US20050121350A1 - Use indication system for medical device - Google Patents
Use indication system for medical device Download PDFInfo
- Publication number
- US20050121350A1 US20050121350A1 US10/989,580 US98958004A US2005121350A1 US 20050121350 A1 US20050121350 A1 US 20050121350A1 US 98958004 A US98958004 A US 98958004A US 2005121350 A1 US2005121350 A1 US 2005121350A1
- Authority
- US
- United States
- Prior art keywords
- tabs
- sterilization
- tab
- instrument
- cycles
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/26—Accessories or devices or components used for biocidal treatment
- A61L2/28—Devices for testing the effectiveness or completeness of sterilisation, e.g. indicators which change colour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/08—Accessories or related features not otherwise provided for
- A61B2090/0813—Accessories designed for easy sterilising, i.e. re-usable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2/00—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor
- A61L2/02—Methods or apparatus for disinfecting or sterilising materials or objects other than foodstuffs or contact lenses; Accessories therefor using physical phenomena
- A61L2/04—Heat
- A61L2/06—Hot gas
- A61L2/07—Steam
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2202/00—Aspects relating to methods or apparatus for disinfecting or sterilising materials or objects
- A61L2202/20—Targets to be treated
- A61L2202/24—Medical instruments, e.g. endoscopes, catheters, sharps
Definitions
- the field of the invention is sterilization cycle counting for a disposable medical instrument.
- This system enables a user to track the number of uses of a reusable medical device.
- This system incorporates sterilization indicator tabs that are added to a portion of the plastic hub of reusable arthroscopic shavers and burrs.
- the invention was created to develop a method that could be used by the operating room staff which would indicate how many times a reusable shaver blade has been cycled. Without such a system, the operating room personnel have no way of knowing how many times the device has been cycled; i.e. used and sterilized.
- a typical cycle of use for a reusable blade or burr would be as follows:
- a cycle counter for sterilization cycles for a disposable instrument features a plurality of tabs. With each sterilization, after the initial use, a tab is removed by medical personnel. The instrument is disposed of after the final use with no tabs left.
- FIG. 1 is an exploded side elevational view of a prior art shaver blade.
- FIG. 2 is an end view of a component of the shaver blade of FIG. 1 , modified in accordance with the principles of this invention.
- FIG. 3 shows a cross-section of FIG. 2 taken along the line A-A.
- FIG. 4 is an enlarged view of a portion of FIG. 3 .
- a prior art shaver blade 10 comprises an inner member 18 rotatably situated within an outer member 19 .
- the outer member has a molded hub 19 a at its proximal end to facilitate its attachment to a handpiece (not shown).
- Inner member 18 has a conventional spring retainer 12 which is press fit adjacent a ring tang 13 b to facilitate the retention of the shaver blade within the handpiece in a manner enabling rotation of the inner member.
- Retainer 13 is situated adjacent a hub 13 a of the inner member.
- the proximal rim 13 of retainer 12 is smooth and circular.
- the hubs 13 a and 19 a as well as components 12 and 13 b are molded from suitable polymeric material and rim 13 is modified to form new rim 16 having tabs 14 .
- the sterilization indicator tabs 14 provide a simple, visual, inexpensive method of indicating how many times the shaver blade has been cycled. If the number of recommended uses is seven, six small, removable sterilization indicator tabs 14 are molded into the distal rim 16 of plastic spring retainer component 12 formed. These tabs are easily removable and, if they are removed by the user one at a time after each sterilization, they become visual indicators for the operating room personnel of how many times the device has been cycled. These tabs are an integral feature of the device and their removal does not adversely affect the performance of the device in any way.
- the tabs may be attached to or integrally formed with other portions of the hubs of the inner or outer members.
- the tabs could be formed as extensions from the proximal or distal ends of hubs 13 a or 19 a.
- the new processing cycle would be as follows:
- tabs may be molded into rim 16 , depending upon how many uses one desires to track.
Abstract
A cycle counter for sterilization cycles for a disposable instrument features a plurality of tabs. With each sterilization after the initial use, a tab is removed by medical personnel. The instrument is disposed of after the final use with no tabs left.
Description
- The field of the invention is sterilization cycle counting for a disposable medical instrument.
- This system enables a user to track the number of uses of a reusable medical device. This system incorporates sterilization indicator tabs that are added to a portion of the plastic hub of reusable arthroscopic shavers and burrs. The invention was created to develop a method that could be used by the operating room staff which would indicate how many times a reusable shaver blade has been cycled. Without such a system, the operating room personnel have no way of knowing how many times the device has been cycled; i.e. used and sterilized.
- A typical cycle of use for a reusable blade or burr would be as follows:
-
- 1) Product is delivered, sealed and sterilized, to the hospital.
- 2) Product is used for surgery.
- 3) The shaver is cleaned at the hospital site using common cleaning techniques.
- 4) The device is then autoclaved (or otherwise sterilized) along with other reusable devices.
- 5) The device is delivered acseptically back to the surgical suite.
- With conventional arthroscopic/endoscopic shavers there is no visual indicator of how many times the device has been through this cycle. It has been reported that some devices have been used well beyond the recommended useful life. One such device is described by its manufacturer to be qualified for a given number of uses, for example, seven. The effectiveness of the device beyond this point is not recommended and the manufacturer advises that the device be disposed of after the recommended number of cycles.
- A cycle counter for sterilization cycles for a disposable instrument features a plurality of tabs. With each sterilization, after the initial use, a tab is removed by medical personnel. The instrument is disposed of after the final use with no tabs left.
-
FIG. 1 is an exploded side elevational view of a prior art shaver blade. -
FIG. 2 is an end view of a component of the shaver blade ofFIG. 1 , modified in accordance with the principles of this invention. -
FIG. 3 shows a cross-section ofFIG. 2 taken along the line A-A. -
FIG. 4 is an enlarged view of a portion ofFIG. 3 . - As shown in
FIG. 1 , a priorart shaver blade 10 comprises an inner member 18 rotatably situated within an outer member 19. The outer member has a moldedhub 19 a at its proximal end to facilitate its attachment to a handpiece (not shown). Inner member 18 has aconventional spring retainer 12 which is press fit adjacent a ring tang 13 b to facilitate the retention of the shaver blade within the handpiece in a manner enabling rotation of the inner member.Retainer 13 is situated adjacent a hub 13 a of the inner member. In the prior art device theproximal rim 13 ofretainer 12 is smooth and circular. In the preferred embodiment of the invention, thehubs 13 a and 19 a as well ascomponents 12 and 13 b are molded from suitable polymeric material andrim 13 is modified to formnew rim 16 havingtabs 14. Thesterilization indicator tabs 14 provide a simple, visual, inexpensive method of indicating how many times the shaver blade has been cycled. If the number of recommended uses is seven, six small, removablesterilization indicator tabs 14 are molded into thedistal rim 16 of plasticspring retainer component 12 formed. These tabs are easily removable and, if they are removed by the user one at a time after each sterilization, they become visual indicators for the operating room personnel of how many times the device has been cycled. These tabs are an integral feature of the device and their removal does not adversely affect the performance of the device in any way. - It will be understood that the tabs may be attached to or integrally formed with other portions of the hubs of the inner or outer members. For example, the tabs could be formed as extensions from the proximal or distal ends of
hubs 13 a or 19 a. - The new processing cycle would be as follows:
-
- 1) Product is delivered, sealed and sterilized, to the hospital, with 6 sterilization indicator tabs.
- 2) Product is used for surgery.
- 3) The shaver is cleaned at the hospital site using common cleaning techniques.
- 4) One of the sterilization indicator tabs is removed from the device using a common surgical tool such as a forceps.
- 5) The device is then autoclaved along with other reusable devices.
- 6) The shaver is delivered acseptically back to the surgical suite for reuse.
- 7) The cycle is repeated until all tabs have been removed after which the device is disposed of.
- It will be understood that any number of tabs may be molded into
rim 16, depending upon how many uses one desires to track. - It will be understood by those skilled in the art that numerous improvements and modifications may be made to the preferred embodiment of the invention disclosed herein without departing from the spirit and scope thereof.
Claims (15)
1. An apparatus for tracking the number of sterilization cycles for a medical instrument, comprising:
a sterilization cycle counter that gives a visual indication of the number of remaining uses without moving parts or reliance on chemical reaction.
2. The apparatus of claim 1 , wherein:
said counter is not sensitive to heat or pressure cycles from autoclaving.
3. The apparatus of claim 2 , wherein:
said counter comprises a plurality to tabs.
4. The apparatus of claim 3 , wherein:
said tabs are selectively removable.
5. The apparatus of claim 4 , wherein:
one tab is removed by medical personnel for each sterilization.
6. The apparatus of claim 5 , wherein:
the removal of the last tab indicates the final sterilization.
7. The apparatus of claim 6 , wherein:
the tabs are removable, one at a time, with a surgical tool.
8. The apparatus of claim 7 , wherein:
forceps are used to remove each tab.
9. The apparatus of claim 8 , wherein:
for n cycles of the instrument including the initial use, n−1 tabs are provided.
10. The apparatus of claim 1 wherein the apparatus is a shaver blade and the sterilization cycle counter comprises a plurality of removable tabs secured to a component of the shaver blade.
11. The apparatus of claim 10 wherein said component is the hub of the shaver blade.
12. The apparatus of claim 10 wherein said component is a spring retainer.
13. A method of keeping track of sterilization cycles for a medical instrument, comprising:
providing a tab for each remaining sterilization cycle;
removing said tab in close proximity in time to said sterilization;
disposing of the instrument after use, when no tab remains.
14. The method of claim 13 , comprising:
providing n-1 tabs for an instrument that can be used n times, including the initial use.
15. The method of claim 14 , comprising:
removing a tab with forceps.
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/989,580 US20050121350A1 (en) | 2003-12-06 | 2004-11-16 | Use indication system for medical device |
EP04257470A EP1537881A1 (en) | 2003-12-06 | 2004-12-01 | Use indicator system for medical device |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US52762903P | 2003-12-06 | 2003-12-06 | |
US10/989,580 US20050121350A1 (en) | 2003-12-06 | 2004-11-16 | Use indication system for medical device |
Publications (1)
Publication Number | Publication Date |
---|---|
US20050121350A1 true US20050121350A1 (en) | 2005-06-09 |
Family
ID=34468056
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/989,580 Abandoned US20050121350A1 (en) | 2003-12-06 | 2004-11-16 | Use indication system for medical device |
Country Status (2)
Country | Link |
---|---|
US (1) | US20050121350A1 (en) |
EP (1) | EP1537881A1 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090050253A1 (en) * | 2007-08-23 | 2009-02-26 | Opsec Security Group, Inc. | Reprocess Indicating Device |
US8961520B2 (en) | 2011-11-28 | 2015-02-24 | Christopher G. Sidebotham | Medical cutting tool quality control systems and methods |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP2731517A2 (en) | 2011-07-11 | 2014-05-21 | Medical Vision Research & Development AB | Status control for electrically powered surgical tool systems |
Citations (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4268958A (en) * | 1979-11-01 | 1981-05-26 | Ray Hilbert | Apparatus and method for counting the number of shaves for which a razor blade is used |
US4321999A (en) * | 1979-12-31 | 1982-03-30 | Higgins Sam M | Reusable surgical implements holder |
US4752087A (en) * | 1986-09-17 | 1988-06-21 | Ruth Weisbach | Medication recordkeeping indicia |
US4941688A (en) * | 1989-11-15 | 1990-07-17 | Truman Jones | Periodic event recorder |
US5062209A (en) * | 1990-07-27 | 1991-11-05 | Elliot Rais | Use indicator for a disposable razor |
US5240107A (en) * | 1992-12-02 | 1993-08-31 | James Casale | Razor holder with shave counter |
US5313935A (en) * | 1992-12-31 | 1994-05-24 | Symbiosis Corporation | Apparatus for counting the number of times a surgical instrument has been used |
US5335994A (en) * | 1988-10-04 | 1994-08-09 | G.I.R. | Temperature monitoring device containing at least one element of an alloy which memorizes its shape |
US5359993A (en) * | 1992-12-31 | 1994-11-01 | Symbiosis Corporation | Apparatus for counting the number of times a medical instrument has been used |
US5407069A (en) * | 1994-01-26 | 1995-04-18 | Arthrex, Inc. | Shaver blade sterilization case with built-in counter |
US5421286A (en) * | 1993-03-05 | 1995-06-06 | Mclean; Scott | Disposable shaver with counter and method of counting and quantitatively comparing the useful life of disposable shavers |
US5452335A (en) * | 1992-12-31 | 1995-09-19 | Symbiosis Corporation | Temperature cycle counter |
US5766200A (en) * | 1993-05-06 | 1998-06-16 | Linvatec Corporation | Rotatable endoscopic shaver with polymeric blades |
US5956850A (en) * | 1995-06-07 | 1999-09-28 | Poulsen; Thomas Edward | Disposable razor with means for recording usage |
US6032609A (en) * | 1997-11-10 | 2000-03-07 | Luoma; Van A. | Dosage indicator medicine container |
US6223137B1 (en) * | 1999-03-25 | 2001-04-24 | The University Of Tennessee Research Corporation | Method for marking, tracking, and managing hospital instruments |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6166538A (en) * | 1998-08-26 | 2000-12-26 | Linvatec Corporation | Autoclave cycle monitor for autoclaved instruments |
US6779715B2 (en) * | 2001-12-06 | 2004-08-24 | Lumitex, Inc. | Counter mechanisms |
-
2004
- 2004-11-16 US US10/989,580 patent/US20050121350A1/en not_active Abandoned
- 2004-12-01 EP EP04257470A patent/EP1537881A1/en not_active Withdrawn
Patent Citations (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4268958A (en) * | 1979-11-01 | 1981-05-26 | Ray Hilbert | Apparatus and method for counting the number of shaves for which a razor blade is used |
US4321999A (en) * | 1979-12-31 | 1982-03-30 | Higgins Sam M | Reusable surgical implements holder |
US4752087A (en) * | 1986-09-17 | 1988-06-21 | Ruth Weisbach | Medication recordkeeping indicia |
US5335994A (en) * | 1988-10-04 | 1994-08-09 | G.I.R. | Temperature monitoring device containing at least one element of an alloy which memorizes its shape |
US4941688A (en) * | 1989-11-15 | 1990-07-17 | Truman Jones | Periodic event recorder |
US5062209A (en) * | 1990-07-27 | 1991-11-05 | Elliot Rais | Use indicator for a disposable razor |
US5240107A (en) * | 1992-12-02 | 1993-08-31 | James Casale | Razor holder with shave counter |
US5359993A (en) * | 1992-12-31 | 1994-11-01 | Symbiosis Corporation | Apparatus for counting the number of times a medical instrument has been used |
US5313935A (en) * | 1992-12-31 | 1994-05-24 | Symbiosis Corporation | Apparatus for counting the number of times a surgical instrument has been used |
US5452335A (en) * | 1992-12-31 | 1995-09-19 | Symbiosis Corporation | Temperature cycle counter |
US5421286A (en) * | 1993-03-05 | 1995-06-06 | Mclean; Scott | Disposable shaver with counter and method of counting and quantitatively comparing the useful life of disposable shavers |
US5766200A (en) * | 1993-05-06 | 1998-06-16 | Linvatec Corporation | Rotatable endoscopic shaver with polymeric blades |
US5407069A (en) * | 1994-01-26 | 1995-04-18 | Arthrex, Inc. | Shaver blade sterilization case with built-in counter |
US5956850A (en) * | 1995-06-07 | 1999-09-28 | Poulsen; Thomas Edward | Disposable razor with means for recording usage |
US6032609A (en) * | 1997-11-10 | 2000-03-07 | Luoma; Van A. | Dosage indicator medicine container |
US6223137B1 (en) * | 1999-03-25 | 2001-04-24 | The University Of Tennessee Research Corporation | Method for marking, tracking, and managing hospital instruments |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20090050253A1 (en) * | 2007-08-23 | 2009-02-26 | Opsec Security Group, Inc. | Reprocess Indicating Device |
US8961520B2 (en) | 2011-11-28 | 2015-02-24 | Christopher G. Sidebotham | Medical cutting tool quality control systems and methods |
Also Published As
Publication number | Publication date |
---|---|
EP1537881A1 (en) | 2005-06-08 |
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
AS | Assignment |
Owner name: LINVATEC CORPORATION, FLORIDA Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:BOGREN, ROBERT G.;FAGAN, MARIANNE;ADAY, JORGE L.;REEL/FRAME:015997/0948 Effective date: 20041116 |
|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |