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J’agis!

Gelb, Adrian W. MBChB; Mainland, Phoebe MBBS; Phillips, Peter MRPharmS; Sharpe, Paul MBChB; Kinsella, Stephen Michael MBBS; Bailly, Anne-Laure MD, PhD; Jaffe, Rory MD

doi: 10.1213/ANE.0000000000001428
Letters to the Editor: Letter to the Editor

World Federation of Societies of Anaesthesiologists Safety and Quality of Practice Committee, Department of Anesthesia, University of California San Francisco, San Francisco, California, adrian.gelb@ucsf.edu

World Federation of Societies of Anaesthesiologists Safety and Quality of Practice Committee, ISO/TC210/JWG4 Small Bore Connectors Workgroup

Welsh Non-Luer Connectors Reference Group, Director, Surgical Materials Testing Lab, Abertawe Bro Morgannwg University Health Board, United Kingdom

NHS England Small Bore Connector Advisory Group

Obstetric Anaesthetists’ Association Representative on the NHS England Small Bore Connector Advisory Group

Convener of CEN/CLC TC3 WG2 Small Bore Connectors

CHPSO Patient Safety Organization AAMI (USA) Small Bore Connectors Workgroup

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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, MBChB

World Federation of Societies of Anaesthesiologists Safety

and Quality of Practice Committee

Department of Anesthesia

University of California San Francisco

San Francisco, California

adrian.gelb@ucsf.edu

Phoebe Mainland, MBBS

World Federation of Societies of Anaesthesiologists Safety

and Quality of Practice Committee

ISO/TC210/JWG4 Small Bore Connectors Workgroup

Peter Phillips, MRPharmS

Welsh Non-Luer Connectors Reference Group

Director, Surgical Materials Testing Lab,

Abertawe Bro Morgannwg University Health Board

United Kingdom

Paul Sharpe, MBChB

NHS England Small Bore Connector Advisory Group

Stephen Michael Kinsella, MBBS

Obstetric Anaesthetists’ Association Representative on the

NHS England Small Bore Connector Advisory Group

Anne-Laure Bailly, MD, PhD

Convener of CEN/CLC TC3 WG2 Small Bore Connectors

Rory Jaffe, MD

CHPSO Patient Safety Organization AAMI (USA) Small Bore

Connectors Workgroup

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REFERENCE

1. Birnbach DJ, Brull SJ, Prielipp RC. J’Accuse! Failure to prevent epidural and spinal catheter misconnections. A A Case Rep. 2016;6:107–110.
© 2016 International Anesthesia Research Society