The draft report, titled FDA Safety Innovation Act(FDASIA) Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework, was released in April by the U.S. Food and Drug Administration, Office of the Coordinator for Health Information Technology (ONC), and the Federal Communications Commission (FCC). The three agencies then spent several months collecting feedback.
“Although AAMI doesn’t typically submit comments to regulatory agencies, health IT represents a significant patient safety issue that needs to be addressed from a multidisciplinary, non-advocacy lens,” said AAMI President Mary Logan.
AAMI heralded the report as a “reasonable first step” toward providing regulatory clarity for health IT, but added that more action is required. “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 its comments, AAMI also stressed the value of bringing systems engineering principles into healthcare. These principles have been used successfully in a variety of high-reliability industries. “AAMI recognizes that regulation of health IT is the focus of the FDASIA report, but was surprised that the implementation of systems engineering principles is not afforded more attention.” It is critical that the healthcare industry embraces systems engineering, AAMI noted, pointing to a recent report from the President’s Council of Advisors on Science and Technology that echoed this call.
In their framework, the agencies recommend the creation of a Health IT Safety Center, a public–private entity designed to promote health IT as a key component to ensuring patient safety. ONC would create the center and would work with the FDA, FCC, Agency for Healthcare Research and Quality, and other health IT stakeholders to promote “a sustainable, integrated health IT learning system.”
AAMI praised the effort, but noted that as the report is currently worded, governmental actors would play a bigger role than the private players. The comments highlighted the AAMI Foundation’s Healthcare Technology Safety Institute (HTSI) as a model that the center could emulate. Many of the issues HTSI works on — including the prioritization of physiological alarms and improving the monitoring of patients on opioids — intersect with health IT. AAMI suggested the foundation and HTSI serve as founding partners of the center and participate in its governance structure.
AAMI’s comments are available at www.aami.org/news/2014/070914_AAMI_Response_FDASIA_Report.pdf
Guide Designed to Help Dialysis Facilities
As the largest funder of dialysis therapy in the United States, the Centers for Medicare & Medicaid Services (CMS) requires that providers comply with certain performance criteria to ensure the safety of patients with end-stage renal disease (ESRD). However, there are differences between CMS requirements and a suite of International Organization of Standardization standards adopted by AAMI.
To help explain the key differences, as well as how facilities can respond, AAMI has released Dialysis Water and Dialysate Recommendations: A User Guide. The guide’s editor, Glenda Payne, is director of clinical services for Nephrology Clinical Solutions. Previously, she was a member of the CMS core faculty for training surveyors responsible for surveys of dialysis facilities.
“Altogether, this work makes an important contribution to reducing conflict between the surveyors and the surveyed and will help advance the cause of patient safety,” wrote Richard Ward, past user co-chair of the AAMI Renal Disease and Detoxification Committee, in the guide’s forward.
The idea for the updated resource came as a result of an evolution in AAMI standards. In 2008, CMS published a major revision of its conditions for coverage to incorporate almost all of ANSI/AAMI RD52:2004, Dialysate for hemodialysis. However, in 2011, AAMI adopted a suite of standards that revised RD52. Subsequently, AAMI issued Technical Information Report 43, 2011, Ultrapure dialysate for hemodialysis and related therapies, which revised and replaced RD52. These changes meant the CMS conditions for coverage no longer mirrored AAMI standards.
“Discrepancies involve both performance criteria, such as the maximum allowable levels for bacteria and endotoxin in water and dialysate, and recommended approaches to maintaining compliance with the fluid quality standards, with the current AAMI standards emphasizing compliance through the development and implementation of a facility-specific quality management program,” according to the document.
To help reduce confusion, the guide provides a table of differences that defines the discrepancies between the CMS regulation and interpretive guidance and the newer suite of standards that AAMI adopted. “I hope this guide will help all dialysis providers move to the use of higher quality water, and thus provide better quality treatment for dialysis patients,” said Payne.
The publication is available for $205, or $120 with AAMI member discount, as a book or in PDF format. Purchasers can also buy both the book and PDF as a set for $310, or $185 with AAMI member discount.
To purchase the guide, go to my.aami.org/store/.
Federal Recognition of Healthcare Technology Management Urged
AAMI has asked the U.S. government to recognize healthcare technology management as a professional field in its official occupational classifications, as well as add “clinical engineer” and “clinical systems engineer” to its roster of job titles.
In comments submitted to the U.S. Office of Management & Budget (OMB) for its standard occupational classification (SOC), AAMI says that the names and titles have changed amid “explosive growth of technology used in healthcare.” Federal recognition of the terms, AAMI says, would help to clarify roles and responsibilities.
“There has been confusion and misunderstanding about the current classification for the field of healthcare technology management,” AAMI said in its comments, adding that the field includes a range of professionals, including clinical engineers, biomedical equipment technicians, radiology equipment specialists, and others. The OMB should revise the SOC system to reflect this growth, AAMI urged.
The SOC system is used by federal statistical agencies to classify workers into occupational categories. All private, public, and military occupations are classified under the system, which provides information on employment levels, trends, pay and benefits, demographic characteristics, required skills, and other information, according to an OMB notice in the May 22 Federal Register. Individuals, businesses, researchers, educators, and policymakers may use the data to conduct analyses. The 2010 SOC revision is in effect, and the OMB has said it is considering a revision for 2018.
In its comments, AAMI proposed that “Healthcare Technology Management—Engineers” be listed under the category “17—Architecture and Engineering Occupations.” The comments include a description of the nature of work performed by these professionals, including the coordination and acquisition of new healthcare technology, development of preventive maintenance schedules and guidelines, and review of safety alerts and recall notices.
The job titles of clinical engineer and clinical systems engineer do not appear in the current SOC, but AAMI suggest including the titles under the HTM-Engineers occupation. AAMI described the primary employers of these professionals, including healthcare delivery organizations and medical device companies, as well as the rigorous education required to obtain these positions.
In addition, AAMI called on the OMB to change the name of the occupation “Medical Equipment Repairers” to “Healthcare Technology Management-Technicians.” This occupation would be reclassified under “17-Architecture and Engineering Occupations,” moving it from “49-Installation, Maintenance, and Repair Occupations.
AAMI’s full comments are available at www.aami.org/news/2014/072114_SOC.pdf
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