Standards Development

Scope

The proposed revision to ISO80369-1 is to provide a process for manufacturers of medical devices whose application area is not currently addressed by the ISO 80369-x series to incorporate a connector design utilizing a 6% Luer taper that conforms to the requirements of ISO 80369-7, Clause 6. This change requires the manufacturer to carry out a risk assessment to demonstrate that the risk of unintended connection between the application areas envisioned is acceptably low, as accomplished through a required risk analysis.

To accomplish the proposed change, a revision is proposed to incorporate:

• Additional changes to Clause 1 (Scope), included in the attached working draft (WD), to remove ambiguity concerning the coverage of clinical applications not specifically itemized in the existing scope language.

• A minor change to a note in Clause 1 (Scope) included in the attached working draft (WD).

• Minor change to Clause 5 to reference the exception in new subclause 6.6.

• New subclause 6.6 that details the requirements in order for the option described above to be utilized.

• Minor change to rationale for Clause 6 as a whole. • Additional rationale for subclause 6.6. • New Annex G for risk management for subclause 6.6.

No further revision is suggested.

A working draft is included as Annex A, consisting of a version of the existing ISO 80369-1:2018 with all suggested changes in blue text accompanied by strikethrough deletions.

Purpose

The primary purpose of the proposed revision is to ensure the continued availability of therapy to patients. The series does not address all therapeutic applications that utilized a 6% luer (based on ISO 594 design) and pose a low risk of misconnections. The majority of the identified misconnection risks have been addressed by the new ISO 80369 connector series and use of these for other applications may occur based on a positive outcome of the risk assessment. (See ISO TC210 JWG4 N448).

While ISO 80369-7 (Intravascular and hypodermic applications) adopted the ISO 594 luer connector design with minor changes, the therapeutic applications that do not have a specific standard could adopt ISO 80369-7 standard. However, this is problematic as the other therapeutic applications do not claim an intravascular or hypodermic indication. Updating ISO 80369-7 to broaden the applications is unnecessary when the risk level of misconnections is acceptably low. ISO594 is now superseded by ISO80369-7, hence application areas historically claiming conformance to ISO594 and not within the intravascular or hypodermic application have no defined conformity pathway. The intent of this proposal is to define a clear pathway which will ensure material, performance and risk assessment requirements are met. This does not lessen the requirements on the manufacturer.

Requiring a new connector for each therapeutic application where the risk of misconnection is low would increase the risk to patients through the denial of therapy as healthcare facilities would not have access to the infinite number of accessories and syringes that would be required for each different clinical application, further exacerbated by potentially unique manufacturer proprietary connections. For example, the current standard states that if a therapeutic application is not listed, the default solution is to create a manufacturer proprietary luer design that would only work with manufacturer specific accessories. This puts a burden on the healthcare system to ensure space to store all the additional accessories and syringes. ISO 80369-1 Annex D.4 also requests that ISO TC 210 will review the submitted proprietary design. Since the introduction of the ISO series, the proposer is unaware of any proprietary design being submitted to TC210 for review and a General Application ISO80369-x and Urinary Application ISO80369-4 were deemed not to be required by ISO TC210 JWG4 experts. (See ISO TC210 JWG4 N448). The standard currently states LAD (Luer Activated Device) connectors in ISO 80369-7 are to be compatible to connectors used in the intravascular and hypodermic field. There are other connectors that, although not used in the intravascular and hypodermic field, pose low risk to the patient when connected to the clinical applications listed in ISO 80369-1 and therefore can be considered compatible. Same as the LAD connectors, these low risk clinical applications require connections with 6% luer taper accessories and devices in order to properly function. The intent of this proposal is to provide a conformity pathway for applications historically designed to ISO 594 which are also deemed compatible with ISO 80369-7.

Historically, therapeutic areas including Endoscopy and Urology devices have utilized the ISO 594 series standard to enable connection to broadly available syringes and accessories in the field to support therapeutic care. There have been no adverse events reported that relate to misconnections with different clinical applications. After reviewing the ISO documentation related to ISO 80369-1:2018, the analysis of misconnections in the clinical setting tended to focus on the misconnections between intravascular / hypodermic and enteral applications due to adverse events. However, there are numerous clinical applications impacted that have had no adverse events related to misconnections. This fact was also acknowledged at the ISO TC 210 Joint Working Group 4 meeting in January 2020 when the need for an ISO 80369-4 (Urinary Application) was deemed not necessary.

The secondary purpose of the proposed revision addresses the issue that different regulatory bodies are interpreting the series differently. Even though the ISO 80369 series is not harmonized, regulatory bodies are expecting manufacturers to maintain state of the art. Some regulators expect conformance to the specific therapeutic application (ISO 80369-2 through ISO 80369-7) while other regulators expect conformance to ISO 80369-1 first before considering specific therapeutic standards. As mentioned in the first purpose above, not all therapeutic applications have a specific application listed in ISO 80369- 1 so the only remaining alternative is to create a new proprietary luer design.

The proposed revision will ensure the continued safe use of luers historically designed per ISO 594, which in turn will allow continued supply to the market, and address regulatory concerns described above.