A series of meetings were held recently to sort out a whole succession of connector standards. The meetings took place over a period of two weeks in Seattle. The standards fall into the category of ISO 80369, running form 80369-1 through 80369-7.

Richard Nass

December 15, 2010

6 Min Read
Making progress on connector standards

The first part of the standard, 80369-1, is the governing document that says “thou shall not use Luer connectors in medical devices for certain markets.” That document was reviewed in Seattle and is ready to be submitted to the committee members around the world. The next step is a vote that will occur around the beginning of the year. That document is the cornerstone on which all the other standards reference back to. The key take away from the -1 document is that you can only use Luers in one market, which is vascular access.

The 80369-2 standard represents respiratory connectors. Because the -1 document says that you shouldn’t use a Luer with a respiratory connector, the respiratory standards group is determining what is the recommended connector for respiratory. There’s currently a draft document that defines two proposed connectors, one for low pressure and one for high pressure.

The two connectors are both currently manufactured by Value Plastics. According to Chuck Philipp, a vice president at Value Plastics, “One of the people on the committee saw that Value Plastics had connectors that might work and asked us if we would be willing to make those connectors available to the standards committee. This means that we must be willing to provide all of the drawings and other details necessary so that other people can also make those connectors.”

In other words, Value Plastics is offering those connectors up to the market to copy. Their advantage is a head start in the process. That could be roughly three months, assuming other vendors wait until the specification is finalized before they begin to develop their low-cavity tooling. Currently however, the respiratory committee is considering a few changes to the connectors, which would mean that Value Plastics would have to make tooling changes to accommodate this.

The respiratory committee met, reviewed the standards document and the specifications for these two connector sets, and looked at the testing procedures that are going to be used. Philipp acknowledged that there’s still some work to be done. “One or possibly both of the connector sets has to be changed a little to make them more workable for respiratory. So we’re updating the drawings for that right now. And then there’s a certain amount of lab testing that needs to be done to make sure they can stand up to the pressures. We will be doing that testing.”

In the first quarter of next year, the standard will go back out for review by all the members. That may seem like a long duration, but there are reasons for it. For example, every time you send a document out with drawings, specs, etc., you must allow two to three months for people to review it and submit comments, then have those comments collected. The standards committee then meets again, which will occur in Tokyo in April. At that point, the committee will review the comments.

Assuming there are no show stoppers, the appropriate comments are incorporated and everything is sent back out for another review. This takes about six months because it now must go through the ISO standards organization.

The 80369-3 standard defines a connector for enteral feeding. There’s more of a sense of urgency for this standard because the state of California has passed a law that says these connectors can not be Luers as of January 1, 2014 or 36 months after the approval of a recognized standard. Unfortunately, there is still a lot of work to be done to select the appropriate connectors and update the standard before it can go out for the next round of review.

There are two aspects to an enteral feeding set. One is where the feeding bag/bottle is, for example, hanging from the side of the bed, where a connector connects to the bag/bottle. Three different connectors are being proposed. All will be included in the standard, although one is for Japan and two are for most other parts of the world.

The second aspect is the patient-side connector. This is the connector that goes to the needle that goes into the patient. The committee has defined two connectors, but again, it must go through a lengthy review process before they reach the next stage, which is the molding and testing of the connectors.

“The connectors defined by the committee are non-standards, meaning that no one currently molds them,” says Philipp. “We would have to take the specifications and develop new molds and then produce parts from those molds to provide those connectors. That makes it fair for everybody.”

The 80369-4 committee, which defines connectors for urinary devices, has not met yet. They’re waiting until all the other standards committees meet and define their connectors. It was determined that urinary wasn’t as big a risk to mis-connect as some of the others.

The 80369-5 standard defines the connections to blood pressure cuffs. This part of the industry has mostly moved away from Luer connections because there is significant risk involved with accidently making the wrong connection.

There are currently three different connector sets used primarily in blood pressure cuffs. The committee is looking to put them into the standard and then submit the standard for review, comment, and approval. These documents should go out in the first quarter of next year for the next round of review.

A fourth connector that’s peripherally part of the 80369-5 standard is for neo-natal applications. The current standard only defines the connectors that will be used on adult blood-pressure cuffs.

“We are working with manufacturers on the new neo-natal blood pressure connector,” says Jim Brown, business unit manager for medical products at Colder Products, one of the leading connector providers. “The tiny neo-natal cuffs switch the polarity, the male-female connector, from the adult connector. The line that comes from the monitor technically can’t be plugged into an IV line. Hence, the risk is lower, which is why this standard is being tackled in the second phase. These revisions will likely be added when the group meets in Tokyo.”

The 80369-6 standard covers neuraxial, spine, epidurals, etc. This standard is legislated by California, and the group has until 2013 to come up with a connector, at least for use in California. They have defined two unique connectors, neither of which is currently being produced. The updated standards document should go out for review in the first quarter.

The final, yet lesser ballyhooed standard is 80369-7. There is a six-degree tapered Luer that’s currently defined into two standards, ISO 594-1 and -2. The role of this committee is to roll ISO 594-1 and -2 into the ISO 80369 standard, as -7.

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