To the Editor:
We read the editorial by Birnbach et al1 with interest and echo their sentiment about the importance of the issues. Connector interconnectivity and the associated misadventures are indeed a major risk to patients. However, we believe that in their enthusiasm they have misstated some important aspects of the problem. Implied, but not stated by Birnbach et al, is that this is a global problem requiring a global solution, which necessitates a completely new set of international standards (ISO 80369), and the adoption of these standards by industry across the global neuraxial medical device arena.
The accusation that the entire anesthesia community has turned a blind eye is wrong. Clinicians are cautious about design change to devices they rely on because these may have unintended consequences for patient safety. It is also possible that some national anesthesia societies may not have been engaged in the process because they were unaware of the standardization efforts. However, The World Federation of Societies of Anaesthesiologists (WFSA), a global anesthesia alliance representing over 140 countries, has chosen to participate directly in this process. Other participants have included many manufacturers, the Food and Drug Administration, Association for Advancement of Medical Instrumentation (AAMI), and the CHPSO Patient Safety Organization, representing over 350 hospitals and other providers in the Western United States. These truly international discussions have been amicable, constructive, and focused on improving patient safety while also cognizant of the logistical realities of managing a significant design change and global deployment.
Efforts to resolve this problem were initiated in Europe by The European Committee for Standardization (CEN) in 1999, but the development of a solution has been surprisingly difficult. Attempts in the UK between 2009 and 2015 to deploy non-Luer equipment largely failed because of concerns about proprietary designs, poor clinical acceptability of epidural devices, and knowledge of the impending publication of ISO 80369 series.
In 2008, California hospitals, in the interests of patient safety, successfully advocated for a legal requirement for nonconnectivity by January 1, 2011, for enteral, epidural, and intravenous connectors. This deadline had been extended several times with the recognition that without standardization and well-tested replacements for Luer, patient risk could increase.
Now the standards have been developed and tested. The new enteral connectors are already rolling out, and nonmisconnecting neuraxial medical devices will be appearing late 2016, in time for the latest California deadline of January 1, 2017, then spreading worldwide in 2017. Given the difficulty of designing nonmisconnecting connectors in the restricted dimensional space available for small-bore medical devices, enormous progress has been made since 1999.
Major unanswered questions remain: will national anesthesia organizations participate as this process unfolds with the necessary education, alerts, and management of resistance to change to safer but less convenient products, or will they leave it to manufacturers and regulatory agencies alone?
Adrian W. Gelb, MBChBWorld Federation of Societies of Anaesthesiologists Safetyand Quality of Practice CommitteeDepartment of AnesthesiaUniversity of California San FranciscoSan Francisco, Californiaadrian.email@example.com
Phoebe Mainland, MBBSWorld Federation of Societies of Anaesthesiologists Safetyand Quality of Practice CommitteeISO/TC210/JWG4 Small Bore Connectors Workgroup
Peter Phillips, MRPharmSWelsh Non-Luer Connectors Reference GroupDirector, Surgical Materials Testing Lab,Abertawe Bro Morgannwg University Health BoardUnited Kingdom
Paul Sharpe, MBChBNHS England Small Bore Connector Advisory Group
Stephen Michael Kinsella, MBBSObstetric Anaesthetists’ Association Representative on theNHS England Small Bore Connector Advisory Group
Anne-Laure Bailly, MD, PhDConvener of CEN/CLC TC3 WG2 Small Bore Connectors
Rory Jaffe, MDCHPSO Patient Safety Organization AAMI (USA) Small BoreConnectors Workgroup