CA2473542A1 - Antimicrobial urine collection system and methods of manufacturing the same - Google Patents

Antimicrobial urine collection system and methods of manufacturing the same Download PDF

Info

Publication number
CA2473542A1
CA2473542A1 CA002473542A CA2473542A CA2473542A1 CA 2473542 A1 CA2473542 A1 CA 2473542A1 CA 002473542 A CA002473542 A CA 002473542A CA 2473542 A CA2473542 A CA 2473542A CA 2473542 A1 CA2473542 A1 CA 2473542A1
Authority
CA
Canada
Prior art keywords
urine collection
collection system
phr
bag
antimicrobial
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.)
Granted
Application number
CA002473542A
Other languages
French (fr)
Other versions
CA2473542C (en
Inventor
Ronald L. Bracken
James M. Lambert
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
CR Bard Inc
Original Assignee
Individual
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of CA2473542A1 publication Critical patent/CA2473542A1/en
Application granted granted Critical
Publication of CA2473542C publication Critical patent/CA2473542C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

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
    • A61L28/00—Materials for colostomy devices
    • A61L28/0007—Materials for colostomy devices containing macromolecular materials
    • A61L28/0011—Materials for colostomy devices containing macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F5/00—Orthopaedic methods or devices for non-surgical treatment of bones or joints; Nursing devices; Anti-rape devices
    • A61F5/44—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices
    • A61F5/441—Devices worn by the patient for reception of urine, faeces, catamenial or other discharge; Portable urination aids; Colostomy devices having venting or deodorant means, e.g. filters ; having antiseptic means, e.g. bacterial barriers
    • 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
    • A61L28/00—Materials for colostomy devices
    • A61L28/0034—Use of materials characterised by their function or physical properties
    • A61L28/0038—Medicaments; Biocides

Abstract

An antimicrobial urine collection system comprising a urine collection bag (1) and tubing (4) each made from a polymer, wherein the polymer comprises therein from about 0.1 to 20 phr of an antimicrobial agent. The anti microbial agent is preferably a phosphoric acid metal salt, preferably one in which zinc is the metal. The agent can be compounded into the polymer material for forming the system components.

Claims (24)

1. An antimicrobial urine collection system comprising a urine collection bag and tubing coupled to the bag and constructed to transport urine to the bag, the bag and tubing each made from a polymer, wherein said polymer of the bag or tubing comprises therein from about 0.1 to 20 phr of an antimicrobial agent substantially uniformly distributed therein, said antimicrobial agent not substantially affecting the clarity of the polymer, and exhibiting an antimicrobial effect.
2. The urine collection system according to claim 1, wherein said polymer comprises therein from about 0.5 to 7.5 phr of an antimicrobial agent.
3. The urine collection system according to claim 1, wherein said polymer comprises therein from about 4.5 phr of an antimicrobial agent.
4. The urine collection system according to claim 1, wherein said polymer is selected from the group of polymers consisting of polyethylene, polypropylene, ethylene vinyl acetate, metallocene catalyzed polyethylene, or blends thereof.
5. The urine collection system according to claim 1, wherein said polymer is polyvinyl chloride.
6. The urine collection system according to claim 1, wherein said polymer of said collection bag comprises from about 0.1 to 20 phr of an antimicrobial agent.
7. The urine collection system according to claim 1, wherein said polymer of said tubing comprises from about 0.1 to 20 phr of an antimicrobial agent.
8. The urine collection system according to claim 1, wherein said polymer of said tubing and said polymer of said collection bag each comprise from about 0.1 to 20 phr of an antimicrobial agent.
9. The urine collection system according to claim 8, wherein said polmer of said tubing and said collection bag collection bag are each polyvinyl chloride.
10. The urine collection system according to claim 1, wherein said antimicrobial agent is an organic acid metal salt.
11. The urine collection system according to claim 10, wherein said organic acid metal salt is a salt comprising phosphoric acid esters and zinc metal.
12. The urine collection system according to claim 10, wherein said antimicrobial agent comprises from about 0.3 to 5 phr of a phosphoric acid metal salt and in addition, from about 0.2 to 2.5 phr of a stabilizer.
13. The urine collection system according to claim 1, wherein said antimicrobial agent comprises from about 0.05 to 15 phr of a phosphoric acid metal salt and in addition, from about 0.1 to 5 phr of a stabilizer.
14. The urine collection system according to claim 1, wherein said antimicrobial agent comprises from about 0.3 to 5 phr of a phosphoric acid metal salt and from about 0.2 to 2.5 phr of a stabilizer.
15. The urine collection system according to claim 1, wherein said antimicrobial agent comprises from about 3 phr of a phosphoric acid metal salt and from about 1.5 phr of a stabilizer.
16. An antimicrobial urine collection system comprising a catheter joined to tubing and comprising a rubber material, wherein said rubber material comprises therein from about 0.1 to 20 phr of an antimicrobial agent.
17. The urine collection system according to claim 16, wherein said rubber material is natural rubber or silicone rubber.
18. The urine collection system according to claim 16, wherein said antimicrobial agent is an organic acid metal salt.
19. The urine collection system according to claim 18, wherein said organic acid metal salt is a salt comprising phosphoric acid esters and zinc metal.
20. An antimicrobial urine collection system comprising a urine collection bag and tubing coupled to the bag and constructed to transport urine to the bag, the bag and tubing each made from a polymer, wherein said polymer of the bag or tubing comprises therein from about 0.1 to 20 phr of an organic acid metal salt substantially uniformly distributed therein, said organic acid metal salt exhibiting an antimicrobial effect.
21. The urine collection system according to claim 20, wherein said bag or tubing exhibit an effective gram positive, gram negative and yeast zone of inhibition.
22. The urine collection system according to claim 20, further comprising a catheter, said catheter, collection bag and tubing each manufactured in such a way so as to release said antimicrobial agent in a sustained and controlled manner.
23. A method for manufacturing antimicrobial PVC tubing comprising the steps of:
compounding an antimicrobial agent comprising phosphoric acid esters and zinc metal into PVC
resin pellets at an effective concentration to provide an antimicrobial effect in the tubing;

placing said pellets into an extruder; and extruding said pellets through said extruder to form a tube having antimicrobial effectiveness.
24. A method for manufacturing antimicrobial PVC film for use as a urine collection bag comprising the steps of:
compounding an antimicrobial agent comprising phosphoric acid esters and zinc metal into PVC
resin pellets at an effective concentration to provide an antimicrobial effect in the film;
placing said pellets into a calendar; and calendaring said pellets into a thin film to having antimicrobial effectiveness.
CA2473542A 2002-01-18 2003-01-13 Antimicrobial urine collection system and methods of manufacturing the same Expired - Lifetime CA2473542C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/052,766 US6716200B2 (en) 2002-01-18 2002-01-18 Antimicrobial urine collection system and methods of manufacturing the same
US10/052,766 2002-01-18
PCT/US2003/000952 WO2003061732A2 (en) 2002-01-18 2003-01-13 Antimicrobial urine collection system and methods of manufacturing the same

Publications (2)

Publication Number Publication Date
CA2473542A1 true CA2473542A1 (en) 2003-07-31
CA2473542C CA2473542C (en) 2010-03-16

Family

ID=21979756

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2473542A Expired - Lifetime CA2473542C (en) 2002-01-18 2003-01-13 Antimicrobial urine collection system and methods of manufacturing the same

Country Status (8)

Country Link
US (1) US6716200B2 (en)
EP (1) EP1471959B1 (en)
JP (1) JP2005526543A (en)
AT (1) ATE546114T1 (en)
AU (1) AU2003205121B2 (en)
CA (1) CA2473542C (en)
MX (1) MXPA04006967A (en)
WO (1) WO2003061732A2 (en)

Families Citing this family (40)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050191355A1 (en) * 1999-05-27 2005-09-01 Foss Manufacturing Co., Inc. Anti-microbial and antifungal fluid conduits and methods of manufacture thereof
US8409508B2 (en) * 2002-04-23 2013-04-02 Biofire Diagnostics, Inc. Sample withdrawal and dispensing device
US20040126280A1 (en) * 2002-12-31 2004-07-01 Leaman Donald H. Method and apparatus for preserving urine specimens at room temperature
US8747882B2 (en) 2005-04-21 2014-06-10 Astra Tech Ab Catheter assembly with bactericidal effect
JP2007061312A (en) * 2005-08-30 2007-03-15 Hayabusa Giken:Kk Waste fluid measuring bag
US20070161949A1 (en) * 2006-01-06 2007-07-12 Knox Susan J Catheter system for minimizing retrograde bacterial transmission from a catheter tubing
US8430855B2 (en) * 2006-12-06 2013-04-30 Medline Industries, Inc. Fluid collection system and methods of using same
US7846142B2 (en) * 2006-12-06 2010-12-07 Medline Industries, Inc. Fluid collection system and methods of using same
DE102007018277A1 (en) † 2007-04-18 2008-10-30 Medical Service Gmbh Catheter set
WO2009046176A1 (en) * 2007-10-02 2009-04-09 C. R. Bard, Inc. Drainage catheter with one-way valve
EP2044963B1 (en) * 2007-10-03 2011-12-14 Astra Tech AB Catheter receptacle provided with an antimicrobial compound
JP2011510110A (en) * 2008-01-04 2011-03-31 シー．アール．バード，インコーポレイテッド Synthetic polyisoprene folly catheter
CN102131531A (en) 2008-06-30 2011-07-20 Cr巴德公司 Polyurethane/polysoprene blend catheter
US8357105B2 (en) 2008-08-07 2013-01-22 Covidien Lp Anti-reflux mechanism for urine collection systems
WO2010151682A2 (en) * 2009-06-25 2010-12-29 Rochester Medical Corporation Silicone catheter containing chlorhexidine gluconate
CA2772947A1 (en) * 2009-09-03 2011-03-10 Hollister Incorporated Foley catheter collection system
US8522813B2 (en) 2010-09-08 2013-09-03 Covidien Lp Needleless sampling port
WO2013118268A1 (en) * 2012-02-09 2013-08-15 東洋紡株式会社 Medical tube
WO2015031851A2 (en) 2013-08-30 2015-03-05 Hollister Incorporated Device for trans anal irrigation
CN105636633A (en) 2013-10-16 2016-06-01 C·R·巴德股份有限公司 Catheter insertion tray with integrated instructions
HUE063426T2 (en) 2014-05-30 2024-01-28 Hollister Inc Flip open catheter package
US10737013B2 (en) 2014-07-08 2020-08-11 Hollister Incorporated Portable trans anal irrigation device
EP3166662B1 (en) 2014-07-08 2023-06-07 Hollister Incorporated Trans anal irrigation platform with bed module
US11654042B2 (en) 2015-07-31 2023-05-23 Medivance Incorporated Urine output collection and monitoring system
WO2017185029A1 (en) 2016-04-22 2017-10-26 Hollister Incorporated Medical device package with a twist cap
US11103676B2 (en) 2016-04-22 2021-08-31 Hollister Incorporated Medical device package with flip cap having a snap fit
WO2018009871A1 (en) 2016-07-08 2018-01-11 Hollister Incorporated Wireless electronic pump design for a body cavity irrigation device
AU2017375606B2 (en) 2016-12-14 2021-12-23 Hollister Incorporated Transanal irrigation device and system
US11141562B2 (en) 2017-02-21 2021-10-12 Hollister Incorporated Medical device package with flip cap having a snap fit
WO2018183752A1 (en) 2017-03-31 2018-10-04 C.R. Bard, Inc. Catheter insertion-tray systems and methods thereof
US20210187238A1 (en) 2017-10-25 2021-06-24 Hollister Incorporated Caps for Catheter Packages
CA3084803A1 (en) 2017-12-08 2019-06-13 Hollister Incorporated A catheter product and package with hygienic means for removal from the package
USD884188S1 (en) * 2018-01-05 2020-05-12 Medline Industries, Inc. Vented urine meter
US10894148B2 (en) 2018-01-31 2021-01-19 C. R. Bard, Inc. Balloon-manipulating devices, balloon catheter assemblies, and methods thereof
CA3097891A1 (en) 2018-04-24 2019-10-31 C.R. Bard, Inc. Catheterization packages and methods thereof
US11938277B2 (en) 2018-05-22 2024-03-26 C. R. Bard, Inc. Catheterization system and methods for use thereof
EP3810022A4 (en) 2018-06-20 2022-04-27 C. R. Bard, Inc. Urinary catheter-insertion kits with integrated instructions for use and methods thereof
CN112566550A (en) 2018-08-10 2021-03-26 C·R·巴德股份有限公司 Automated urine output measurement system and method
US11703365B2 (en) 2020-07-14 2023-07-18 C. R. Bard, Inc. Automatic fluid flow system with push-button connection
US11931151B2 (en) 2020-12-22 2024-03-19 C. R. Bard, Inc. Automated urinary output measuring system

Family Cites Families (45)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3598127A (en) * 1968-06-06 1971-08-10 James G Wepsic Catheter having antibacterial substance therein provided with means permitting slow release of said substance
US4372313A (en) 1980-04-11 1983-02-08 The Kendall Company Body drainage receptacle with anti-septic catheter contact surface in receiving pocket
EP0065884B1 (en) 1981-05-27 1986-08-20 Unitika Ltd. Urethral catheter capable of preventing urinary tract infection and process for producing the same
US4603152A (en) 1982-11-05 1986-07-29 Baxter Travenol Laboratories, Inc. Antimicrobial compositions
US4592920A (en) * 1983-05-20 1986-06-03 Baxter Travenol Laboratories, Inc. Method for the production of an antimicrobial catheter
US4675347A (en) * 1983-10-29 1987-06-23 Unitika Ltd. Antimicrobial latex composition
US4623329A (en) 1983-12-15 1986-11-18 The Procter & Gamble Company Drainage and infusion catheters having a capillary sleeve forming a reservoir for a fluid antimicrobial agent
DE3563814D1 (en) 1984-02-23 1988-08-25 Unitika Ltd Bladder assist device
US4581028A (en) 1984-04-30 1986-04-08 The Trustees Of Columbia University In The City Of New York Infection-resistant materials and method of making same through use of sulfonamides
US4563485A (en) 1984-04-30 1986-01-07 The Trustees Of Columbia University In The City Of New York Injection-resistant materials and method of making same through use of nalidixic acid derivatives
DE3422510A1 (en) * 1984-06-16 1985-12-19 Basf Ag, 6700 Ludwigshafen METHOD FOR THE PRODUCTION OF O, O'-METHYLENETHER GROUPS LINKED PHENOLRESOLETHERS AND THE USE THEREOF
US4723950A (en) 1984-12-12 1988-02-09 C. R. Bard, Inc. Urine drainage bag outlet with barrier against microbial infection
US4917686A (en) 1985-12-16 1990-04-17 Colorado Biomedical, Inc. Antimicrobial device and method
US4696329A (en) 1986-06-09 1987-09-29 Mateer Burt Co., Inc. Feedback control for automatic filling machine
US5019378A (en) * 1987-12-29 1991-05-28 Cuno, Incorporated Elastomeric composition containing therapeutic agents and articles manufactured therefrom
DE3931659A1 (en) 1988-10-12 1990-04-19 Martin Rahe DEVICE FOR RECORDING UNCONTROLLABLE ELIMINATED URINS
US4925668A (en) 1989-01-18 1990-05-15 Becton, Dickinson And Company Anti-infective and lubricious medical articles and method for their preparation
US5007897A (en) 1989-05-30 1991-04-16 Kalb Irvin M Drug delivery catheter
US5269770A (en) 1990-01-10 1993-12-14 Rochester Medical Corporation Microcidal agent releasing catheter with balloon
US5098379A (en) 1990-01-10 1992-03-24 Rochester Medical Corporation Catheter having lubricated outer sleeve and methods for making and using same
US5137671A (en) 1990-01-10 1992-08-11 Rochester Medical Corporation Methods of making balloon catheters
US5261896A (en) 1990-01-10 1993-11-16 Rochester Medical Corporation Sustained release bactericidal cannula
AU7998091A (en) 1990-05-17 1991-12-10 Harbor Medical Devices, Inc. Medical device polymer
US5176665A (en) 1991-01-18 1993-01-05 Alza Corporation Antimicrobial device for urine drainage container
US5236422A (en) 1991-06-24 1993-08-17 Eplett Jr James D Antiseptic urinary catheter cuff
FR2679142B1 (en) 1991-07-18 1995-06-09 Nice Sophia Antipolis Universi PROCESS FOR THE PROTECTION OF PROSTHESES, IMPLANTABLE PROVISIONAL OR DEFINITIVE MATERIALS AGAINST COLONIZATION AND BACTERIAL INFECTION.
US5217493A (en) 1992-03-11 1993-06-08 Board Of Regents, The University Of Texas System Antibacterial coated medical implants
US5492763A (en) * 1992-06-08 1996-02-20 Spire Corporation Infection resistant medical devices and process
US5362754A (en) 1992-11-12 1994-11-08 Univ. Of Tx Md Anderson Cancer Center M-EDTA pharmaceutical preparations and uses thereof
US5554147A (en) 1994-02-01 1996-09-10 Caphco, Inc. Compositions and devices for controlled release of active ingredients
US5624704A (en) 1995-04-24 1997-04-29 Baylor College Of Medicine Antimicrobial impregnated catheters and other medical implants and method for impregnating catheters and other medical implants with an antimicrobial agent
US5820607A (en) 1995-06-05 1998-10-13 Board Of Regents, University Of Texas Systems Multipurpose anti-microbial silastic sheath system for the prevention of device-related infections
US5772640A (en) 1996-01-05 1998-06-30 The Trustees Of Columbia University Of The City Of New York Triclosan-containing medical devices
US5709672A (en) 1995-11-01 1998-01-20 Texas Tech University Health Sciences Center Silastic and polymer-based catheters with improved antimicrobial/antifungal properties
US6558686B1 (en) 1995-11-08 2003-05-06 Baylor College Of Medicine Method of coating medical devices with a combination of antiseptics and antiseptic coating therefor
US5843436A (en) 1996-04-22 1998-12-01 The Trustees Of Columbia University, In The City Of New York Method of preventing and treating bacterial infection of sutures and prosthetic devices, and promoting ingress of leukocytes into tumor foci
US5945319A (en) 1996-04-25 1999-08-31 Medtronic, Inc. Periodate oxidative method for attachment of biomolecules to medical device surfaces
DE19636800A1 (en) * 1996-09-11 1998-03-12 Audio Service Gmbh As In-ear hearing aid
US5718624A (en) 1996-11-01 1998-02-17 Volk Enterprises, Inc. Support structure for storing poultry retainers
US6242526B1 (en) * 1997-01-28 2001-06-05 Stepan Company Antimicrobial polymer latexes derived from unsaturated quaternary ammonium compounds and antimicrobial coatings, sealants, adhesives and elastomers produced from such latexes
DE19705579A1 (en) 1997-02-14 1998-08-20 Huels Chemische Werke Ag An article with microorganism repellent coating, its preparation and use
DE19716606A1 (en) 1997-04-21 1998-10-22 Huels Chemische Werke Ag Bacteria-repellent and blood-compatible modified surfaces
US6110483A (en) 1997-06-23 2000-08-29 Sts Biopolymers, Inc. Adherent, flexible hydrogel and medicated coatings
US6119192A (en) 1998-10-21 2000-09-12 Integrated Technology Express, Inc. Circuit and method for configuring a bus bridge using parameters from a supplemental parameter memory
US6224579B1 (en) 1999-03-31 2001-05-01 The Trustees Of Columbia University In The City Of New York Triclosan and silver compound containing medical devices

Also Published As

Publication number Publication date
WO2003061732A3 (en) 2003-10-30
WO2003061732A2 (en) 2003-07-31
ATE546114T1 (en) 2012-03-15
AU2003205121B2 (en) 2008-12-18
EP1471959A2 (en) 2004-11-03
US20030139730A1 (en) 2003-07-24
US6716200B2 (en) 2004-04-06
EP1471959A4 (en) 2006-05-17
EP1471959B1 (en) 2012-02-22
CA2473542C (en) 2010-03-16
MXPA04006967A (en) 2004-11-26
JP2005526543A (en) 2005-09-08

Similar Documents

Publication Publication Date Title
CA2473542A1 (en) Antimicrobial urine collection system and methods of manufacturing the same
AU2002350113B2 (en) Method to reduce the rate of diffusion of slow-release materials through polymers and process for making drip irrigation devices with long-term control of root growth
US5928744A (en) PVC-free multilayer tube for medical purposes, process for the production thereof and use
AU2003205121A1 (en) Antimicrobial urine collection system and methods of manufacturing the same
US5178495A (en) Polymeric film with biocide
US9144958B2 (en) Sheets for use with medical containers
CN104788787A (en) Film material for greenhouse and preparation method of film material
CA2470392A1 (en) Medical devices employing chain extended polymers
JP2002029904A (en) Method for producing insect-proofing film
US20070231391A1 (en) Anti-microbial and hydrophilic article and methods for manufacturing the same
JPH06327759A (en) Medical apparatus and method using chloride-free odor interruption material
KR20120130183A (en) Process to make biodegradable a synthetic polymer
EP3464430B1 (en) Methods of improving adhesion of non-di-(2-ethylhexyl)phthalate polyvinyl chloride to an acrylic- or abs-based polymer
JPH0690628A (en) Bag for culturing fruit
JPH11246727A (en) Biodegradable resin composition and molding
CN116919704B (en) Environment-friendly artificial fistula bag convenient to firmly connect and preparation method thereof
JP2575463B2 (en) Agricultural synthetic resin coating
JPH0977882A (en) Water-blocking sheet
JPH0532834A (en) Resin film or sheet excellent in heat sealability
JP2654088B2 (en) Agricultural synthetic resin coating
CN114763423A (en) Efficient PE film capable of being degraded continuously and production method thereof
JPS5890960A (en) Agricultural laminated film
JP3234612B2 (en) Agricultural synthetic resin film
JPS605464B2 (en) Surface protection film
JP2654098B2 (en) Agricultural synthetic resin coating

Legal Events

Date Code Title Description
EEER Examination request
MKEX Expiry

Effective date: 20230113