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HTM Community Database Project

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(This page was last revised on 12-8-18)

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Background

In December 2011, The Centers for Medicare and Medicaid Services (CMS) published what has become known as "the 2011 clarification memo" in which they redefined their expectations about how healthcare facilities should perform routine maintenance of their medical equipment. A copy of the memo is available at https://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/downloads/SCLetter12_07.pdf. This was later amended with a second publication that is sometimes called "the 2013 clarification memo". A copy of this document is available at: http://www.cms.gov/Medicare/Provider-Enrollment-and-Certification/SurveyCertificationGenInfo/Downloads/Survey-and-Cert-Letter-14-07.pdf http://www.aami.org/productspublications/articledetail.aspx?

While these two clarification memos have relaxed the strict requirement in the "Interpretive Guidelines" that medical equipment should always be maintained "according to the manufacturer's recommendations", they have spelled out some additional requirements that the Healthcare Technology Management (HTM) Community at large felt to be both unnecessary and needlessly onerous. The central issue in the ensuing discussions has been whether or not the current practices of the non-manufacturer servicers (the in-house and independent maintenance providers) which are generally found to be acceptable to The Joint Commission - do, in fact, provide an acceptable level of patient safety.

However, what the ensuing discussions between the CMS and representatives of the HTM Community have highlighted is that there is no generally agreed way of quantifying current levels of maintenance-related medical equipment safety in a way that is understandable and meaningful to a reasonable lay person.

Vision statement and objectives

To begin to address this need several members of the HTM Community with a a vision of a world in which medical device maintenance is performed as cost-efficiently as possible, but in a way that achieves an acceptable level of patient safety have come together under the aegis of the Association for the Advancement of Medical Instrumentation (HTM ComRef 30.) to form an ad-hoc Maintenance Practices Task Force with the following four objectives:

Objective #1. Develop, and gain community-wide acceptance for, a scientifically sound, but simple to understand, RCM-based methodology for determining which types of medical devices are actually made safer by periodic planned maintenance - along with a simple explanation of why routine PM fails to improve the safety of the great majority of medical devices.
Objective #2. Develop guidelines and tools to facilitate a rational optimization of PM programs for medical devices, including a standardized format for the maintenance documentation required to support the analytical methods being proposed.
Objective #3. Create a community-wide database to provide a substantial body of quantitative evidence to support the proposed RCM-based optimization.
Objective #4. Build up a collection of information on each device’s demonstrated level of PM-related reliability and safety based on aggregated maintenance data from each specific manufacturer - model version of the different types of medical devices.


A tentative plan for implementation of the project is laid out in another section (see The Plan)


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