Safety features for medical devices requiring assistance and supervision

• US 9,375,527 B2
• Filed: 04/09/2015
• Issued: 06/28/2016
• 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): PHAM, QUANG
• Application Number:
  US14/682,440
• Publication Number:
  US 20150209501A1
• Time in Patent Office: 446 Days
• US Class Current: 1/1
• 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 during a patient treatment session at a treatment location, comprising:

generating, by a controller, attached to, embedded in, or collocated with said medical treatment device, an enabling signal, based on an authentication of an authorized person other than a patient to be treated using an authentication device attached to said medical treatment device used to treat said patient, to cause said medical treatment device to become operable during said patient treatment session at said treatment location;

generating, by said controller, automatically and at predefined time intervals during said patient treatment session, one or more verification request signals requesting an individual other than said patient to manually input a verification response into a user interface of said controller attached to, embedded in, or co-located with the treatment device;

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

upon receipt of said verification response from said individual, verifying that said individual is present at said treatment location and identifying that said individual is an authorized individual other than said patient based on said verification response;

generating an alarm signal to indicate an impending termination of the treatment session within a specified time if said verifying failed to confirm that the individual is present at the treatment location and that the individual is the authorized individual;

waiting for the authorized individual to input a verification response within said specified time; and

terminating said treatment session responsively to a lack of confirmation of the presence and identity of said individual at the treatment location after said waiting.

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

3. The method of claim 1 wherein the verifying includes reading a magnetic medium including a data key associated with said individual.

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

5. The method of claim 1, further comprising displaying requirements for a treatment procedure of said treatment session.

6. The method of claim 1, further comprising transmitting a message to a supervisor upon the generation of the alarm signal.

7. The method of claim 1, wherein the predefined time intervals includes 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.

8. A medical treatment device being used during a patient treatment session at a treatment location, 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 and at predefined time intervals during the treatment session, generate one or more verification request signals requesting the helper to manually input of a verification response into a user interface of the monitoring system in response to the one or more verification request signals, the verification response verifying that the helper is present at the treatment location, and identifying that the helper is an authorized helper to be at the treatment location;

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

the monitoring system generating a signal indicative of an abnormal condition when the pattern of presences of the authorized 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.

9. The medical device of claim 8, 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 authorized helper is present at the treatment location.

10. The medical system of claim 8, wherein the one or more sensors include an authentication device including at least one of a key code receiver, an RFID reader, 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.

11. The medical system of claim 8, wherein the monitoring system goes into the failsafe operational mode in response to the abnormal condition.

12. The medical system of claim 8, wherein the monitoring system generates an alert signal in response to the abnormal condition.

13. The medical system of claim 8, 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.

14. A method for controlling an extracorporeal blood treatment machine at a treatment location to reduce risk of continuing blood treatment of a patient in the absence of an authorized helper other than the patient received the blood treatment in the immediate vicinity of the extracorporeal blood treatment machine, comprising:

prompting, by the extracorporeal blood treatment machine, at predetermined time intervals after starting the treatment, for an input, manually entered by the authorized helper into a user interface of the extracorporeal blood treatment machine, effective to confirm 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 input to determine that the helper is present at the treatment location and that the helper is the helper authorized to be present at the treatment location, continuing the blood treatment process by the extracorporeal blood treatment machine; and

(2) responsively to any absence of a receipt and confirmation of the input to determine that the helper is present at the treatment location and that the helper is the helper authorized to be present at the treatment location, implementing a failsafe operational mode 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, by the extracorporeal blood treatment machine, for the input at the predetermined time intervals to receive a subsequent input entered by the authorized helper into the user interface of the extracorporeal blood treatment machine 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 identity and presence of the helper is confirmed.

15. The method of claim 14, 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 authorized helper.

16. The method of claim 14, 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 authorized helper.

17. The method of claim 14, wherein the subsequent input includes authenticating the identity of the authorized helper to ensure it is the authorized helper.

18. The method of claim 14, wherein the blood treatment process is a renal replacement therapy.

19. The method of claim 14, wherein the controlling said extracorporeal blood treatment machine to implement said failsafe operational mode includes clamping blood lines of the extracorporeal blood treatment machine.

20. The method of claim 14, wherein implementing said failsafe operational mode includes generating one of an automated cellular message and an automated telephonic message to an ambulance service.

21. The method of claim 14, wherein implementing said failsafe operational mode includes slowing a pumping rate through blood lines of the extracorporeal blood treatment machine or terminating said blood treatment process.

22. The method of claim 14, 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 within the predefined time, and controlling said extracorporeal blood treatment machine to implement the failsafe operational mode responsively to the lapse of the predefined time.

23. The method of claim 14, 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.

24. The method of claim 14, wherein the receiving subsequent input includes authenticating the authorized 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.