Comprehensive tissue management system
First Claim
1. A method for tracking the internal processing by a medical establishment of a piece of transplantable material provided by a supplier for subsequent transplantation or implantation into a patient, such method comprising:
- (a) assigning a unique identification code to the transplantable material upon its receipt by the medical establishment from the supplier;
(b) inspecting the transplantable material upon its receipt from the supplier for an unsafe condition.(c) ensuring that each processing step comprising handling, storage, reconstitution or surgical use of the transplantable material by staff members of the medical establishment is conducted strictly in a manner compliant with prevailing regulations and industry standards;
(d) assessing the patient after transplantation or implantation of the transplantable material for evidence of an adverse effect;
(e) investigating any such adverse effect discovered in the patient to determine whether it constitutes an adverse reaction; and
(f) reporting any such adverse reaction to the supplier that supplied the transplant material to the medical establishment.
1 Assignment
0 Petitions
Accused Products
Abstract
The present invention provides a comprehensive tissue management method and system for transplantable materials like tissues and organs. The tracking portion of the system verifies that staff members of a medical establishment like a hospital have handled, stored, transported, reconstituted, and used the tissue or organ materials in a safe and regulatory-compliant manner from the point of receipt to the point of issuance or surgical use throughout the hospital'"'"'s organization. The tracing portion of the system creates an integral record that documents which hospital staff members have provided which processing steps to the tissue or organ, any associated materials used in conjunction with such tissue or organ, and an identification of the tissue or organ that was transplanted or implanted inside a patient. Such a system will enable adverse reaction investigations for transplant patients.
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Citations
20 Claims
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1. A method for tracking the internal processing by a medical establishment of a piece of transplantable material provided by a supplier for subsequent transplantation or implantation into a patient, such method comprising:
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(a) assigning a unique identification code to the transplantable material upon its receipt by the medical establishment from the supplier; (b) inspecting the transplantable material upon its receipt from the supplier for an unsafe condition. (c) ensuring that each processing step comprising handling, storage, reconstitution or surgical use of the transplantable material by staff members of the medical establishment is conducted strictly in a manner compliant with prevailing regulations and industry standards; (d) assessing the patient after transplantation or implantation of the transplantable material for evidence of an adverse effect; (e) investigating any such adverse effect discovered in the patient to determine whether it constitutes an adverse reaction; and (f) reporting any such adverse reaction to the supplier that supplied the transplant material to the medical establishment. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9)
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10. The method for tracing a piece of transplantable material received by a medical establishment from a supplier throughout the internal life of the transplantable material within the medical establishment until it is transplanted or implanted into a patient, such method comprising:
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(a) assigning a unique identification code for the transplantable material upon its receipt by the medical establishment from the supplier; (b) documenting each processing step comprising login, handling, storage, reconstitution, or surgical use applied by staff members to the transplantable material; (c) documenting the identity of each staff member who comes into contact with the transplantable material; (d) documenting the date and time of each processing step applied to the transplantable material; (e) documenting all materials used to prepare and process the transplantable material; (f) documenting the unique identification code of the transplantable material transplanted or implanted into the patient; and (g) tracing the transplantable material back to the supplier that supplied it to the medical establishment or to the specific processing step applied by a staff member of the medical establishment to the transplantable. - View Dependent Claims (11, 12, 13, 14, 15, 16, 17, 18, 19, 20)
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Specification