Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
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Wednesday, June 20, 2012

AHLA announced guidelines for apology, compensation of AE victims.

How to apologize for adverse events
American Health Lawyers Association released guidelines on honest disclosure
June 15, 2012 | By Karen M. Cheung  FierceHealthCare
American Health Lawyers Association (AHLA) this week released guidelines for providers on disclosing serious clinical adverse events.
"In analyzing disclosures of information in connection with SCAEs, there are regulatory and legal considerations regardless of the type of incident," Elisabeth Belmont of MaineHealth, AHLA public interest committee task force chair, said in an announcement Wednesday.

AHLA noted that the process is multi-faceted and requires careful planning and coordination of administration and clinicians with the organization. Regardless if the adverse event came from system failures or human errors, hospitals should offer timely and honest communication with empathy to the patient and the family, AHLA noted.

In Massachusetts, Beth Israel Deaconess Medical Center, Massachusetts General Hospital and Baystate Health are testing liability reform with a "disclosure, apology and offer" program, in which legal action is a last resort. The process promotes transparency, in which the hospital investigates and explains why an adverse event occurred and establishes systems to improve patient safety and reporting. When appropriate, the hospital apologizes and offers fair financial compensation without the patient having to resort to legal action.

The honest, transparent approach to adverse events is exemplified in a very public, still-discussed apology. President and CEO Sandra Coletta of Rhode Island's Kent Hospital was hailed for doing the right thing by apologizing for the death of actor James Woods's brother, Michael. In 2006, Michael Woods died of a heart attack, waiting in the emergency room. The hospital attributed the death to both human errors and poorly designed space.
"Quite honestly, I did nothing other than what my mother taught me," Coletta previously said about the apology process. "I think all too often in healthcare, we evaluate, and we are counseled, and we read books upon books. But, sometimes, you just have to go back to your core value.

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