AAMI has unveiled a white paper that spells out six specific risk principles that the medical device industry and the U.S. Food and Drug Administration (FDA) ought to consider in post-market risk management.
The 15-page “Risk Principles and Medical Devices: A Post-Market Perspective” is available at www.aami.org/hottopics/risk/AAMI/020615_AAMI_risk_white_paper_draft.pdf. It is intended to articulate “a shared view of risk” with the ultimate goal of better coordination and understanding between manufacturers and regulators when it comes to post-market activities, such as medical device recalls.
“It is hoped that a shared view will minimize the differences in analyses of risk and resulting conclusions reached by industry and CDRH (Center for Devices and Radiological Health) related to appropriate remedial actions,” reads the paper, which was developed by AAMI in coordination with a working group of industry representatives and federal regulators. “A common and consistent approach to risk will optimize and expedite patient care.”
The draft paper’s release comes ahead of an anticipated spring public workshop on the subject of post-market risk management by the CDRH, the arm of the FDA responsible for oversight of the medical device industry.
The focus on risk principles stems from a belief shared by the working group members that there can be little, if any, progress in making headway on sometimes contentious post-market quality and safety issues until there is agreement on what industry and the agency should keep in mind in the first place.
“We hope this white paper enriches the vital conversation on risk management,” said AAMI President Mary Logan. “More collaboration and understanding on expectations between industry and regulators can only mean a smoother process with post-market compliance issues and will help to enhance patient safety.”
The six risk principles identified in the white paper are:
Evaluation and Judgment. The emphasis here is making an “informed” judgment by looking at an assortment of data, including (but not limited to) experience with the device, company standards, the history of similar devices, and potential planned mitigations.
Loss of Benefit Assessment. In short, “multiple benefit/risk scenarios” must be considered “in order to arrive at the optimal outcome.”
Populations. Are there subpopulations included in the “indication for use” at greater risk or benefit than the overall population?
Use Environment and Clinical Assessment. The context of the environment in which the device will be used must be part of the evaluation.
Communication. Risks and problems associated with any given device “should be communicated effectively to relevant stakeholders.”
Recovering Loss of Benefit and Mitigation. What can be done to “return the benefit of the device to acceptable levels”?
Logan emphasized the importance of collecting comments from all stakeholders on the ideas expressed in the paper. The deadline to submit comments, which may be emailed to Logan at mlogan@aami.org and Lauren Clauser at lclauser@aami.org is May 20, 2015.
“Now is the time for all participants in post-market compliance activities to weigh in and help to harmonize expectations between the FDA and industry,” Logan said. “The more feedback we receive on this draft paper, the better the end result will be.”
The working group’s discussion identified a number of other next steps. They include deciding how to “weigh” the risk principles; how to handle the recall of products with compliance issues (technical violations); how to make precedents more transparent so that industry can learn from them; and to what extent an existing standard on risk management to medical devices (AAMI/ANSI/ISO 14971) should be changed to include more post-market issues to help both industry and regulators.
The white paper includes many other next steps, as well as details on the risk principles themselves. The working group was comprised of representatives selected by three national industry trade associations – AdvaMed, the Medical Imaging & Technology Alliance (MITA), and the Medical Device Manufacturers Association (MDMA) – as well as representatives selected from the FDA and AAMI.
The white paper is but one example of AAMI’s leadership in focusing attention on the issue of risk management in the medical device world. The spring edition of Horizons, AAMI’s biannual supplement, will focus on the issue, as will a joint AAMI/FDA summit planned for Sept. 29-30, 2015.
Certification Expansion Eyed for Sterilization Field
Working with subject matter experts, AAMI is developing plans to offer new certification in industrial sterilization, a reflection of the growing importance of this specialty.
“These professionals, while very important to our industry, saw their roles arise spontaneously and rather organically. This is the first time their roles really have been defined,” said Joe Lewelling, vice president of standards development and emerging technologies.
A lot of work remains, but the goal is to deploy the industrial sterilization certification in the fourth quarter of this year.
The effort began in earnest in late January when AAMI hosted a group of 12 subject matter experts to map out the parameters of the certification.
“The task was enormous given the landscape of industrial sterilization technologies,” AAMI Credentials Institute (ACI) Director Jan paul Miller noted. “The discussions were focused and always directed to finding the best way to assess the competence of candidates who will sit for this exam.”
Created this past November, the ACI will replace both the International Certification Commission for Clinical Engineering and Biomedical Technology and United States Certification Commission. Its mission is to serve as the trusted source for quality professional development and credentials for health care technology-oriented professionals and entities in higher education, industry and health care delivery.
Guided by Miller and James Hellrung, a research associate at Applied Measurement Professionals, a subcontractor for ACI, the group created an operational definition of an industrial sterilization scientist, as well as the areas of expertise in which the individual must be competent
Initially, the group considered adopting a generalist approach for this certification. However, after intense discussion, the experts settled on three separate certifications, each with a common core of knowledge related to industrial sterilization: ethylene oxide, dry heat and radiation.
Once a wider group validates the logical job task analysis, a detailed content outline will be created. Other subject matter experts then will author items for the test. More than 40 industrial sterilization experts have signed up to work on the industrial sterilization certification. The next step is to train the writers and develop acceptable test questions.