Current Advocacy Priorities
Joint Commission changed its hospital safety framework in January 2026
For hospitals and critical access hospitals, the former National Patient Safety Goals were replaced by 14 National Performance Goals. They include leadership and safety culture, infection prevention, medication management, and staff competence.
The easily missed detail: Joint Commission says this reorganizes existing requirements rather than adding new requirements. Other accreditation programs, including ambulatory care, retain their own applicable goals.
A 2026 outpatient injection investigation highlights ingredient-quality risks
In a September 2026 update, CDC reported more than 25 illnesses across four states following glutathione injections, with at least three hospitalizations. The investigation began after illnesses at a Texas outpatient wellness clinic.
CDC reported that implicated injections were compounded using dietary supplement-grade glutathione, which is inappropriate for injectable preparations. The illnesses were likely associated with elevated endotoxins; the investigation remained ongoing.
Why it matters: An ingredient suitable for oral supplements is not necessarily suitable for injection. CDC recommends that clinics verify ingredient suitability with the compounding pharmacy and follow applicable recalls. This is a specific investigation, not a finding against all compounded medications. CDC investigation and recommendations.
Replacing a disposable component does not change the designation of the retained device.
FDA defines a single-use device as intended for one use, or for one patient during a single procedure. Adding a new tip does not establish permission to reuse a retained bottle, pump, or assembly that is itself labeled single-use.
Single-patient use is a separate designation: it may permit repeated use for the same patient under the labeling, while restricting use across patients. The exact model and component instructions determine what is permitted.
FDA also recognizes regulated reprocessing of certain single-use devices, with reprocessors subject to manufacturer requirements. Routine office cleaning should not be treated as equivalent to that pathway.
Why it matters: Staff need to verify the designation of the complete system and each retained component—not infer multi-patient suitability from the availability of replacement tips. FDA explanation of single-use devices and regulated reprocessing.
A reusable device is only as safe as its complete reprocessing workflow
FDA explains that reusable medical devices require a multistep process involving cleaning followed by the appropriate disinfection or sterilization. Inadequate cleaning can leave biological material that allows microorganisms to survive subsequent processing.
A quick rinse, exterior wipe, or air drying should not be assumed to replace the manufacturer’s complete instructions. For systems with reservoirs, pumps, tubing, and detachable components, staff must identify which components require processing and carry out every applicable step.
Why it matters: “Reusable” describes a permitted use under specified conditions. It does not establish that the device is safe for the next patient when required cleaning, disinfection, sterilization, or other processing steps have been omitted. FDA guidance on reusable-device reprocessing.
Shared medication reservoirs can remain a safety concern even when the patient-contact tip is changed
In a device that supplies medication from the same reservoir to multiple patients, replacing the tip does not, by itself, establish that the medication, pump, and internal fluid pathway remain protected from contamination. The assessment must consider the entire system, its labeling, and its actual use.
CDC recommends dedicating multidose medication vials to one patient whenever possible and keeping shared multidose vials outside the immediate treatment area.
Why it matters: A fresh tip addresses one component. Hospitals and clinics also need to assess whether the shared medication supply and retained components are suitable for use across patients. CDC core infection-prevention practices.
A glucose-meter error message became a serious patient-safety issue.
In April 2026, updated in May, FDA warned about affected TRUE METRIX glucose-monitoring systems, including a professional-use system and products carrying other brand names.
The same E-5 error code could indicate either a test-strip problem or glucose above 600 mg/dL. Confusing those situations could delay treatment or prompt inappropriate treatment. FDA reported that the manufacturer had received reports of 114 serious injuries and one death associated with the issue as of January 16, 2026.
Why it matters: Device safety includes how users interpret messages—not just whether the device powers on or produces readings. FDA recommends transitioning to an alternative testing method when possible, while continuing glucose testing until an alternative is available. FDA safety communication.
RF microneedling received a warning about potentially serious injuries.
On October 15, 2025, FDA warned about reports of burns, scarring, fat loss, disfigurement, and nerve damage with certain uses of radiofrequency microneedling for dermatologic and aesthetic procedures. Some injuries required surgery or other medical intervention.
Why it matters: Procedures marketed as skin “tightening” or “rejuvenation” can involve substantial medical risks. FDA emphasizes appropriately trained licensed providers, informed discussion, and adverse-event reporting. The warning concerns reported complications and an ongoing evaluation; it does not establish how frequently those injuries occur. FDA warning.
Connected patient monitors can create clinical risks through cybersecurity vulnerabilities.
FDA issued a January 2025 warning, updated in July, concerning certain Contec CMS8000 and Epsimed MN-120 patient monitors. The update included information about a manufacturer security advisory and software patch.
Why it matters: Cybersecurity belongs in clinical equipment oversight as well as IT. Vulnerabilities can potentially permit unauthorized access or commands affecting device operation. FDA’s cybersecurity page states that it was not aware of associated patient injuries or deaths or deliberate targeting of specific devices in clinical use in the listed cases. FDA cybersecurity information.
