Scalpel Weekly News

Week of: March 07, 2016

IN THE NEWS


1,000 Reports to FDA on Skull Clamp Slippage Injuries

On February 25, 2016, the FDA reported that from January 2009 to January 2016 it had received more than 1,000 medical device reports (MDRs) associated with the slippage or movement of a skull clamp before and/or during surgical procedures, resulting in more than 700 injuries. These reports describe unintended patient movement during surgical procedures that resulted in injuries including skull fractures, facial injuries (bruises and cuts), deep cuts (lacerations), and blood clots (hematoma). Click title to continue reading...


 
MEDICAL ALERTS


Consent Decree with Florida Dietary Supplement Distributor; Herpes Treatment

On February 26, 2016, the FDA announced that a Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. The complaint, filed by the U.S. Department of Justice on behalf of the FDA, sought a permanent injunction against the Florida resident, doing business as Viruxo LLC, a distributor of dietary supplements, for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge for his intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims. Click title to continue reading...



FDA Alerts Hospitals to Stop Using Custom Ultrasonics Endoscope Reprocessors

In a Safety Alert issued February 23, 2016, the FDA revised its November 2015 Safety Communication to provide updated information about its communications with Custom Ultrasonics of Ivyland, PA, regarding its November 2015 Recall Order. The FDA’s most recent inspection of the Custom Ultrasonics’ facility in April 2015 documented continued violations. Violations include the inability to validate that the automated endoscope reprocessors (AERs) can adequately wash and disinfect endoscopes to mitigate the risk of patient infection. Click title to continue reading...



New CDC Test for Zika Authorized by FDA for Emergency Use

In response to a request from the CDC, the FDA issued, on February 26, 2016, an Emergency Use Authorization (EUA) for a diagnostic tool for Zika virus that will be distributed to qualified laboratories and, in the United States, those that are certified to perform high-complexity tests. Click title to continue reading...


  CASE ALERTS


Psychiatrist Disclosure of Man's Diagnosis to Wife; Not Malpractice Claim

A man sought treatment from a psychiatrist for several years for anxiety and depression, during the course of which the psychiatrist concluded that the man suffered from borderline personality disorder (BPD), although the psychiatrist did not share that diagnosis with the man. The man’s wife at the time also engaged the psychiatrist’s services, although only for purposes of managing her medications. The psychiatrist referred the couple to a separate practitioner for marriage counseling. Click title to continue reading...



Podiatrist Performed Surgery Improperly on Woman’s Foot

A woman suffered from pain in her right heel. She saw a podiatrist who took x-rays of her feet and informed her she had a bunion, hammer toes, and a problem with her ankle. Specifically, the podiatrist diagnosed her with (1) hallux abductovalgus deformity (bunion deformity), (2) talipes valgus, (3) plantar fasciitis, and (4) hammer toe deformities in the fourth and fifth toes. The podiatrist told her surgery was the only way to correct all these problems and it would be better to take care of everything at once. The podiatrist did not discuss other forms of treatment. Click title to continue reading...



Man with Hypersomnia Incapable of Any Full-Time Employment

A man suffered from pain in his back that radiated to his legs. He had a herniated disk and mild arthritis in the lumbar region of his spine (his lower back). The symptoms worsened. His doctor treated him for back pain, joint and leg pain, and hypersomnia (excessive daytime drowsiness) caused, it was later discovered, either by a neurological disorder called narcolepsy or more likely by severe obstructive sleep apnea, which causes a patient’s breathing to stop and start repeatedly while the patient is asleep. Click title to continue reading...


FEATURE


Social Security-Sleep Disorder

As a special feature to our Premium subscribers we have included this feature containing an illustrative Medical Statement for a Social Security disability claim involving a sleep disorder. Click title to continue reading...