MASSDEVICE ON CALL —The Medical Device Patient Safety Act, introduced this week in the Senate, calls for increased safety measures for device approval from the FDA.
The bill, introduced by Sens. Chuck Grassley (R-Iowa), Herb Kohl (D-Wis.) and Richard Blumenthal (D-Conn.), would beef up the FDA’s safety regulations, allowing the federal watchdog agency to conduct safety studies of devices after they’ve been approved and to grant conditional approvals contingent on further trials.
The bill would also strengthen the rules for the FDA’s 510(k) protocol, which currently only requires device makers to show that their products are similar to those already-cleared devices.
Med-tech lobby AdvaMed issued a statement opposing the bill, insisting that the FDA needs a clearer recall process rather than more regulation.
"It is important for the America public to realize that the medical technology industry has a well-documented safety record," Janet Trunzo, executive vice president of AdvaMed said prepared remarks, noting that less that 0.5% of all devices cleared by the FDA are involved in a serious recall.
"We believe expanding the FDA’s authority to require post-market studies as a condition of 510(k) clearance is unnecessary given the agency already has broad authority to require manufacturers to conduct post-market studies for higher-risk devices cleared via 510(k)," said Trunzo.
The bill was sparked by a slew of high-profile lawsuits against medical device goliaths Johnson & Johnson (NYSE:JNJ), C.R. Bard Inc. (NYSE:BCR), American Medical Systems Holdings Inc. (NSDQ:AMMD) and Boston Scientific Corp. (NYSE:BSX) for transvaginal mesh devices that may do more harm than good.
Add to that the high-profile metal-on-metal hip implant recalls by J&J subsidiary DePuy Orthopaedics, which has spawned its own raft of lawsuits. Analysts have estimated that settlement of those cases could cost JNJ up to $1 billion.
Another high-profile case involves Medtronic Inc.’s (NYSE:MDT) 2007 Sprint Fidelis recall, which was implicated in more than 100 deaths (Medtronic has said that only 13 fatalities had the leads as a "possible or likely contributing factor"). The various transvaginal mesh products, DePuy’s hip implants and Medtronic’s Sprint Fidelis were all cleared through the FDA’s 510(k) device review fast-track.
"Our mission is to protect the public health," Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health said in a meeting with investors yesterday. "But it’s also to promote public health by promoting innovation. There’s this misperception out there that the two are inconsistent but we think they are very compatible."
MDT builds new research base in Ireland
Med-tech titan Medtronic plans to build a new 25,000 square-foot research facility next to its existing center in Galway, Ireland, according to the Galway City Tribune. The proposed plans include a new customer innovation center and a research facility. Read more
Kessler Foundation tests exoskeletal device in 6 patients
The Kessler Foundation tested the Ekso Bionics’ robotic exoskeleton in 6 patients with traumatic spinal cord injury, according to a press release. The Ekso system enables wheelchair users to stand and walk. Read more
House approves power-boost bill
The U.S. House of Representatives approved a bill that would require major regulations related to health care, greenhouse gas emissions, consumer product safety and employer behavior to gain congressional approval before being implemented, according to Law360.com. The bill passed with a 241-184 vote. Read more
Robotic therapy could mean big improvements for stroke victims
Severely impaired stroke victims could walk better when conventional rehabilitation programs were supplemented with a robotic assist system, according to a study. Read more