As a private scrub nurse for a general surgeon, Sharon Smith noticed a loss in operating room productivity due to time spent manually setting up and breaking down major instrument kits for surgery.
|A newly commercialized instrument tray improves operating room productivity.|
Set up involves lining a sterile back table with towels, de-stringing ringed instruments onto another tightly rolled towel and finally, gathering and organizing the forceps, knife handles, scissors, retractors and other loose instruments. This process can take up to 15 minutes.
In 1995, she invented a device for a general instrument kit that would come from a sterile processing department, all set up with complete instrumentation ready to use. Predetermined placeholders for relocation of instruments improve the speed and accuracy of the initial and final count.
In 2002 she was awarded a patent for her invention.
Last June her invention received 501(k) clearance from the Office of Device Evaluation at the U.S. Food and Drug Administration. A medical device startup in Acton, Massachusetts called MacPherson Medical has been developing the tray. "Stat-Mat is a unique solution for operating room personnel, delivering improved productivity and significant economic benefits," says Brad MacPherson, CEO of MacPherson Medical.
The Stat-Mat Minor surgical tray consists of three primary components: a base, cover, and instrument roll. The base and cover are made of Radel polyphenylsulfone (PPSU) resin from Solvay Specialty Polymers (Alpharetta, GA), which meets the requirements for biocompatibility set by ISO-10993 and is compatible with standard steam sterilization methods. The instrument roll is made of aluminum and is used to keep ringed instruments open during sterilization.
MacPherson says that PPSU was selected over metal because of its durability, light weight, easy formability, and sterilizability. The instrument roll and special pockets and holders make sure that instruments stay in place and avoid damage. This eliminates jumbled piles of instruments and ensures fast and accurate instrument counts, according to MacPherson.
The surgical tray weighs about 14 pounds (6 kg) with full instrumentation. The PPSU withstands repeated disinfection and autoclaving-more than 1000 cycles-while maintaining its toughness and impact resistance.
Both the opaque base and transparent cover are thermoformed by Symmetry Medical (Manchester, NH). MacPherson Medical is also considering the use of PPSU for other products in the Stat-Mat line.
Solvay Specialty polymers was recently formed from the Solvay Advanced Polymers, Solvay Solexis and Solvay Padanaplast companies along with the Solvin PVDC product line. In June, the company announced a major expansion in the healthcare market, including a 50% increase in staffing for sales, marketing, and technology functions in the U.S. and Europe. Plans for further expansion in Asia-Pacific are also underway.