Gossypiboma
Gossypiboma is the technical term for a surgical sponge accidentally left inside a patient's body. It is derived from the Latin "gossypium" (cotton) and the Swahili "boma" (place of concealment).
Actual occurrences are difficult to come by since nearly all cases are settled out of court. Statistical studies by researchers however put the number of occurrences between 3,000 and 5,000 cases a year.
Sponges are counted by hand before and after surgeries. This method was codified into recommended guidelines in the 1970's by the A.O.R.N.
Computerized Solutions
No significant and successful advancements had been made in the field until late 20th century.
The first break through came in 1997 when an UCLA MBA student and his urologist father co-developed and patented a turn-key system that would require the adherence of special labels at the manufacturing level to the sponges a hospital uses. These sponges then could easily be read by a handheld scanner while the nursing staff followed their established sponge counting protocols and procedures, much like at a grocery store checkout counter.
Since each item has a unique code, the system will assist the nurse in keeping an accurate count by not letting the same sponge be counted twice accidentally. Ohio University's Center For Auto Identification recent studies had compelling results: data matrix tags had at worst a 1 in 10 million scan error rate and at best a 1 in 612 million scan error rate.
After sustained testing, development, and studies while operating under an FDA exemption, the developer, SurgiCount Medical, received 510(k) clearance by the FDA for the system in March of 2006 to commercially roll out the system. Currently the Safety Sponge System is the only FDA approved system and is the only system that is market ready.
Radio Frequency Identification Technology
In 2004, Gautam Gandhi and Steve Fleck, MBA students from Carnegie Mellon won several national business plan competitions for ClearCount Medical Solutions. RFID technology is used instead of the line-of-sight approach to lost sponges. RFID is an appealing concept because it requires just waving a wand over an area to communicate wirelessly with a tag. The company obtained FDA clearance in 2007.
The Future
Using the high of the range (5,000) of retained sponges per year with the 30 million relevant surgeries per annum, an accuracy rate of 99.98% is the norm of hospitals.