FDA reissues policy for coagulation systems

The U.S. FDA re-posted a policy document spelling out the agency’s expectation surrounding the use of coagulation systems designed to measure the viscoelastic properties of whole blood. As was the case in the Jan. 14 policy, the Jan. 28 policy is limited to devices registered under product codes JPA (multi-purpose systems for in vitro coagulation studies) and QFR (coagulation systems for measurement of whole-blood viscoelastic properties). The standing policy is that the agency would not object to several modifications of such systems without conventional premarket notification, such as those undertaken to expand the indications for use to include hospitalized patients suspected of COVID-19 associated coagulopathy. However, modifications to unit software or hardware that directly affects the measurement capabilities of the device would still require conventional regulatory filings/notification.

FDA announces recall of Penumbra’s Jet 7

The U.S. FDA said the class I recall of the Penumbra Jet 7 reperfusion catheter with Xtra Flex technology is due to the prospect of damage to the device’s distal tip, although the recall does not affect Jet 7 units that lack the Xtra Flex feature. Penumbra Medical Inc., of Alameda, Calif., recalled the device in December 2020 after the FDA had received more than 200 medical device reports associated with the catheter, including 14 fatalities, while other adverse events include cerebral infarct. The company advised customers to remove all remaining units from inventory for return to the manufacturer. The recall affects more than 22,600 devices distributed in the U.S. between June 17, 2019, and Dec. 14, 2020, while slightly more than 6,000 other units were distributed in other nations.

Stericycle to buy buses as part of settlement

The U.S. Department of Justice and the Environmental Protection Agency announced a settlement with Stericycle Inc., of Lake Forest, Il., regarding allegations of violation of state and federal statute at the company’s waste incinerator at North Salt Lake, Utah. The agreement, which settles allegations the company violated both the federal Clear Air Act and unspecified state air quality regulations, requires payment of a $600,000 civil penalty and the purchase of low-emitting school buses for a local school district at a cost of $2 million for 20 or fewer buses. The company is alleged to have violated limits for emissions of nitrogen oxides and to have failed to properly conduct stack tests.

Athena agrees to $18M fine

The U.S. Department of Justice said Athena Health Inc., of Watertown, Mass., has agreed to pay $18.25 million to settle allegations of violations of federal law in connection with promotions of the company’s electronic health record (EHR) software. Athena is alleged to have violated both the False Claims Act (FCA) and the Anti-Kickback Statute (AKS) by three means, including by inviting existing and prospective customers to concierge events that offered free tickets to events such as the Kentucky Derby. Other violative conduct alleged to have been undertaken by Athena includes payments of up to $3,000 to existing customers for referrals of new customers, and payments to competitors that were going out of business for client referrals. The underlying qui tam lawsuits were filed by three former employees, whose shares of the settlement have not been determined.

WHO refreshes essential diagnostics list

The World Health Organization (WHO) has published its annual update to the list of essential diagnostics for use in labs and at the point of care (POC), which in this instance emphasizes antigen and polymerase chain reaction testing for the COVID-19 pandemic and for endocrine diseases. Among the tests recommended for endocrine disorders are those for measurement of total cortisol, luteinizing and follicle-stimulating hormones, and prolactin. WHO Director-General Tedros Ghebreyesus said, “in all countries, the use of appropriate diagnostic tests can help inform evidence-based treatment and responsible use of medicines, resulting in improved allocation of resources and better health outcomes.” The guidelines emphasize that POC tests should be widely available at primary care sites or at community health centers in order to ensure that patients in low- and middle-income nations can be diagnosed and treated based on information beyond symptoms.

TGA pulls two pandemic-driven exemptions

Australia’s Therapeutic Goods Administration (TGA) said it has withdrawn the COVID-19 exemptions for ventilators and certain items under the category of personal protective equipment, effective Jan. 31, 2021. The ventilator exemption commenced April 8, 2020, although any ventilators already in inventory in hospitals and other clinics can be used past the end of the month. Going forward, any ventilators made available for sale must be listed in the Australian Register of Therapeutic Goods (ARTG). The exemption for face masks and other, unspecified PPE items was put in place March 22, 2020.