Becker's Hospital Review

104 CMO / CARE DELIVERY Thousands of patients received heart pump with known safety issues, ProPublica finds By Mackenzie Bean A heart pump with a history of manu- facturing and quality issues was im- planted into thousands of patients even aer the FDA was aware the device did not meet federal standards, according to an in- vestigative report ProPublica published Aug. 5. Five takeaways: 1. e FDA first identified manufacturing issues involving the HeartWare Ventricular Assist Device in 2011, a year before the de- vice hit the market. e agency found more safety lapses in 2014 and issued a warning letter to the heart pump's maker, HeartWare, which Medtronic acquired in 2016. Accord- ing to ProPublica, the FDA relied on Heart- Ware and Medtronic to voluntarily address the issues instead of forcing them to do so by issuing an injunction or fines. e companies were never penalized by the FDA when they failed to correct issues by set deadlines, ac- cording to the report. 2. From 2014 to present, the companies is- sued 15 serious recalls about the heart pump. e FDA shared formal notices and repeat- edly alerted healthcare providers of the is- sues, but many patients were unaware, the report found. More than 19,000 patients were implanted with the device, which is meant to keep heart failure patients alive while they wait for a transplant. Most of these patients received the device aer 2014, when the FDA knew it did not meet federal standards, according to ProPublica. By 2020, the FDA had received more than 3,000 reports of pa- tient deaths potentially linked to the device. "Medtronic continuously evaluates our de- vices at each stage of their life cycles to en- sure we are meeting regulatory requirements and the evolving needs of patients and the healthcare professionals that serve them," the company said in a statement to Becker's. "We regularly receive and evaluate real-world information to identify, address, correct and communicate issues when they arise." 3. Medtronic pulled the device from the mar- ket in June aer finding a competing device from Abbott produced better clinical out- comes. e American College of Cardiology called Medtronic's move "a success of med- ical device feedback and monitoring" in an Aug. 5 article. e field of le ventricular as- sist devices is constantly evolving, the group said, adding that Abbott's device was built upon lessons learned from competitors and preceding devices. 4. Before stopping sales of the heart pump, Medtronic said it worked closely with Abbott to ensure alternative device options were available for patients. e company also has a program to support, monitor and in- form about 4,000 patients implanted with the device and their caregivers. "e decision to withdraw HVAD is consis- tent with our deeply held commitment to design and manufacture medical technolo- gy that improves patient health outcomes," Medtronic told Becker's. "Medtronic respects the physician-patient relationship and is fo- cused on working with healthcare providers to ensure that there is no gap in patient care. … Clinical and technical teams are and will continue to be available to ensure ongoing patient support." 5. e FDA said it has actively monitored issues with the heart pump and met with Medtronic more than 100 times aer it acquired HeartWare to review safety con- cerns and ensure they were being correct- ed. e FDA also launched formal reviews of new device modifications and tracked whether the heart pump had a "reasonable assurance of safety and effectiveness," the agency told ProPublica. "e patients and providers who rely upon this life-sustaining device to treat ad- vanced, end-stage heart failure were always at the forefront of our decision-making," an FDA spokesperson said in a statement to Becker's. "e FDA is continuing to work with Medtronic to ensure that all deficiencies are resolved, and with Abbott, to ensure an adequate supply of HeartMate 3 devices are available for future patients." n Plastic barriers may sometimes worsen COVID-19's spread, experts say By Mackenzie Bean C lear plastic barriers have become a staple in many public settings amid the pandemic, but scien- tists say they often do little to prevent COVID-19's spread, and at times, may actually make things worse, The New York Times reported Aug. 19. The plastic shields are intended to protect people from germs in public settings such as classrooms, offices or stores. However, researchers who study aerosols and ventilation say the barriers can impede normal air flow and create "dead zones" where aerosol particles accumulate in high concen- trations, preventing clean air from cycling back into a room. "If you have a forest of barriers in a classroom, it's going to interfere with proper ventilation of that room," Linsey Marr, PhD, professor of civil and environmental engineering at Blacksburg-based Virginia Tech and a leading expert on viral transmission, told the Times. "Everybody's aerosols are going to be trapped and stuck there and building up, and they will end up spreading beyond your own desk." There is little real-world evidence available on how the clear barriers affect the risk of contracting COVID-19, but preliminary studies suggest they offer limited protection, according to the Times. For example, modeling studies done by British researchers found the plastic shields ef- fectively blocked large particles from someone coughing, but not smaller aerosols exhaled while someone speaks. " Smaller aerosols travel over the screen and become mixed in the room air within about five minutes," Cath- erine Noakes, PhD, a ventilation expert and professor of environmental engineering for buildings at the University of Leeds in England, told the Times. "This means if people are interacting for more than a few minutes, they would likely be exposed to the virus regardless of the screen." n

• Cover