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Technical Committee on Medical Equipment (HEA-MED) - Essays
Technical Committee on Medical Equipment (HEA-MED)
Technical Committee on Medical Equipment (HEA-MED) M E M O R A N D U M DATE: July 20, 2015 TO: Principal and Alternate Members of the Technical Committee on Medical Equipment (HEA-MED) FROM: Jon Hart,
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Technical Committee on Medical Equipment (HEA-MED) M E M O R A N D U M DATE: July 20, 2015 TO: Principal and Alternate Members of the Technical Committee on Medical Equipment (HEA-MED) FROM: Jon Hart, Staff Liaison SUBJECT: AGENDA PACKAGE NFPA 99 First Draft Meeting (A2017) Enclosed is the agenda for the NFPA 99 First Draft meeting of the Technical Committee on Emergency and Security Management, which will be held on Tuesday, August 11, 2015 at the Sheraton Inner Harbor Hotel, in Baltimore, MD. Please review the attached Public Inputs in advance, and if you have alternate suggestions, please come prepared with proposed language and respective substantiation. If you have any questions prior to the meeting, please do not hesitate to contact me at: Office: (617) For administrative questions, please contact Elena Carroll at (617) I look forward to working with everyone. 1 Table of Contents Part 1 Meeting Agenda Part 2 Committee Roster Part 3 Committee Distribution Part 4 Previous Meeting Minutes Part 5 Sample Meeting Motions Part 6 Public Inputs 2 Technical Committee on Medical Equipment (HEA-MED) NFPA 99 First Draft Meeting (Annual 2017) Tuesday, August 11, 2015 Sheraton Inner Harbor Hotel 300 S. Charles Street, Baltimore, MD AGENDA 1. Call to Order 8:00 am 2. Introductions and Attendance 3. Chairman Comments 4. Approval of Previous Meeting Minutes 5. Staff Liaison Presentation on NFPA Revision Process and A2017 Cycle 6. Preparation of the First Draft Review Public Inputs Create First Revisions 7. New Business 8. Discuss dates for the TC Second Draft Meeting (Between 5/16 and 7/25, 2016) 9. Adjournment No later than 5:00 pm Please submit requests for additional agenda items to the chair and staff liaison at least seven days prior to the meeting. Please notify the chair and staff liaison as soon as possible if you plan to introduce any new material not submitted through Public Input at the meeting. 3 Technical Committee on Medical Equipment (HEA-MED) NFPA 99 First Draft Meeting (Annual 2017) Tuesday, August 11, 2015 Sheraton Inner Harbor Hotel 300 S. Charles Street, Baltimore, MD Key Dates for the Annual 2017 Revision Cycle Public Input Closing Date July 6, 2015 Final Date for First Draft Meeting September 14, 2015 Ballots Mailed to TC before October 26, 2015 Ballots Returned By November 16, 2015 Correlating Committee First Draft Meeting December 15, 2015 Final First Draft Posted March 7, 2016 Public Comment Closing Date May 16, 2016 Final Date for Second Draft Meeting July 25, 2016 Correlating Committee Second Draft Meeting by November 21, 2016 Final Second Draft Posted January 16, 2017 Closing Date for Notice of Intent to Make a Motion (NITMAM) February 20, 2017 Issuance of Consent Document (No NITMAMs) May 12, 2017 NFPA Annual Meeting (Boston) June 2017 Issuance of Document with NITMAM August 10, 2017 Technical Committee deadlines are in bold. 4 Technical Committee Roster 5 Address List No Phone Medical Equipment Health Care Facilities Donald D. King Chair Kaiser Permanente 1800 Harrison Street, 19th Floor Oakland, CA American Society for Healthcare Engineering Alternate: Chad E. Beebe U 10/29/2012 HEA-MED Barry E. Brown Principal Airgas, Inc Starwood Trail Lilburn, GA Alternate: William C. Fettes 07/13/2015 Jonathan Hart HEA-MED IM 8/2/2010 HEA-MED Charles Connor Principal Detroit Medical Center 3663 Woodward Avenue, Detroit, MI U 03/07/2013 HEA-MED David A. Dagenais Principal Wentworth-Douglass Hospital 789 Central Avenue Dover, NH NFPA Health Care Section U 10/23/2013 HEA-MED Keith Ferrari Principal Praxair, Inc Gresham Lake Road Raleigh, NC Compressed Gas Association Alternate: Gary L. Bean M 1/25/2007 HEA-MED Gerald R. Goodman Principal Texas Woman s University Health Care Administration Program 6700 Fannin, #7015 Houston, TX SE 1/10/2008 HEA-MED Pamela Gwynn Principal UL LLC 12 Laboratory Drive Research Trianlge Park, NC RT 10/23/2013 HEA-MED Alan Lipschultz Principal HealthCare Technology Consulting LLC Strand Drive, #306 North Bethesda, MD Association for the Advancement of Medical Instrumentation M 1/25/2007 HEA-MED John Maurer Principal The Joint Commission 1 Renaissance Boulevard Oak Terrace, IL E 10/23/2013 HEA-MED Ronald C. Reynolds Principal Virginia State Fire Marshal s Office 1005 Technology Park Drive Glen Allen, VA E 08/09/2012 HEA-MED Ezra R. Safdie Principal US Department of Veterans Affairs Veterans Benefits Administration 1800 G Street, Room 506 Washington, DC U 3/4/2008 HEA-MED Lawrence S. Sandler Principal Springtide Court Bonita Springs, FL SE 1/25/2007 HEA-MED Kevin A. Scarlett Principal Washington State Department of Health 1701 North Mildred Street Tacoma, WA E 07/29/2013 HEA-MED Robert M. Sutter Principal B&R Compliance Associates PO Box Lehigh Valley, PA Alternate: Kenneth Gerard Funk SE 1/25/2007 HEA-MED 6 1 Address List No Phone Medical Equipment Health Care Facilities Gary L. Bean Alternate Air Products & Chemicals, Inc Satellite Blvd. NW, Suite 100 Suwanee, GA Compressed Gas Association Principal: Keith Ferrari M 7/23/2008 HEA-MED Chad E. Beebe Alternate ASHE - AHA PO Box 5756 Lacey, WA Principal: Donald D. King 07/13/2015 Jonathan Hart HEA-MED U 03/05/2012 HEA-MED William C. Fettes Alternate Airgas, Inc Knox Street Overland Park, KS Principal: Barry E. Brown Jonathan Hart Staff Liaison National Fire Protection Association 1 Batterymarch Park Quincy, MA IM 1/25/2007 HEA-MED 3/1/2012 HEA-MED Kenneth Gerard Funk Alternate Environmental Technologies Associates (ETA), Inc. 240 Ashland Trail Tyrone, GA Principal: Robert M. Sutter SE 07/29/2013 HEA-MED 7 2 Technical Committee Distribution 8 Distribution by % HEA-MED Medical Equipment Name Company Representation Class Office John Maurer The Joint Commission E Principal Ronald C. Reynolds Virginia State Fire Marshal s Office E Principal 07/13/2015 Kevin A. Scarlett Washington State Department of Health E Principal Voting Number 3 Percent 21% Barry E. Brown Airgas, Inc. IM Principal Voting Number 1 Percent 7% Keith Ferrari Praxair, Inc. CGA M Principal Alan Lipschultz HealthCare Technology Consulting LLC AAMI M Principal Voting Number 2 Percent 14% Pamela Gwynn UL LLC UL RT Principal Voting Number 1 Percent 7% Gerald R. Goodman Texas Woman s University SE Principal Lawrence S. Sandler SE Principal Robert M. Sutter B&R Compliance Associates SE Principal Voting Number 3 Percent 21% Donald D. King Kaiser Permanente ASHE U Chair Charles Connor Detroit Medical Center U Principal David A. Dagenais Wentworth-Douglass Hospital NFPA/HCS U Principal Ezra R. Safdie US Department of Veterans Affairs USVA U Principal Voting Number 4 Percent 29% Total Voting Number 14 9 Previous Meeting Minutes 10 MINUTES NFPA Technical Committee on Medical Equipment (HEA-MED) May 20, 2013 Second Draft Meeting Adobe Connect Web Meeting 1. Call to Order. The meeting was called to order at 9:00 am Eastern on Monday, May 20, 2013, by Committee Chair, Alan Lipschultz. 2. Attendance and Introductions: Attendance was taken and those present at the meeting introduced themselves and stated who they represent on the committee. Those who were present at the meeting are listed below: Name Lipschultz, Alan Chair Connor, Charles Principal Ferrari, Keith Principal Fettes, William Principal Goodman, Gerald Principal King, Don Principal Kostinsky, Harvey Principal Reynolds, Ronald Principal Safdie, Ed Principal Sandler, Larry Principal Sutter, Robert Principal Bean, Gary Alternate Beebe, Chad Alternate Hart, Jonathan Staff Liaison Poacsek, David Guest Representing Association for the Advancement of Medical Equipment Detroit Medical Center Compressed Gas Association Airgas, Inc. Texas Women s University Kaiser Permanenete ECRI Institute Virginia State Fire Marshal s Office US Department of Veterans Affairs B&R Compliance Associates Compressed Gas Association American Society of Healthcare Engineers NFPA Invacare 3. Chairman Comments: Alan Lipschultz spoke to the agenda for the meeting and provided opening comments. 11 4. Minutes Approval: The minutes of the HEA-MED August 16, 2012 First Draft Meeting were approved as distributed in the Agenda Package. 5. Staff Liaison Presentation: Jon Hart proceeded to give the staff presentation for the meeting which included general meeting procedures and review of the Annual 2014 revision cycle. 6. Development of Second Draft: The committee reviewed all public comments (PC) and resolved them by taking a committee action, providing a statement, and/or creating a second revision (SR) based on the PC. Other Second Revisions were also created. See the Second Draft and Second Draft Report for the official committee actions. 7. New Business: A discussion on the use of the words appliance and equipment was had and it was determined that as it currently stands, some confusion could result from how they might possibly be considered interchangeable. It is too late a time in this revision process to evaluate for the 2015 edition, but the issue will be looked at in detail for the subsequent edition. 8. Meeting Adjourned: The meeting was adjourned at 12:30 pm on May 20, Sample Motions for First Draft Meeting 13 NEW PROCESS ACTIONS AND MOTIONS Possible Action #1: Resolve PI (no change to section) Action Required Sample motion Make a statement to resolve a PI I move to resolve PI # with the following statement... Possible action #2: Create First Revision (make a change to a section) Action Required Sample motion Step 1 Create a First revision based one or more PIs I move to create a First Revision based on PI # Step 2 If the revision is related to multiple PIs, generate a statement to respond to all of them together Step 1 Create a First Revision I move to create a First Revision as follows... Step 2 Generate a statement (substantiation) Possible Action 3: Create Committee input Step 1 Create proposed revision for solicitation of public comments I move to create CI with a proposed revision to X as follows... Step 2 Generate a statement to explain the intent and why the Committee is seeking public comment 14 Public Input 15 Public Input No. 60-NFPA [ Global Input ] 1. Delete entire subsection (5) as follows: (5) *Means are employed to ensure that additional devices or nonmedical equipment cannot be connected to the multiple outlet extension cord after leakage currents have been verified as safe. 2. Delete corresponding Annex A material A (5) as follows: A (5) Power taps used in conjunction with an isolated power system are not subject to this requirement. Additional Proposed Changes File Name Description Approved TIA_ pdf NFPA 99 TIA 15-1 Log No NOTE: This public input originates from Tentative Interim Amendment No (Log 1104) issued by the Standards Council on August 14, 2014 and per the NFPA Regs., needs to be reconsidered by the Technical Committee for the next edition of the Document. Submitter s Substantiation: The Technical Committee accepted a public comment (NFPA 99 HEA-MED A11 ROC; Log #272 HEA-MED) which would have deleted (5), but another public comment Log #64 HEA-MED on that section was Accepted in Principal and resulted in adding annex material A (5) to that section. (Both items reported in the NFPA 99 Report on Comments A2011.) NFPA, when compiling the revised version of the document, did not incorporate the first committee action and implemented the second action, without determining the position of the committee on this issue. Technical background: Both of the ROC proposals were based on the recognition that it is impractical to completely eliminate the use in hospitals of multiple outlet extension cords that allow clinicians and staff to plug and unplug devices as needed. The situation in the OR was adeptly explained in ROC Log #64, It is near impossible to plug all electrical devices used in an operating room to a wall receptacle. The cord length on equipment are not long enough to reach the wall and even if it did it would restrict safe movement around the OR table. The problem, however, exists not just in the OR. For example, it is often necessary to use three or more infusion pumps, in addition to other devices, on one patient in a patient room. There may not be an adequate number of outlets nearby and running multiple cords, perhaps with extension cords, can hamper access to the patient and present a trip hazard. Instead, having an appropriate quality and properly maintained multiple outlet extension cord mounted on an IV pole, allows a safe method of powering whatever number of IV pumps is needed for a patient. The Committee action to accept proposal Log #272 would have allowed this type of use of multiple outlet extension cords and eliminated any need for further exceptions or annex material. Furthermore, the use of isolated power, currently mentioned in the annex material, does not address concerns related to touch (leakage) current values that are addressed in the main text to which the annex comment is attached. Isolated power does not limit equipment touch currents to values required within the main document. Emergency Nature: Uncorrected, the present requirements pose an unreasonable burden on hospitals and clinicians and restricts safe access to patients not only in the operating room, but also in other patient care areas. Furthermore, as accrediting bodies, such as The Joint Commission (TJC) and the U.S. Centers for Medicare & Medicaid Services (CMMS) incorporate these requirements into their assessments and survey processes, it becomes increasingly difficult to reverse these decisions and facilities are forced to implement alternative practices that may be either unnecessarily expensive (e.g., renovations to increase outlet numbers and accessibility throughout the hospital) or less safe (e.g., use of more single outlet extension cords running greater distances to access multiple wall outlets). Hospitals have already approached ECRI Institute regarding this problem, and it is therefore not just a theoretical concern, but one which facilities are being forced to address now. This TIA would address at least three of the factors to be considered when assessing the emergency nature of a TIA proposal (REGULATIONS GOVERNING COMMITTEE PROJECTS, /RegsGovCommProjects_2012.pdf) (b) The document contains a conflict within the document or with another NFPA document. This factor applies, because, as discussed in the technical background above, the Annex reference to isolated power is not related to the associated main document text. (d) The proposed TIA intends to offer to the public a benefit that would lessen a recognized (known) hazard or ameliorate a continuing dangerous condition or situation. Adherence to the requirements may hinder access to the patient and pose a trip hazard. (f) The proposed TIA intends to correct a circumstance in which the revised document has resulted in an adverse impact on a product or method that was inadvertently overlooked in the total revision process, or was without adequate technical (safety) justification for the action. As discussed above, the current situation is the result of NFPA procedures in place at the time (and since corrected) that allowed for decisions to be made based on a procedural mishap without addressing technical considerations. Submitter Full Name: TC on HEA-MED Organization: NFPA Submittal Date: Fri Apr 10 09:51:24 EDT of 1 7/8/ :27 AM 16 National Fire Protection Association Report of 2 7/8/ :28 AM Public Input No. 61-NFPA [ Global Input ] 1. Revise text to read as follows: Elimination of Sources of Ignition Smoking materials (e.g., matches, cigarettes, lighters, lighter fluid, tobacco in any form) shall be removed from patients receiving respiratory therapy * When a nasal cannula and its associated supply tubing are delivering oxygen outside of a patient care room, no sources of open flame shall be permitted in the site of intentional expulsion * When any other oxygen delivery equipment not specified in is in use, N no sources of open flame, including candles, shall be permitted in the area of administration * Solid fuel-burning appliances shall not be permitted in the area of administration * Sparking toys shall not be permitted in any patient care room Nonmedical appliances that have hot surfaces or sparking mechanisms shall not be permitted within oxygen-delivery equipment or within the site of intentional expulsion. A O u tside of a patient care room, prohibits sources of open flames within the site of intentional expulsion [1 ft (0.3 m)] of a nasal cannula. No sources of open flame are permitted within the area of administration [15 ft (4.3 m)] for other types of oxygen delivery equipment or in patient care rooms (see ). The amount of oxygen delivered by a nasal cannula is limited. One (1) ft (0.3 m) is sufficient separation from an oxygen- enriched atmosphere produced by a nasal cannula which is an oxygen delivery equipment used outside of patient care areas. In the open air, dilution goes to ambient levels (not oxygen-enriched atmosphere) within a few inches of the cannula openings, but 12 in. (300 mm) provides an adequate safety factor. Other oxygen delivery equipment such as masks, are not included since masks would not typically be associated with mobile patients in health care facilities and may deliver greater quantities of oxygen than nasal cannula. The household-style nursing homes that include kitchens intended for residents use and enclosed gas fireplaces present a source of flame ignition to which residents will be exposed. Residents utilizing a nasal cannula would potentially not be allowed to participate in the cooking because it would place the cooking flame within the site of intentional expulsion. However, they would be allowed in the kitchen area to assist in preparing the food and to socialize with other residents and staff in the kitchen similar to what happens in the kitchens of residential environments. The primary concern is that flame-producing equipment exists in many places in a nursing home and that it would be impractical to maintain a resident with a nasal cannula a minimum of 15 ft (4.3 m) (Area of Administration) away from the flame-producing equipment. Typical flameproducing equipment found in a nursing home includes the following: 1. Candles in chapels 2. Open kitchens using gas cooking equipment 3. Fireplaces 4. Fuel-fired heating equipment 5. Private family dining rooms using fuel-fired equipment 6. Canned cooking fuel (e.g., used under chafing dishes) A Patients and hospital personnel in the area of administration should be advised of respiratory therapy hazards and regulations. Visitors should be cautioned of these hazards through the prominent posting of signs. (See ) A Solid fuel burning appliances include wood-burning fireplaces, wood stoves, and similar appliances. These pose a greater risk in locations where oxygen is being provided than gas-fueled appliances, in part due to their ability to emit embers into the environment. A Such toys have been associated with fire incidents in health care facilities. A suggested text for precautionary signs for oxygen tent canopies and oxygen hoods used in pediatric nursing units is the following: CAUTION: OXYGEN IN USE ONLY TOYS APPROVED BY NURSES MAY BE GIVEN TO CHILD Additional Proposed Changes File Name Description Approved TIA_ pdf NFPA 99 TIA 15-2 Log No A Public Input has been created for the Issued TIA No This TIA was issued on AUGUST 14, Per the NFPA Regs., all issued TIAs must be reconsidered by the Technical Committee for the Next Edition of the Document. Submitters Substantiation: The proposed TIA will address potentially restrictive interpretations for the presence of open flames in the vicinity of nasal cannula oxygen delivery equipment. The area of administration is defined as any point within a room within 15 ft of oxygen equipment or an enclosure containing or intended to contain an oxygen- enriched atmosphere. Section prohibits sources of open flame, including candles, in the area of adm
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