Aami Microbiological Methods Working Group

EQN074

AAMI/EQ, Medical Equipment Management Committee

Minutes of the 5-6 December 2016 meeting

Rosen Shingle Creek

Orlando, FL

1.  Call to order and introductions

The EQ committee meeting was called to order on Monday, December 5, 2016 at 9:04 AM by AAMI staff Amanda Benedict. Cochair Michael Angel was unable to attend the meeting. Ms. Benedict served as recording secretary.

In attendance were:

Pat Baird

Amanda Benedict

Britt Berek

Robert Boyd

Dennis Carr

Andrew Durfor

Steve Grimes

Megan Hayes

Julio Heurta

John Knapp

Jane Parker

John Rhoads

Brandyn Zoeller

2.  Approval of the agenda

The agenda (doc. EQN072) was approved as distributed following a motion by Steven Grimes, seconded by Julio Huerta. The AAMI antitrust statement, patent policy, code of conduct and conflict of interest statement were reviewed.

3.  Approval of minutes of the 3 December 2014 meeting

The minutes of the 3 December 2014 meeting (doc. EQN063) were approved as distributed following a motion by Megan Hayes, seconded by Julio Huerta.

4.  Update on the status of the AAMI EQ Committee

Ms. Benedict provided a brief status report on the EQ committee. Members who know of other experts and interested parties who might want to participate in developing the new standards projects were asked to encourage them to join the committee and refer them to AAMI for information.

Britt Berek’s nomination for the open EQ cochair role will be moved forward to the AAMI Standards Board.

It was noted that in addition to published standards EQ56 and EQ89, two new standards projects were recently approved for development under EQ: EQ93 and EQ94. Working on these two new standards will be the primary focus for the meeting. The committee reviewed the scope and timelines of the new projects and changes to the NWIP for EQ94 (the healthcare technology acquisition) standard as approved by the AAMI Standards Board.

Some concern was expressed about the EQ93 vocabulary standard and the potential breadth of it.

5.  Development of new standards

Attendees shifted into a discussion of EQ93. Pat Baird mentioned his work and how he developed a "Rosetta Stone" for another project. The group is favorable to the suggestion to have an annex to translate QSR language and other groups’ terminology. Britt Berek gave an example of “corrective maintenance” versus “run to fail.” A suggestion was considered to create a translation table, as there is a need to be able to "translate to the language" of various groups.

It was a great agreed that it was best to use terms are already out there. Steve Grimes has a running list that he can share with the group. The group can do a crosswalk to explain if definitions are more IT-based, or clinical, etc. It was pointed out that acronyms are heavily used and very from language to language, with the example given of CAD.

Group discussed how to make the document user-friendly and searchable. For example, alphabetical by each group? Suggestion raised that this may need to be an interactive document that is filterable and sortable. A static PDF would be preferred term table and then a table sorted alpha by each group’s terminology. It's possible to indicate a preferred term among many terms meaning the same thing -perhaps that will evolve organically depending on how many groups use each term.

Some documents put forward were SKMTglossary.org, which is the standard definition mining tool that is public and health informatics related. IEEE has something similar to this.

Simple knowledge organization system tool

Steve Grimes suggested to make sure that all relevant standards are included, for example TIR57.

It was noted that this document could become very big. It might become necessary to set a cap on terms included and perhaps include just the most critical terms.

Suggestion raised to have a pilot of this group to see how the first pass of the document works out.

The audience for the EQ93 standard itself is HTM, manufacturers, regulators, IT. The group will want to include all important terms used in connection with medical equipment management and maintenance programs. Some stuff won't need a translation for other stakeholders.

Steve Grimes sent a link to his document and explained the columns. He will add TIR57 and send it out to the group.

Step one is finding commonality, as the point is to have one definition. Reminder was made that this is a voluntary standard and less it should become mandated by a regulatory body. The overall goal is a tool to help professionals communicate better. Megan suggested the extra columns are informative but may not be needed at the end, and mentioned the potential for an “us versus them” perception of not being able to standardize all definitions.

After Steve adds TIR57 to his document, a column will be added for volunteer and then the document should be circulated to the group. Megan Hayes offered to add MITA definitions.

Britt suggested helping small groups of interest/stakeholder groups to add their missing definitions.

The group will continue working on the spreadsheet off-line. AAMI will send it out later. A request was made to have it in Google docs as a collaborative platform, if possible.

The group moved into a discussion of development approaches for EQ94. There is a need to add members/stakeholders to work on this document, in particular.

Steve Grimes mentioned the need to include a feedback loop to help her find the acquisition process in organizations, and including things like security and supportability that haven't been considered in the past. It was noted that the joint commission is asking for this type of standard. Britt Berek suggested casting a broader net on who should be involved in acquisition decisions. Acquisition emphasizes the procurement. The standard needs to ping those questions and who in the organization should answer them.

STRATA - tool for capital planning. "STAT process" was mentioned.

The group expressed that it does not want the standard to bog down the process, or make it so onerous that it halts the process. It needs to be a scalable process.

Pat Baird offered to report the EQ discussions back to the AAMI Supportability SLA group so their work is compatible with this.

The VA document, MRHA document and EQ94 outline was circulated to the group in attendance to review overnight for the second day of the meeting.

The meeting was adjourned at 4:18 PM on December 5th and reconvened at 9:04 AM on December 6th with a discussion of the plan for the day. The group reviewed the EQ94 outline again.

Julio Huerta raised that many of the manufacturers, including smaller ones, are based overseas and sometimes equipment is not approved by any testing lab. It is not an FTA requirement but it is an OSHA requirement. OEM doesn't want to do it, then the hospital has to do it and it costs.

Refinements were made to the outline. Decision was made to include a statement to "make sure the equipment complies with any required regulatory schemes."

VA docs might be included in a way requiring citation.

·  Pre-procurement: go/no-go

·  Implementation planning (tech specs)

·  Procurement

·  Post-procurement

The group discussed the need to get VA participation in the development of EQ94, as well as procurement specialists.

Members in attendance were asked to send Amanda Benedict any relevant tools that they are using.

Note that steps may be skipped, depending on type of process. That will need to be indicated specifically.

The outline should be sent out to all of EQ for feedback in February. Volunteers will be needed to draft sections and send in sample forms.

6.  Other business/next meeting

EQ Committee will hold WebEx meetings in March/April to make progress and meet in-person in conjunction with the AAMI Conference in June in Austin, TX. There is a need to add more committee members in the meantime.

7.  Adjournment

There being no further business, the meeting was adjourned at 10:48 AM on December 6th following a motion by Steve Grimes.