RFID-based systems attempt to both count and detect. Sponges contain a dime sized RFID chip. At the beginning of a count, sterile products are placed on top of a RFID interrogator to scan items in. Systems have a large built-in bucket receptacle to place sponges in / scan them out.

Besides the significant interference issues raised in the JAMA study, there are many flaws in an RFID-based approach:

1.    The cost of the system is high
   
   
   1. Counting machines cost between $15,0000-$20,000 each The additional per procedure cost of sponges is between $40-$65 Hospitals are faced with either purchasing a machine for every single OR (including infrequently used rooms like Cisto and backups) or having two differing sponge counting protocols (RFID and non-RFID) and two differing sponge suppliers (RFID and non-RFID)

   
   
2.    Lack of standardized protocols/patient profiling
   
   
   1. Studies also prove that there is no profile of whom retained items can happen to. Any adjunct technology must be used on all patients, not a selected percentage of patients.

   
   
3.    Cannot be used in certain procedures
   
   
   1. The RFID chips are too large to fit through trocars and other laparoscopic equipment.
   2. Hospitals are required to maintain two sets of surgical sponge inventories and have two sets of sponge counting
      protocols depending only on what type of sponge is used during that procedure. AORN, Joint Commission,
      and FDA recommended practices call for one uniform protocol.
   3. Sponges that come in custom kits are not readable through the kit itself. The RFID machine must be wrapped and
      covered every procedure and the sponges brought out to the machine from the sterile field.

   
   
4.    RFID instruments are very unlikely to happen
   
   
   RFID-based system sellers are not manufacturers but systems integrators of other companies' technologies. The RFID-based system companies do not manufacture the RFID chips, the sponges, or the RFID interrogators (readers) that power their machine. Their claims for being able to sell RFID instruments are incredulous based on:
   
   

   1. They are not in the RFID chip manufacturing/designing business
   2. The instrument business is highly fragmented and specialized
   3. Hospitals often have half a dozen different brands of similar instruments in their OR's and kits by request of surgeons
   4. Most instruments (sharps, scalpels, scissors, etc.) are two small to have a chip attached. This would mean introducing two instrument counting protocols -with and without RFID instruments
   5. The RFID-based machines' methodology of counting out is by throwing items into the bucket. This is an unlikely method to want to use to count out reusable instruments since they have to be retrieved from the bucket after counting.

   
   
5.    Lack of proof to claims
   
   
   1. a. RFID-based manufacturers do not substantiate the claims on their brochure and websites that their technology is “proven” by offering any documentation or study either of the accuracy and effectiveness of the Smart-Sponge System or of the base science behind the technology. They just say it is proven.
   2. Self-rationalization that there is “proof” by way of RFID deployment in other industries is not comparable. A clothing retailer may be happy with 95% accuracy in return for the ability to reduce inventory-taking staff headcount by three people per store. That clothing store however does not have morbidity issues when a t-shirt goes missing because of the 5% error rate.
   3. In 2006, a non-formal and simple clinical evaluation sponsored by ClearCount Medical was published in the Archives of Surgery. While the results of the non-real, 8 patient and 28 sponge evaluation were positive, the author concluded: "Despite this engineering success, the possibility of human error and retained sponges remains because handheld scanning can be performed incorrectly." Please click here for a more detailed explanation of this misunderstood study. ClearCount does not sell the prototype that was reviewed in the evaluation and this evaluation should not be misconstrued as supporting the Smart-Sponge System.

   
   
6.    Technological issues
   
   
   1. Radio frequency technologies have clear, undeniable and well documented problems being able to transmit through liquids and metals, let alone the different densities found within a human being. False negatives scans are possible.
   2. As the recent JAMA article discussed, radio frequency devices can very easily interfere with other vital pieces of equipment in the OR such as ventilators and pacemakers
   3. The FDA and CDRH has reported tests of their own as interfering with equipment and pacemakers.
   4. RF frequencies from other products (car keys, door passes, pacemakers) can cause false positives reads
   5. Tags can fail/become inert and not be discoverable

   
   
7.    The machines are very large
   
   
   1. Each machine is the size of a washing machine. While each does have rollers, the machines take up a very large footprint for a machine whose only function is counting sponges and require to be plugged into a wall outlet.

   
   
8.    User error remains
   
   
   1. User error completely remains with wanding patients in regards to the distance held  over a patient, speed of moving the wand.

   
   
9.    No documentation of sponges
   
   
   1. No electronic records exist
   2. No sponge information is saved for record keeping
   3. No possibility to examine reports electronically at  a later time