AAMI News September 2019

New Type of AAMI Resource Aims to Address Need for Rapid Guidance

Jennifer Padberg
Jennifer Padberg, MPH, Astd, is AAMI’s senior vice  president of standards program and policy. Here, she raises the curtain on a new type of guidance document for professionals in the health technology community.

Over the last four decades, AAMI has amassed a very large and highly respected portfolio of health technology standards and technical information reports (TIRs). This is largely due to AAMI’s role as an unbiased convener and the commitment of AAMI members and the community to develop safe and effective health technology.

The pace at which technology is evolving makes it difficult for traditional standards and TIRs to keep up. AAMI members have voiced the need to have quicker guidance on issues where limited data exist, where there is variation in practice, or where there is confusion among stakeholders. To that end, the AAMI staff have, with consultation from members, developed a process by which much more rapid guidance can be provided in a new deliverable—an AAMI consensus report on emerging issues (or consensus report).

Defining Scope

Before we jump into what a consensus report is, let’s review what it is not.

A consensus report is not a standard. Standards are often broad in scope and may recommend to manufacturers the information that should be included with a product, basic safety and performance criteria, and conformance measures that can be used to assess compliance. Standards also sometimes provide clinical users with guidelines for the use, care, evaluation, or processing of health technology. The development of standards is a highly rigorous and lengthy process, often taking three to five (or more) years to formulate, review, acquire consensus, and publish.

A consensus report is also not a TIR, which reviews technical issues relevant to a particular technology and often includes a statement of expert opinion. A TIR also may include differing opinions or serve as interim guidance while a standard is being developed. TIRs also can take extended periods of time to develop—although historically, not as long as traditional standards.

The common denominator in both standards and TIRs is that they abide by the American National Standards Institute’s (ANSI’s) Essential Requirements for Due Process, which entails the following:

  • Openness
  • Lack of dominance
  • Balance of interests
  • Coordination and harmonization
  • Notification of development
  • Consideration of views and objections
  • Consensus

We all agree that due process is optimal in the promulgation of recommendations related to the safety, performance, and effectiveness of health technology. However, the steps required to achieve due process can mean a delay in the dissemination of much-needed guidance, which leaves the health technology community without answers to critical questions or with gaps in their knowledge.

Conversely, a consensus report can provide concise, prompt, and practical guidance on narrowly focused topics of high importance. These new reports are intended to respond to an urgent or immediate need for guidance in the following situations:

  • While more robust data or information develops on emergent areas
  • When variation in the development, implementation, or use of a product or process exists
  • When existing standards or other documents require additional context or clarification

A consensus report also may serve as a tool that can be used by regulators as supplemental information to already recognized standards or TIRs. In addition, it can propose areas where new information or data are needed to address a particular problem.

These concise “nuggets” of information (as described by one AAMI member and advisor), will be based on the collective knowledge and experience of stakeholders. While a consensus report may serve as the basis of a future standard or TIR, it will not be subjected to the same requirements as traditional standards or TIRs.

Developing a Consensus Report

As with a standard or TIR, the first step in the development of a consensus report will be the initial concept proposal. Developed and submitted by an AAMI member or by a member of the AAMI staff, the proposal will include:

  • A well-defined, narrowly focused scope and rationale explaining why the development of a consensus report is appropriate.
  • A description of how the topic aligns with AAMI’s Strategic Plan.
  • A list of stakeholders in support of and/or affected by the proposal, including the names and contact information for potential participants.
  • An outline or rough draft, as well as a summary of any data or other documentation that supports, affects, or potentially duplicates any part of the proposed work.

Within a month’s time, the proposal will be reviewed and approved internally by AAMI, and the AAMI Standards Board will have an opportunity to review and raise any objections to the proposal. AAMI will select a small task group of experts (three to nine people) who will complete the work and a review group representing a balance of stakeholder interests to serve as the consensus body (an existing AAMI standards committee may serve in this capacity).

The task group will then meet (either in person or virtually) to complete and prepare the draft for circulation. The draft will be circulated by AAMI staff to the review group for comment. The task group will address the comments and finalize the draft. This process is estimated to take approximately six to eight weeks.

Within the next 30 days, the draft will be circulated back to the review group for an up/down approval reaching “substantial agreement,” which is defined as minimum approval by at least two-thirds of those voting (excluding abstentions), with at least two-thirds of eligible voters returning ballots (including abstentions). The draft will also be circulated to the AAMI Standards Board at this time, with an opportunity to raise objections to approval. If objections are raised, the final decision on approval will be taken by consensus of the Standards Board. The task group is not required to resolve technical comments received at this stage and can defer such comments to the next iteration. If a technical change is made, a re-ballot of the review group is required. Relevant editorial comments can be accepted. Once approved, the consensus report will be published as a stand-alone document.

A consensus report will be reviewed post publication by the task group and review group on a somewhat regular basis (~12 to 24 months) to determine the need to reaffirm, revise, transition to a TIR/standard, incorporate into an existing document(s), or be withdrawn.

The target length from acceptance of the proposal to publication of the report is three to four months. This timeline depends on numerous factors—most importantly, the ability of the task group members to quickly assemble and commit to the rapid completion of the document.

A Defined Purpose

Each of these documents—standards, TIRs, and consensus reports—is important and serves a defined purpose. Consensus reports will not (and should not) include requirements and will not be used to show conformance. They will not replace a standard or TIR; rather, they will support or inform them.

A few topics for consensus reports that have been suggested in the software/health information technology space include:

  • Good practices for using cloud storage solutions.
  • Common mistakes when conducting computer system validation.
  • New risks related to artificial intelligence.