Medical Devices Need More Monitoring to Avoid Patient Harm

With little effective post-market monitoring of medical devices, patients are being harmed by faculty devices.

Dr. Kevin Kavanagh, board chairman of Health Watch USA, an organization whose mission is to “promote health care transparency, competition and patient advocacy,” writes in the Lincoln Herald-Leader (Kentucky.com) that patients are often “sacrificial lambs” to the medical device industry, harmed by the devices that are supposed to treat them and maintain or improve quality of life.

In an op-ed piece for the Herald-Leader, Dr. Kavanagh offers examples of harmful devices. He writes about the power morcellator, a surgical tool that enables hysterectomies to be performed through a small incision. But the morcellator, which cuts tissue into tiny pieces that can be removed through the incision, has been found to spread cancer in a patient’s abdomen. Kavanagh also notes the high failure rates for metal-on-metal-hip implants and the cases of metal poisoning they cause. He warns about medical endoscopes that can spread antibiotic-resistant bacteria; and safety problems with vaginal mesh implants to treat pelvic organ prolapse and stress urinary incontinence. “These devices and others have been implanted in hundreds of thousands of people and have caused harm and death in untold numbers,” Kavanagh writes.

No agency is effectively monitoring what happens after devices are implanted in patients, and a “safety feedback loop” to spur device improvement and safeguard patients, is all but lacking, according to Kavanagh. The House of Representatives recently passed the 21st Century Cures Act, but instead of strengthening medical device oversight, Kavanagh says the act further weakens device-testing requirements.

Kavanagh warns patients that the benefits of many implants are overstated while the risks are underestimated. Before undergoing an implant procedure the patient should ask:

• What is the implant’s failure rate?
• How does the tissue react around the implant?
• If the implant fails can it be taken out?

In addition to asking these questions, Kavanagh says patients should check the rates of MRSA (Methicillin-resistant Staphylococcus aureus) and C. Difficile infections at their hospital. This information is available on Hospital Compare (https://www.medicare.gov/hospitalcompare/). Patients having a hip or knee implant or a lumbar or cervical spine fusion should check the surgeon’s complication rates on ProPublica’s Surgeon Scorecard web site: https://projects.propublica.org/surgeons/. After surgery, the patient should keep all follow-up appointments and have recommended testing to be sure the device is functioning correctly and not causing unwanted side effects.

A report from Johns Hopkins published in the Journal of Patient Safety says that over half of all medical hospital inpatients had an implant. “Almost everyone has a stake in health-care policy regarding implants,” according to Kavanagh’s Herald-Leader piece. “We all need to encourage Congress to amend the 21st Century Cures Act to assure effective pre-market testing and post-market monitoring of medical devices

 

 

 

 

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