.

incorrectly answered questions related to protecting confi dential information.

do not understand how to protect and dispose of data correctly.

were correct in answering questions about protecting mobile devices and information.

failed to answer questions accurately on using the Internet safely.

understood how to protect themselves against scams.

did not answer questions about building safe passwords accurately.

25% 28% 77% 21% 86% 12% 89%

were able to answer questions about avoiding ransomware attacks correctly.

Source: “2018 Beyond the Phish Report,” Wombat Security. 6 This document includes updated guidance

on Unique Device Identifi cation (UDI) direct mark requirements. It also supersedes a guid- ance issued in January 2018, which outlined the FDA’s compliance policy for UDI label, date format, and direct mark requirements for class I and unclassifi ed devices. The new guidance provides additional

FDA policy on enforcing UDI direct mark re- quirements for non-sterile devices requiring a UDI direct mark that were manufactured and labeled before their applicable direct mark compliance date provided the device bears a non-UDI direct mark and the labeler has developed a method by which, using the non-UDI mark, the full UDI may be made available. For class I and unclassifi ed devices (other than life-supporting or life-sustaining de- vices), whose direct mark compliance date is September 24, 2020, the FDA does not intend to enforce UDI direct mark requirements until September 24, 2022); additionally, after that date, the FDA does not intend to enforce UDI direct mark requirements for such devices that are non-sterile, were manu- factured and labeled prior to September 24, 2022, and remain in inventory but bear a non-UDI mark from which the full UDI may be made available. This guidance also clarifi es certain direct mark compliance dates. Medical devices that are not implantable or life-supporting or life-sustaining but which require a direct mark and were manufactured and labeled prior to their label compliance date do not need to be directly marked until one year after their direct mark compliance date. However, devices which require a direct mark that were manufactured after their label compliance date but before their direct mark compliance date do not get a one year grace period and must be directly marked as of the direct mark compliance date, based on the established compliance dates. This policy is in response to industry con- cerns that reworking devices in inventory to comply with UDI direct mark requirements would be a costly burden. By changing the previous policy, there may still be some achievement of the benefi ts of UDI for de- vices that have remained in inventory while reducing the risk that industry will choose to avoid the cost of remediation by discarding


inventory and potentially creating device shortages.

Though this guidance document is in ef- fect immediately, it is available for comment at

AAMI publishes provisional health IT standard, seeks feedback

The use of IT systems to support healthcare delivery promises to make that care more effi cient and accessible, and to achieve bet- ter patient outcomes. But health IT systems are not without risk—poor design, incorrect confi guration, or improper use can hold back this technology’s benefi ts and create hazards to patient safety and health.

In order to help promote the safety and

effectives of health IT systems, AAMI has published a provisional standard: HIT1000- 1(PS):2018, Safety and effectiveness of health IT software and systems—Part 1: Fundamen- tal concepts, principles, and requirements. It was developed to help healthcare vendors, delivery organizations, and clinicians iden- tify and minimize patient risks to health IT systems so they remain safe and effective from design and development through im- plementation, use, and ultimately retirement. HIT1000-1 is intended as the first in a four-part series, with subsequent editions focusing on quality systems, risk manage- ment, and usability principles as they relate to health IT.

Envisioned to “not reinvent the wheel,” the HIT1000 series is built upon existing stan- dards from other industries, adapting them to the particular characteristics of health IT software and systems.

Mark Segal, PhD, co-chair of AAMI’s Health IT Committee and principal at Digital Health Policy Advisors, LLC in Chicago, said that HIT1001-1 “sets the stage” for the further work that will be published throughout next year by defi ning high-level concepts, principles, and terms intended to help ori- ent those who are involved in developing, implementing, or using health IT. “Most current health IT software is not regulated by the Food and Drug Administra- tion, and the current standards used for the medical device industry just aren’t a good fi t for health IT software,” Segal said. Current health IT standards for quality and safety are used only by the vendors as they develop their health IT software. However, much of the impact on the safety and usabil- ity of software is determined by the actions of those who implement and customize it, said co-chair David Classen, chief medical information offi cer at PascalMetrics. The development of the HIT1000 series represents a major step in realizing the rec- ommendations of the Institute of Medicine’s

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