UNM Dodges Queries on FDA Adverse Event Report Alleging Harm to Neurosurgery Patients – Part One.

After UNM settled two serious cases involving bullying, concerns of misconduct, and fraudulent representations regarding HSC research projects, new information, from multiple credible sources, alleges harm to UNMH Neurosurgery Department patients.

Background – Introduction

Four months ago, The Candle reported on the shake-up in leadership at the University of New Mexico’s Health Sciences Centers.

UNM President Garnett Stokes replaced Dr. Douglas Ziedonis with Dr. Mike Richards as the (interim) Executive Vice President for Health Sciences and as CEO of the UNM Health System.

The abrupt announcement was a surprise to many political and business leaders in New Mexico, and it came, as The Candle reported, just weeks after Stokes approved a raise in pay to Ziedonis.

Collen Heild of the Albuquerque Journal reported Stokes as stating, “this is a strategic leadership decision. Because when I look at health care and what our health system needed, what New Mexico needed, I decided we had to pivot.”

Stokes offered some general reasons about the change in leadership being about the need to address the growing health care needs of the state of New Mexico … but it certainly was an abrupt “pivot.”

The Candle learns of other elements that may have led to the change in leadership.

After story broke about Ziedonis’ reduction in duties, The Candle received information from sources inside UNM regarding the settlement of a Human Rights complaint made by a young Hispanic woman graduate of the UNM School of Medicine who had been recruited as a resident of the Neurosurgery residency program.

(The Candle reporting on that complaint and settlement can be linked here.)

Shortly after receiving information that led to the reporting of the Human Rights complaint, The Candle was informed by UNM sources of a $2 million settlement involving a research doctor who had filed a whistleblowers suit against the University due to retaliation.

(Reporting by The Candle on that matter can be linked here.)

Several other sources began communicating to The Candle about a culture of fear and retaliation against those who speak out about issues such as inadequate supervision and unaddressed complaints of mistreatment.

Reports came from multiple faculty and learners, alleging potential harm done to patients through the improper use of a relatively new and experimental medical device on patients treated in the neurosurgery department.

The Candle found, through our own research, a report filed on the FDA’s Manufacturer and User Facility Device Experience (MAUDE) Database regarding the device, known as the IRRAflow catheter.

The individual who filed the report to the FDA system regarding the IRRAflow device wrote the following:

“I am deeply concerned about the inappropriate use of the irraflow intraventricular irrigation system within the department of (b)(6). The irraflow system is designed to provide dynamic intracranial pressure control via continuous irrigation and drainage of cerebrospinal fluid (csf) for treating conditions such as intraventricular hemorrhage and infection. However, recent evidence suggests its application at unm has resulted in unnecessary harm to multiple patients due to careless use, inadequate training of medical personnel, and possible design flaws. Please read below.Reports of severe infections, mechanical failures, and improper pressure settings causing intracranial pressure imbalances highlight the urgent need for proper training and guidelines to ensure safe and effective use of this device. Reference report mw5161124.” [Emphasis added.]

The Candle also spoke with several individuals with first hand knowledge of the use of the device at UNM in the neurosurgery department and was told that some of the harm done to patients may have been fatal – they have requested anonymity due to their fear of retaliation by UNM officials for speaking out publicly about their concerns, and point to the recent cases of retaliation that settled out of court.

The IRRAflow device is marketed as an alternative to a device known as an external ventricular drain (EVD).

An EVD is a temporary device implanted through the skull to treat hydrocephalus, with the goal of relieving intracranial pressure and has been used for decades worldwide, including at UNMH.

On December 17, 2024, The Candle emailed requests to University medical leaders seeking to speak with UNM HSC and UNM Hospital officials about the use of the IRRAflow Device.

UNM did not respond to our initial email.

On December 20, 2024, in a follow-up email, and letter, to President Stokes, UNMH CEO Kate Becker, Dr. Richards, and School of Medicine Dean Patricia Finn, MD, The Candle again asked to speak with knowledgeable persons included in the request a list of eleven specific and general related matters involving the research use of the IRRAflow device on patients. (A copy of the letter is included at the end of Part One of this reporting.)

The letter also noted The Candle was aware that “communications exist alerting physicians and leaders at the UNM SOM Neurosurgery department of concerns similarly described as those outlined in the MAUDE report…”

While The Candle did receive a response from UNM’s Communications Director Cinnamon Blair, the response was void of any answers or explanations to the detailed information The Candle requested to discuss with medical officials regarding reports of the use of a “…relatively new neurosurgery device at UNM resulted in unnecessary harm (possibly including death) to multiple patients due to careless use and or inadequate training of medical personnel, as well as possible design problems…”

In a separate article from this three part series on UNM HSC, The Candle will be soon reporting on the deliberate manner by which UNM avoids transparency in its operations despite being a public agency and receiving millions of dollars in federal, state and county funding.

Here is the Responsive Email from UNM”

“Thank you for your inquiry regarding the use of medical devices at the University of New Mexico Hospital. We appreciate your commitment to thorough reporting on matters of public interest.

“Please feel free to use the below response relative to your inquiry:

“The University of New Mexico Health Sciences Center and UNM Hospital are dedicated to providing the highest quality care to our patients while maintaining strict adherence to patient safety protocols and ethical standards. We take all concerns about patient care seriously and have rigorous processes in place to investigate and address any issues that may arise. All our clinical practices are subject to stringent oversight and review processes to ensure patient safety and compliance with all applicable regulations.”

Thanks and happy holidays! Best, Cinnamon

Copy of letter emailed to UNM President Stokes, UNMH CEO Kate Becker, Dr. Richards, and School of Medicine Dean Patricia Finn, MD, and the Communications Department at HSC. (Note: The second email included this letter and was actually emailed on the morning December 20, 2024.)

(In part two of this reporting, The Candle will go into more detail regarding the use of EVD’s and the IRRAflow device, including the relative high percentage of patients who do not survive various severe conditions of brain surgery.

Part two will also report on studies done about the use of IRRAflow, its limitations, and its potential promise for improvement of Intraventricular hemorrhage (IVH) treatment.)