FDA discusses devices linked to infections in York
Since York Hospital became the first hospital in the U.S. to identify a connection between an infection and a device used during open-heart surgery, two other hospitals have publicly alerted patients of potential contamination in the same manner.
According to reports filed with the U.S. Food and Drug Administration,as many as 13 other health care facilities in the country have identified similar infections and have yet to acknowledge it publicly.
The FDA held a two-day panel June 2-3 on heater-cooler units, which have been publicly linked to nontuberculous mycobacteria, or NTM, in patients at York Hospital, Penn State Milton S. Hershey Medical Center and University of Iowa Hospitals and Clinics.
An investigation at York Hospital by the Centers for Disease Control and Prevention triggered notification in October 2015 of 1,300 patients who had undergone open-heart surgery dating back to October 2011 because NTM infections are slow-growing and often difficult to identify.
Similar procedures were followed at the Hershey and Iowa medical facilities.
During the panel, the FDA met with infectious disease specialists, device manufacturers and various state health officials to discuss, among other related topics, mitigating contamination of the devices and when and how to notify patients and providers of the risks.
In its brief summary of the conference, the FDA noted that the panel did not recommend notifying all patients if a facility discovers one patient identified with an infection.
"Instead, ... if one patient is identified with an infection, the panel recommends that an investigation be initiated at the facility where the surgery occurred, and local authorities should be informed," the summary stated, noting that the panel was more receptive to recommending notification of all patients if more than one infection was identified.
Medical device reports: The FDA also showed in its presentation for the panel that, between Jan. 1, 2010, and Feb. 29, 2016, it had received 180 medical device reports (MDRs) related to heater-cooler devices associated with patient infections or device contamination.
Manufacturers are required to submit reports to the FDA if they become aware that a device might have caused or contributed to a death or serious injury. User facilities, often hospitals, are only required to submit reports to the FDA if they suspect a device might have caused or contributed to a death, though clinicians and patients may submit reports voluntarily at any time.
According to FDA data, the administration has seen a yearly increase in reports received between 2006, when it received less than 200,000, and 2015, when it received nearly 1 million.
FDA spokeswoman Deborah Kotz wrote in an email that the increase might have been caused by numerous factors, including an increase in the number of devices on the market and increased awareness of reporting procedures.
Madris Tomes, who previously worked with the FDA's adverse medical device reporting system, said she witnessed an administration emphasis on pushing devices through the approval process without compensating by hiring additional employees to review the influx of reports, known as postmarket surveillance.
"(The postmarket surveillance team) was completely overwhelmed while I was there," said Tomes, who left in 2014 and has since started her own company, Device Events, which created a new system using public FDA data.
Kotz wrote that the FDA considers postmarket surveillance a high priority and has been taking steps to establish a national evaluation system that would use data generated during routine patient care and captured electronically.
She added that while MDRs are valuable, the system has limitations, "including the potential submission of incomplete, inaccurate, untimely, unverified or biased data."
"Additionally, we may receive multiple reports related to the same event, making it difficult to determine actual numbers of events," Kotz wrote.
The numbers: The 180 reports filed on heater-cooler devices came from a total of 55 facilities, including 16 facilities in 10 U.S. states, according to FDA data.
According to those reports, heater-cooler units have been implicated in at least 45 patient infections and nine deaths in the U.S.
Those numbers suggest there may be patients infected by heater-cooler devices in hospitals that haven't publicly alerted other patients, because York Hospital (10 infected, six of whom died), Hershey Medical Center (three infected, two of whom died) and Iowa Hospitals and Clinics (three infected, one of whom died) only add up to 16 infections with nine deaths.
Kotza wrote that the FDA redacts names of user facilities in public postings of its reports to abide by federal privacy regulations. She added that state names may be obtained through a Freedom of Information request, which The York Dispatch submitted on June 10.
Lawrence Muscarella, who independently advises and audits hospitals on infection-control practices at his Montgomery County business, expressed concern that the country's health care overseers are withholding pertinent information.
"The failure of today’s health care system to be transparent and proactive and to ensure each of these potentially infected patients is informed of the risk of a deadly infection not only raises concerns about potential conflicts of interest but is indisputably improper," Muscarella said.
Muscarella said he was particularly disappointed with the CDC because it is charged with overseeing public health concerns.
CDC spokeswoman Melissa Brower wrote in an email that the CDC, which had a representative at the FDA's panel, was not able to offer any insight on the subject at this time.
The manufacturers: The heater-cooler device manufactured by LivaNova, formerly Sorin, accounted for 160 of the 180 reports, though the FDA noted that the company has approximately 60 percent of the device's market share.
York Hospital was using Sorin/LivaNova's device, but WellSpan spokesman Brett Marcy has said that the hospital switched to a similar device manufactured by Cincinnati Sub-Zero because of continued concerns.
Cincinnati Sub-Zero's device has been listed in reports as associated with one patient infection and six contaminated devices in the U.S., according to FDA data.
Meanwhile, the FDA had sent a warning letter in late December to Sorin/LivaNova alleging multiple violations, including inadequate information regarding the validity of its new cleaning procedures.
On June 1, the administration sent out a safety communication in which it states that Sorin/LivaNova found bacteria contamination in August 2014 on its production line and in its water supply at the facility where the heater-cooler devices were manufactured.
Notably, two York County men filed a $5 million suit earlier this year against LivaNova in relation to the potential contaminations.