Public Safety Warnings from FDA Spike in 2015

Qmed Staff

December 2, 2015

7 Min Read
Public Safety Warnings from FDA Spike in 2015

FDA has had a been a busy year releasing Medical Device Safety Communications safety communications. Outlined in the warnings include problems related to duodenoscopes, reprocessed flexible bronchoscopes, and cybersecurity.

Qmed Daily

To date, FDA has released 18 safety communications in 2015. Compare that with 2014, when it released six such communications, or 2013, when it released nine. Several of the documents were related to themes such as the ability of infusion pumps to be hacked, duodenoscope infections, and sub-par mammography.


In the first month of the year, FDA released a warning about the use of bone graft substitutes with recombinant proteins or synthetic peptides in patients under the age of 18. FDA warned that using the products in underage products could cause severe injuries such as excess bone growth, fluid accumulation, inhibited bone healing, and swelling, all of which could be worsened owing to the patients' smaller size and the fact that their bones are still growing.


A warning about certain types of duodenoscopes (Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes) warned that their design may impede effective cleaning. In the same month, an 18-year-old high school student hospitalizedwith acarbapenem-resistant Enterobacteriaceae (CRE) infection sued Olympus Corp. in Los Angeles County Superior Court over its duodenoscope linked to the outbreak,according to the Los Angeles Times. FDA critics began publicly stating at roughly the same time that FDA wasn't doing enough to address the problem. "This problem has been known since at least 1987," said John Allen, MD, the president of the American Gastroenterological Association to CNN.


FDA followed its February safety communications with an announcement in March that Olympus had "issued new, validated manual reprocessing instructions for the TJF-Q180V duodenoscope to replace those provided in the original labeling."The agency explained that it had reviewed the reprocessing instructions as part of its ongoing review of a 510(k) applications for the TJF-Q180V duodenoscope, which had initially made it to market without a 510(k). FDA granted Olympus permission to continue marketing the device while the application was under review.

Also in March, FDA reported that there were quality problems related to mammograms performed at a facility in Raleigh, NC. The American College of Radiology (ACR) performed a review of mammograms performed at the Richard D. Adelman, MD's, Family Medicine practice between August 25, 2012, and August 25, 2014 and found a number of problems, leading the organization to revoke the facility's accreditation.


In April, FDA released new warnings about the quality of mammograms at certain facilities: this time at the Coastal Diagnostic Center in Pismo Beach, CA and the Huntington Radiology in Huntington Park, CA.


FDA released a warning about the unintentional injection of soft tissue fillers into blood vessels in the face, which can cause serious albeit rare problems such as  vision impairment, blindness, stroke and damage, or death of the skin (necrosis) and underlying facial structures.

Also in May, FDA released its first warning of the year related to Hospira's PCA3 and PCA5 infusion pumps, which it states are vulnerable to hacking. The device could grant an unauthorized user with malicious intent to take over control of the device and under- or over-delivery critical drug doses.                                                                              


FDA released yet another safety communication over a Hospira infusion system vulnerable to hacking--this time going as far as to advise health providers to stop using the device altogether.

Both Hospira and independent researcher Billy Rios confirmed that the Hospira Symbiq infusion system could be accessed remotely through a hospital's network, allowing unauthorized user to potentially change drug dosages for patients, according to the communication

Also in July, FDA released a warning related to the LARIAT Suture Delivery Device from SentreHEART which had been linked to 45 adverse events, including six deaths and serious injuries and other problems including hemorrhage, fluid collection around the heart, fluid collection around the heart that causes low blood pressure and decreased heart function leading to shock, and fluid collection around the lung. Of the 45 adverse events, 34 necessitated emergency heart surgery.


In August, FDA released another notice related to duodenoscopes, this time providing recommendations on how to reprocess them more effectively. FDA is saying facilities should apply one of four methods on top of following the device manufacturer's cleaning instructions: microbiological culturing, sterilization with ethylene oxide gas, liquid chemical sterilant processing system, and repeat high-level disinfection. None of the four options that FDA has outlined are great, though, when it comes to decontaminating the complex devices.

The agency sounded an alarm on Left Ventricular Assist Devices (LVADs)from Thoratech and HeartWare. Since FDA approval of devices from the two companies, there has been an increased rate of pump thrombosis (blood clots inside the pump) among people using Thoratec's HeartMate II, and a high rate of stroke among people using the HeartWare HVAD, FDA says.

Also in August, FDA released another warning related to the quality of mammograms at a diagnostic imaging facility in Orlando, FL.


An FDA warning points out the potential dangers of using reprocessed flexible bronchoscopes, which had been linked to a number of infections. FDA received 109 Medical Device Reports (MDRs) of infection or device contamination about flexible bronchoscopes between January 2010 and June 2015, but that there were 50 MDRs in 2014 alone, explains MD+DI.

FDA warned that the some cranial perforators are dangerous for use in neurosurgery. While the devices are to automatically stop after penetrating the skull, the automatic clutch mechanism in some units may not work properly, causing severe injuries. The safety notice explains that, from January 2005 to August 2015, FDA more than 300 medical device reports related to cranial perforators with an automatic clutch mechanism problem, leading to more than 200 injuries.


An October warning pointed to the danger of nontuberculous mycobacterium infections linked with heater-cooler devices used in open-heart surgeries. As many as 1300 patients at WellSpan York Hospital may have been potentially exposed to the bacterial strain from October 1, 2011 to July 24, 2015.


In November, FDA ordered a recall for endoscope reprocessors and released a safety communication pointing out that the company Custom Ultrasonics (Ivyland, PA) has continually violated federal law and a consent decree entered with the company in 2007. According to the terms of a consent decree cited in the recall, FDA in 2012 ordered Custom Ultrasonics to stop manufacturing and distributing automated endoscope reprocessors (AERs) and AER components.

FDA has issued a warning to clinicians about possible hazards associated with the coatings on intravascular medical devices. Device makers apply these hydrophilic and hydrophobic lubricious coatings to catheters, guide wires, delivery sheaths and implant delivery systems to reduce friction during minimally invasive brain, heart, and peripheral artery procedures. The coatings are helpful to physicians, but can peel, flake, shed, divide into layers, or slough off the devices, and injure patients,the agency said.

FDA has confirmed nine deaths from heart attacks and brain bleeds caused by coating particles that detached from devices during brain and heart catheterization procedures. Two other patient deaths were reported, but not attributed to device coatings.

Since 1 January 2014, FDA has received about 500 medical device reports (MDRs) on the coating separations. Serious adverse events reported in these MDRs and in the scientific literature include pulmonary embolism and infarction, myocardial embolism and infarction, embolic stroke, tissue necrosis, and death.

Since Jan. 1, 2010, there have been 11 recalls from various manufacturers associated with these coatings peeling or flaking off medical devices. Most were associated with guidewires, but sheaths, retrieval devices and embolization device delivery wires have also been recalled, FDA said.

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