By Joe Messa
The Food and Drug Administration held a two-day workshop last summer to address concerns regarding dirty medical devices. During the meeting, device manufacturers and hospital representatives met with officials from the CDC (Centers for Disease Control and Prevention) and FDA to detail the challenges of thoroughly cleaning complex but reusable medical devices between procedures.
Surgical instruments have become smaller and more complex, with moving parts, tiny holes, and long narrow channels running the length of the implements, making them harder to clean. Tiny parts of the surgical instruments can become clogged with human tissue and blood not visible to the naked eye. In cases where surgical instruments are made of materials like rubber and do not heat all the way through, steam sterilization sometimes does not work which creates additional challenges for sterilizing the instruments.
In 2009, a Texas man and at least seven other joint surgery patients at Methodist Hospital in Houston who acquired dangerous infections following their surgeries. The reports led the FDA to begin a safety review of arthroscopic shavers, a medical device used in joint surgeries that is prone to retain tissue between patients.
John Harrison of Mission, Texas, had a routine surgery to repair the rotator cuff in his right shoulder. A few weeks after the surgery his scar had become infected and required an emergency checkup. When surgeons opened up Harrison’s shoulder, they found that an infection had eaten away part of his shoulder bone and rotator cuff, screws and metal hardware placed in his shoulder had pulled loose and sutures had come undone. Although the infection was treated, Harrison required additional in home care for months and was unable to work while he recovered.
Following the outbreak, Methodist closed its operating rooms and cancelled knee and shoulder surgeries as Centers for Disease Control and Prevention investigators looked for the cause. The investigations pointed to two main surgical instruments and medical devices that were not properly cleaned— cannulas and arthroscopic shavers. In 2011, Harrison filed a lawsuit against Methodist Hospital and the manufacturer
of the arthroscopic shaver, Stryker.
Methodist Hospital says it followed Stryker’s instructions on cleaning the medical devices and even brought in Stryker representatives to show them how the device was retaining tissue, even after it was cleaned according to the manufacturer’s instructions.
As a part of the FDA’s safety review, arthroscopic shaver manufacturers were asked to investigate how well their shavers were being cleaned at health care institutions. In addition to Stryker, Massachusetts-based arthroscopic shaver manufacturer, Smith & Nephew, inspected 72 shavers at eight hospitals and surgery centers. The company revealed that all but three of the 72 devices contained “residuals” after cleaning by hospital staff.
Stryker declined to release the results of the arthroscopic shaver study it performed at the request of the FDA, but said the company’s results were similar to Smith and Nephew’s. In October 2009, five months after the infection outbreak at Methodist, Stryker more detailed cleaning instructions for their arthroscopic shavers. The process included ten steps— with a final step that recommends cleaning staff use a digital scope to visually inspect the insides of the handpiece.
The Philadelphia medical malpractice lawyers at Messa & Associates are experienced at handling cases involving medical malpractice resulting from infections as a result of dirty surgical instruments or medical devices. Our extremely skilled team of Philadelphia medical malpractice lawyers and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you or a loved one has suffered personal injuries as a result of surgical instruments or medical devices that were not properly cleaned, or any other type of negligent care received by a medical provider, contact the medical malpractice lawyers of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
Joseph L. Messa, Jr. is the founding partner of Messa & Associates, P.C. He is an AV-rated attorney (highest rating available), listed in the Bar Register of Preeminent Lawyers. Read More