Device recalls in the second quarter of calendar year 2020 surpassed 300 for the first time since the second quarter of 2018, according to a report by Stericycle Expert Solutions Inc., of Indianapolis. However, the report noted that there has been a flurry of unofficial recall activity in connection with the COVID-19 pandemic, including recalls imposed by U.S. state departments of health and the Federal Emergency Management Agency (FEMA), although those non-FDA numbers are not included in the Stericycle summary. Recall events numbered more than 340 over the first quarter, which puts the total on pace to reach more than 1,200 by the end of the year. Conversely, the average number of device units caught up in the typical recall was 86,000, the smallest average number of units in 13 quarters. Sterilization issues affected the largest share of recalled device units at roughly 63%, and approximately 83% of the recalls were for products distributed nationally across the U.S. There were 92 medical device recalls in the month of July 2020, which trends with the overall monthly average in recent years, but is down slightly compared to the two previous months. Drug recalls totaled 67 events in the second quarter, a number that is down 28% from the previous quarter, while the 17.5 million drug units captured in those recalls is off nearly 66%. Failed drug specifications accounted for 24% of events, returning this to the top of causes for recall, but failed specs have led recalls 14 times in the past 18 quarters. Foreign materials drove the largest number of recalled drug units, however, which the report chalked up to a single recall that captured 8.8 million units.
The U.S. Centers for Medicare & Medicaid Services said it has extended the timeline for publication of a final rule for physician self-referral law as part of the Regulatory Sprint to Coordinated Care. The draft rule, published in October 2019, would have carved out additional safe harbors for value-based payment arrangements between physicians and other parties, along with additional exceptions for donations of electronic health record technologies. The timeline for publication of the final rule was initially set for August 2020, but the CMS said that timeline has been extended to Aug. 31, 2021.
The U.S. FDA said it will hold an Oct. 22 meeting of the patent engagement advisory committee regarding artificial intelligence and machine learning in medical devices. The meeting, which will be conducted virtually, will address the importance of ensuring that a variety of demographic groups are represented in development of these algorithms, as well as the impact of the user interface on usability.
The U.S. Department of Health and Human Services said it has distributed nearly $2.5 billion to nursing homes across the U.S. for the purchase of personal protective equipment for nursing home staff, half the planned total allocation of $5 billion. The funds were distributed to more than 15,000 nursing homes across the nation and is supplemental to roughly $5 billion that was distributed to skilled nursing facilities. The Agency for Healthcare Research and Quality will provide technical assistance for protection of staff and residents of nursing homes.
The U.K. National Institute of Health and Care Excellence (NICE) recommended the use of high-sensitivity troponin test as an option for early rule-out of non-ST-segment elevated myocardial infarction (NSTEMI-MI) for those presenting in emergency departments with angina and suspected acute coronary syndrome (ACS). The recommendation lists nine tests for use in this context, eight of which present similar cost profiles compared to standard troponin diagnostics. However, NICE recommended further research into the Triage True test by Quidel Corp. of San Diego to ascertain test performance at the point of care.