Posted by: Salvatore J. Zambri, founding member and partner
According to a recent investigative study by the Center for Public Integrity, a nonprofit organization that focuses on ethics and public service, contaminated surgical instruments are creating additional worries for surgeons and their patients. Surgical tools are supposed to be cleaned and sterilized between operations, and manufacturers of those tools are supposed to provide detailed instructions for the cleaning process. A big part of the problem is that cleaning technicians are not required to obtain any certification at all to clean and sterilize instruments. By comparison, manicurists and dog groomers are required to take infection control courses for licensing. Another part of the problem is that manufacturers are not required to design devices that can be easily cleaned in real world environments. The end result is that instruments frequently come into the operating room carrying bits of blood, bone and tissue from a previous operation, as well as potentially dangerous and sometimes deadly bacteria. Earlier instruments were primarily made of metal or glass, both of which can withstand high temperatures required for sterilization. Newer high-tech devices cannot withstand that level of heat and must be cleaned.
Hospital-acquired infections continue to be problematic because of the difficulty in tracking them and the challenges of thoroughly cleaning reusable medical devices. During a workshop held last summer by the FDA, representatives from manufacturers, hospitals, CDC and FDA, a presentation by Jahan Aziz, a major hospital’s risk management clinical engineer, demonstrated how prevalent the problem is. After showing the group 350 surgery-ready suction tips, which were cleaned by the recommended method, he revealed that 343 of them contained debris from earlier procedures. According to Charles Hancock, an independent medical device sterilization consultant, the supply of dirty devices in hospitals is potentially massive due to the design of the instruments, the lack of training for cleaning technicians, and the frantic pace of the instrument sterilization process.
The FDA is working on creating a draft recommendation for reprocessing of medical devices as well as suggestions for manufacturers’ development of more robust instructions for reprocessing for the real world hospital market. In addition, the draft is intended to serve as a guide for device manufacturers as they seek FDA clearance for new devices.
As this story develops and more information is available from the FDA reviews and recommendations, we will revisit the topic and post another blog entry.
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About the author:
Mr. Zambri is a Board-Certified Civil Trial Attorney and Past-President of the Trial Lawyers Association of Metropolitan Washington, D.C. The association has recently named him the ” 2011 Trial Lawyer of the Year“. He has also been acknowledged by Washingtonian magazine as a “Big Gun” and among the “top 1%” of all of the more than 80,000 lawyers in the Washington metropolitan area. The magazine also acknowledged him as “one of Washington’s best–most honest and effective lawyers” who specializes in medical malpractice matters, product liability claims, and serious automobile accident claims. Mr. Zambri was recently (2011 edition) acknowledged as one of the “Best Lawyers in America” by Best Lawyers, and has also been repeatedly named a “Super Lawyer” by Law and Politics magazine (2011)–a national publication that honors the top lawyers in the country.
Mr. Zambri is regularly asked to present seminars to lawyers and doctors, as well as both medical and law students concerning defective drugs, medication errors, medical malpractice litigation, and safety improvements.
If you have any questions about your legal rights, please email Mr. Zambri at [email protected] You may also reach him at 202-822-1899.