|
 
February 2024
Volume 24, Issue 2
The U.S. Food and Drug Administration’s (FDA) MedSun program provides this monthly newsletter to inform patients and patient advocates about FDA information on medical device related topics. The MedSun program, launched in 2002 by the FDA’s Center for Devices and Radiological Health (CDRH), uses a secure online reporting system to receive medical device adverse event reports from a network of over 300 clinical facilities across the United States. MedSun sites work collaboratively with the FDA to assist in detecting, understanding, and sharing information concerning the safety of medical products and play a critical role in the FDA’s postmarket surveillance efforts.
|
|
Letters to Health Care Providers |
|
|
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 edited for clarity.
|
|
Type: Pump, infusion
Manufacturer: ICU Medical, Inc.
Brand: Plum 360
Model: 30010 Plum 360 Infuser
Event: For almost eight months, we have been having issues with battery failure on the Plum 360 Pumps. Currently, we are experiencing more than 60 failures per week. Examples of the issues include:
- Device shut down with minimal warning during patient transport.
- Devices alarm battery depleted while plugged in, then it shuts down.
- Pumps are having battery failures indicating “reset service battery” error.
Type: Syringe, piston
Manufacturer: Cardinal Health
Brand: Magellan ½ mL Insulin Safety Syringe
DI: 10884521005976
Model: 8881893050
Lot: 326529X
Cat: 8881893050
Event: There have been multiple reports indicating the 1/2 mL insulin safety syringes are poor quality, with multiple lots involved. There are complaints that the needle will fold when staff attempt to draw up insulin or when recapping, and the needle pokes through the cap. The staff said using these syringes can be dangerous. Staff must be extra careful when handling them because they bend so easily, and the cap does not stay on well.
|
Type: Mini CArm
Manufacturer: Orthoscan
Cat: 1000-0017
Event: We are having ongoing operational and image quality problems with our Mini-C arm. These challenges have led to increased surgical time and an increased number of images taken to find a usable image for a patient undergoing surgery. This concern has been escalated to the device manufacturer multiple times. The manufacturer brought in an upgraded newer machine; however, we continue experiencing similar problems. Device performance concerns have not been satisfactorily addressed. We recently had a software upgrade that was supposed to correct some of the concerns, but it has not satisfactorily done so. Additionally, the timing for x-ray initiation must be perfect. Historically, our previous machine worked well and we could tap the pedal and get a good image. With this current machine, we must press and hold the pedal button on the side of the machine for the perfect amount of time for it to focus. If it isn’t held long enough, a grainy unusable image is produced. If held too long, the device switches to live fluoroscopy. The vendor explains this is the way it is designed; no adjustments can be made to improve this situation. As a result, many more images are taken than necessary. This increases surgical time and surgeon frustration. The pedal is more challenging to operate so the operating room team typically uses the button. It is extremely challenging to get to the button in surgical hand cases. The staff run the risk of bumping the machine which would blur the image, contaminating the drape or themselves. It is extremely challenging to maintain good ergonomics and the team is put at risk for injuries, particularly the scrub nurse who is trying to obtain the image. The surgeon and resident are holding the limb because the extremity must be held perfectly still to get a usable image. We have escalated this concern to our Radiology leaders and have asked for a replacement. In this event, the orthopedic surgeon was an open reduction and internal fixation of the left scaphoid fracture with left distal radius cancellous bone graft. The surgeon start time was 3:19 p.m. and stop time was 8:53 p.m. The length of the procedure was negatively impacted by the functional challenges of the orthoscan.
|
|
Neonatal and Pediatric Reports |
|
 |
|
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.
|
Type: Pediatric Hemodialysis System
Manufacturer: Bellco SRL
Brand: Carpediem
Model: IB7010250
Event: After changing the effluent bag, the machine read that it was leaking, and the screen began to flicker. The screen fluctuated between flickering and appearing fuzzy. During this time, we were unable to operate the machine or see anything on the screen. The screen resumed to normal after a few minutes and dialysis resumed.
|
|
Important Information: Final Rule to Amend the MQSA
In 2023, the FDA issued the final rule to amend the MQSA (Mammography Quality Standards Act) regulations. Facilities subject to the MQSA must comply with all applicable requirements, including the breast density notification, no later than September 10, 2024. MQSA inspectors will look for the new items, including mammography report requirements, patient lay summaries, communication of results, and medical outcomes audit
Federal Breast Density Requirements Include:
Mammography Reports
The mammography report shall include an overall assessment of breast density, classified in one of the following categories:
- “The breasts are almost entirely fatty.”
- “There are scattered areas of fibroglandular density.”
- “The breasts are heterogeneously dense, which may obscure small masses.”
- “The breasts are extremely dense, which lowers the sensitivity of mammography.”
Dr. Robert M. Califf, FDA Commissioner, on Realizing the Promise of Real-World Evidence
What we now call real-world data (RWD) have been used for years in medical product development to inform study design and endpoint selection, identify potential participants and trial sites, and assess safety in the post-marketing setting.
Related, real-world evidence (RWE) is the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD. In this article, Dr. Califf discusses some of the challenges and advancements in RWD and RWE.
|
FDA and CMS: Americans Deserve Accurate and Reliable Diagnostic Tests, Wherever They Are Made
Both the FDA and the Centers for Medicare & Medicaid Services (CMS) believe patients and providers need to have confidence that laboratory tests work. The FDA and CMS issued a joint statement reiterating mutual support of FDA oversight of the analytical and clinical validity of laboratory developed tests (LDTs).
FDA Facilitates Broader Adoption of Vaporized Hydrogen Peroxide for Medical Device Sterilization
Agency Continues to Encourage Ethylene Oxide Sterilization Alternatives
The FDA announced that it considers vaporized hydrogen peroxide (VHP) to be an established method of sterilization for medical devices, recognizing VHP’s long history of safety and effectiveness. The FDA has revised the final guidance, Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile, to list VHP as an example of an Established Category A method of sterilization, which is expected to strengthen the capacity to adopt alternative sterilization processes that pose less potential risk to the environment and communities in which they operate.
New CTTI Report: Recommendations for ClinicalTrials.gov Reporting
The FDA announced a newly published report the Clinical Trials Transformation Initiative (CTTI) prepared on the findings of a collaborative project with FDA to understand the barriers to timely, accurate and complete registration and reporting of summary results information for applicable clinical trials on ClinicalTrials.gov.
The report provides strategies and recommendations for improving registration and reporting summary results information for applicable clinical trials.
|
OMHHE Enhance Equity Research Hub
The FDA Office of Minority Health and Health Equity (OMHHE) Enhance Equity Research Hub provides information about OMHHE-funded research projects that are a vital part of achieving the OMHHE mission to promote and protect the health of diverse populations through research and communication of science that addresses health disparities.
|
|
|
Links to FDA CDRH Databases and Other Information Sources |
|
U.S. Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993 |
|
|
|
|
