May, 2011 Update
The joint working group, and four of the standards committees met in Washington DC during the week of May 16-20, to make progress on defining the connector standards for each market specific segment. Here is a summary of the meeting:
Joint Working Group
Initially, all the standards members met as a join group to discuss items that should be discussed in a group setting. The group reviewed the progress of the CAD Task Force. A CAD library has been established so each group has access to the other groups designs. The CAD experts are utilizing a macro driven spreadsheet to conduct initial screenings for misconnections followed by detailed 3D analysis of possible misconnections.
At the end of the week, the joint working group members met again to review progress and discuss next steps. Much of the discussion centered on usability testing, which will be necessary to be completed, once each connector design is completed. It will be important to evaluate these new connectors in each standard to make sure that device performance and usability are not compromised in a real clinical setting.
The group also decided that PG 7 must thoroughly define all undefined dimensions of luer connectors in order for the other groups to avoid possible misconnections when finalizing their own designs.
ISO 80369-3: Enteral Feeding
To improve on the committees progress, attendees to the committee meeting were narrowed to a few delegates from each region of the world. With a smaller group of people, this committee spent the meeting focused on more definition of the proposed connectors. At the nutrition source, three connector options remain in the standard. These connector designs have been proposed with dimensional details, but are still in review by the committee, and are not available to the general market. The Enteral committee is seeking to have one connector design for the patient connection, but this design is not yet finalized.
ISO 80369-5: Blood Pressure (Limb Cuff Inflation)
There continues to be three connector sets in the standard, as described previously. Further evaluation will be necessary to confirm that each of the connectors defined do not mate with a luer. This group defined those dimensions that were previously undefined and specified and area on each of the connector designs to accommodate the elastomeric seal.
ISO 80369-6: Neuraxial Devices
There are three different connector sets proposed for this standard. Further discussion and evaluation will be necessary to confirm that these connectors do not mate with luers or other connector sets proposed in other committees.
ISO 80369-7: Intravascular or Hypodermic
This group resolved to define in the standard all the relevant dimensions that exist today so that the remaining PG’s can avoid misconnections. Toward this end much discussion took place regarding which dimensions are controlled by the standard and which are not. Finally, the group defined most of the undefined dimensions by ranging the dimensions to those in the marketplace today. The group agreed to survey manufacturers with the intent to narrow the range on the internal diameter of the male luer and the external diameter of the male luer collar.
CAD Group Meeting
The CAD experts for each committee continue to meet and evaluate proposed connector designs to ensure that the proposed designs do not mate with luers, and will not mate with proposed designs from other standards committees. This work is ongoing, as connector designs in the committees are adjusted and changed.
The PG2 Respiratory standards committee did not meet. Two connector designs are still proposed, as described previously. The PG4 Urinary standards committee has not begun to meet yet, and there is no timetable for this committee to begin meeting.