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July 2023
Volume 23, Issue 7
The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA-related information on a variety of topics, including new products the FDA has authorized for marketing, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.
The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), involves the reporting of problems with medical products from a network of approximately 300 hospitals, nursing homes, and home health facilities around the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products. MedSun uses a secure, online reporting system for reporting problems with the use of medical devices and plays a critical role in the FDA’s postmarket surveillance efforts.
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Letters to Health Care Providers |
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CDRH Seeks Public Comment: Increasing Patient Access to At-Home Use Medical Technologies
The FDA’s Center for Devices and Radiological Health seeks input from the public, particularly patients, patient advocacy organizations, health care providers, consumers, the medical device industry, clinical researchers, and others on advancing health equity and facilitating access to medical devices designed to be safe and effective when used outside of traditional clinical settings, for example, medical devices intended for use in the home.
Advancing health equity will ensure all patients, regardless of race, sexual orientation, gender identity, age, physical abilities, geographic location, educational background, and economic status will have access to safe, effective, and high-quality medical technologies, including at-home use devices, which may provide significant improvements in healthcare, quality of life, and wellness.
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The Patient Engagement Advisory Committee (PEAC) Virtual Meeting on Advancing Health Equity in Medical Devices
The PEAC will meet on September 6, 2023, to discuss and make recommendations on advancing health equity in medical devices. Topics for discussion include:
- Ways to advance access to medical devices that allow for care outside a hospital or clinical care setting, for example, in the home setting.
- Considerations for improving reach and comprehension of the FDA’s patient and caregiver communications, across diverse demographic groups.
- Patient-focused considerations for when a device should be evaluated in diverse populations to support marketing authorization.
Reports of Squamous Cell Carcinoma in the Capsule Around Breast Implants
The FDA previously issued safety communications about reports of squamous cell carcinoma (SCC) and various lymphomas occurring in the capsule that forms around breast implants.
The FDA continues to recommend that health care providers report all cases of SCC, various lymphomas, BIA-ALCL and any other cancers in the capsule around the breast implant to the FDA. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.
As of March 22, 2023, health care providers can also submit case reports of SCC, various lymphomas, and any other cancers in the capsule around breast implants to the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (ALCL) Etiology and Epidemiology (PROFILE), a collaborative effort between the American Society of Plastic Surgeons (ASPS), the Plastic Surgery Foundation (PSF), and FDA. Health care providers can continue to submit case reports of Breast Implant-Associated Anaplastic Large Cell Lymphoma (BIA-ALCL) to PROFILE as well.
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The reports that follow represent a cross section of device related events sent by MedSun Representatives during the prior month. The reports are presented as submitted by MedSun Representatives and in some instances, have been summarized and/or edited for clarity.
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Type: Device, Biopsy, Endomyocardial
Manufacturer:Argon Medical Devices, Inc.
Brand: Jawz Endomyocardial Biopsy Forceps
Model #: 190081
Lot #: 5457408 and 5512986
Cat #: 190081
Event Description:Under echo guidance, the bioptome got stuck in presumably the RV (right ventricle). The provider was unable to pull it back without significant resistance and could not open the jaws or maneuver the device. The patient went into SVT (supraventricular tachycardia) and was very uncomfortable. Due to an arrhythmia and discomfort, the provider pulled the bioptome with significant tension noted and retrieved a large piece of tissue on the end, though the jaws remained shut. The provider could not release the tissue which was still attached to the bioptome. The patient immediately flipped out of the SVT rhythm and felt better. The patient remained hemodynamically stable.
Type: Catheter Remote Control System
Manufacturer: Stereotaxis, Inc.
Brand: Stereotaxis
Type: Cardiac Ablation Percutaneous Catheter
Manufacturer: Biosense Webster, Inc
Brand: Carto Smartablate Pump
Event Description: In any Stereotaxis case, the SmartAblate pump for Carto will function fine for a few seconds until it eventually alarms for bubbles/microbubbles. But there are no bubbles! We have tried setting the device on different surfaces, alcohol swabbing the bubble sensor, and switching out pumps but the problem persists. We suspect something in the Stereotaxis device causes an interference with the sensor. When we need to do small lesions for ablations and have these problems, we must troubleshoot. Sometimes cases are converted completely to manual ablation and the Stereotaxis is cancelled altogether. The manufacturer is aware of these issues and recommended taping the tubing to the side of the smart ablate pump during Stereotaxis cases, to secure the tubing and reduce vibrations during ablation that seem to then cause the pump to alert.
Type: Clamp, Vascular
Manufacturer: Terumo Medical Corp
Brand: TR Band
Model #: TRB24-REG
Lot #: 0000318689
Cat #: TRB24-REG
Event Description: The TR Band was placed on the patient's wrist to stop the bleeding after a cardiac catheterization procedure. The appropriate amount of air was added to the band, but it began to lose air which caused a hematoma to develop.
Type: Orthopedic stereotaxic instrument
Manufacturer: Globus Medical, Inc.
Brand: Excelsius GPS
Model #: 6143.2844
Cat #: (10)FSA105AA
Event Description: Infection Prevention and Sterile Processing have ongoing deep concern about cannulas being sufficiently cleaned, bioburden removed, and sterilized.
During borescope & ATP testing for residual living cells, debris has been flushed out of devices, residual living human cells remain after cleaning; inspections failed. When removing and flushing adapter while manually cleaning the cannula in the sonic cleaning device, the team noted the cannula came apart. This device is made of pieces, and they do not seal together. The two-piece plastic cannula meets inside the metal outer cannula, but it is not sealed or glued together. Surrounding the plastic cannula between the plastic and metal cannula, remnants, or debris of what we assume could be from multiple patients was flushed out. The plastic cannula is threaded and glued at both ends but not completely sealed inside at the junction of the connecting pieces. Fluid and blood have worked their way from the two-piece inner plastic cannula to the outer metal piece. With the borescope, the staff noted bioburden film. The ATP testing confirmed there were residual living human cells remaining on the item, despite cleaning the item for over eight hours. The manufacturer initiated an investigation in January 2023 into this problem. As of May 2023, they are working with the Customs Department to create a one-piece item.
Top photo shows debris being removed from a cannula that had been cleaned. Bottom photo shows the interior view of a plastic cannula. Debris is visible on a cannula which had gone through the cleaning process.
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Neonatal and Pediatric Reports |
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These reports describe medical device events involving neonatal or pediatric patients, or those events involving a medical device that is indicated for use in neonatal and pediatric patient populations.
The FDA defines pediatric patients as those who are 21 years of age or younger (that is, from birth through the twenty-first year of life, up to but not including the twenty-second birthday) at the time of the diagnosis or treatment.
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Type: Ventilator, Continuous, Facility Use
Manufacturer: Hamilton Medical AG
Brand: Hamilton-g5
Model #: 159001 G5
Cat #: 159001
Event Description: The patient was admitted to the ICU when the nurse saw the patient "brady down" on the monitor and then immediately and flat line. Staff were in the room within less than 30 seconds to initiate a code and begin CPR. The Code Team completed one round of CPR with a dose of epinephrine given with return of pulse. During the code respiratory therapy (RT) attempted to recalibrate a component of the ventilator because an error was reading "loss of PEEP." This did not result in functional ventilator status; therefore, the ventilator was removed and replaced with a new one. During this time, the patient was receiving bagged oxygen to ensure perfusion. Post code evaluation (with RT, physician, and code team) determined the likely cause of asystole event was a catastrophic ventilator failure. The ventilator was removed from use and circulation. The ventilator from the event was walked and provided to Biomed for further assessment.
FDA to Update AccessGUDID Database and OpenFDA
On August 14, 2023, the FDA will update the fields released in the public AccessGUDID Database and the openFDA Unique Device Identifier endpoint to include Global Medical Device Nomenclature (GMDN) Term Codes along with the status of the GMDN Term Code, Active or Obsolete. If a labeler submitted an FDA Preferred Term (FDA PT) Code to meet their GMDN Code data entry requirement, the equivalent GMDN Code will now also be released publicly. This latest update is intended to provide end users with enhanced search and retrieval capabilities for GUDID data.
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FDA Meetings, Conferences and Workshops |
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Links to FDA CDRH Databases and Other Information Sources |
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U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993 |
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