UNMH Knew of Complaints Linking Misuse of Device to Harm, Including Death, of Numerous Patients – Part Three.
Late last summer, University of New Mexico medical professionals contacted The Candle expressing concerns about a culture of intimidation and their fear of retaliation from leadership personnel at New Mexico Health Sciences Center (HSC) facilities.
Some of the bullying behavior was related to discrimination and harassment towards medical students, residents, and faculty – behavior that was included among the reasons UNM’s School of Medicine had lost accreditation for its Neurosurgery Residency program in 2019.
And they expressed extreme frustration with leaders of the School of Medicine and the Neurosurgery department for not taking seriously the potential, and unnecessary, damage done to a significant number of neurosurgery patients.
When pressed about their concerns, the sources consistently alleged that more than a dozen UNM patients may have died due to a lack of understanding of, insufficient training for, and careless use of a relatively new medical device that UNM Hospital has been using on an increasing number of neurosurgery department patients.
The same group of medical professionals also raised concerns that patients, or their advocates, were not properly informed by UNM personnel when it came to seeking their consent in the use of the IRRAflow device.
New UNM HSC Leader Won’t Discuss Medical Device Used on UNMH Patients
As reported further below, UNM clinical care medical staff and leaders have known about the concerns raised for more than a year.
The University of New Mexico Health System, Office of Clinical Affairs, states on its website that it “strives to enhance and support the delivery of high-quality health care by the Health System’s dedicated caregivers. We provide a network of infrastructure and services for the Medical Staff and clinical teams of the UNM Health System, creating a foundation for the Health System’s success in its clinical mission.”
Mike Richards, MD, the newly appointed Executive Vice President of UNM Health Sciences and CEO of the UNM Health System, was the top administrator for Clinical Affairs during the time the concerns of patient harm, including death, were reported to UNM officials.
The website also claims that Clinical Affairs, “maintains established standards of excellence in providing high-quality care to the community, by working to support the efforts of our front-line clinical caregivers and teams.
Richards and other top administrators at UNM refuse to be questioned regarding the concerns of harm done to UNMH patients as described by the medical professional sources interviewed by The Candle.
(More this weekend on Richards, and other UNM officials and their wall of silence.)
Some Background Information on the IRRAflow Medical Device
The medical device referred to by UNM medical employees is known as an IRRAflow device.
It was developed as an alternative to what is known as a standard external ventricular drainage (EVD) device, used in a temporary method of draining cerebrospinal fluid (CSF) from the ventricles in the brain.
Standard EVD’s have been in use for decades, while the IRRAflow device was introduced in the last few years.
The company that owns and produces the device is IRRAS.
It has previously pitched the IRRAflow device as an important innovation – one that, in addition to its potential to improve care for an extremely vulnerable patient population, has great growth and financial advantages for investors.
Company officials anticipate other potential uses for the IRRAflow device.
IRRAS informed investors and others about that financial potential of the device in a document entitled “Market overview”, writing:
“… Each year, in the US and EU alone, approximately 5.4 million people are affected by traumatic brain injury … These patients, requiring treatment following intracranial bleeding, represent an addressable market size in Europe and the US combined for the IRRAflow products of approximately USD 1.8 billion, according to IRRAS´estimate based upon current average selling prices. An expansion into targeted intracranial drug delivery in the future would add approximately USD 4.6 billion.” – From a Market Review IRRAS Document in or about 2022.
UNM Made Aware Misuse of Medical Device Related to Alleged Harm to Patients
The Candle received additional confirmation that Neurosurgery department leaders were made aware of at least one of the significant adverse events (SAE) involving an alleged fatality related to the misuse of the medical device that likely resulted in an abnormal inflow of fluid causing a dangerous buildup of pressure on the brain tissue.
In addition to the SAE referred to above, other examples of the problematic use of the medical device have also been brought to the attention of the UNM leadership in 2023 and 2024.
(The Candle reported in Parts One and Two of this series, of an another report that was filed with the FDA in October of 2024, raising concerns of the lack of sufficient training and misuse of the IRRAflow device at UNM.)
Under FDA rules, the UNM Hospital is required to file a report with the FDA whenever it “has acquired information that reasonably suggests a reportable adverse event has occurred.”
The U.S. Code of Federal Regulations, 21 CFR Part 803 Subpart A § 803.1, states that medical device user facilities, such as UNMH, must
- report deaths and serious injuries that a device has or may have caused or contributed to,
- establish and maintain adverse event files, and
- submit summary annual reports.
Such reports are necessary to assist the FDA mission “to protect the public health by helping to ensure that devices are … safe and effective for their intended use.”
UNM’s Silence – Like a Cancer Grows
In order to provide better understanding of UNM’s use and experience with the medical device and safeguards for protection of patient rights, The Candle wrote to UNM leaders seeking to speak with appropriate medical personnel about the following:
- The number of IRRAflow devices that have been used on patients under the care of
UNM Hospital and/or the School of Medicine physicians and support medical
personnel; - The UNM HSC policies that involve testing devices and one or more human subjects;
- The UNM Institutional Review Board, as established under federal law;
- The manner by which UNM HSC staff and/or contractors sought informed consent from
patients that underwent surgical procedures that utilized the IRRAflow device(s); - The resolution of concerns raised about the use of the IRRAflow devices;
- The number of adverse events, including deaths, experienced by patients for which the
IRRAflow device was used; - The descriptions of the adverse events referred to in item # 6, above, with appropriate
patient identity protections observed; - The number of IRRAflow devices purchased for use at the UNM Hospital and the UNM
School of Medicine in conjunction with the research and testing on human subjects; - The monetized value of the IRRAflow devices used at UNM Hospital and the UNM
School of Medicine; - The number of IRRAflow devices received as an in-kind type of donation or loan by
UNM HSC entities/employees/contractors from IRRAS for use at the UNM Hospital and
the UNM School of Medicine in conjunction with the research and testing on human
subjects; - The financial and research relationship between UNM HSC entities and IRRAS, such as
(but not limited to) the professional services agreement that Dr. Carlson informed me
of in his communication to me earlier this week
UNM officials consistently refused to provide anyone that could speak to any of the above items. Communications officers responded generally claiming to comply with all regulations and strict adherence to patient safety protocols and ethical standards, as well as proper oversight.
As a device user facility, the hospital became aware when medical personnel, who are employed by or otherwise formally affiliated with UNMH, obtained information about a reportable event.
That FDA requirement should have been addressed by UNM Hospital when Chad Cole, MD, (Associate Professor, Vice Chair of Clinical Operations for Neurosurgery), Peter Shin, MD, (Dr. Shin served as Interim Chair of Neurosurgery and Residency Program Director), and John Russell, MD, (professor and former longtime chair of The University of New Mexico Department of Surgery, and an acting Chair of Neurosurgery), were each made aware of the significant adverse events and were made aware of other instances of the misuse of the device.
It is likely that at least two other doctors, who were also leaders in the Neurosurgery department, were aware of the problems that were reported to Cole, Shin and Russell.
Christian Ricks, MD, (Assistant Professor, and Residency Program Director of SOM – Neurosurgery), and Andrew Carlson, MD (Assistant Professor) held leadership roles at the Neurosurgery department, and likely knew or should have known, about the concerns raised by other health practitioners.
Ricks was one of the doctors named in a Human Rights Act complaint about discrimination and retaliation that UNM settled and refuses to discuss publicly.
(Click here, for related reporting from The Candle last December about the Human Rights Act complaint of mistreatment of young Hispanic resident doctor at UNM School of Medicine – The Candle will be publishing an update to the December reporting next week.)
Medical Device Company Identifies Dr. Carlson led UNM Team as “Valued Partner”
A University of New Mexico Hospital Team (led by UNM School of Medicine’s former Assistant Professor Andrew Carlson, MD) was identified as a “Valued Partner” by IRRAS, the developer and marketer of IRRAflow – the device referred to above.
As reported earlier, the IRRAflow device represents a major investment by IRRAS, which expects a return on its investments.
Since at least 2019, through part of 2024, Carlson developed assessments of the success of the device, and had his team publish their assessments in medical journals.
Such publications have had a buttressing effect for IRRAS’ roll out of production and sales of the IRRAflow device.
IRRAS writing about the type of efforts of its “valued partner” (Carlson’s UNM Team) in late 2022, “It is important for our team to increase the rate of product adoption, and the generation of impactful clinical data will play a key role in this effort.“ [Emphasis added.]
One study produced by the UNM Team led by Dr. Andrew Carlson, concluded IRRAflow is safe, suggesting future use in Clinical Trials.
The UNM retrospective study was of patient files from 2019 through 2022, (a single-center case-control study including patients with IVH treated with EVD compared to IRRAflow).
It is entitled: Continuous irrigation with thrombolytics for intraventricular hemorrhage: case-control study.
Carlson-led UNM Team’s Study Inferior to Randomized Clinical Trial
But, as will be reported on further in this series, the Carlson led study offers a lower degree of scientific evidence about the safety and use of the IRRAflow device than does a more disciplined study released a few months before the Carlson paper.
The JAMA Open Network (part of the Journal of American Medical Association), published the Intraventricular Lavage vs External Ventricular Drainage for Intraventricular Hemorrhage – A Randomized Clinical Trial, which was conducted in Denmark about the same time the Carlson-led team was doing its retrospective review.
The Denmark Randomized Clinical Trial (RCT) of IRRAflow, warned of dangers, writing it “found significantly higher risks of SAEs and catheter occlusions in the intervention group. The trial was terminated early, as recommended by an independent data safety monitoring board, due to safety concerns at preplanned interim analysis of 20 patients.”
“Meaning – These findings suggest that caution should be taken when using intraventricular lavage for IVH treatment and technology adaptations should be implemented to mitigate future adverse events.”
UNM Leaders, Apparently Unresponsive to Reports of Alleged Death and Harm to Patients, Double Down on Secrecy
Despite knowing of the concerns related to the inappropriate use of the medical device, there seems to have been no course correction made by the leadership.
It wasn’t until The Candle alerted UNM leaders about a report to the FDA MAUDE system regarding the IRRAflow device, that UNM finally acknowledged they were “actively reviewing the recent concerns brought forward.”
Despite questions and requests for interviews, that, and the University’s insistence that its operations comply with all rules and regulations, is all UNM will comment on.
The MAUDE reported complaint was filed in mid October 2024, and warned of harm done to “multiple patients” due to its misapplication at UNM.
The report states, “…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…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.”
UNM Hospital Required to File Reports on Medical Device Problems
Unless UNM has received an exemption under the U.S. Code of Federal Regulations (21 CFR Part 803 Subpart B§ 803.20), the Hospital must file a Medical Device Problem Report with the FDA and the manufacturer no later than 10 work days after the day that it becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death; and with the manufacturer if the information reasonably suggests that a device has or may have caused or contributed to a serious injury.
The manufacturer also has reporting responsibilities when it becomes aware of information that reasonably suggests that a device has or may have caused or contributed to a death or serious injury.
UNM Hospital is also required to file annual reports that include all medical device problem reports on events that result in death of serious injury event reported to the manufacturer and/or the FDA.
About a week ago, The Candle wrote to BOTH UNM and the manufacturer of the IRRAflow device asking if they have generated or acted on any reports of problems encountered with the device in its application at the UNM Hospital.
There has been no response from IRRAS nor from its “valued partner” UNM.
(More reporting on these and related matters this weekend and next week.)
Over the past few months, The Candle spoke with several individuals with first hand knowledge of the use of a device referred to in this reporting on the UNM neurosurgery department. Some of the harm done to patients may have been fatal. These sources and others – all medical personnel with personal knowledge of UNM medical practices – requested anonymity due to their fear of retaliation by UNM officials for speaking out publicly about their concerns. For evidence of their concerns, they point to recent cases of retaliation settled out of court. Click here and here for The Candle’s reporting on the retaliation cases they identified.