RAPID Response to questions from readers

(formerly Dear SIRS)

RAPID Response and the APSF Mission

In the spring of 2004, the APSF Newsletter published a groundbreaking article entitled “Misplaced Valve Poses Potential Hazard” as the inaugural contribution to the Dear SIRS (now RAPID Response) column. In that article, James Berry, MD, and Steve Blanks, CRNA, reported the unexpected occurrence of high airway pressure, up to 40 cm H2O of PEEP, when the exhaust line from the scavenging system became occluded. It turned out that the active scavenging systems they used had been assembled with a relief valve intended for the passive scavenging system product. Datex-Ohmeda was the manufacturer at that time and in response, Michael Mitton, CRNA, Director of Clinical Affairs, wrote: “Datex-Ohmeda has identified the cause of the incorrect assembly and has instituted changes in the assembly process to avoid a repeat of this error.” Collaboration identified a problem that could be fixed by the manufacturer, the cause was identified and the problem publicized in a publication circulated to large numbers of anesthesia professionals.

This collaboration between users and manufacturers to identify and solve problems highlights the unique role that APSF plays in engaging all stakeholders to address patient safety concerns.

The concept for the RAPID Response column was developed by Michael Olympio, MD, and Robert Morell, MD, then chairman of the APSF Committee on Technology and editor of the APSF Newsletter, respectively. The initial name for the column was Dear SIRS, an acronym for Safety Information Response System. Michael Olympio and Robert Morell recognized that users were uniquely qualified to identify patient safety concerns related to medical devices, but that collaboration with industry to address these concerns was lacking. The APSF has always been highly effective at convening stakeholders in patient safety and the APSF Committee on Technology (COT), by design, includes both users and manufacturers. The seeds were there for a collaborative forum between industry and users.

Rapid Response Editors

Since its inception, the RAPID Response column has become an integral part of the APSF Newsletter, a highly accessed part of the website and a major activity for the members of the APSF COT. One or more letters to this column appear in almost every issue of the APSF Newsletter. Other letters are addressed by facilitating a connection between the reporting individual and the related manufacturer but are not necessarily published. In the last two years, the RAPID Response articles generated more than 45,000 pageviews to the APSF website. Figure 1 highlights topics from the top 25 accessed articles during that time.

Figure 1: Top 25 Rapid Response Articles by Page Views, May 1, 2018–June 2, 2020
Data analytics initiated in 2018.

How Do Flow Sensors Work? 6,325
Humidity Levels in ORs 3,905
Potential Burn Hazard from General Electric MRIs 3,765
Reusable Anesthesia Breathing Circuits Considered 3,499
Not All Manifolds are the Same: Lessons in Intravenous Drug Administration 2,021
Dräger Fabius Leak Test Questioned 1,662
Safety Issues With Gas Scavenging System in GE Avance and GE Aespire Anesthesia Machines 1,645
Measurement of Expiratory Limb Circuit Pressure: A Potential Anesthesia Machine Safety Issue 1,581
Why Do the Gauss Lines Matter? 1,441
Line Isolation Still Important 1,256
Volatile Anesthetic Unintentionally Not Delivered 1,140
PEA Arrest During Transport of a Ventilated Patient Due to a Clogged Respiratory Filter on Ambu® Bag 860
Reader Questions Why Some Anesthesia Machines Allow O2 Flow Below Basal Metabolic Needs 843
LTA Tip Breaks in Patient’s Airway 765
Airway Topicalization Atomizer Parts Break Off in Patient’s Airway 720
An Incident of GlideScope® Stat Cover Failure 713
Nitrogen Contamination of Operating Room Oxygen Pipeline 676
“No Read” Errors Related to Prefilled Syringes 672
Perils and Pitfalls With the Rapid Infusion Catheter (RIC) 672
O2 Blender Causes Concern 649
Descending Bellows Drives Question 645
Defective Pediatric Endotracheal Tubes (ETTs) 543
Burette Malpositioned Shut Off Valve Could Lead to Venous Air Embolism 522
Defective Central Venous Catheter Introducer Needle 440
Monitoring Gaps 393

Managing the communication between users of devices and manufacturers can be delicate at times. Users can be emotional and confrontational in reporting perceived safety concerns. Manufacturers are appropriately concerned about the market perception of their products, especially when the problem is a use error and not inherent to the device. APSF attempts to broker a constructive conversation that fosters education on the proper use of devices and product improvement, without endorsing or criticizing a particular device or design.

While the large majority of people reading this column are almost certainly clinicians, the value of the Rapid Response column is appreciated by our colleagues in industry.

Congratulations to the Anesthesia Patient Safety Foundation (APSF) on the impact of the Dear SIRS column now named Rapid Response! While providing clinicians an environment to alert their peers of unique findings is important, what’s made Dear SIRS so special is the process. The careful evaluation of each submission. Determining the opportunity to educate versus the need for a possible design change. Providing industry the opportunity to explain their technology as part of the publication. The process is unique. It’s pure and unbiased. It’s true to the APSF’s mission to improve the safety of patients during anesthesia care.

As someone who is called upon to co-author a response from time to time in order to provide an industry perspective, I’m proud for the opportunity to play a small part in the Rapid Response column. And I’m thankful for the vision the APSF had to create a forum where clinicians and industry around the world can learn and advance the delivery of anesthesia together.

David Karchner
Senior Director of Marketing
Draeger Medical

The APSF focuses on the noble cause of patient safety during anesthesia care. In pursuing that cause, APSF provides an environment for rare collaborations. As an engineer, my training was to solve the root cause of problems so that they do not reoccur. RAPID Response has contributed directly to making anesthesia safer by providing a forum for selfless clinicians to share their observations and safety concerns. The process of evaluating these reports, a collaborative process between expert clinicians and experts in industry, leads to better devices and safer anesthesia care. RAPID Response has led to education and device improvements to eliminate root causes of harm—and that leads toward improved safety! I’ve been honored to be a part of this process for a number of years, both working in industry R&D and at ECRI while serving in APSF. Kudos to everyone involved with making the Rapid Response happen!

David T. Jamison PMP
Executive Director, Selection and Evaluation
ECRI

Some contributors to this column have raised the question about publishing in the APSF Newsletter rather than sending a letter to the editor of a major anesthesia journal. In general, journals do not necessarily have the editorial priority or connections to insure a collaborative response with industry. More importantly, the APSF Newsletter has much greater visibility in the anesthesia community. At the time of this writing, the APSF Newsletter circulates to more than 100,000 anesthesia professionals in North America and is translated into five different languages for international distribution. Recently, APSF created the ability to publish newsletter content on the APSF website in advance of print publication. No journal provides that degree of accessibility for time-critical patient safety information.

While the RAPID Response column appears in print every four months, letters received by APSF are acted upon as they are received. If appropriate, a connection with the manufacturer or related industry is sought. Depending upon the complexity of the report, it can sometimes take time to make the appropriate connection with industry which can delay the response. As soon as the response is available, it is sent to the original letter writer in advance of the printed response. Recently, APSF has developed the capability to post the RAPID Response reports with industry response to the APSF website and announce them through social media in an effort to communicate information to the anesthesia community as rapidly as possible.

Michael Olympio, MD, and Robert Morell, MD, are to be congratulated for their vision in creating the Rapid Response process. The chair of the APSF COT and editor-in-chief of the Newsletter manage this activity and I want to recognize the contributions over the years of A. William (Bill) Paulsen, PhD, former COT chair, and Steven Greenberg, MD, current editor-in-chief of the APSF Newsletter who succeeded Robert Morell. Medical devices and technology are integral to the patient care process. For all parties involved, clinicians and manufacturers, patient safety is a paramount concern and there are always opportunities for improvement, whether it be in user training, product design, or manufacturing. The collaboration between users and manufacturers is essential to rapid identification of patient safety issues. RAPID Response is just one of many programs in support of the APSF mission that “No one shall be harmed by anesthesia care.”

 

Jeffrey Feldman, MD, MSE is professor of Clinical Anesthesiology, Children’s Hospital of Philadelphia, Perelman School of Medicine, University of Pennsylvania, and chair of the APSF Committee on Technology


Dr. Feldman has received consulting compensation from Micropore, Inc., and Dräger Medical.


Thanks to Michael Olympio, MD, A. William Paulsen, PhD, and Robert Morell, MD, for contributing to the content of this article.

 

The information provided is for safety-related educational purposes only, and does not constitute medical or legal advice. Individual or group responses are only commentary, provided for purposes of education or discussion, and are neither statements of advice nor the opinions of APSF. It is not the intention of APSF to provide specific medical or legal advice or to endorse any specific views or recommendations in response to the inquiries posted. In no event shall APSF be responsible or liable, directly or indirectly, for any damage or loss caused or alleged to be caused by or in connection with the reliance on any such information.