Bullying has caught the CDC's attention because of its strong association with suicide, and the agency is now talking up the need for interventions. Also this week: more reliable flu and TB tests.
CDC Joins Anti-Bullying Effort
Citing links between bullying and suicide, the CDC now considers bullying a public health problem and is promoting efforts to fight it.
The agency convened an expert panel to produce a special issue of the , published last week. A total of 10 articles address different aspects of the topic, including risk factors for bullying (both the conventional schoolyard forms as well as "cyberbullying") and the effectiveness of anti-bullying interventions. But most of the papers dealt with suicidality: risk factors, exacerbators, and outcomes.
An introductory editorial by researchers from the CDC and the federal Substance Abuse and Mental Health Administration noted that much is still unknown about the roots of bullying as well as the best methods to prevent it and its sometimes fatal consequences.
Still, they argued, "stakeholders in education and health should consider broadening their focus beyond just providing services to those who are already involved in bullying or suicide-related behaviors, but also in implementing strategies to prevent bullying and suicidal behavior from occurring in the first place."
FDA Seeks to Boost Reliability of TB, Flu Tests
An FDA advisory committee has told the agency that it should stiffen requirements for diagnostic tests for the flu, and FDA also hopes to foster development of more reliable tuberculosis (TB) tests.
At a meeting earlier this month, the agency's Microbiology Devices advisory panel voted unanimously in favor of reclassifying flu tests from the current Class I, the least rigorous, to Class II with "special controls." If adopted by the FDA, as is likely, manufacturers of flu diagnostics would have to submit more data demonstrating the tests' reliability than is currently required.
Separately, the FDA issued a draft guideline for new TB tests that detect mycobacterial DNA in respiratory specimens.
Currently, TB is based either on serology, which cannot distinguish between previous exposures and current infection, and on culture-based methods that may take weeks to yield results. Nucleic acid tests offer the promise of near-instant results that clearly indicate the presence of active infection.
The new guideline, which the FDA will formalize after receiving comments from industry and the public, spells out the standards that manufacturers should meet in designing and evaluating such tests. They will be reviewed under the same regulatory category as the advisory recommended for flu tests: Class II with special controls.
FDA Warns on Device 'Cybersecurity'
In light of the large and growing number of medical devices that rely on wireless communication technology, the FDA told manufacturers and healthcare facilities last week to pay attention to the potential for malevolent tampering by hackers and others.
"Recently, the FDA has become aware of cybersecurity vulnerabilities and incidents that could directly impact medical devices or hospital network operations," the agency said.
Although no patient injuries had occurred of which the FDA was aware, it said that the "vulnerabilities and incidents" included so-called malware on network-connected medical devices and hospital computers.
The agency also said it had found instances of poor password practices and failure to install software security patches and upgrades in systems with known vulnerabilities.
The FDA instructed hospitals and other healthcare facilities to take computer security seriously by monitoring network activity for unauthorized use, keeping up with antivirus software and firewalls, and controlling access to hospital computer systems and networked devices.
Product Recalls:
The following recalls were announced by the FDA:
, because of complaints about cuff leak or deflation when the inflation valve cap is removed incorrectly in certain lots.
, because a software malfunction can prevent alarms from sounding when hardware components fail.
, because the dilator may be prone to breakage during use.
In each case, the manufacturer or distributor has sought to notify customers by letter of the recall and has provided instructions for replacement or repair.
Tagging the Wandering Patient
A British psychiatrist recommended use of GPS technology to keep track of dementia patients with a tendency to wander.
Writing in BMJ, Rupert McShane, MD, of the Oxford Health NHS Foundation Trust in England, said that such patients should wear small, GPS-enabled locators that would allow their caregivers to find them quickly if they disappear.
He cited a previous study indicating that 40% of dementia patients get lost at some point, and other research suggesting high rates of serious illness and death among those who stay lost for more than a day.
McShane also acknowledged difficulties with the proposal, such as its likely stigmatizing effect as well as practical problems with GPS technology and identifying the patients most in need of such help.