by
Loren Bonner, DOTmed News Online Editor | May 09, 2013
From the May 2013 issue of HealthCare Business News magazine
The FDA staff participates on AAMI standards committees, often serving in leadership roles, and they definitely help shape the direction standards take, which is as it should be. Although the CDRH doesn’t regulate health care organizations or the work of health care technology management professionals, the decisions made by the CDRH can definitely impact HTM — ask any HTM professional whether FDA recalls have an impact on their work! And, new FDA regulations, like the new UDI rule, definitely impact the work of HTM professionals. AAMI’s relationship with the FDA is important to the entire AAMI community, in part, because of the opportunity for mutually supportive dialogue on important technology-related issues and in part, because the FDA wants and needs to hear the expertise that HTM professionals bring to medical device issues.
DMBN: Last year, we covered the issue surrounding the CMS rule regarding preventive maintenance. What is the latest with this?
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ML: In late June 2012, representatives of AAMI and ASHE met with CMS officials to discuss the CMS directive regarding PM practices. The meeting was productive and cordial, with both sides agreeing that discussions would continue. During that meeting, the CMS officials raised questions and concerns about several specific areas, and asked the AAMI/ASHE team to gather information on those areas and report back. So as a follow-up to that meeting, AAMI coordinated the development of a 244- page packet of information, including data on typical HTM practices, such as evidence-based maintenance. The packet addressed the specific concerns raised by CMS.
For instance, CMS wanted to learn more about common algorithms and methodologies used to determine maintenance methodologies or frequencies; existing guidance in use by the field; examples of evidence-based maintenance and equipment history documentation; estimates of the impact of the CMS letter on the field; and other items.
The packet submitted to CMS — available at www.aami.org/cmspacket.pdf — addresses those and other related issues using documentation from hospital systems, published articles, guidance documents, and other resources, to demonstrate that evidence-based maintenance strategies employed in hospitals are safe and effective.
Having reviewed the packet, CMS officials said in an e-mail to me that they are “working on an updated memo” — suggesting that they are looking more closely at their guidance on the PM issue. In that e-mail, which was sent last fall, CMS officials called the 244-page packet “most helpful.” They provided no details on what an updated memo might look like, nor did they provide a timeline.
