August 2006
ISO/IEC small bore connector new work proposal package
For committee membership application (in WORD), go to http://www.aami.org/Applications/CommitteeCentral-app/Documents/ACFDB06.doc For more information about the work item or the U.S. sub-TAG being formed by AAMI to develop U.S. positions on this work (if approved), contact hwoehrle@aami.org
ISO/TC 210 N291
April 2006
Recommendations from the Ad Hoc meeting of interested parties on Medical Device Small Bore Connectors 27 April 06 Saint-Denis, France AFNOR
Recommendation (Paris) 1
The ad hoc group proposes to set-up a JWG between ISO TC 210, IEC TC 62, and CEN BTTF 123 for the development of standards for small-bore connectors for liquids and gases in healthcare applications under the Vienna agreement with ISO TC 210 administrative lead. The following concerned groups should be invited to liaise and to nominate experts to actively participate in this JWG: ISO TC 76, ISO TC 84, ISO TC 121, ISO TC150, ISO TC 172, CEN TC 205, and CEN TC 215.
Recommendation (Paris) 2
The ad hoc group recommends that to execute Recommendation (Paris) 1 the scope of ISO TC 210 be extended to cover small-bore connectors for liquids and gases in specific healthcare applications.
Recommendation (Paris) 3
The ad hoc group proposes that ISO TC 210 issues NWIP to ISO TC 210, IEC TC 62, and CEN BTTF 123 using the appropriate format to cover the development of standards for small-bore connectors for liquids and gases in specific healthcare applications. This NWIP should include information from CEN CR 13825:2000 for its justification and should be accompanied by CEN prEN WI CSS99013 part 1 as a document for consideration as an attached draft.
Recommendation (Paris) 4
The ad hoc group proposes that to execute Recommendation (Paris) 3 the JWG develops standards covering general aspects of non-interchangeability and appropriate validation procedures for small-bore connectors for liquids and gases in specific healthcare applications, and additional parts covering requirements for connectors for specific applications.
Recommendation (Paris) 5
The ad hoc group proposes that the JWG develops the standards using Project Teams of relevant experts for the requirements for connectors for specific applications.
Attendance Name Anne-Laure Bailly Philip Bickford Smith Clive Bray Mette-Marie Brendstrup Ton Clutton-Brock Richard Chan Maurice Freeman Mathiew Giang Ann Graham Roger Gray Tim Hancox Carol Herman Ralph Hilberath Reiner Hoffman Eamonn Hoxey Peter Kinast Hubertus Lasthaus Mattias Marzinko Stan Mastrangelo Masaaki Naito Dave Osborn Trudy Phelps Hillary Woehrle Country France IK UK Denmark UK USA UK France USA UK Switzerland USA France Germany UK Germany Germany Germany USA Japan USA UK USA Affiliation Chairman, CEN/BT TF 123 Convener, CEN/BT TF 123 PG 6 Member, CEN/BT TF 123 PG 2 Secretary, ISO/TC 84 Convener, CEN/BT TF 123 PG 4 Member, ISO/TC 150/SC 2/WG 4 Member, CEN/BT TF 123 Secretary, CEN/BT TF 123 Member, ISO/TC 121/SC 2 Convener, CEN/BT TF 123 PG 7 ISO Central Secretariat Member, ISO/TC 210 EUCOMED Member, IEC/TC 62D Chairman, ISO/TC 210 Member, IEC/TC 62D Convener, CEN/BT TF 123 PG 3 Member, CEN/BT TF 123 Member, ISO/TC 210 Member, ISO/TC 210 Secretary, ISO/TC 121/SC 3 Secretary, CEN/BT TF 123 Secretary, ISO/TC 210
PROPOSED DRAFT REVISION OF THE SCOPE FOR ISO/TC 210 SCOPE: Standardization of requirements and guidance in the field of quality management and corresponding general aspects for medical devices, including standards and guidance for crosscutting technology used in medical devices and that is not covered by the scope of another technical committee.
Excluded: - generic quality management standards dealt with by ISO/TC 176; - quality management standards for pharmaceutical products; - technical requirements for specific types of medical devices, - technical requirements for crosscutting technology that is covered by the scope of another technical committee. NOTE 1 An example of such a crosscutting technology that would be included in this scope is small-bore connectors for liquids and gases in specific healthcare applications. NOTE 2 In order to promote global harmonization the Technical Committee may also develop standards on general aspects stemming from the application of quality principles to medical devices, where these are not covered by the scope of another technical committee.
NEW WORK ITEM PROPOSAL
Date of presentation
DRAFT
Proposer
Reference number (to be given by the Secretariat)
ISO/TC 210 Secretariat
Secretariat
ISO/TC 210 / SC
N DRAFT
AAMI (for ANSI)
A proposal for a new work item within the scope of an existing committee shall be submitted to the secretariat of that committee with a copy to the Central Secretariat and, in the case of a subcommittee, a copy to the secretariat of the parent technical committee. Proposals not within the scope of an existing committee shall be submitted to the secretariat of the ISO Technical Management Board. The proposer of a new work item may be a member body of ISO, the secretariat itself, another technical committee or subcommittee, or organization in liaison, the Technical Management Board or one of the advisory groups, or the Secretary-General. The proposal will be circulated to the P-members of the technical committee or subcommittee for voting, and to the O-members for information. See overleaf for guidance on when to use this form. IMPORTANT NOTE: Proposals without adequate justification risk rejection or referral to originator. Guidelines for proposing and justifying a new work item are given overleaf.
Proposal (to be completed by the proposer) Title of proposal (in the case of an amendment, revision or a new part of an existing document, show the reference number and current title) English title
Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
French title
(if available)
Scope of proposed project
International Standard covering general aspects of non-interchangeability and appropriate validation procedures for small bore connectors for liquids and gases in healthcare applications.
Concerns known patented items (see ISO/IEC Directives Part 1 for important guidance) Yes No If "Yes", provide full information as annex Technical Specification Publicly Available Specification Technical Report
Envisaged publication type (indicate one of the following, if possible) International Standard
Purpose and justification (attach a separate page as annex, if necessary)
The purpose of this proposed international standard is to reduce the risk of accidental misconnection of connectors between devices. The increasing complexity of medical interventions, and the associated medical devices has led to a requirement for users to connect a multiplicity of external tubes to various types of diagnostic and therapeutic devices before use. Fundamentally the main routes of delivery to the body are: intravascular, enteral, respiratory and neuraxial. Some medical devices are intended to be connected to one of these routes depending upon the application or function of the device, via connectors. Misconnections, which result in the delivery of a substance inappropriately to the body, create risks to the patients. The problem results from the application of a single connector design to a number of incompatible applications. Providing alternative connectors for various applications could significantly reduce the risk of misconnection. This is the first part in a proposed series of international standards that will cover the general requirements for small bore connectors for liquids and gases in healthcare applications. Possible future parts (NWIPs will be issued) will cover requirements for connectors for specific applications such as: vascular, enteral, respiratory, neuraxial, urethral/urinary, circumferential cuff inflation systems for limbs, and endoscopes. If aproved, this NWIP will form the basis of a new ISO/TC 210-IEC/TC 62 Joint Working Group on Small bore connectors. All documents balloted by this ISO/IEC JWG will be concurrently balloted for approval by CEN under the Vienna Agreement. Members of ISO/TC 210, IEC/TC 62 and CEN BTTF 123 are asked to nominate experts to the TC 210 Secretariat to participate in this work.
Target date for availability (date by which publication is considered to be necessary) 2010
FORM 4 (ISO) v.2005.1 Page 1 of 3
New work item proposal
Proposed development track
1 (24 months)
2 (36 months - default)
3 (48 months)
Relevant documents to be considered
CEN prEN 15546-1, CEN CR 13825:2000
Relationship of project to activities of other international bodies Liaison organizations Need for coordination with: IEC CEN Other (please specify)
ISO/TC 76, ISO/TC 84, ISO/TC 121, ISO/TC 150, ISO/TC 172, CEN BTTF 123, CEN/TC 205 and CEN/TC 215.
a new ISO/TC 210-IEC/TC 62 JWG that will conduct parallel ballot with CEN under the Vienna Agreement
Preparatory work (at a minimum an outline should be included with the proposal) A draft is attached An outline is attached. It is possible to supply a draft by Yes No
The proposer or the proposer's organization is prepared to undertake the preparatory work required Proposed Project Leader (name and address) Name and signature of the Proposer (include contact information)
To be determined
ISO/TC 210 Secretariat
Comments of the TC or SC Secretariat Supplementary information relating to the proposal This proposal relates to a new ISO document; This proposal relates to the amendment/revision of an existing ISO document; This proposal relates to the adoption as an active project of an item currently registered as a Preliminary Work Item; This proposal relates to the re-establishment of a cancelled project as an active project. Other: Voting information The ballot associated with this proposal comprises a vote on: Adoption of the proposal as a new project Adoption of the associated draft as a committee draft (CD) (see ISO Form 5, question 2.3.1) Adoption of the associated draft for submission for the enquiry vote (DIS or equivalent) (see ISO Form 5, question 2.3.2) Other: Annex(es) are included with this proposal (give details)
prEN 15546-1
Date of circulation Closing date for voting Signature of the TC or SC Secretary
Hillary Woehrle
Use this form to propose:
a) a new ISO document (including a new part to an existing document), or the amendment/revision of an existing ISO document; b) the establishment as an active project of a preliminary work item, or the re-establishment of a cancelled project; c) the change in the type of an existing document, e.g. conversion of a Technical Specification into an International Standard. This form is not intended for use to propose an action following a systematic review - use ISO Form 21 for that purpose. Proposals for correction (i.e. proposals for a Technical Corrigendum) should be submitted in writing directly to the secretariat concerned.
Guidelines on the completion of a proposal for a new work item
(see also the ISO/IEC Directives Part 1) a) Title: Indicate the subject of the proposed new work item. b) Scope: Give a clear indication of the coverage of the proposed new work item. Indicate, for example, if this is a proposal for a new document, or a proposed change (amendment/revision). It is often helpful to indicate what is not covered (exclusions). c) Envisaged publication type: Details of the types of ISO deliverable available are given in the ISO/IEC Directives, Part 1 and/or the associated ISO Supplement. FORM 4 (ISO) v.2005.1 Page 2 of 3
New work item proposal
d) Purpose and justification: Give details based on a critical study of the following elements wherever practicable. Wherever possible reference should be made to information contained in the related TC Business Plan. 1) The specific aims and reason for the standardization activity, with particular emphasis on the aspects of standardization to be covered, the problems it is expected to solve or the difficulties it is intended to overcome. 2) The main interests that might benefit from or be affected by the activity, such as industry, consumers, trade, governments, distributors. 3) Feasibility of the activity: Are there factors that could hinder the successful establishment or global application of the standard? 4) Timeliness of the standard to be produced: Is the technology reasonably stabilized? If not, how much time is likely to be available before advances in technology may render the proposed standard outdated? Is the proposed standard required as a basis for the future development of the technology in question? 5) Urgency of the activity, considering the needs of other fields or organizations. Indicate target date and, when a series of standards is proposed, suggest priorities. 6) The benefits to be gained by the implementation of the proposed standard; alternatively, the loss or disadvantage(s) if no standard is established within a reasonable time. Data such as product volume or value of trade should be included and quantified. 7) If the standardization activity is, or is likely to be, the subject of regulations or to require the harmonization of existing regulations, this should be indicated. If a series of new work items is proposed having a common purpose and justification, a common proposal may be drafted including all elements to be clarified and enumerating the titles and scopes of each individual item. e) Relevant documents and their effects on global relevancy : List any known relevant documents (such as standards and regulations), regardless of their source. When the proposer considers that an existing well-established document may be acceptable as a standard (with or without amendment), indicate this with appropriate justification and attach a copy to the proposal. f) Cooperation and liaison: List relevant organizations or bodies with which cooperation and liaison should exist.
FORM 4 (ISO) v.2005.1
Page 3 of 3
A Growing Concern . . .
New Standards Work Proposed to Help Prevent Tubing Misconnections
I
n an effort to reduce the incidence of accidental misconnections between tubing and medical devices connected to a patient, an international new work item proposal (NWIP) suggesting a series of international standards with a goal of reducing these potentially harmful misconnections is being considered. The series of international standards—proposed by ISO/TC 210 (Quality management and corresponding general aspects for medical devices)—would begin with a Part 1 general requirements standard for small-bore connectors for liquids and gases in healthcare applications. A small-bore connector is one that has a maximum bore diameter of 8.5 millimeters. Providing alternative connectors for various applications could significantly reduce the risk of misconnections. To determine the feasibility of addressing misconnection issues through international standards for small-bore connectors, an ad hoc group
of experts recently met in Saint-Denis, France, where it proposed the establishment of a new ISO/TC 210 and IEC/TC 62 joint working group (JWG) on smallbore connectors. All documents balloted by this ISO/IEC JWG would be balloted concurrently for approval by CEN under the ISO/CEN Vienna Agreement. Although work is underway around the world to address this subject, members of various international committees were invited to attend the ad hoc meeting to see if work could be done internationally instead of regionally. Additional parts of the proposed series would cover requirements for vascular, enteral, respiratory, neuraxial, and urethral/urinary connectors, as well as circumferential cuff inflation systems for limbs and endoscopes. As part of its justification for the proposed standards, the NWIP presented by ISO/TC 210 states, “the increasing complexity of medical interventions, and the associated medical devices, has led to a requirement for users to con-
nect a multiplicity of external tubes to various types of diagnostic and therapeutic devices before use. . . . Misconnections, which result in the delivery of a substance improperly to the body, create risks to the patients.” Concern over the dangers of tubing and catheter misconnections is growing. The Joint Commission (JCAHO) recently issued a Sentinel Event Alert urging healthcare organizations to pay special attention to how tubes and catheters are connected to patients and challenging manufacturers of these devices to redesign them in ways that would make misconnections much less possible. AAMI has begun forming a U.S. Technical Advisory sub-Group (subTAG) to develop U.S. positions on international drafts, provided the NWIP is approved internationally. Those interested in becoming part of this U.S. sub-TAG are encouraged to contact Hillary Woehrle at hwoehrle@aami.org.
AAMI News
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