ISO 80369 is Coming—Will You Be Ready?

The race is on for medical device manufacturers to prepare for compliance with new global standards intended to prevent tubing misconections expected to be published in 2016 and 2017.

The race is on for medical device manufacturers to prepare for compliance with new global standards intended to prevent tubing misconections expected to be published in 2016 and 2017.

Jim Skog

Robin Rogers was 35-weeks pregnant and losing weight. Her doctor ordered the 24-year-old to be hospitalized and fed by a tube inserted through her nose to her stomach. But when a nurse accidently connected the tube from the food bag to an intravenous (IV) line in her vein, Rogers and her baby died within hours. As a New York Times article noted, “Putting such food directly into the bloodstream is like pouring concrete down a drain.”

Rogers’ brutal death is among an untold number of fatalities and injuries caused by misconnecting different tubes that deliver a patient’s medication, nutrients, fluids, and gases. Causes of misconnection can be human error from fatigue, medical device tubes that look alike, and small-bore luer connectors with an inner diameter of about 0.1 in. that link lines together and are used for different applications.

For about 100 years, luer connectors have been the connector of choice because of their universal design, low cost, and simplicity. These popular connectors have male and female components that join to form a secure yet detachable leak-proof connection. A push fitting (luer slip) or a screw-in threaded fitting (luer lock) connects the male and female tapered fittings. The all-purpose design of the estimated 1 billion luers manufactured each year increases the chance of healthcare staff unknowingly mating tubes from different applications.

Meet with medical tubing and components suppliers at the BIOMEDevice Boston expo, April 13-14, 2016, at the Boston Convention and Exhibition Center. 

 

It’s possible for a coronary care unit to have up to 40 different tubes with connectors for one patient. The Joint Commission, a nonprofit that accredits and certifies healthcare organizations and programs, noted in a 2014 “Sentinel Event Alert” that “[t]he risk from tubing misconnection is high, considering that almost all patients admitted to the hospital are likely to receive an IV.”

In the case of Maryann Fossen, who died as the result of a tube misconnection after routine surgery to treat carpal tunnel syndrome, a nurse mistakenly connected an IV tube to a blood pressure cuff, which forced air into her bloodstream. She died almost immediately from an air embolism. 

New Standards 

Around 2007, an international group of manufacturers, clinicians, and regulators including FDA began collaborating with ISO and AAMI to develop a suite of new connector design standards, the ISO 80369 series of small-bore connector standards. The group’s goal was to establish global standards that would reduce the risk of connectors for two unrelated patient delivery systems being physically misconnected. 

The culmination of their work, ISO 80369-1, was published in January 2011. The sweeping standard provides general connector requirements for liquids and gases for connectors in healthcare applications. It also describes testing methods for noninterconnectability for unrelated delivery systems.

Although it’s been a slow and deliberate process of meetings, ongoing communication, and voting over the years, the international work group has made enormous strides for seven different connector standards. Today, several have been published by ISO or are close to being finalized (see Figure 1). 

Figure 1. Shown are descriptions of standards and finalized or expected publication dates for ISO 80369 1-7 and ISO 80369-20.

ISO Standard Description Expected Publication Date

ISO 80369-1

  • General requirements for small bore connectors, which convey liquids or gases in healthcare applications. 
  • Misconnection test methods 
  • Published
  • Second edition Q2 or Q3 2016
ISO 80369-2 Breathing systems and driving gases Q3 or Q4 2016
ISO 80369-3 Enteral and gastric Pending as of January 1, 2016
ISO 80369-4 Urethral and urinary TBD—no active
ISO 80369-5 Limb cuff inflation Q1 or Q2 2016
ISO 80369-6 Neuraxial devices Q1 or Q2 2016
ISO 80369-7 Intravascular (IV) or hypodermic (traditional luer with additional dimensional specifications) Q3 or Q3 2016; until then, ISO 594-1 and 594-2 apply
ISO 80369-20 Test methods for each application Published

 

Enteral (feeding) applications that use a luer connector have had the highest misconnection rate. A 2011 article in Nutrition of Clinical Practice found 116 misconnections of enteral feeding tubes to IV lines from 1972 to 2010, resulting in 21 deaths. Moreover, officials believe misconnections are underreported, especially when a patient is not harmed. 

The ISO standard for enteral connectors calls for a design that keeps connectors from linking to those for other clinical uses, stiffer material so staff can’t force flexible connectors together, a locking feature that signals the appropriate connection, and the inability to mate with female luer-lock connectors. Healthcare facilities that have ordered sets with the old connector will receive transition sets that can link current connectors with the standardized connectors to help the organizations as they work through existing inventory. 

By certain dates in 2016 and 2017, California healthcare facilities will be prohibited from using connectors for IV, enteral, and epidural applications “that would fit into a connector other than the type it was intended for, unless an emergency or urgent situation exists and the prohibition would impair the ability to provide healthcare.”

The first law took effect January 1, 2016, and targets connectors for IV applications. Only IVs may continue to use small-bore luer connectors. Connectors for the five other applications must be designed so they can’t connect to a luer or to each other. 

California’s deadline for enteral application connectors is July 1, 2016. For epidural application connectors, it’s January 1, 2017.

Any of California’s 350 hospitals, 1200 nursing homes, and other healthcare organizations that don’t comply with the law will receive notice from the California Department of Public Health for failure to meet the deadline. The facility then will have 10 days to submit an acceptable plan of correction and implement the plan to become compliant.

Preparing for Change

Bringing new, safer connectors to the healthcare market involves meticulous coordination between connector manufacturers, medical-device companies that incorporate connectors into their equipment, and healthcare facilities. 

Forecasting how many connectors to produce for the market is a challenge. Purchasing agents and officials at hospitals and other healthcare facilities must determine how long their inventory will last and then time the changeover to ensure supply is always on hand. Unfortunately, some facilities haven’t yet started this process. 

This can create a dilemma for manufacturers. Connector suppliers need to know how many connectors to manufacture so they can dedicate the appropriate amount of materials, staff, and time. The same goes for medical device companies. Why produce connectors and updated medical devices when you don’t know how many are needed and when? Why risk financial loss with products sitting idle in a warehouse?

Another factor: California is the only state requiring facilities to switch to new enteral feeding and epidural connectors in 2016 and 2017. In other states, it’s a different story. Some hospitals may elect to make the change in 2016; others may switch down the road. Internationally, the shift to new connectors is inconsistent, with just a few countries now introducing mandates or campaigns to encourage use of new connectors. 

Facilities in California, across the nation, and around the globe that are placing orders earlier. Longer lead times for switching to new connectors makes it easier for suppliers to predict and meet the demand. But for those facilities that haven’t placed orders to switch, the $64,000 question for suppliers continues to be, “When will they place their orders?” 

As part of its “Stay Connected” campaign, the Global Enteral Device Supplier Association (GEDSA) noted in an ISO 80369 FAQ document that “[w]hile manufacturers are doing everything possible to bring these upcoming changes to the attention of healthcare organizations and plan for an orderly transition in the supply chain, the industry (manufacturers) cannot manage the process for healthcare providers.”

Besides ordering ISO-compliant connectors and equipment, hospitals and healthcare facilities also must train staff, update inventory-management software with new part numbers, determine systems for transferring patients between facilities that use different connectors, and make preparations for avoiding delays in healthcare services. As AAMI noted, the impact for the healthcare industry will be “monumental.”

Easing the Transition 

No one is solely responsible for managing communication about this shift. ISO, FDA, AAMI, the Joint Commission, GEDSA, and others have regularly shared ISO 80369 updates and implementation tips for healthcare facilities, connector suppliers, and device manufacturers. Because movement toward ISO 80369 has been slow and the message that “it’s coming soon” has been heard multiple times, some small-bore connector and device manufacturers may still be caught unprepared. 

But even with the delays, manufacturers can’t lose their focus. It can take some manufacturers up to 18 months to revamp their manufacturing process to meet a change like the ISO 80369 requirements. 

Device manufacturers who haven’t reached out to a connector supplier should do so immediately. ISO 80369 requires precise timing with regard to design, in-house testing, documentation, and implementation. On-site audits along with proof of ISO 13485 certification and GMP practices are among the must-haves in a small-bore connector supplier. Before spending time meeting with a possible vendor, ask for proof of this information up-front. 

To ensure they don’t under- or over-produce devices, device manufacturers also should consult with their distributor to verify volumes of medical devices needed and understand sell through and turnover on a timely basis. 

The Bottom Line: Patient Safety

ISO 80369 is a tremendous step forward in reducing tubing misconnections and saving lives. Throughout the transition to these new small-bore connectors—and at all levels—communication is key. As automotive industry guru Lee Iacocca said, “You can have brilliant ideas, but if you can't get them across, your ideas won't get you anywhere.” 

It’s imperative that industry organizations, regulatory agencies, manufacturers, hospitals and other end-users communicate like never before. Together, they have the responsibility to eliminate misconnections that can cause serious injury and even patient deaths. 

Jim Skog is the global business development manager at Nordson Medical. Reach him at [email protected].

[image courtesy of HYENA REALITY/FREEDIGITALPHOTOS.NET]

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