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.
Please share what you have learned!
Twitter: @JjrkCh

Sunday, July 22, 2012

Medical Errors

It is very disturbing yet essential that Robert M. Wachter, MD, Professor and Associate Chair of the Department of Medicine at the University of California, San Francisco and chief of the medical service at UCSF Medical Center must communicate to the public about the epidemic of hospital errors.
In addition to the lack of accountability of hospitals and an increase in errors at for-profit hospitals, there is a parallel in the medical device industry. Joint replacement is the #1 expenditure of Medicare, yet we learn of the devastating failure of metal-on-metal hips from foreign registries after tens of thousands of implants and revisions have taken place.
The FDA charter does not legally require surgeons to report device failures unless there is a fatality. 510(k) approvals allow untested devices to be implanted with no independent post-market follow up. Patient harm is not acknowledged and therefore the patient harm continues unabated. The industry gets more profitable and powerful and potentially more destructive of limited public healthcare funding.
The cries to protect industry jobs and threats that the industry will abandon the U.S. to profit overseas would not be necessary if the products were actually safe and effective, as advertised.
Excellent program.
Although it was mentioned how in some cases "mistakes" are made for the sake of profits, it was not said that many well intentioned health care providers cannot report these systems due to gagging clauses in their contracts.
Those who report issues to their upper levels many times face hostility and have to leave their jobs.
Is about time to lobby for legislation that protects "whistle blowers" on issues of safety and negligent practices. Including cancellation of "non compete" clauses on their contracts when they have to leave their jobs after reporting their institution/employer.
Listen to the program that prompted these responses:

No comments:

Post a Comment