SAFETY FEATURES FOR MEDICAL DEVICES REQUIRING ASSISTANCE AND SUPERVISION

• US 20090222671A1
• Filed: 10/25/2006
• Published: 09/03/2009
• Est. Priority Date: 10/25/2005
• Status: Abandoned Application

• Current Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Original Assignee: Nxstage Medical Incorporated (Fresenius SE & Co. KGaA)
• Inventors: Brugger, James M., Treu, Dennis M., Burbank, Jeffrey H.
• Application Number:
  US12/091,728
• Publication Number:
  US 20090222671A1
• Time in Patent Office: Days
• US Class Current: 713/186
• 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 device, comprising:

authenticating an authorized person other than a patient to be treated using a device attached to a treatment device used to treat said patient;

generating an enabling signal to cause said treatment device to become operable in response to a result of said authenticating;

verifying at least one time during a treatment interval that an individual other than said patient is at a treatment location where said patient and said treatment device are located;

performing a warning procedure responsively to a result of said verifying, said warning procedure including generating a signal to indicate an impending termination of treatment within a specified time;

waiting for said individual to verify a presence of said individual within said specified time;

terminating a treatment of said patient responsively to and after said step 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.

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

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 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 an authorized person at least three times during a treatment interval, the three times being spaced apart such that the third time is more than half-way through the treatment interval.

9. A medical device, comprising:

controls for operating the medical device;

a lock that prevents at least some functions of the medical device from being operable through the controls;

the lock granting initial access to the medical device when a key is applied to the lock;

a message generator that indicates that the medical device will go into a failsafe mode unless the lock is applied again at at least one time during a treatment interval;

the lock permitting continued operation of the medical device in response to the key being applied at the at least one time;

the medical device being configured to go into the failsafe mode when the key is not applied during the at least one time.

10. The device of claim 9, wherein the lock is configured to perform machine-recognition of a biometric indicator of identity.

11. The device of claim 9, further comprising a display and a message generator that displays requirements for a treatment procedure.

12. The device of claim 9, further comprising a communication device including one of a wireless terminal, a telephone, and a networked terminal that generates a message indicating the failure of the key to be applied to the lock at the at least one time.

13. The device of claim 9, wherein the key includes a magnetic medium storing a data key.

14. The device of claim 9, wherein the lock includes a video camera and a device configured for machine-classification of a video image from the video camera.

15. The device of claim 9, further comprising authenticating an authorized person at least three times during a treatment interval.

16. The device of claim 9, wherein the lock prevents access by locking an access panel covering the controls.

17. A medical device, comprising:

a medical treatment component;

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

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;

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

18. The medical device of claim 17, wherein the monitoring system includes a video camera and a video classification engine that monitors a scene that includes a patient and a helper.

19. The medical system of claim 17, 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.

20. The medical system of claim 17, wherein the monitoring system goes into a failsafe mode in response to the abnormal condition signal.

21. The medical system of claim 17, wherein the monitoring system causes the medical treatment component to go into a failsafe mode in response to the abnormal condition signal.

22. The medical system of claim 17, wherein the monitoring system generates an alert signal in response to the abnormal condition signal.

23. The medical system of claim 17, 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.