CT Center for Patient Safety Newsletter
February 2012
senator blumenthal 
Senator Blumenthal finds his consumer voice in Washington 
Senator Blumenthal and activist Carolyn Sires   U.S. Sen. Richard Blumenthal has joined two other senators introducing legislation designed to protect patients from unsafe medical devices without derailing the current fast-tracking system of medical device approvals. 

Called the Medical Device Patient Safety Act, the proposal would mandate that the Food and Drug Administration (FDA) track recalled medical devices and better manage recalls when problems occur, said Blumenthal, a Democrat.

"Patients will be better protected," Blumenthal said Wednesday. "This idea is common sense and it fixes a badly broken system."

Under the current system of bringing new medical devices to market, "96 percent are fast-tracked with virtually no clinical testing" if they are considered a modification of an existing medical device, Blumenthal said.

Faulty medical devices such as metal-on-metal hip implants, knee replacements and defibrillators have been subject to worldwide recalls, he said. When they fail, patients are left with debilitating pain.

Carolyn Sires, 49, a physical therapist and owner of Physicians Physical Therapy in West Haven, attended Blumenthal's press conference to support the proposed legislation because of her experience with a faulty hip implant, saying, "I have been a testing mechanism for this product."

After researching products and selecting one that she described as the best for active people, Sires, then 45, had her hip replaced with a metal-on-metal device in 2008. For a year afterward, she experienced fevers, infections, the inability to walk and a host of other ailments. She visited multiple doctors and underwent a battery of tests. Her doctors didn't realize her body was reacting to the metal-on-metal hip because they were unaware of other patients having similar problems from their new hips, she said.

The hip was recalled a year later, and when she had surgery to have it removed in 2009, her doctor said her muscles had been shredded. She has since had a third hip replacement, suffers chronic pain, takes multiple medications to fight infection, has to have fluid drained from her body every three months and, at 49, has been told she has the choice between her current condition or spending the rest of her life in a wheelchair.

Senator Blumenthal's legislation is sorely needed, said Jean Rexford, executive director of the Connecticut Center for Patient Safety. "I think we might be doing a better job of monitoring what we're putting in cars than what we're putting in people," she said, decrying the practice of putting 96 percent of new medical devices into the market without actually testing if they are substantially similar to existing products. There are currently no legal requirements for surgeons to notify anyone if their patients have an adverse reaction to a medical device, added Rexford.


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And as always, thank you for your financial support.
Dear Members.

On January 6, the Office of Inspector General released another report that should cause us all great concern.  The inspector general estimated that more than 130.000 Medicare beneficiaries experienced one or more adverse events in hospitals in a single month. 

Nearly all hospitals have some type of systems for employees to inform managers of adverse events - defined as significant harm experienced by patients as a result of medical care.  Federal investigators identified many unreported events by having independent doctors review records.  The report concluded "Even after hospitals investigate preventable injuried and infections that have been reported, they rarely change their practices to prevent repetition of the adverse events."

Harming patients should not be a cost of doing business.   From what I can see, in most cases, healthcare harm rarely  costs them nothing yet the patient and his or her family bears the onus of their error.  Where is the outcry from those who know that these events are happening in their hospitals without even changing their practices?  Where is the outcry from the public demanding transparency and accountability?

CT Center for Patient Safety, with your help, is determined to continue to grow our voice.


Transparency and Accountability Needed NOW!

Senator Grassley, Republican from Iowa,  has written to officials Connecticut asking what has been done about the ten doctors in the state who are over prescribing potentially dangerous medications.  Apparently, one doctor in our state in 2009 prescribed three times the amount of oxycontin as the second highest prescriber in the state.  A ProPublica investigation in Florida found that the state allowed at least three physicians to keep prescribing drugs to the poor amid clear signs of possible misconsduct.  One doctor kept prescribing narcotic pain pills to Medicaid patients for more than a year after he was arrested and charged in 2010 with trafficking.  That is Florida but is Connecticut any less opaque?  Where are the regulators?  How do we know what has happened?  How do we know anything? 

 The ProPublica website is a very rich source of interesting information.  I came across one doctor in Connecticut, Dr. Torres.  In 2010, Dr. Richard Torres accepted over $50,000 in compensation for speaking from five different drugs companies?  Do you think they know?  What is more important is that the public probably does not know.  Under every license the state issues, there should be a list of outside income that might influence prescribing patterns.


 It is almost like Dr. Torres  has two jobs!

SAVE THE DATE:  March 7, 2012
You are invited to hear

Helen Haskell

Nationally Recognized Patient Safety Advocate

Founder, Mothers Against Medical Error

Wednesday, March 7, 2012; 1:00 - 3:00 p.m.

Saint Francis Hospital and Medical Center

Chawla Auditorium

Free parking available in Visitor Garage.

RSVP by March 5, to (877) 783-7262


In honor of National Patient Safety Awareness Week



Please join us to learn about patient safety in the context of today;s healthcare system and the role you can play as your own advocate.

Lisa Chedekel has done a remarkable job of putting

 Connecticut's adverse event reporting in context. 


There are no audits of the data. 

Errors are self reported and underreported. 

In 2010 there were more cases of wrong site surgery     than in any previous year! 


Read the full article and then go to the Department

of Public Health Website and read the now posted adverse

event report.


  We must demand greater transparency and accountability.  We want action NOW on ways to achieve full reporting of healthcare harm and medical error.



Hospital Errors Persist, State Probes Rare

The legislative sessnion begin February 6, 2012.  We will be providing updated information about initiatives in our upcoming newsletters.