Medical pump with operator-authorization awareness

• US 10,074,446 B2
• Filed: 02/26/2015
• Issued: 09/11/2018
• Est. Priority Date: 06/06/2012
• Status: Active Grant

• Current Assignee: Zyno Medical, LLC
• Original Assignee: Zyno Medical, LLC
• Inventors: Lee, Chaoyoung, Sjolander, Todd, Zhang, Mei
• Primary Examiner(s): Bosworth, Kami A
• Assistant Examiner(s): Carpenter, William
• Application Number:
  US14/632,318
• Publication Number:
  US 20150165118A1
• Time in Patent Office: 1,293 Days
• CPC Class Codes: A61M 2005/14208 with a programmable infusion control system, characterised by the infusion program
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/3584 using modem, internet or bluetooth
• CPC Class Codes: A61M 2205/3592 using telemetric means, e.g. radio or optical transmission
• CPC Class Codes: A61M 2205/50 with microprocessors or computers
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: A61M 2205/6018 providing set-up signals for the apparatus configuration
• CPC Class Codes: A61M 2205/6054 Magnetic identification systems
• CPC Class Codes: A61M 2205/6072 Bar codes
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61M 5/1456 with a replaceable reservoir comprising a piston rod to be moved into the reservoir, e.g. the piston rod is part of the removable reservoir
• CPC Class Codes: G16H 20/17 delivered via infusion or injection
• 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 40/40 for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: G16Z 99/00 Subject matter not provided for in other main groups of this subclass

Abstract

A medical pump for delivering medicament through an IV line to a patient may provide for awareness of the operator and operator authority limiting access by any individual to particular tasks of procedure review, pump programming, pump loading, patient set up, pump operation, and the like associated with the treatment provided by the medical pump. Identifying the operator allows the assignment of particular authority levels to the operators to ensure proper operation of the medical pump, and/or proper operators have made the necessary review to perform the necessary set up of the medical pump facilitating collaborative healthcare delivery. A record of operator intervention and authority levels may be logged to permit an automatic checklist process by the medical pump. Authentication process and pump operation parameters can be communicated through Near Field Communication (NFC).

Claims

1. A programmable medical pump comprising:

a housing;

a pump supported by the housing to receive an IV line;

at least one sensor supported by the housing to monitor a flow of medicament through the IV line when received within the pump;

a first wireless communication device configured to communicate identifying data identifying only to an individual who is within a predetermined distance;

a second wireless communication device configured to communicate identifying data identifying an individual outside of the predetermined distance; and

an electronic computer communicating with the pump and at least one sensor and executing a stored program fixed in non-transitory media of a computer memory and communicating with the pump and at least one sensor to;

(a) receive from a first individual identifying data identifying the first individual;

(b) determine whether the first individual identifying data was received through the first communication device or the second communication device;

(c) apply the identifying data identifying the first individual to a data structure linking individuals to authorization levels to receive a first authorization level for the first individual, where each authorization level provides a subset of permitted operations of the programmable medical pump wherein at least one authorization level includes a subset of permitted operations which require the first individual identifying data to be received through the first communication device;

(d) determine whether or not the first authorization level requires the first individual identifying data to be received through the first communication device;

(e) if the first individual identifying data is received through the first wireless communication device, execute operations from related to the first individual commands only if those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual; and

(f) if the first individual identifying data is received through the second communication device, execute operations from related to the first individual commands only if (i) those commands do not require the first individual identifying data to be received through the first wireless communication device and only if (ii) those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual; and

(g) record in a log file the data identifying the individual and at least one of a time of accepting commands from the first individual and the commands accepted from the first individual

wherein the authorization levels comprise a default level permitting an individual to perform predetermined operations of the programmable medical pump, including stopping operation of the medical pump, without receiving identifying data from the individual or linking the individual to authorization levels.

2. The programmable medical pump of claim 1 wherein the electronic computer is programmed to perform the steps of:

receive from a second individual data identifying the second individual;

determine whether the second individual identifying data was received through the first communication device or the second communication device;

apply the data identifying the second individual to the data structure to determine receive a second authorization level for the second individual, the second authorization level providing a subset of permitted operations of the programmable medical pump permitting operations of the programmable pump different from those of the subset of the first authorization level;

determine whether or not the second authorization level requires the second individual identifying data to be received through the first communication device;

if the second individual identifying data is received through the first communication device, execute operations related to the second individual commands only if those commands are within the subset of permitted operations of the programmable pump of the second authorization level for the second individual, and

if the second individual identifying data is received through the second communication device, execute operations related to the second individual commands only if (i) those commands do not require the second individual identifying data to be received through the first communication device and only if (ii) those commands are within the subset of permitted operations of the programmable pump of the second authorization level for the second individual; and

recording in a log file the identity of the second individual and at least one of a time of accepting commands from the second individual and the commands accepted from the second individual.

3. The programmable medical pump of claim 1 wherein the electronic computer is supported by the housing and the data structure is stored in the computer memory.

4. The programmable medical pump of claim 3 wherein the electronic computer includes a network connection with a remote database and the data structure is periodically synchronized with a remote database.

5. The programmable medical pump of claim 4 wherein the remote database is selected from the group consisting of an electronic medical record holding information about a medical history of the patient and a drug dispense database holding information about medicaments.

6. The programmable medical pump of claim 1 wherein the electronic computer further reviews the log file to determine recorded activities of specific authorization levels before allowing some operations of the pump.

7. The programmable medical pump of claim 6 wherein the review of the log file includes determining recordation of activities requiring at least two individuals of a given authorization level providing mutual oversight on a given activity.

8. The programmable medical pump of claim 1 wherein the pump includes a near field communication device and:

a) the first individual data is received by the near field communication device;

b) the permitted operations include but are not limited to downloading infusion parameters and/or pump setup information and executing accordingly; and

c) the permitted operations include but are not limited to uploading pump current status data and/or historical data to a computer system through wired or wireless communication.

9. The programmable medical pump of claim 1 wherein the data identifying the first individual is received by a manually operated keypad comprising at least one of mechanical switches and a touchscreen keypad.

10. The programmable medical pump of claim 1 wherein the data identifying the first individual is biometric data acquired from the first individual using a biometric sensor.

11. The programmable medical pump of claim 1 wherein the permitted operations relate to programming of the pump with respect to flow rate of the medicament or flow volume of the medicament.

12. The programmable medical pump of claim 1 wherein the permitted operations relate to an identification of medicaments used with the pump.

13. The programmable medical pump of claim 1 wherein the electronic computer is programmed such that step (a) is repeated whenever there is input from the user of commands changing operation of the programmable pump.

14. The programmable medical pump of claim 1 wherein the electronic computer is contained within the housing.

15. A method of operating a programmable medical pump having:

a housing;

a pump supported by the housing to receive an IV line;

at least one sensor supported by the housing to monitor a flow of medicament through the IV line when received within the pump;

a first wireless communication device configured to communicate identifying data identifying only to an individual who is within a predetermined;

a second communication device configured to communicate identifying data identifying an individual who is not within a predetermined distance; and

an electronic computer communicating with the pump and at least one sensor and executing a stored program fixed in non-transitory media of a computer memory and communicating with the pump and at least one sensor to;

(a) receive from a first individual identifying data identifying the first individual;

(b) determine if the first individual identifying data was received through the first communication device or the second communication device;

(c) apply the identifying data identifying the first individual to a data structure linking individuals to authorization levels to receive a first authorization level for the first individual, where each authorization level provides a subset of permitted operations of the programmable medical pump, wherein at least one authorization level includes a subset of permitted operations which require the first individual identifying data to be received through the first communication device;

(d) determine whether or not the first authorization level requires the first individual identifying data to be received through the first communication device;

(e) if the first individual identifying data is received through the first wireless communication device;

accept from the first individual commands only if those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual, and

(f) if the first individual identifying data is received through the second communication device, execute operations from related to the first individual commands only if (i) those commands do not require the first individual identifying data to be received through the first wireless communication device and (ii) those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual;

(g) record the data identifying the individual and at least one of a time of accepting commands from the first individual and the commands accepted from the first individual;

wherein the authorization levels comprise a default level permitting an individual to perform predetermined operations of the programmable medical pump, including stopping operation of the medical pump, without receiving identifying data from the individual or linking the individual to authorization levels;

the method comprising the steps of;

(1) receiving from the first individual identifying data identifying the first individual;

(2) determining whether the first individual identifying data was received through the first communication device or the second communication device;

(3) applying the identifying data identifying the first individual to a data structure linking individuals to authorization levels, each authorization level providing a subset of permitted operations of the programmable medical pump and a specified proximity to the pump to receive a first authorization level for the first individual;

(4) determining whether or not the first authorization level requires the first individual identifying data to be received through the first communication device;

(5) if the first individual identifying data is received through the first communication device, execute operations related to the first individual commands only if those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual;

(6) if the first individual identifying data is received through the second communication device, execute operations related to the first individual commands only if (i) those commands do not require the first individual identifying data to be received through the first communication device and only if (ii) those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual; and

(7) recording the identity of the individual and at least one of a time of accepting commands from the first individual and the commands accepted from the first individual.

16. A programmable medical pump comprising:

a housing;

a pump supported by the housing to receive an IV line;

at least one sensor supported by the housing to monitor a flow of medicament through the IV line when received within the pump;

a first wireless communication device configured to communicate identifying data identifying only to an individual who is physically proximate to the pump;

a second communication device configured to communicate identifying data identifying an individual who is not physically proximate to the pump; and

an electronic computer communicating with the pump and at least one sensor and executing a stored program fixed in non-transitory media of a computer memory and communicating with the pump and at least one sensor to;

(a) receive from a first individual identifying data identifying the first individual;

(b) determine whether the first individual identifying data was received through the first communication device or the second communication device;

(c) apply the identifying data identifying the first individual to a data structure linking individuals to authorization levels to receive a first authorization level for the first individual, where each authorization level provides a subset of permitted operations of the programmable medical pump, wherein at least one authorization level includes a received through the first communication device;

(d) determine whether or not the first authorization level requires the first individual identifying data to be received through the first communication device;

(e) if the first individual identifying data is received through the first wireless communication device, execute operations related to the first individual commands only if those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual; and

(f) if the first individual identifying data is received through the second communication device, execute operations related to the first individual commands only if (i) those commands do not require the first individual identifying data to be received through the first wireless communication device and (ii) those commands are within the subset of permitted operations of the programmable pump of the first authorization level for the first individual; and

(g) record in a log file the data identifying the individual and at least one of a time of accepting commands from the first individual and the commands accepted from the first individual.