MEDICAL PROCEDURE MONITORING SYSTEM

• US 20180153481A1
• Filed: 10/03/2017
• Published: 06/07/2018
• Est. Priority Date: 07/16/2012
• Status: Active Grant

• Current Assignee: Valco Acquisition LLC
• Original Assignee: Surgical Site Solutions, Inc. (Becton, Dickinson & Co)
• Inventors: Wagner, David W., Zenati, Marco, Flaherty, J. C., Flaherty, R. M., Maron, Jason
• Granted Patent: US 10,537,291 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 2017/00203 with speech control or speech recognition
• CPC Class Codes: A61B 2017/00207 with hand gesture control or hand gesture recognition
• CPC Class Codes: A61B 2090/502 Headgear, e.g. helmet, spectacles
• CPC Class Codes: A61B 2505/05 Surgical care
• CPC Class Codes: A61B 2560/0276 Determining malfunction
• CPC Class Codes: A61B 34/30 Surgical robots
• CPC Class Codes: A61B 5/7278 Artificial waveform generation or derivation, e.g. synthesising signals from measured signals A61B5/327 takes precedence
• CPC Class Codes: A61B 5/7282 Event detection, e.g. detecting unique waveforms indicative of a medical condition A61B5/4094, A61B5/4818, A61B5/349, A61B5/0823 take precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/749 Voice-controlled interfaces
• CPC Class Codes: A61B 90/361 Image-producing devices, e.g. surgical cameras
• CPC Class Codes: A61B 90/50 Supports for surgical instruments, e.g. articulated arms
• CPC Class Codes: A61B 90/90 Identification means for patients or instruments, e.g. tags
• CPC Class Codes: A61C 19/00 Dental auxiliary appliances dental chairs or accessories therefor, working stands whether or not combined with chairs A61G15/00
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 70/20 relating to practices or guidelines
• CPC Class Codes: H04R 2201/107 Monophonic and stereophonic headphones with microphone for two-way hands free communication

Abstract

A system and method for monitoring a medical procedure performed in a clinical environment is provided. An audio recorder is configured to produce a verbal data signal that is representative of a verbal communication occurring in the clinical environment, and a data analyzer is configured to detect an adverse condition based upon the verbal data signal. An alert module is configured to alert an operator upon the detection of an adverse condition.

Claims

1. A system for monitoring a medical procedure performed in a clinical environment comprising:

an audio recorder constructed and arranged to produce a verbal data signal representative of verbal communication that occurs in the clinical environment;

a data analyzer constructed and arranged to receive the verbal data signal from the audio recorder, analyze the verbal data signal and detect at least one adverse condition; and

an alert module constructed and arranged to alert at least one operator when the at least one adverse condition is detected by the data analyzer.

2. The system of claim 1 wherein the medical procedure comprises a procedure selected from the group consisting of:

a surgical procedure such as a minimally invasive surgical procedure;

a laparoscopic surgical procedure;

an open surgical procedure;

an interventional procedure;

a reconstructive surgery;

a robotic or robotically-enabled procedure;

an outpatient procedure;

a dental procedure such as a fully anesthetized dental procedure; and

combinations thereof.

3. The system of claim 1 wherein the clinical environment comprises a setting selected from the group consisting of:

an operating room;

a catheterization lab;

an intensive care unit;

a control room for an operating room;

an outpatient surgery treatment room;

a dentist'"'"'s office;

a surgeon'"'"'s office such as a maxillofacial surgeon'"'"'s office; and

combinations thereof.

4. The system of claim 1 wherein the audio recorder comprises at least one microphone.

5. The system of claim 1 wherein the audio recorder comprises multiple microphones.

6. The system of claim 5 wherein the multiple microphones are in proximity to the at least one operator.

7. The system of claim 5 wherein the multiple microphones comprise a first microphone positioned in proximity to a first operator and a second microphone in proximity to a second operator.

8. The system of claim 1 wherein the audio recorder is selected from the group consisting of:

a microphone;

an operator-worn microphone or headset;

a room microphone;

an omnidirectional microphone;

a Bluetooth device;

a telephone;

a mobile telephone;

a wireless device; and

combinations thereof.

9. The system of claim 1 wherein the audio recorder comprises an operator-worn headset.

10. The system of claim 9 wherein each operator of the at least one operators wears a headset.

11. The system of claim 10 wherein each headset comprises an identifier associated with the operator.

12. The system of claim 1 wherein the audio recorder comprises an intercom system.

13. The system of claim 1 wherein the audio recorder is further constructed and arranged to produce a non-verbal data signal.

14. The system of claim 13 wherein the non-verbal data signal comprises audio signals produced by equipment positioned in the clinical environment.

15. The system of claim 14 wherein the data analyzer is further constructed and arranged to receive the non-verbal data signal from the audio recorder, analyze the non-verbal data signal and detect an equipment status signal.

16. The system of claim 15 wherein the equipment status signal comprises an equipment warning signal.

17. The system of claim 1 further comprising a video camera constructed and arranged to produce a video data signal.

18. The system of claim 17 wherein the data analyzer is constructed and arranged to receive the video data signal from the video camera and analyze the video data signal.

19. The system of claim 18 wherein the data analyzer is further constructed and arranged to detect an operator gesture.

20. The system of claim 19 wherein the operator gesture comprises a gesture selected from the group consisting of:

a head nod or other affirmatory response;

a head shake or other non-affirmatory response;

a shrug;

an indecisive response; and

combinations thereof.

21. The system of claim 18 wherein the data analyzer is further constructed and arranged to detect at least one spoken word in the video data signal.

22. The system of claim 18 wherein the data analyzer is further constructed and arranged to detect at least one adverse condition in the video data signal.

23. The system of claim 17 wherein the data analyzer is constructed and arranged to combine the verbal data signal and the video data signal to produce a combined signal and to analyze the combined signal.

24. The system of claim 17 wherein the data analyzer is constructed and arranged to combine and analyze the verbal data signal and the video data signal, and to detect an adverse condition based on the combined analysis.

25. The system of claim 1 wherein the verbal data signal comprises communication data received from a single operator.

26. The system of claim 1 wherein the verbal data signal comprises communication data from at least a first operator and a second operator.

27. The system of claim 26 wherein the data analyzer is constructed and arranged to differentiate communication data of the first operator from communication data of the second operator.

28. The system of claim 1 wherein the verbal data signal comprises verbal communication that occurred prior to initiation of the medical procedure.

29. The system of claim 1 wherein the verbal data signal comprises verbal communication that occurred during the performance of the medical procedure.

30. The system of claim 1 wherein the verbal data signal comprises verbal communication that occurred after the performance of the medical procedure.

31. The system of claim 1 wherein the data analyzer comprises a component selected from the group consisting of:

microprocessor;

microcontroller;

analog to digital converter;

digital to analog converter; and

combinations thereof.

32. The system of claim 1 wherein the data analyzer comprises spoken word recognition software employing at least one algorithm, wherein the algorithm converts the verbal data signal to text data.

33. The system of claim 32 wherein the at least one algorithm is biased to correlate at least a portion of the verbal data signal to one or more medical terms.

34. The system of claim 33 further comprising a library of medical terms and wherein the bias is based on the library of medical terms.

35. The system of claim 32 further comprising a library of medical terms.

36. The system of claim 32 wherein the at least one algorithm is biased to correlate at least a portion of the verbal data signal to one or terms input by an operator.

37. The system of claim 32 wherein the at least one algorithm is biased to correlate at least a portion of the verbal data signal to at least one quantitative value input by an operator.

38. The system of claim 37 wherein the at least one quantitative value comprises a range of values.

39. The system of claim 32 wherein the at least one algorithm is biased to correlate at least a portion of the verbal data signal to a range of quantitative values wherein the range comprises quantitative values that are typically associated with a parameter.

40. The system of claim 32 wherein the at least one algorithm is biased to correlate at least a portion of the verbal data signal to a previously received verbal data signal.

41. The system of claim 40 wherein the at least a portion of the verbal data signal comprises a quantitative value.

42. The system of claim 1 wherein the data analyzer comprises a memory module constructed and arranged to store patient historic data.

43. The system of claim 42 wherein the stored patient data comprises data selected from the group consisting of:

sex;

age;

height;

weight;

race;

medical history; and

combinations thereof.

44. The system of claim 42 wherein the data analyzer comprises an algorithm to extract the patient historic data from the verbal data signal.

45. The system of claim 42 wherein the system further comprises in input device constructed and arranged to allow an operator to enter the patient historic data.

46. The system of claim 45 wherein the input device comprises a device selected from the group consisting of:

a keyboard;

a touch screen display; and

combinations thereof.

47. The system of claim 1 wherein the data analyzer is constructed and arranged to identify patient data in the verbal data signal.

48. The system of claim 47 wherein the patient data is selected from the group consisting of:

ACT;

blood pressure;

heart rate;

pulse rate;

respiratory rate;

glucose levels;

saturated O2 pressure;

saturated CO2 pressure;

core body temperature;

skin temperature;

total lung capacity;

residual volume;

expiratory reserve volume;

vital capacity;

tidal volume;

alveolar gas volume;

actual lung volume;

EEG bands such as Delta, Theta, Alpha, Beta, Gamma and Mu;

EKG information such as RR interval, P wave length/amplitude, PR interval, amplitude of QRS complex, J-point detection, absolute and relative refractory periods, QT interval and U &

J Wave detection;

blood volume;

extra embolic gases;

heparin volume;

protamine sulfate volume; and

combinations thereof.

49. The system of claim 1 wherein the data analyzer is constructed and arranged to identify equipment data in the verbal data signal.

50. The system of claim 49 wherein the equipment data is selected from the group consisting of:

instructions to turn a piece of equipment on or off;

instructions to modify the settings of one or more pieces of equipment; and

combinations thereof.

51. The system of claim 1 wherein the data analyzer is constructed and arranged to identify procedure data in the verbal data signal.

52. The system of claim 51 wherein the procedure data is selected from the group consisting of:

total procedure length;

length of a procedural step;

time of initiation of a procedural step;

time since last administration of a drug or other agent; and

combinations thereof.

53. The system of claim 52 wherein the procedural steps are selected from the group consisting of:

patient preparation;

anesthesia induction;

opening/sternotomy;

initiation of bypass;

cardiac repair;

termination of bypass;

closure;

post-op;

anesthesia;

insufflation;

laparoscopic insertion such as laparoscopic insertion prior to a cholecystectomy;

diagnosis confirmation;

port incisions;

removing bile;

grasping a structure such as a gallbladder;

isolating and dividing structures;

separation of a first structure from a second structure such as a gallbladder from a liver;

removal of a structure such as a gallbladder;

irrigation such as abdominal wall irrigation;

prostatectomy such as a robotic prostatectomy;

docking of a robot;

dissection such as SV dissection;

hemostasis;

completion of anastamosis;

removal of drapes; and

combinations thereof.

54. The system of claim 1 wherein the data analyzer is constructed and arranged to identify a request for information data in the verbal data signal.

55. The system of claim 54 wherein the request for information data comprises a request for information selected from the group consisting of:

a patient parameter;

a procedural parameter;

an equipment parameter; and

combinations thereof.

56. The system of claim 54 wherein the system is constructed and arranged to provide a quantitative and/or qualitative response to the request.

57. The system of claim 1 wherein the data analyzer is constructed and arranged to identify an acknowledgement of receipt of information.

58. The system of claim 57 further comprising a library of acknowledgement terms.

59. The system of claim 1 wherein the data analyzer is constructed and arranged to correlate the verbal data signal received to a first operator or to a second operator.

60. The system of claim 59 wherein the data analyzer comprises an algorithm for detecting the adverse condition, wherein the algorithm comprises a first analysis on data correlated to the first operator and a second, different analysis on data correlated to the second operator.

61. The system of claim 59 wherein the data analyzer correlates the verbal data signal of the first operator based on a first identifier and correlates the verbal data signal of the second operator based on a second identifier, wherein the first identifier is different from the second identifier.

62. The system of claim 61 wherein a headset worn by the first and second operators comprises the identifier.

63. The system of claim 1 wherein the data analyzer is constructed and arranged to correlate the verbal data signal to an operator type.

64. The system of claim 63 wherein the operator type comprises a function selected from the group consisting of:

a surgeon;

an anesthesiologist;

a scrub nurse;

a circulating nurse;

hospital administrator; and

combinations thereof.

65. The system of claim 63 wherein the data analyzer comprises an algorithm, and wherein the algorithm detects the adverse condition based on the operator type and the verbal data signal.

66. The system of claim 1 wherein the data analyzer is constructed and arranged to filter and/or segregate verbal data received from the at least one operator.

67. The system of claim 66 wherein the filtered and/or segregated verbal data is prioritized based on an operator hierarchy.

68. The system of claim 1 wherein the data analyzer is constructed and arranged to filter and/or segregate verbal data received from a non-operator.

69. The system of claim 1 wherein the data analyzer comprises a memory module.

70. The system of claim 69 wherein the memory module is constructed and arranged to store one or more portions of the verbal data signal.

71. The system of claim 69 wherein the memory module is constructed and arranged to store processed verbal data signal.

72. The system of claim 69 wherein the memory module is constructed and arranged to store a library of values.

73. The system of claim 72 wherein the library of values comprises multiple spoken word terms to be recognized.

74. The system of claim 72 wherein the library of values comprises one or more quantitative values, wherein the data analyzer comprises an algorithm which compares the verbal data signal to the one or more quantitative values.

75. The system of claim 69 wherein the memory module is constructed and arranged to store historic medical statistics and/or other medical data.

76. The system of claim 69 wherein the memory module is constructed and arranged to store one or more portions of a video data signal produced by a video camera.

77. The system of claim 1 wherein the data analyzer comprises a threshold and wherein the detection of the at least one adverse condition is based on data extracted from the verbal data signal exceeding the threshold.

78. The system of claim 77 wherein the threshold comprises a value or a range of values input to the system by an operator.

79. The system of claim 77 wherein the threshold comprises a value or a range of values relating to at least one of a patient, procedural or equipment parameter.

80. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on an identification of a key word in the verbal data signal.

81. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a detection of an unrecognized voice in the verbal data signal.

82. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a detection of an unrecognized term in the verbal data signal.

83. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a determination that a first operator has been active and/or present above a threshold of time.

84. The system of claim 83 wherein the first operator comprises a surgeon.

85. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a detection of a heightened frequency of recognized terms at an improper time.

86. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a lack of receipt of information.

87. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a determination that multiple pieces of similar data have not been received within a pre-determined time interval.

88. The system of claim 87 wherein the time interval comprises an operator adjustable time interval.

89. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on a determination that a particular operator is not present.

90. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on an analysis of patient historic data.

91. The system of claim 1 wherein the data analyzer is constructed and arranged to detect the at least one adverse condition based on an analysis of a set of medical statistics.

92. The system of claim 91 wherein the set of medical statistics is pre-selected by an operator.

93. The system of claim 1 wherein the alert module is constructed and arranged to notify a single operator of the detection of the at least one adverse condition.

94. The system of claim 93 wherein the alert module notifies a single operator based upon an identifier associated with the operator.

95. The system of claim 94 wherein a headset worn by the operator comprises the identifier.

96. The system of claim 1 wherein the alert module is constructed and arranged to notify multiple operators of the detection of the at least one adverse condition.

97. The system of claim 1 wherein the alert module comprises an audio transducer.

98. The system of claim 97 wherein the alert module is constructed and arranged to produce an audible beep when the at least one adverse condition is detected.

99. The system of claim 97 wherein the data analyzer is constructed and arranged to detect a first adverse condition and a second adverse condition, and wherein the audio transducer is constructed and arranged to produce a first audio pattern when the first adverse condition is detected and a second audio pattern when the second adverse condition is detected.

100. The system of claim 97 wherein the audio transducer is constructed and arranged to produce a sound selected from the group consisting of:

a computer generated voice;

a recording of a human voice; and

combinations thereof.

101. The system of claim 1 wherein the alert module comprises a visual display.

102. The system of claim 101 wherein the visual display is constructed and arranged to provide alpha-numeric text when an adverse condition is detected.

103. The system of claim 1 wherein the alert module comprises a tactile transducer.

104. The system of claim 103 wherein the tactile transducer comprises an operator-worn tactile transducer.

105. The system of claim 103 wherein the tactile transducer comprises a vibrating transducer.

106. The system of claim 1 wherein the alert module comprises multiple alert transducers.

107. The system of claim 1 wherein the alert module comprises at least one alert transducer selected from the group consisting of:

an audio transducer such as speaker and a piezo transducer;

a visual transducer such as LCD screen, a touch screen, and a light such as an LED;

a tactile transducer such as a vibrating transducer and a thermal transducer; and

combinations thereof.

108. The system of claim 1 further comprising a data input module constructed and arranged to allow at least one operator to input data to the system.

109. The system of claim 108 wherein the data input module comprises a voice data input module.

110. The system of claim 109 wherein the data input module comprises a microphone.

111. The system of claim 108 wherein the data input module comprises a text data input module.

112. The system of claim 111 wherein the data input module comprises a device selected from the group consisting of:

a keyboard;

a touch screen;

a motion-sensing input device;

a cell phone;

a handheld electronic organizer;

a mouse;

a tablet;

a hospital computer or computer network;

a wireless connection such as a cellular service;

an internet connection;

an electronic file transfer port such as USB port;

a memory storage device such as a USB memory stick; and

combinations thereof.

113. The system of claim 108 wherein the data input module is constructed and arranged to receive operator voice data from a first operator.

114. The system of claim 113 wherein the data analyzer is constructed and arranged to convert the verbal data signal to text data based on the received first operator voice data.

115. The system of claim 113 wherein the data analyzer is constructed and arranged to correlate the verbal data signal to the operator voice data to identify the operator.

116. The system of claim 108 wherein the data analyzer comprises memory, wherein the operator input data comprises spoken word terms, and wherein the data analyzer is constructed and arranged to store the spoken word terms in the memory.

117. The system of claim 116 wherein the data analyzer further comprises an algorithm, and wherein the algorithm comprises a comparison of the verbal data signal to the spoken word terms stored in the memory which converts the verbal data signal to text data.

118. The system of claim 108 wherein the data analyzer comprises memory, wherein the operator input data comprises quantitative data, and wherein the data analyzer is constructed and arranged to store the quantitative data in the memory.

119. The system of claim 118 wherein the data analyzer further comprises an algorithm, and wherein the algorithm comprises a comparison of the verbal data signal to quantitative data stored in the memory.

120. The system of claim 119 wherein the quantitative data stored in the memory comprises a threshold value used in the comparison.

121. The system of claim 108 wherein the data input module is constructed and arranged to send and/or receive information from a healthcare information system.

122. The system of claim 1 further comprising a data output module.

123. The system of claim 122 wherein the data output module is constructed and arranged to provide patient and/or procedural information to at least one operator.

124. The system of claim 123 wherein the patient and/or procedural information provided is in response to a request by the at least one operator.

125. The system of claim 123 wherein the patient and/or procedural information comprises information selected from the group consisting of:

a current or real-time parameter;

a historic parameter;

an average of multiple parameter values;

a maximum of multiple parameter values; and

combinations thereof.

126. The system of claim 122 wherein the data output module is constructed and arranged to provide patient and/or procedural information in paper form.

127. The system of claim 122 wherein the data output module is constructed and arranged to provide patient and/or procedural information in electronic form.

128. The system of claim 122 wherein the data output module is constructed and arranged to provide information selected from the group consisting of:

an adverse condition detected;

an operator'"'"'s entry and/or exit time into the clinical setting;

a procedure event that surpasses a threshold;

an evidence-based decision support reminder;

a captured video;

a recommendation generated by the data analyzer; and

combinations thereof.

129. The system of claim 122 wherein the data output module is constructed and arranged to transfer information to a healthcare information system.

130. The system of claim 1 wherein the data output module is constructed and arranged to provide data in real-time.

131. The system of claim 1 wherein the data output module is constructed and arranged to provide data after completion of a procedure.

132. The system of claim 1 further comprising a data monitoring module.

133. The system of claim 132 wherein the data monitoring module is constructed and arranged to confirm proper information is received.

134. The system of claim 132 wherein the data monitoring module is constructed and arranged to confirm proper information is continually received within a pre-determined time interval.

135. The system of claim 1 further comprising an operator position monitoring module.

136. The system of claim 135 wherein the operator position monitoring module is constructed and arranged to monitor an operator position by detecting an operator voice in the verbal data signal.

137. The system of claim 135 wherein the operator position monitoring module comprises a motion sensor.

138. The system of claim 135 wherein the operator position monitoring module comprises a video camera.

139. The system of claim 135 wherein the operator position monitoring module comprises a timecard entry assembly.

140. The system of claim 1 further comprising at least one sensor.

141. The system of claim 140 wherein the at least one sensor comprises one or more sensors selected from the group consisting of:

a temperature sensor;

an acoustic sensor;

an electromagnetic sensor;

a pressure sensor;

a motion sensor; and

combinations thereof.

142. The system of claim 1 further comprising a patient treatment device.

143. The system of claim 142 wherein the treatment device is selected from the group consisting of:

scalpel;

electrocautery device;

grasper;

guidewire;

interventional catheter;

anesthesia injection device;

RF or cryogenic ablation equipment;

retractor;

ECMO device;

ventricular assist device;

ventilator;

bone awl;

bone tamper;

bone gouge;

bone file;

bone mallet;

osteotome;

defibrillator;

drill;

radiosurgery system;

CPB machine;

endoscope;

cross clamp;

robotic surgical system;

colonoscope;

polytectomy snare; and

combinations thereof.

144. The system of claim 142 wherein the treatment device is modified if an adverse event is detected.

145. The system of claim 144 wherein the modification comprises a disabling or powering down of the treatment device.

146. The system of claim 1 further comprising a checklist wherein the data analyzer detects the at least one adverse condition based upon an analysis of the checklist.

147. The system of claim 146 wherein the checklist comprises at least a portion that is customized for a particular operator.

148. The system of claim 147 wherein the checklist is constructed and arranged to be customized prior to the performance of a medical procedure.

149. A method for monitoring a medical procedure performed in a clinical environment comprising:

producing a verbal data signal representative of verbal communication that occurs in the clinical environment;

receiving the verbal data signal;

analyzing the verbal data signal;

detecting at least one adverse condition; and

alerting at least one operator when the at least one adverse condition is detected.

150. The method of claim 149 wherein the medical procedure comprises a procedure selected from the group consisting of:

a surgical procedure such as a minimally invasive surgical procedure;

a laparoscopic surgical procedure;

an open surgical procedure;

an interventional procedure;

a reconstructive surgery;

a robotic or robotically-enabled procedure;

an outpatient procedure;

a dental procedure such as a fully anesthetized dental procedure; and

combinations thereof.

151. The method of claim 149 wherein the clinical environment comprises a setting selected from the group consisting of:

an operating room;

a catheterization lab;

an intensive care unit;

a control room for an operating room;

an outpatient surgery treatment room;

a dentist'"'"'s office;

a surgeon'"'"'s office such as a maxillofacial surgeon'"'"'s office; and

combinations thereof.

152. The method of claim 149 wherein producing the verbal data signal is via an audio recorder.

153. The method of claim 152 wherein the audio recorder is selected from the group consisting of:

a microphone;

an operator-worn microphone or headset;

a room microphone;

an omnidirectional microphone;

a Bluetooth device;

a telephone;

a mobile telephone;

a wireless device; and

combinations thereof.

154. The method of claim 149 further comprising producing a non-verbal data signal.

155. The method of claim 154 wherein the non-verbal data signal comprises an equipment status signal, and wherein the method further comprises receiving the equipment status signal and detecting the equipment status signal.

156. The method of claim 154 further comprising receiving the non-verbal data signal and analyzing the non-verbal data signal.

157. The method of claim 149 further comprising producing a video data signal.

158. The method of claim 157 further comprising receiving the video data signal and analyzing the video data signal.

159. The method of claim 157 further comprising detecting an operator gesture wherein the operator gesture comprises a gesture selected from the group consisting of:

a head nod or other affirmatory response;

a head shake or other non-affirmatory response;

a shrug;

an indecisive response; and

combinations thereof.

160. The method of claim 159 further comprising detecting at least one spoken word in the video data signal.

161. The method of claim 159 further comprising detecting at least one adverse condition in the video data signal.

162. The method of claim 159 further comprising combining the verbal data signal and the video data signal to produce a combined signal and analyzing the combined signal.

163. The method of claim 159 further comprising analyzing the verbal data signal and the video data signal and detecting an adverse condition based on the combined analysis.

164. The method of claim 149 wherein receiving the verbal data signal comprises receiving communication data from a single operator.

165. The method of claim 149 wherein receiving the verbal data signal comprises receiving data from at least a first operator and a second operator.

166. The method of claim 165 further comprising differentiating the communication data of the first operator from the communication data of the second operator.

167. The method of claim 149 wherein receiving the verbal data signal comprises receiving verbal communication that occurred prior to initiation of the medical procedure.

168. The method of claim 149 wherein receiving the verbal data signal comprises receiving verbal communication that occurred during the performance of the medical procedure.

170. The method of claim 149 wherein receiving the verbal data signal comprises receiving verbal communication that occurred after the performance of the medical procedure.

171. The method of claim 149 wherein analyzing the verbal data signal is via a data analyzer wherein the data analyzer comprises a component selected from the group consisting of:

microprocessor;

microcontroller;

analog to digital converter;

digital to analog converter; and

combinations thereof.

172. The method of claim 149 wherein analyzing the verbal data signal comprises converting the verbal data signal to text data via spoken word recognition software employing at least one algorithm.

173. The method of claim 172 further comprising correlating at least a portion of the verbal data signal to one or more medical terms stored in a library.

174. The method of claim 149 wherein analyzing the verbal data signal comprises correlating at least a portion of the verbal data signal to one or more terms input by an operator.

175. The method of claim 149 wherein analyzing the verbal data signal comprises correlating at least a portion of the verbal data signal to at least one quantitative value or range of quantitative values input by an operator.

176. The method of claim 149 wherein analyzing the verbal data signal comprises correlating at least a portion of the verbal data signal to a range of quantitative values wherein the range comprises quantitative values that are typically associated with a parameter.

177. The method of claim 149 wherein analyzing the verbal data signal comprises correlating at least a portion of the verbal data signal to a previously received verbal data signal.

178. The method of claim 177 wherein the at least a portion of the verbal data signal comprises a quantitative value.

179. The method of claim 149 further comprising storing patient historic data.

180. The method of claim 179 wherein the stored patient data comprises data selected from the group consisting of:

sex;

age;

height;

weight;

race;

medical history; and

combinations thereof.

181. The method of claim 179 further comprising extracting the patient historic data from the verbal data signal.

182. The method of claim 179 further comprising entering the patient historic data via an input device.

183. The method of claim 182 wherein the input device comprises a device selected from the group consisting of:

a keyboard;

a touch screen display; and

combinations thereof.

184. The method of claim 149 further comprising identifying patient data in the verbal data signal.

185. The method of claim 184 wherein the patient data is selected from the group consisting of:

ACT;

blood pressure;

heart rate;

pulse rate;

respiratory rate;

glucose levels;

saturated O2 pressure;

saturated CO2 pressure;

core body temperature;

skin temperature;

total lung capacity;

residual volume;

expiratory reserve volume;

vital capacity;

tidal volume;

alveolar gas volume;

actual lung volume;

EEG bands such as Delta, Theta, Alpha, Beta, Gamma and Mu;

EKG information such as RR interval, P wave length/amplitude, PR interval, amplitude of QRS complex, J-point detection, absolute and relative refractory periods, QT interval and U &

J Wave detection;

blood volume;

extra embolic gases;

heparin volume;

protamine sulfate volume; and

combinations thereof.

186. The method of claim 149 further comprising identifying equipment data in the verbal data signal.

187. The method of claim 186 wherein the equipment data is selected from the group consisting of:

instructions to turn a piece of equipment on or off;

instructions to modify the settings of one or more pieces of equipment; and

combinations thereof.

188. The method of claim 149 further comprising identifying procedure data in the verbal data signal.

189. The method of claim 188 wherein the procedure data is selected from the group consisting of:

total procedure length;

length of a procedural step;

time of initiation of a procedural step;

time since last administration of a drug or other agent; and

combinations thereof.

190. The method of claim 189 wherein the procedural steps are selected from the group consisting of:

patient preparation;

anesthesia induction;

opening/sternotomy;

initiation of bypass;

cardiac repair;

termination of bypass;

closure;

post-op;

anesthesia;

insufflation;

laparoscopic insertion such as laparoscopic insertion prior to a cholecystectomy;

diagnosis confirmation;

port incisions;

removing bile;

grasping a structure such as a gallbladder;

isolating and dividing structures;

separation of a first structure from a second structure such as a gallbladder from a liver;

removal of a structure such as a gallbladder;

irrigation such as abdominal wall irrigation;

prostatectomy such as a robotic prostatectomy;

docking of a robot;

dissection such as SV dissection;

hemostasis;

completion of anastamosis;

removal of drapes; and

combinations thereof.

191. The method of claim 149 further comprising identifying a request for information data in the verbal data signal.

192. The method of claim 191 wherein the request for information data comprises a request for information selected from the group consisting of:

a patient parameter;

a procedural parameter;

an equipment parameter; and

combinations thereof.

193. The method of claim 191 further comprising providing a quantitative and/or qualitative response to the request.

194. The method of claim 149 further comprising identifying an acknowledgement of receipt of information wherein the identification of the acknowledgement is based on a library of acknowledgement terms.

195. The method of claim 149 further comprising correlating the verbal data signal to a first operator or to a second operator.

196. The method of claim 195 further comprising detecting the adverse condition via an algorithm, wherein the algorithm comprises a first analysis on data correlated to a first operator and a second, different analysis on data correlated to a second operator.

197. The method of claim 195 further comprising correlating the verbal data signal of the first operator based on a first identifier and correlating the verbal data signal of the second operator based on a second identifier, wherein the first identifier is different from the second identifier.

198. The method of claim 149 further comprising correlating the verbal data signal to an operator type.

199. The method of claim 198 further comprising detecting the adverse condition based on the operator type and the verbal data signal via an algorithm.

200. The method of claim 149 further comprising filtering and/or segregating verbal data received from at least one operator.

201. The method of claim 200 further comprising prioritizing the filtered and/or segregated verbal data based on an operator hierarchy.

202. The method of claim 149 further comprising filtering and/or segregating verbal data received from a non-operator.

203. The method of claim 149 further comprising storing data selected from the group consisting of:

one or more portions of the verbal data signal;

one or more processed data signals;

a library of values where the values include spoken words to be recognized and/or quantitative values;

historic medical statistics and/or other medical data;

one or more portions of a video data signal produced by a video camera; and

combinations thereof.

204. The method of claim 149 wherein detecting the adverse condition is based on data extracted from the verbal data signal exceeding a threshold.

205. The method of claim 204 wherein the threshold comprises a value or a range of values input to the system by an operator.

206. The method of claim 204 wherein the threshold comprises a value or a range of values relating to at least one of a patient, procedural or equipment parameter.

207. The method of claim 149 wherein detecting the adverse condition is based on an identification of a key word in the verbal data signal.

208. The method of claim 149 wherein detecting the adverse condition is based on a detection of an unrecognized voice in the verbal data signal.

209. The method of claim 149 wherein detecting the adverse condition is based on a detection of an unrecognized term in the verbal data signal.

210. The method of claim 149 wherein detecting the adverse condition is based on a determination that a first operator has been active and/or present above a threshold of time.

211. The method of claim 149 wherein detecting the adverse condition is based on a detection of a heightened frequency of recognized terms at an improper time.

212. The method of claim 149 wherein detecting the adverse condition is based on a lack of receipt of information.

213. The method of claim 149 wherein detecting the adverse condition is based on a determination that multiple pieces of similar data have not been received within a pre-determined time interval.

214. The method of claim 213 further comprising adjusting the time interval.

215. The method of claim 149 wherein detecting the adverse condition is based on a determination that a particular operator is not present.

216. The method of claim 149 wherein detecting the adverse condition is based on an analysis of patient historic data.

217. The method of claim 149 wherein detecting the adverse condition is based on an analysis of a set of medical statistics.

218. The method of claim 217 further comprising selecting the set of medical statistics.

219. The method of claim 149 wherein alerting the at least one operator when the adverse condition is detected comprises alerting a single operator.

220. The method of claim 149 wherein alerting the at least one operator when the adverse condition is detected comprises alerting multiple operators.

221. The method of claim 149 wherein alerting the at least one operator when the adverse condition is detected comprises producing at least one of an audible sound;

a tactile feedback;

or a visual display.

222. The method of claim 221 wherein detecting at least one adverse condition comprises detecting a first adverse condition and a second adverse condition, and wherein the method further comprises producing a first audio pattern when the first adverse condition is detected and a second audio pattern when the second adverse condition is detected.

223. The method of claim 149 further comprising entering data into a data input module.

224. The method of claim 223 wherein the data comprises voice data;

text data; and

combinations thereof.

225. The method of claim 223 wherein the data input module comprises a device selected from the group consisting of:

a keyboard;

a touch screen;

a motion-sensing input device;

a cell phone;

a handheld electronic organizer;

a mouse;

a tablet;

a hospital computer or computer network;

a wireless connection such as a cellular service;

an internet connection;

an electronic file transfer port such as USB port;

a memory storage device such as a USB memory stick; and

combinations thereof.

226. The method of claim 223 wherein entering data comprises receiving operator voice data from a first operator via the input data module.

227. The method of claim 226 further comprising converting the verbal data signal to text data based on the received first operator voice data.

228. The method of claim 226 further comprising correlating the verbal data signal to the operator voice data to identify the first operator.

229. The method of claim 226 further comprising storing the operator voice data in a memory.

230. The method of claim 229 further comprising comparing the verbal data signal to the operator voice data stored in memory and converting the verbal data signal to text data.

231. The method of claim 226 further comprising storing quantitative data in memory.

232. The method of claim 231 further comprising comparing the verbal data signal to the quantitative data stored in the memory.

233. The method of claim 231 wherein the quantitative data stored in the memory comprises a threshold value used in the comparison.

234. The method of claim 223 further comprising transmitting information from a healthcare information system to the data input module.

235. The method of claim 149 further comprising providing patient and/or procedural information to at least one operator via an output module.

236. The method of claim 235 wherein the patient and/or procedural information provided in response to a request by the at least one operator.

237. The method of claim 235 wherein the patient and/or procedural information comprises information selected from the group consisting of:

a current or real-time parameter;

a historic parameter;

an average of multiple parameter values;

a maximum of multiple parameter values; and

combinations thereof.

238. The method of claim 235 wherein providing the patient and/or procedural information comprises providing information in paper form.

239. The method of claim 235 wherein providing the patient and/or procedural information is providing information in electronic form.

240. The method of claim 235 wherein the patient and/or procedural information is selected from the group consisting of:

an adverse condition detected;

an operator'"'"'s entry and/or exit time into the clinical setting;

a procedure event that surpasses a threshold;

an evidence-based decision support reminder;

a captured video;

a recommendation generated by the data analyzer; and

combinations thereof.

241. The method of claim 235 further comprising transferring the patient and/or procedural information to and/or from a healthcare information system.

242. The method of claim 235 wherein providing the patient and/or procedural information occurs in real-time.

243. The method of claim 235 wherein providing the patient and/or procedural information occurs after completion of a procedure.

244. The method of claim 149 further comprising confirming proper information is received via a data monitoring module.

245. The method of claim 244 wherein confirming the proper information is received comprises confirming the proper information is continually received within a pre-determined time interval.

246. The method of claim 149 further comprising monitoring an operator position by detecting an operator voice in the verbal data signal via an operator position monitoring module.

247. The method of claim 246 wherein the operator position is monitored via at least one of a motion sensor;

a video camera;

or a timecard entry assembly.

248. The method of claim 149 further comprising sensing at least one parameter via at least one sensor.

249. The method of claim 248 wherein the at least one sensor comprises one or more sensors selected from the group consisting of:

a temperature sensor;

an acoustic sensor;

an electromagnetic sensor;

a pressure sensor;

a motion sensor; and

combinations thereof.

250. The method of claim 149 further comprising treating a patient via a patient treatment device.

251. The method of claim 250 wherein the treatment device is selected from the group consisting of:

scalpel;

electrocautery device;

grasper;

guidewire;

interventional catheter;

anesthesia injection device;

RF or cryogenic ablation equipment;

retractor;

ECMO device;

ventricular assist device;

ventilator;

bone awl;

bone tamper;

bone gouge;

bone file;

bone mallet;

osteotome;

defibrillator;

drill;

radiosurgery system;

CPB machine;

endoscope;

cross clamp;

robotic surgical system;

colonoscope;

polytectomy snare; and

combinations thereof.

252. The method of claim 250 further comprising modifying the treatment device if an adverse event is detected.

253. The method of claim 252 wherein the modification comprises a disabling or powering down of the treatment device.

254. The method of claim 149 further comprising analyzing a checklist and detecting the at least one adverse condition based upon the analysis of the checklist.

255. The method of claim 254 further comprising customizing the checklist so that at least a portion of the checklist is customized for a particular operator.

256. The method of claim 255 wherein the checklist is customized prior to the performance of a medical procedure.