Monday, July 02, 2012

Obamacare - Implantable Radiofrequency Transponder System for Patient Identification and Health Information

Guidance for Industry and FDA Staff
Class II Special Controls Guidance
Document: Implantable
Radiofrequency Transponder
System for Patient Identification
and Health Information

Table of Contents
1. BACKGROUND..................................................................................................................................................1
2. SCOPE..................................................................................................................................................................2
3. RISKS TO HEALTH ..........................................................................................................................................3
4. RECOMMENDED MITIGATION MEASURES ............................................................................................4
A. BIOCOMPATIBILITY ........................................................................................................................................4
B. INFORMATION SECURITY PROCEDURES (DESIGN AND VALIDATION)..............................................................4
C. SOFTWARE VALIDATION ................................................................................................................................5
D. MIGRATION TESTING OF IMPLANTED TRANSPONDER .....................................................................................5
E. PERFORMANCE TESTING OF IMPLANTED TRANSPONDER ................................................................................5
F. PERFORMANCE TESTING OF INSERTER............................................................................................................5
G. PERFORMANCE TESTING AND HAZARD ANALYSIS OF ELECTRONIC SCANNER ...............................................5
H. ELECTROMAGNETIC COMPATIBILITY..............................................................................................................5
I. ELECTRICAL SAFETY PERFORMANCE TESTING...............................................................................................5
J. STERILITY ......................................................................................................................................................6
K. MAGNETIC RESONANCE IMAGING COMPATIBILITY ........................................................................................6
L. LABELING.......................................................................................................................................................6
5. LIMITATIONS OF EXEMPTION FROM PREMARKET NOTIFICATION ............................................7
See for yourself fda.gov

Driver in diabetic shock killed by cops with pepper spray and Tasers

The widow of a Baltimore, Maryland man that died after being assaulted by cops and repeatedly stunned with Taser guns is hoping that a just-filed lawsuit will bring justice following the slaying of her husband.

Linda Johnson is seeking more than $10 million in punitive damages stemming from a May 27, 2010 run in with the law that left her husband, a 48-year-old, dead.

Carl D. Johnson was driving home from a Bible study class two years ago, his wife says, when he suffered a severe diabetic reaction. Several 911 calls were placed by automobile drivers who witnessed Johnson drive erratically on the shoulder of a Baltimore-area highway after he allegedly went into shock. When cops made it to the scene to investigate the incident, though, things took a turn for the worst.




Responding officers say Mr. Johnson did not cooperate with them as they approached his vehicle, but his wife writes in a court filing that things were different. According to the complaint, State Trooper Davon Parker arrived on the scene first, tapped on the window or Mr. Johnson’s car and then blasted the man with a burst of pepper-spray.

Still suffering from the diabetes-related episode, Johnson exited the car only to be clubbed at least once in the knee. Police accounts attest that Johnson tried to fight off the officers, but the just-filed lawsuit insists that a second officer then arrived and assaulted Johnson similarly with his own nightstick.

According to the complaint, Baltimore County Police Officer Nicholas Wolferman then arrived, struck Johnson “at least three times” with his baton and then, along with another officer, “grabbed Mr. Johnson and threw him over the guardrail.”

His widow says she believes five cops were present when Officer Andrew O’Neill fired his Taser gun at Johnson twice. Then, reads the complaint, another officer punched the man in the face before he was handcuffed.

By the end of altercation, 52 individuals in all were believed to be dispatched to the scene. More than a dozen were on the scene, says Mrs. Johnson, when cops removed the man’s wallet — which included a medical alert cart explaining his condition — as he laid dying on the ground.

Johnson then went into cardiac arrest and was pronounced dead an hour later.

More at endthelie.com

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