from youarewithinthenorms.com
NORMAN J CLEMENT RPH., DDS, NORMAN L. CLEMENT PHARM-TECH, MALACHI F. MACKANDAL PHARMD, BELINDA BROWN-PARKER, IN THE SPIRIT OF JOSEPH SOLVO ESQ., INC., SPIRIT OF REV. IN THE SPIRIT OF WALTER R. CLEMENT BS., MS, MBA. HARVEY JENKINS, MD, PH.D., IN THE SPIRIT OF C.T. VIVIAN, JELANI ZIMBABWE CLEMENT, BS., M.B.A., IN THE SPIRIT OF THE HON. PATRICE LUMUMBA, IN THE SPIRIT OF ERLIN CLEMENT SR., EVELYN J. CLEMENT, WALTER F. WRENN III., MD., JULIE KILLINGSWORTH, RENEE BLARE, RPH, DR. TERENCE SASAKI, MD LESLY POMPY MD., CHRISTOPHER RUSSO, MD., NANCY SEEFELDT, WILLIE GUINYARD BS., JOSEPH WEBSTER MD., MBA, BEVERLY C. PRINCE MD., FACS., NEIL ARNAND, MD., RICHARD KAUL, MD., IN THE SPIRIT OF LEROY BAYLOR, JAY K. JOSHI MD., MBA, AISHA GARDNER, ADRIENNE EDMUNDSON, ESTER HYATT PH.D., WALTER L. SMITH BS., IN THE SPIRIT OF BRAHM FISHER ESQ., MICHELE ALEXANDER MD., CUDJOE WILDING BS, MARTIN NJOKU, BS., RPH., IN THE SPIRIT OF DEBRA LYNN SHEPHERD, BERES E. MUSCHETT, STRATEGIC ADVISORS
These sources collectively explore the complex landscape of technology and its impact on healthcare and governance, particularly focusing on the opioid crisis and the implications of AI-driven systems.
THE ANAND-CLEMENT RULE AND THE RISE OF ARTIFICIAL STUPIDITY (AS): [AI(alg*) =AS]
NarxCare is a misbranded CDS device subject to FDA regulation.
NarxCare is a medical device because the software is intended for use in the mitigation or prevention of SUDs, including the disease of opioid use disorder, and does not satisfy the criteria for non-device CDS.
Yet, a search by the Petitioner of FDA’s publicly available establishment registration and device listing databases, unique device identification database, and premarket notification (510(k)) database, did not yield any relevant results using search terms such as Bamboo, Bamboo Health, Appriss Health, and NarxCare.
Furthermore, a search of FDA’s device product classification database using terms such as opioid and software did not yield any results for NarxCare-type software that identifies patients with potential opioid addiction. However, the search did yield results for CDS software that, like NarxCare, uses algorithms to analyze data inputs to produce predictive clinical decision support. For example, a partial product category listing for “Burn Resuscitation Decision Support Software” states:
Definition: The burn resuscitation decision support system (BRDSS) is intended for use in prediction of hourly fluid volume during initial 24 hours of burn resuscitation. It is intended for patients who have greater than 20% total body surface area burn.
Technical Method: BRDSS is a software based calculator that uses an algorithm to calculate resuscitation volume using physiological data inputs. The algorithm used is developed by the manufacturer and may not be the typical algorithm used in standard practice to calculate fluid management for burn patients.
Submission Type: 510(k) [premarket notification required]
Device Class: 2106
Given these results, the Petitioner has reason to believe that Bamboo is required to, but has not yet registered as an establishment, listed NarxCare as device, and submitted a premarket notification.107 Therefore, NarxCare is misbranded and subject to enforcement action by the FDA.
Most importantly, Bamboo’s failure to comply with the FD&C Act and FDA regulations means that FDA has not substantiated NarxCare’s safety and effectiveness. Yet, the software has been integrated into PDMPs across the country, is used “millions of times” per day, and continues to have a significant impact on medical decision making to the detriment of patients with pain and other marginalized groups.
“FDA should take prompt action to prevent serious, adverse health consequences or death.”
The FDA should promptly take appropriate action within its authority, including issuing a Warning Letter and commencing mandatory recall procedures, to prevent serious adverse health consequences or death.
There is evidence that Bamboo is in significant violation of the FD&C Act and FDA regulations that could justify FDA enforcement action if not promptly resolved.
Therefore, FDA should issue Bamboo a Warning Letter requiring it to comply with all applicable provisions of the Act and FDA regulations to prevent serious, adverse health consequences and death.
Additionally, there is a reasonable probability that NarxCare could cause serious, adverse health consequences or death for people with a legitimate need for controlled prescription medications given that
(1) NarxCare is used millions of times per day;
(2) the software has a significant impact on prescribers’ and dispensers’ judgment regarding treatment with controlled medications; and
(3) reducing access to medically necessary treatments can have devastating outcomes, as described in Section II-C above, especially in light of the nation’s drug poisoning crisis.
Therefore, FDA should commence mandatory recall procedures to limit the threat of serious adverse health consequences and death of patients who are negatively impacted by NarxCare.
THE ANAND-CLEMENT RULE AND THE RISE OF ARTIFICIAL STUPIDITY (AS): [AI(alg*) =AS]
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