SAFETY FEATURES FOR MEDICAL DEVICES REQUIRING ASSISTANCE AND SUPERVISION

• US 20130069778A1
• Filed: 09/14/2012
• Published: 03/21/2013
• 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.
• Granted Patent: US 9,024,746 B2
• Time in Patent Office: Days
• 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

1-23. -23. (canceled)

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

authenticating an authorized person other than a patient to be treated using an authenticating device attached to a treatment device used to treat said patient, the authorized person enabling a 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 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 within a specified time if the verifying failed to confirm that the response was received at the user interface; and

generating a second signal or if the verifying failed to confirm that the response was received from the individual other than said patient;

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

terminating said treatment of said patient responsively to and after said waiting.

25. The method of claim 24, wherein the authenticating includes machine-recognizing a biometric indicator of identity.

26. The method of claim 24, wherein the performing includes displaying requirements for a treatment procedure.

27. The method of claim 24, wherein the performing includes displaying a message requesting the presence of the individual.

28. The method of claim 24, wherein the authenticating includes reading a magnetic medium including a data key.

29. The method of claim 24, wherein the performing includes transmitting a message to a supervisor.

30. The method of claim 24, wherein the authenticating includes machine-classification of a video image.

31. The method of claim 24, further comprising authenticating the individual at least three times during a treatment session, the three times being spaced apart such that the third time is more than half-way through the treatment session.

32. The method of claim 24, wherein the authorized person is the same as the individual other than the patient.

33. The method of claim 24, wherein the authorized person is different than the individual other than the patient.

34. A medical device, comprising:

a medical treatment component; and

a monitoring system configured to receive data from sensors 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 at least one time during a treatment period 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 an individual 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 individual is present at the treatment location; and

a second input verifying the identity of said individual present 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 individual other than said patient;

the monitoring system being further configured to confirm a pattern of presences of the helper during a treatment period in which the medical treatment component is operative to deliver therapy to a patient based on the verifying;

the monitoring system generating a signal indicative of an abnormal condition when the pattern of presences of the helper is not confirmed.

35. The medical device of claim 34, wherein the monitoring system includes a video camera and a video classification engine that monitors a scene that includes the patient and the helper.

36. The medical system of claim 34, wherein the 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 non-volatile memory card reader, a smart card reader, a video camera, or a bar code reader.

37. The medical system of claim 34, wherein the monitoring system goes into a failsafe mode in response to the abnormal condition signal.

38. The medical system of claim 34, wherein the monitoring system causes the medical treatment component to go into a failsafe mode in response to the abnormal condition signal.

39. The medical system of claim 34, wherein the monitoring system generates an alert signal in response to the abnormal condition signal.

40. The medical system of claim 34, wherein the monitoring system generates an alert signal and waits for the reception of an alert-cancel command after generating the alert signal, the monitoring system causing the medical treatment component to go into a failsafe mode in response to the abnormal condition signal and the failure of the alert-cancel signal command being received.