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| News and Notes |
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REPROCESSED SINGLE-USE MEDICAL DEVICES don't seem to present a greater health risk than first-use devices, according to a report by the Government Accountability Office. According to the GAO, the FDA found that only 65 of the 320,000 adverse effects reports it received between 2003 and 2006 cited a reprocessed device as the suspected cause. The types of events reported, it says, were consistent with what was reported from unused devices. The report also notes that the FDA did not conduct rigorous testing to determine the safety of these devices but, given the small rate of reported events, decided such research would not be an efficient use of resources.
MEDICAL MANUFACTURER CARDINAL HEALTH has announced its acquisition of Enturia, the privately held, Leawood, Kans.-based maker of Chloraprep brand chlorhexidine skin prep applicators, for $490 million. Dublin, Ohio-based Cardinal says the deal will let it expand Chloraprep into foreign markets.
THE "DONDA WEST LAW" would require a patient undergoing elective surgery in California to receive a physical exam before undergoing the procedure. State Assemblywoman Wilmer Amina Carter, a Democrat from Rialto, says such a precaution would ensure that the patient is healthy enough to endure the rigors of general anesthesia. Donda West, 58, the mother of rapper Kanye West, died Nov. 10 at a Los Angeles hospital one day after undergoing breast reduction surgery, a tummy tuck and liposuction.
MEDICAL GROUPS THAT HAVE SEEN THE GREATEST SUCCESS in recent years are more likely than most groups to have instituted formal patient safety protocols; invested in the practice's equipment, facilities and services; implemented electronic medical records and employed automated telephone appointment-reminder systems, according to the Englewood, Colo.-based healthcare research firm Medical Group Management Association, which identified those common qualities in the "better-performing" organizations listed in its annual "Performances and Practices of Successful Medical Groups" report, issued on Feb. 28. |
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| Do Patients Understand What They're Consenting To? |
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It is not unusual for patients to lack a full understanding of the informed consent form they've just signed, even when a healthcare provider discusses the form's details with them, according to a study presented at the American Academy of Orthopedic Surgeons' annual meeting in San Francisco last week.
The study involved 45 patients who were undergoing elective orthopedic surgery. A physician's assistant supplied them with a standardized consent form and spent between 10 and 20 minutes reading the form aloud and explaining its points to the patient. After the patient signed the form, they were given a questionnaire to assess their recollection of its details.
The researchers found that, on average, the patients answered 71.5 percent of the 24 questions correctly. What's more, by their first and second post-operative visits (one to two weeks and one to two months after surgery, respectively), the average recall rate had dropped to about 60 percent.
"[T]he stress of upcoming surgery will certainly have an effect on a patient's comprehension," says Allison E. Crepeau, MD, an orthopedic resident at the State University of New York, Stony Brook, and the study's lead author. But she also notes that patient age and education level seem to play a role. Patients aged 50 years and older answered fewer questions correctly than those younger than 50. Patients with an eighth-grade education scored the lowest on the questionnaire, while the recall rate increased in relation to education level.
"Informed consent has been shown to be an important protection for both the patient and the physician, ensuring that patients undergoing surgery fully grasp the entire process," says Dr. Crepeau in a statement. "Both physicians and patients need to take responsibility by asking questions and openly communicating to help ensure a good result."
David Bernard |
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| Physician-owned Hospitals Brace for Another Attack |
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Physician-owned hospitals are once again under attack, this time by a U.S. House of Representatives bill passed last week that would ban Medicare and Medicaid payments to hospitals with physician ownership of 40 percent or greater. The bill would also prohibit those hospitals from increasing the number of operating rooms or hospital beds in their facilities from the date the law is enacted.
This latest attack on physician-owned hospitals was tucked inside a mental health parity bill (HR 1424) that would require benefits equity for mental health and substance-related disorders under group health plans, and which also prohibits genetic discrimination with respect to employer health insurance. The ban on specialty hospitals would provide $2 billion in funds for the mental health bill over the next 10 years, according to an estimate by the Congressional Budget Office.
"The purpose of the bill is noble, but to use us as a pay-for on it is absolutely ridiculous," says Molly Sandvig, JD, executive director of the Physician Hospitals of America.
By Ms. Sandvig's count, this is the sixth major attack on physician-owned hospitals since 2002. "One a year," she says with a laugh. "I've got a whole PowerPoint presentation. I think we've been in worse shape." For three years, from 2003 until 2006, a moratorium effectively banned new specialty hospitals.
The House bill would also:
restrict physicians' hospital ownership, barring any individual doctor from owning more than 2 percent of an existing hospital and limiting total physician ownership to 40 percent;
eliminate conflicts of interest by mandating the disclosure of ownership status to patients; and
require hospitals to submit annual reports that detail the identity of each physician-owner and any other owners of the hospital.
There are slightly more than 200 physician-owned hospitals in the United States. Critics of doctor-owned hospitals say the doctors' ownership interests give them an incentive to refer patients to their own facility and unnecessarily increase volume, says a fact sheet on the bill.
Ms. Sandvig is hoping that the Senate's version of the mental health parity bill, which would postpone for six months any congressional consideration of changes to physician-owned hospitals' funding, is the version that is adopted for the final legislation.
"The fact that the Senate package has had such strong support from the start bodes well for us," she says. "We're going to be continually facing challenges. Any hospital that's set to open isn't in the best shape, obviously."
Dan O'Connor |
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| Nevada Endoscopy Clinics Closed For Unsafe Practices |
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Authorities shut down the Endoscopy Center of Southern Nevada in Las Vegas, along with five affiliated centers, after an investigation into the cases of six patients - each of whom contracted hepatitis C following procedures that took place at the center on the same day - led to the discovery that the center had reused syringes, single-use vials of anesthesia and scope-cleaning solution, according to the Las Vegas Review-Journal.
The Southern Nevada Health District has notified 40,000 of the centers' patients that they may have been exposed to hepatitis C as well as hepatitis B and HIV, while the Nevada Bureau of Licensure and Certification fined the Endoscopy Center of Southern Nevada $1,000 for each of the following infractions:
Failure by administrators to ensure that staff had reviewed written policies for correctly administering single-dose anesthesia medication, the correct method of instrument reprocessing and the proper method of biopsy instrument disposal;
Failure by administrators to evaluate and revise policies and procedures related to anesthesia administration; and
Failure to ensure that anesthesia was administered by a licensed provider.
Dipak Desai, MD, the center's majority owner, has voluntarily agreed to cease practicing medicine and five of the facility's nurses have surrendered their licenses in the wake of the investigation. Dr. Desai issued a statement on Feb. 28, explaining that the clinic has changed its practices, and bought a full page of advertising space in the March 2 Review-Journal for an open letter in which he offered his sympathy to patients and their families and defended his center's practices.
According to published reports, the FBI and the IRS are also investigating Dr. Desai under allegations of Medicare fraud. A physician formerly employed at the clinic told the Review-Journal that Dr. Desai often ordered unnecessary biopsies, while one of the facility's nurses told the Las Vegas Sun that Dr. Desai routinely billed for 30 minutes of anesthesia even though no procedure took longer than 15 minutes.
In response to this incident, the Nevada Department of Health and Human Services has announced plans to inspect each of the state's 50 ASCs, while the Bureau of Licensure and Certification has released new regulations calling for facilities to increase infection control and drug administration safety. In addition, the Centers for Disease Control and Prevention are offering a fact sheet on syringe reuse.
Nathan Hall |
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