The FDA issued a warning to Philips Medical Systems about problems with manufacturing procedures for its CT and nuclear imaging systems. The problems include failures to oversee proper device design and proper procedures to handle complaints. Inspections conducted at Philips' Cleveland facility, from July 24, 2007, through Sept. 27, 2007, and from Oct. 22, 2007, through Nov. 9, 2007, revealed that the devices were adulterated, said FDA officials. The agency noted that failure to promptly correct the violations may result in regulatory action being initiated by the FDA "without further notice," including seizure, injunction and/or civil money penalties.
New York State's Department of Health has sent letters raising the specter of fines and jail time to six online gene-testing firms that offer consumers the ability to peer into their genome to assess their future risk of getting diseases such as cancer, heart disease and multiple sclerosis. Oftentimes, the services offering these DNA deep-dives are doing so without the involvement of a doctor. California health regulators are also investigating 12 complaints from the public about certain online gene testers. Regulators are concerned about the reliability of the online tests and their potential to send people rushing to their doctor demanding a cure for a fatal disease they may never get.
Plans have been put in motion by Louisiana Gov. Bobby Jindal's administration to set up a Web site where Louisiana consumers can compare the costs and quality performance measures of hospitals and healthcare facilities against each other. Health and Hospitals Secretary Alan Levine outlined the costs, estimated at $500,000 annually, to the Senate Finance Committee. The Committee agreed without objection to the bill setting up the site, and the measure now heads to the full Senate for debate.
A robot in a lab at the University of Tennessee Health Science Center is making spinal medicine more precise. The robot combines off-the-shelf hardware used in structural engineering that has been modified by University professors or grad students. Proprietary software drives the system. Since its development, the robot has been used frequently to study the performance potential of artificial spinal discs.
At a recent appointment with my ophthalmologist, the topic turned to electronic medical records. Turns out my physician was familiar with my journalistic efforts—maybe he recognized me by my picture (which suggests my glasses need updating). He practices in a large faculty group that is affiliated with an academic medical center. The physician group began its EMR journey several years ago and has been deploying new software on a specialty-by-specialty basis.
Although brief, our conversation quickly focused on one of the key obstacles facing physicians as they convert to EMRs. Medicine is so highly specialized that having a one-size-fits-all documentation template is all but impossible. As my doctor explained, ophthalmologists like to document conditions using schematic diagrams of the eye. They also track a variety of measures on eye performance that would be all but alien to other physicians. Thus, his department had not rushed to deploy the EMR, as the department was waiting for its modules to be updated.
My physician is no stranger to technology. He has helped pioneer the use of lasers in corrective eye surgery, and the practice has built up a following for the high-end procedure. Maybe that explains why he volunteered to be the physician guinea pig for the department’s roll-out of the EMR. In the exam room, he showed me a flat-screen monitor, enthusiastically describing how having patient data available during the visit would beat having to rely on a dog-eared paper record.
When it comes to clinical documentation, physicians are not as averse to modern technology as they are sometimes reputed to be. They do, however, have legitimate concerns about how digital recordkeeping will mesh with their specialty. I have talked to many a multispecialty group practice that has made documentation flexibility the cornerstone of their EMR vendor search. They want to see some templates in action—or at least know that their software is pliable enough to fulfill their needs.
That can be a tall order. Just think about the respective worlds of, say, a pediatrician, an orthopedic surgeon, and a gastroenterologist. When they need new glasses, they all go to the eye doctor. But when they need an EMR, it’s another story.
P.S. Thanks to all the many readers who responded to my recent columns. I will print a few of the best letters next week.
With growing support from lawmakers, doctors are prodding the medical device industry to design equipment so that it is suitable for use on children. President Bush signed a law in September 2007 that offers financial incentives to companies that design devices for children, and gives regulators more power to scrutinize the use of adult-size devices in children. The profit potential for the device companies is limited, however, because the law allows experimental kid-size devices to be sold without full federal approval only if they're used to treat rare diseases. Also, kids are healthier than adults and as a result a much smaller market to begin with.