Good morning.  May it please the committee.

I am Bruce Waxman, a Board certified orthopaedic surgeon and member of the Palm Beach Orthopaedic Institute, a thirteen person orthopaedic practice located  in West Palm Beach, Palm Beach Gardens and Jupiter, Florida.  I am also President of SURGICHIP, Incorporated and the inventor of SURGICHIP™.  I graduated from Columbia University Medical School in New York City; I received my orthopaedic surgery training at Harvard University in Boston, Massachusetts.  I served in the United States Air Force as Chief of Orthopaedic Surgery at Tyndall Air Force Base in Panama City, Florida.  Since 1976, I have practiced private orthopaedic surgery in the West Palm Beach area of Florida, specializing in total joint replacement and arthroscopy.  Last year I stopped performing surgery, but continue to practice office orthopaedics full time.

Shortly after graduation from medical school, I became acquainted with the problem of wrong-site surgery.  During my first rotation as an intern, I assumed the care of an elderly patient whose incorrect hip had been operated upon – after a series of medical complications, he died without having had his hip fracture pinned.  When I began private practice, an eager scrub nurse prepped and draped the wrong leg for surgery (I usually perform my own prepping and draping) – fortunately, I noticed the error and did not operate on the incorrect limb.  I did not, however, forget the episode.

In 1991, I began to write “yes” on my intended surgical sites; shortly thereafter, the hospital began to encourage all surgeons to mark their operative sites.  Occasional errors continued, however.  One surgeon confused a patient’s identity and performed the wrong procedure on the correct site – “yes” written on the site had not been a deterrent.  On a national level, these types of surgical errors persist and are of great concern to patients, hospitals, insurance companies and the government.  The Joint Commission on the Accreditation of Healthcare Organizations recently stated that it receives reports of approximately 60 to 96 wrong site / person / procedure cases per year, but that occurrences are probably under reported.

Recently, I developed a system which would give the surgical team pertinent information regarding the identity of a patient, the correct site, and the exact procedure to be performed; I wanted the information to be located on the surgical site so that the

possibility of forgetting to check it would be minimized.  I did not believe handwriting the data on a sticker was practical since handwriting is frequently illegible and the space to record the information, especially a complicated operative procedure, is too limited.  After some research, I decided that bar code labels or Radio Frequency Identification (RFID) chips were possible solutions to the problem.  Using bar code, it is not possible to encode chips with data verifying that they have been read; with RFID, the handheld terminal is able to perform this function and record the date and time the chip was read – I considered verification desirable.  I also thought it was important that the patient’s name and surgery site be prominently visible on the tag to minimize error. Since bar code is line of site, the bars necessarily take up most of the space on the face of the tag leaving little room to print the name and site. Using a large tag to accommodate the information is not practical, especially in small areas such as the wrist/hand and ankle/foot, and on children; a large tag might also obscure the “yes” which should be visible.  Since RFID is not line of sight, the computer chip and antenna may be mounted on the back of the tag leaving the entire face available to clearly display a name, site and other pertinent information (such as “remove prior to sterile prep” and “place on incision site”).  Additionally, I thought RFID readers were far less prevalent in hospitals than bar code readers making attempts at unauthorized reading less likely.  For these reasons, I decided to use RFID and invented SURGICHIP™.

SURGICHIP™ is an FDA approved, patent pending system using RFID technology to help prevent wrong-site, wrong-patient, and wrong-procedure surgery; it is a new use of preexisting technology.  A computer chip encoded with the pertinent data is affixed to the skin with biocompatible adhesive and is removed prior to the incision; the chip is not implanted inside the body.  SURGICHIP™ is used in addition to the other usual safeguards against wrong-site surgery, including the JCAHO Universal Protocol™  (“yes” or the surgeon’s initials / signature are written on the incision site with indelible marker and a “time out” is taken to review the operative consent and verify the patient’s identity).  With SURGICHIP ™ in place it is less likely that the surgical team will forget to check the operative consent or the patient’s identifying wristband. The possibility that the wrong chart will be used and the incorrect procedure therefore performed is minimized since the chip, which has been verified by the patient while awake, does not physically leave the patient until the surgical prep begins.

PHOTOS 1 and 2 show SURGICHIP™, a Texas Instruments “smart tag”.  It is a passive RFID transponder which does not have a battery and can be read at short range only.

PHOTOS 3 to 5 show a computer screen depicting SURGICHIP™ software in use.

PHOTO 6 shows a Zebra technologies RFID printer / encoder.

PHOTO 7 shows a desktop RFID reader used to verify the information encoded on the chip.

PHOTO 8 shows a surgeon reading SURGICHIP™ in the operating room.

PHOTO 9 shows a handheld reader screen with SURGICHIP™ software.

SURGICHIP™ is HIPAA compliant.  The chip is programmed by a designated professional in a private environment; entry into the computer program is password protected. The data encoded on the chip are retrievable by using a custom designed RFID reader only; it is intended for the exclusive use of the surgical team.  The information on the chip is encrypted.  Only an RFID reader equipped with SURGICHIP™ software can read the encoded information.  Entry into the handheld terminal SURGICHIP™ software is password protected; entry into the handheld terminal itself can also be password protected at the discretion of the medical center. The information on the reader is displayed on a small screen that is easily shielded from sight by the professional using SURGICHIP™.  Additionally, reading the chip is performed in a private environment (operating room, enclosed holding area, etc.).  Since the tag is a passive RFID device, it can be read at close range only (9cm, or approximately 5 inches); the risk of surreptitious reading from a distance is therefore minimal. The display is cleared automatically after a preset waiting period, maximum 30 minutes.  The read information may be transmitted to a larger screen or computer, but this is performed only in the same operating room. Once encoded, the chip is locked to prevent inadvertent or intentional altering or deletion of data.  The patient’s name and surgical site are printed on the face of the chip to protect the patient from having the chip placed on the wrong site (the basic reason for using the chip).  The surgical procedure, however, is not printed on the face of the tag and is retrievable only with the use of a SURGICHIP™ RFID reader.  The visible name is analogous to the visible name on a wristband, which is essential for patient identification and is permitted by the “need to know” exception (the concept that in some circumstances the need for knowledge of certain information regarding a patient is so compelling that it outweighs the possible infringement of the right to privacy).  Furthermore, a chip on the head, neck, back, chest, abdomen or extremities is easily covered by a sheet, blanket or surgical cap, all of which are used routinely for surgical patients.  After the chip is removed, it is attached to the progress notes of the patient’s chart and not used on another patient.  It becomes part of the HIPAA protected hospital record.  If desired, the handheld reader can verify that the chip has been read.

 The data stored in the computer are to be accessed by designated hospital personnel only.  Entry into the program is password protected.  At this time, the data are not intended for transfer or transmittal.  In the future, if it becomes necessary to transmit any of the data, they will be de-identified.

Several of my associates and I have used SURGICHIP™ successfully on a limited basis under Institutional Review Board protocols in a hospital and an ambulatory surgical center.  Since SURGICHIP™ was recently approved by the FDA, I have planned pilot projects in four hospitals (two in Florida, one in New York and one in Indiana), and have begun marketing it.

In summary, I believe SURGICHIP™ enables patients to benefit from the use of RFID technology without compromise of their right to privacy.