A managed care lobbying group is calling for tighter controls over the approval, monitoring and maintenance of reusable medical devices, according to news reports.
The Wall Street Journal recently looked at a controversy surrounding New Brunswick, N.J.-based Johnson & Johnson’s Ethicon morcellator, a laparoscopic surgical device used for hysterectomies that was pulled off the market after it was found to spread uterine cancer.
That situation and another one in which a difficult-to-clean reusable duodenoscope device wound up being a root cause of a “superbug” outbreak at the University of California-Los Angeles’ health enterprise led the Food and Drug Administration to issue new guidance about such devices, according to a news report. Superbugs are bacteria resistant to antibiotics.
The guidance calls for companies that make reusable medical devices to thoroughly test and label their products and outline appropriate cleaning methods, the report said.
In the meantime, the Wall Street Journal reported that Washington, D.C.-based America’s Health Insurance Plans wrote to Sen. Bob Casey, D-Penn., contending that the morcellator issue is indicative of weaknesses in medical device approval and regulation once on market.
America’s Health Insurance Plans wants the FDA to “strengthen” its 510(k) device regulation pathway and device tracking, a report said.
On the other side, a device lobbying group is defending 510(k).
FDA’s 510(k) “review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical devices,” Stephen Ubl, chief executive of the Washington-based Advanced Medical Technology Association, told the newspaper in response to the health plan lobbying group’s letter.
AdvaMed’s directors include Michael Mussallem, chief executive of Irvine-based Edwards Lifesciences Corp., and John Kilcoyne, chief executive of Lake Forest-based eye device maker ReVision Optics Inc.
Cancer Study in OC
Kaiser Permanente, an integrated health system that includes hospitals in Anaheim and Irvine, along with a medical group and Orange County’s largest health plan at more than 500,000 members, is participating with Vermillion Inc. in a study designed to enhance the diagnosis and treatment of ovarian cancer.
Austin, Texas-based Vermillion is a bioanalytics company that focuses on gynecologic disease.
It said in a news release that a benchmarking study of quality issues related to the initial diagnosis and treatment of ovarian cancer will be directed from Kaiser’s women and children’s service line in OC. The study will use electronic health records and track patient care from the initial presentation to surgical intervention, diagnosis, initial treatment, and early post-surgical outcomes.
Kaiser and Vermillion will seek to pinpoint opportunities to improve care, including providing faster access to appropriate doctors and reducing inefficiencies, as well as overall costs, according to the release.
DNA Collection Method Coming
Irvine-based CombiMatrix Corp. said it will introduce a new way of collecting DNA samples from newborn and other pediatric patients.
CombiMatrix is a molecular diagnostic company that specializes in DNA-based services for prenatal, postnatal and predonor embryo genetic testing.
The company said in a news release that its new collection method uses a cheek swab rather than a blood draw and can be done in a doctor’s office, saving the need to send patients to a phlebotomy center.
Bits & Pieces
Fountain Valley Regional Hospital and Medical Center said its Dallas-based parent, Tenet Health Corp., gave it a “circle of excellence” award for achievements in quality care, service excellence and operational performance. The 400-bed hospital said it was one of only 12 of Tenet’s 80 hospitals to earn the distinction. … Tustin-based Peregrine Pharmaceuticals Inc. said it presented three abstracts covering its antibodies being developed for cancer treatment at the American Association for Cancer Research’s 106th annual meeting last week in Philadelphia.
