Safety features for medical devices requiring assistance and supervision

• US 9,024,746 B2
• Filed: 09/14/2012
• Issued: 05/05/2015
• Est. Priority Date: 10/25/2005
• Status: Active Grant

• Current Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Original Assignee: Nxstage Medical Incorporated (Fresenius Medical Care AG)
• Inventors: Burbank, Jeffrey H., Treu, Dennis M., Brugger, James M.
• Primary Examiner(s): Lee, Benjamin
• Assistant Examiner(s): PHAM, QUANG
• Application Number:
  US13/618,716
• Publication Number:
  US 20130069778A1
• Time in Patent Office: 963 Days
• Field of Search: 340/521, 340 51- 528, 340/5.51, 340/5.67, 340 58- 585, 726/4, 726/17, 726/21, 716/26, 716/27, 716/28, 716/29, 716/30, 716/31, 716/32, 716/33, 716/34, 716/35, 422/44, 601/4.01, 601/6.14, 601/6.09, 210/650, 210/741
• US Class Current: 340/521
• CPC Class Codes: A61B 5/0077 Devices for viewing the surface of the body, e.g. camera, magnifying lens
• CPC Class Codes: A61B 5/015 By temperature mapping of body part
• CPC Class Codes: A61B 5/0816 Measuring devices for examining respiratory frequency measuring frequency of electric signals G01R23/00
• CPC Class Codes: A61B 5/117 Identification of persons methods or arrangements for recognising patterns, e.g. fingerprints, G06F18/00, G06V40/00; identification of persons by analysing their voice or speech G10L17/00
• 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 5/7475 User input or interface means, e.g. keyboard, pointing device, joystick
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 2205/18 with alarm
• CPC Class Codes: A61M 2205/3553 remote, e.g. between patient's home and doctor's office
• CPC Class Codes: A61M 2205/6009 for matching patient with his treatment, e.g. to improve transfusion security
• CPC Class Codes: G05B 1/01 electric
• CPC Class Codes: G05B 9/02 electric
• CPC Class Codes: G08B 21/182 Level alarms, e.g. alarms responsive to variables exceeding a threshold
• CPC Class Codes: G08B 21/22 responsive to presence or absence of persons
• CPC Class Codes: G16H 20/00 ICT specially adapted for therapies or health-improving plans, e.g. for handling prescriptions, for steering therapy or for monitoring patient compliance
• CPC Class Codes: G16H 30/40 for processing medical images, e.g. editing
• CPC Class Codes: G16H 40/63 for local operation
• 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

An automatic locking system for a medical treatment device helps to ensure that an assistant is present during treatment of a patient. Among the features disclosed biometric authentication to verify that a trained assistant is present, a presence detector to ensure the assistant is continuously present during treatment, and warning and recovery processes that allow intermittent lapses in the continuous presence of the assistant.

Claims

1. A method for verifying proper use of a medical treatment device, comprising:

authenticating an authorized person other than a patient to be treated using an authenticating device attached to said treatment device used to treat said patient, the authorized person enabling said treatment device to be operable during a treatment session at a treatment location;

generating an enabling signal to cause said treatment device to become operable in response to a result of said authenticating by a controller attached to, embedded in, or co-located with the treatment device;

generating, automatically and at predefined time intervals during the treatment session, one or more verification request signals requesting an individual other than said patient to input a verification response into a user interface of the controller in response to the one or more verification request signals, each of the verification responses including;

a first input verifying that said individual is present at the treatment location; and

a second input verifying the identity of said individual present at the treatment location;

prompting said individual to input the verification response into the controller via the user interface;

receiving the verification response to the one or more verification request signals;

verifying that the verification response was received at the user interface and confirming that the verification response was received from the individual other than said patient;

performing a warning procedure responsively to a result of said verifying, said warning procedure including;

generating a first signal to indicate an impending termination of the treatment session within a specified time if the verifying failed to confirm that the verification response was received at the user interface; and

generating a second signal to activate an alarm indicating said impending termination if the verifying failed to confirm that the verification response was received from the individual other than said patient;

waiting for said individual to input a verification response to verify his or her identity and presence at the treatment location within said specified time responsive to the generated first signal; and

terminating said treatment session of said patient responsively to lack of verification of the identity and presence of said individual other than the patient at the treatment location after said waiting.

2. The method of claim 1, wherein the authenticating includes machine-recognizing a biometric indicator of identity.

3. The method of claim 1, wherein the performing includes displaying requirements for a treatment procedure of said treatment session.

4. The method of claim 1, wherein the performing includes displaying a message requesting the presence of the individual.

5. The method of claim 1, wherein the authenticating includes reading a magnetic medium including a data key.

6. The method of claim 1, wherein the performing the warning procedure includes transmitting a message to a supervisor.

7. The method of claim 1, wherein the authenticating includes machine-classification of a video image.

8. The method of claim 1, further comprising authenticating the individual at least three times during the treatment session, the three times being spaced apart such that the third time is more than half-way through the treatment session.

9. The method of claim 1, wherein the authorized person is the same as the individual other than the patient.

10. The method of claim 1, wherein the authorized person is different than the individual other than the patient.

11. A medical treatment device, comprising:

a medical treatment component; and

a monitoring system configured to receive data from one or more sensors connected to the monitoring system to confirm the presence of a helper at a treatment location, the helper being different from a patient receiving treatment by the medical treatment component;

the monitoring system being further configured to

automatically request from the helper during a treatment session to verify a presence of the helper at the treatment location by generating, automatically and at predefined time intervals during the treatment session, one or more verification request signals requesting said helper other than said patient to input a verification response into a user interface of the monitoring system in response to the one or more verification request signals, each of the verification responses including;

a first input verifying that said helper is present at the treatment location based on data received from the one or more sensors; and

a second input verifying the identity of said helper present at the treatment location;

the monitoring system being further configured to prompt said helper to input the verification response into the monitoring system via the user interface and to receive the verification response to the one or more verification request signals;

the monitoring system being further configured to verify that the verification response was received at the user interface and to confirm that the response was received from the helper other than said patient;

the monitoring system being further configured to confirm a pattern of presences of the helper over a plurality of said predefined time intervals during said treatment session in which the medical treatment component is operative to deliver therapy to the patient based on the verifying; and

the monitoring system generating a signal indicative of an abnormal condition when the pattern of presences of the helper is not confirmed, and causing the medical treatment component to go into a failsafe operational mode to reduce risks to said patient during said treatment session.

12. The medical device of claim 11, wherein the monitoring system includes a video camera and a video classification engine that monitors a scene that includes the patient and the helper to confirm that said helper is present at the treatment location.

13. The medical system of claim 11, wherein the one or more sensors include an authentication device including at least one of a key code receiver, an RFID reader, a mechanical lock, a biometric reader, a magnetic stripe reader, a nonvolatile memory card reader, a smart card reader, a video camera, or a bar code reader.

14. The medical system of claim 11, wherein the monitoring system goes into the failsafe operational mode in response to the abnormal condition.

15. The medical system of claim 11, wherein the monitoring system generates an alert signal in response to the abnormal condition.

16. The medical system of claim 11, wherein the monitoring system generates an alert signal and waits for a reception of an alert-cancel command after generating the alert signal, the monitoring system causing the medical treatment component to go into the failsafe operational mode in response to the abnormal condition and the failure of the alert-cancel signal command being received.

17. A method for controlling an extracorporeal blood treatment machine at a treatment location to reduce risk of continuing a blood treatment by said extracorporeal blood treatment machine without the continuous presence of a helper other than a patient in the immediate vicinity of the extracorporeal blood treatment machine, comprising:

prompting, by means of the extracorporeal blood treatment machine, for a first input from the helper which is effective to confirm the presence and identity of the helper at the treatment location of the extracorporeal blood treatment machine and, in response to receiving the first input, beginning a blood treatment process of the extracorporeal blood treatment machine;

prompting, by the extracorporeal blood treatment machine at predetermined time intervals after confirmation of the first input, for a subsequent input by the extracorporeal blood treatment machine effective to confirm the continued presence and identity of the helper at the treatment location of the extracorporeal blood treatment machine and;

(1) responsively to a receipt and confirmation of the subsequent input, continuing the blood treatment process by the extracorporeal blood treatment machine; and

(2) responsively to any absence of a receipt and confirmation of the subsequent input, controlling said extracorporeal blood treatment machine to implement a failsafe operational mode thereof which includes discontinuing the normal blood treatment process to cause the extracorporeal blood treatment machine to go into the failsafe operational mode to reduce risks to said patient during said treatment session; and

continuing the prompting for the subsequent input at the predetermined time intervals throughout the blood treatment process until the blood treatment process is complete or an absence of a receipt and confirmation of the subsequent input is determined;

wherein the subsequent input is of a type that requires an action by the helper such that the attention and presence of the helper is confirmed.

18. The method of claim 17, wherein the subsequent input includes a use of a user interface of the extracorporeal blood treatment machine that requires the physical presence of the helper.

19. The method of claim 17, wherein the subsequent input includes a manual entry through a user interface of the extracorporeal blood treatment machine that requires the physical presence of the helper.

20. The method of claim 17, wherein the subsequent input includes bio-authentication input through a user interface of the extracorporeal blood treatment machine that requires the physical presence of the helper.

21. The method of claim 17, wherein the subsequent input includes authenticating the identity of the helper to ensure it is not the patient being treated by the blood treatment process.

22. The method of claim 17, wherein the blood treatment process is a renal replacement therapy.

23. The method of claim 17, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes clamping blood lines of the extracorporeal blood treatment machine.

24. The method of claim 17, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes generating an automated cellular message.

25. The method of claim 17, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes slowing a pumping rate through blood lines of the extracorporeal blood treatment machine.

26. The method of claim 17, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes generating an automated telephonic message to an ambulance service.

27. The method of claim 17, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes terminating said blood treatment process.

28. The method of claim 17, wherein the subsequent input includes using a portable device to enter the subsequent input, and unlocking and accessing the portable device by unlocking a locking storage of said extracorporeal blood treatment machine for the portable device.

29. The method of claim 17, wherein said extracorporeal blood processing machine performs a warning procedure responsively to said absence of the receipt and confirmation of said subsequent input, said warning procedure including generating a first notification signal to indicate that the failsafe operational mode will be implemented within a predefined time if the subsequent input is not received therewithin and controlling said extracorporeal blood treatment machine to implement the failsafe operational mode responsively to the lapse of the predefined time.

30. The method of claim 17, wherein the subsequent input is applied using a direct input/output interface including one of a keyboard, keypad, speech interface, touchscreen, or a mechanical interface.

31. The method of claim 17, wherein the receiving subsequent input includes authenticating the helper at least three times during the treatment session, the three times being spaced apart such that the third time is more than half-way through the blood treatment process.

32. A medical treatment device for verifying proper use of said medical treatment device at a treatment location during a treatment session by confirming of identity and presence of a helper at the treatment location, comprising:

a medical treatment component; and

a monitoring system configured to authenticate an authorized person other than a patient to be treated using an authentication device attached to the medical treatment device used to treat said patient, the authorized person enabling said medical treatment device to be operable to begin said treatment session at said treatment location;

wherein the monitoring system is configured to generate an enabling signal to cause said medical treatment component to become operable in response to a result of said authentication by the monitoring system attached to, embedded in, or collocated with the medical treatment device;

the monitoring system configured to receive first input data from one or more sensors connected to the monitoring system to confirm the presence of the helper at the treatment location, the helper being distinct from said patient receiving treatment by the medical treatment component;

the monitoring system being further configured to automatically request from the helper during the treatment session to verify the presence of the helper at the treatment location by generating, automatically and at predefined time intervals subsequent to the enabling signal during the treatment session, one or more verification request signals requesting, including by prompting, said helper other than said patient to input a verification response into a user interface of the monitoring system in response to the one or more verification request signals, each of the verification responses including;

the first input for confirming that said helper is present at the treatment location based on data received from the one or more sensors; and

a second input, that is manually entered by said helper via said user interface, for verifying the identity of said helper and determining the presence of said helper at the treatment location;

the monitoring system being further configured to prompt said individual to input the verification response into the monitoring system via the user interface and to receive the verification response to the one or more verification request signals;

the monitoring system being further configured to verify that the verification response was received at the user interface and to confirm that the response was received from the helper other than said patient;

the monitoring system being further configured to confirm a pattern of presences of the helper over a plurality of said predefined time intervals during the treatment session in which the medical treatment component is operative to deliver therapy to the patient based on the verifying; and

the monitoring system generating a signal indicative of an abnormal condition when the pattern of presences of the helper is not confirmed, and causing the medical treatment component to go into a failsafe operational mode to reduce risks to said patient during said treatment session.

33. The medical device of claim 32, wherein the monitoring system includes a video camera and a video classification engine that monitors a scene that includes the patient and the helper to confirm that said helper is present at the treatment location.

34. The medical system of claim 32, wherein the one or more sensors include the authentication device including at least one of a key code receiver, an RFID reader, a mechanical lock, a biometric reader, a magnetic stripe reader, a non-volatile memory card reader, a smart card reader, a video camera, or a bar code reader.

35. The medical system of claim 32, wherein the monitoring system goes into the failsafe operational mode in response to the abnormal condition.

36. The medical system of claim 32, wherein the monitoring system generates an alert signal in response to the abnormal condition.

37. The medical system of claim 32, wherein the monitoring system generates an alert signal and waits for a reception of an alert-cancel command after generating the alert signal, the monitoring system causing the medical treatment component to go into the failsafe operational mode in response to the abnormal condition and the failure of the alert-cancel signal command being received.