JP2014128673A - 薬物投与ならびに医療品および医療用キットの品質および安全性を確実にするための方法およびデバイス - Google Patents
薬物投与ならびに医療品および医療用キットの品質および安全性を確実にするための方法およびデバイス Download PDFInfo
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Abstract
【解決手段】使い捨ての部品、供給品およびキットのIDおよび製造業者に関する情報を格納する品質保証マーカ(QAM16、18)が記載される。とりわけ、1次元および2次元バーコード、1次元および2次元記号表示法、ホログラム、書かれた文字、無線周波数識別デバイス(RFID)、集積チップスマートカード、EEPROMのようないくつかのQAM形式を利用する。
【選択図】図1
Description
Claims (18)
- 医療処置並びに/又は手術処置中に鎮静及び/若しくは鎮痛を必要としている挿管されていない患者への、麻酔医でない者による全身麻酔を伴わない鎮静剤及び/若しくは鎮痛剤の安全な送出をもたらす安全性を高めた方法において、
前記処置中に前記患者に鎮静剤及び/若しくは鎮痛剤を送出するために前記患者に薬物送出装置をつなぐステップと、
前記処理中に前記薬物送出装置によって使用されることになる1つ以上の使い捨て部品に品質保証マーカを与えるステップであって、前記品質保証マーカが、前記使い捨て部品の品質、状態及び/又は識別を前記麻酔医でない者に知らせるための情報をもつステップと、
前記薬物送出装置を起動する前に、前記使い捨て部品が前記使い捨て部品の品質、状態及び/又は識別の要件に適合することを前記麻酔医でない者に確実なものにするために、使い捨て薬物容器及び/又は使い捨てカセットに備えられる前記品質保証マーカを読み取るためのリーダを使用するステップと、
全身麻酔を引き起こすことなく、鎮静及び/若しくは鎮痛管理をもたらすように前記薬物を前記患者に投与するステップであって、開始される前記投与のレートは、少なくとも一部は、安全且つ効果的な慣行に従ったプロセッサによるものであるステップと
を含む方法。 - 前記品質保証マーカは、バーコード、ホログラム、書かれた文字、RFID、EEPROM、集積回路、スマートカード及び磁気ストリップのいずれか1つのタイプである請求項1に記載の方法。
- 前記品質保証マーカがもつ前記情報は、固有シリアル番号、バッチ番号、製造日、製造業者、内容物アイデンティティ、内容物体積及び有効期限のうちの1つ以上の情報を含む請求項1に記載の方法。
- 前記使い捨て部品は、格納される鎮静剤及び/若しくは鎮痛剤を有する容器を含む請求項1に記載の方法。
- 医療処置並びに/又は手術処置中に鎮静剤を必要としている挿管されていない患者への、麻酔医でない者による全身麻酔を伴わない鎮静剤の安全性を高めた送出を提供する鎮静システムにおいて、
前記患者に1つ以上の鎮静剤及び/若しくは鎮痛剤を安全に送出するために麻酔医でない者によって前記患者につながれるように適応した電子薬物送出装置を備え、
前記電子薬物送出装置は、前記患者からモニターされる生理学的な情報を受け取り且つ全身麻酔を伴わずに鎮静を達成するように安全で効果的なレートで薬物送出を制御するためのプロセッサを有し、
前記電子薬物送出装置は、使い捨て品がもつ品質保証マーカを読み取るリーダを有し、前記品質保証マーカは、前記患者に前記薬物を送出する及び前記使い捨て品が前記鎮静システムの特定の要求に適合するのを前記麻酔医でない者に確実なものにするように、前記電子薬物送出装置によって使用され、
前記鎮静システムは、
情報を含み随伴した品質保証マーカを有する少なくとも1つの前記使い捨て品を備え、
前記情報は、前記リーダによって読み取られて、前記麻酔医でない者に対して、前記患者に安全で効果的な鎮静をもたらすように前記鎮静システムと共に用いるのに前記使い捨て品が適するのを確実なものにする、システム。 - 前記品質保証マーカは、バーコード、ホログラム、書かれた文字、RFID、EEPROM、集積回路、スマートカード及び磁気ストリップのいずれか1つのタイプである請求項5に記載のシステム。
- 前記品質保証マーカに含まれる前記情報は、固有シリアル番号、バッチ番号、薬物を識別するもの、製造日、製造業者、内容物アイデンティティ、内容物体積及び有効期限のうちの1つ以上の情報を含む請求項5に記載のシステム。
- 前記使い捨て品は、品質保証マーカを支持するパッケージに含まれる請求項5に記載のシステム。
- 前記使い捨て品は、薬物容器及び/又はカセットを含む請求項5に記載のシステム。
- 医療処置並びに/又は手術処置中に鎮静剤及び/若しくは鎮痛剤を必要としている患者への、麻酔医でない者による鎮静剤及び/若しくは鎮痛剤の安全な送出を可能にするための一体型薬物送出システムにおいて、
前記処置中に患者につながれるように適応した患者健康モニターであって、前記患者の少なくとも1つのモニターされる生理学的状態の測定結果を反映する信号を生成する患者健康モニターと、
前記処置中に前記患者にある薬物投与レートの鎮静剤を送出するための薬物送出機構と、
前記一体型薬物送出システムに取外し可能につながれる少なくとも1つの医療品であって、前記医療品は、品質保証モジュールを随伴し、前記品質保証モジュールは、前記医療品に関する情報を格納し、且つ前記患者に前記医療品を送出する前に前記医療品の品質及び状態を前記麻酔医でない者に確実なものにするものである、医療品と、
前記医療品の前記品質保証モジュールに格納された情報を読み取り、前記情報をプロセッサに伝えるリーダデバイスと、
前記患者健康モニター、前記薬物送出コントローラ及び前記リーダデバイスに動作可能に接続される前記プロセッサであって、前記プロセッサは、前記モニターされる生理学的状態の測定結果のための値を示すアクセス可能なパラメータを有し、前記値は、前記処置に関連付けられる患者の状態の範囲に対応する、前記プロセッサと
を備え、
前記プロセッサは、ソフトウェアに従って動作して、前記処理中に前記信号を受け取り、通常の範囲の外側となる患者の状態の徴候又は可能性のある徴候を特定するように、前記パラメータを使用する前記信号に反映される前記測定結果を解析し、前記患者の状態の徴候又は可能性のある徴候を矯正するように、前記薬物投与レートの可能な変更を示す信号を生成し、
前記プロセッサの信号は、最新の前記測定結果が前記通常の範囲の外側にどの程度だけあるかに依存した作用を示す、一体型薬物送出システム。 - 鎮静及び鎮痛、深い鎮静、並びに/又は全身麻酔のために用いられる請求項10に記載の一体型薬物送出システム。
- 前記医療品に関する前記情報は、前記医療品の識別情報を含み、前記プロセッサによる管理された薬物の送出は、前記医療品に関する前記情報と格納された前記パラメータとを比較することに基づいて、前記医療品の使用を承諾する又は防止することを含む請求項10に記載の一体型薬物送出システム。
- 前記品質保証モジュールは、バーコード、ホログラム、書かれた文字、RFID、EEPROM、集積回路、スマートカード及び磁気ストリップのいずれか1つを含む請求項10に記載の薬物送出システム。
- 前記一体型薬物送出システムに取外し可能につながれる第2の医療品をさらに備え、
前記第2の医療品は、前記第2の医療品に関する情報を格納するための第2の品質保証モジュールを有する請求項10に記載の薬物送出システム。 - 前記リーダは、両方の前記品質保証モジュールに格納される情報を検知することができる請求項14に記載の薬物送出システム。
- 前記品質保証モジュールは、前記一体型薬物送出システムに取外し可能につながれる前記医療品のパッケージに含まれる請求項10に記載の薬物送出システム。
- 前記プロセッサは、一旦、前記医療品が前記一体型薬物送出システムと共に使用されてしまうと、前記医療品の識別子を格納する請求項10に記載の薬物送出システム。
- 前記アクセス可能なパラメータは、受け入れ可能な、シリアル番号、バッチ番号、製造日、製造業者、内容物アイデンティティ、内容物体積又は有効期限を規定する品質保証情報をさらに含む請求項10に記載の薬物送出システム。
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JP2010143020A Pending JP2010246955A (ja) | 2001-09-24 | 2010-06-23 | 薬物投与ならびに医療品および医療用キットの品質および安全性を確実にするための方法およびデバイス |
JP2013271594A Expired - Lifetime JP5904988B2 (ja) | 2001-09-24 | 2013-12-27 | 薬物投与ならびに医薬品および医療用キットの品質および安全性を確実にするためのデバイス |
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2002
- 2002-09-24 US US10/252,818 patent/US20030074223A1/en not_active Abandoned
- 2002-09-24 EP EP02768888A patent/EP1436029A4/en not_active Withdrawn
- 2002-09-24 JP JP2003530197A patent/JP2005503867A/ja active Pending
- 2002-09-24 EP EP11165184A patent/EP2369516A3/en not_active Ceased
- 2002-09-24 CN CNB028233115A patent/CN100463704C/zh not_active Expired - Fee Related
- 2002-09-24 WO PCT/US2002/030184 patent/WO2003026558A2/en active Application Filing
- 2002-09-24 AU AU2002331894A patent/AU2002331894B2/en not_active Ceased
- 2002-09-24 MX MXPA04002759A patent/MXPA04002759A/es active IP Right Grant
- 2002-09-24 CA CA2461312A patent/CA2461312C/en not_active Expired - Fee Related
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2007
- 2007-03-12 US US11/716,609 patent/US20070213684A1/en not_active Abandoned
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2010
- 2010-06-23 JP JP2010143020A patent/JP2010246955A/ja active Pending
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2013
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Also Published As
Publication number | Publication date |
---|---|
EP1436029A4 (en) | 2009-12-30 |
JP5904988B2 (ja) | 2016-04-20 |
WO2003026558A2 (en) | 2003-04-03 |
CA2461312C (en) | 2015-12-01 |
EP1436029A2 (en) | 2004-07-14 |
WO2003026558A3 (en) | 2003-12-18 |
AU2002331894B2 (en) | 2008-05-22 |
EP2369516A3 (en) | 2012-01-18 |
CN100463704C (zh) | 2009-02-25 |
US20030074223A1 (en) | 2003-04-17 |
US20070213684A1 (en) | 2007-09-13 |
MXPA04002759A (es) | 2005-04-08 |
JP2005503867A (ja) | 2005-02-10 |
JP2010246955A (ja) | 2010-11-04 |
EP2369516A2 (en) | 2011-09-28 |
CN1592643A (zh) | 2005-03-09 |
CA2461312A1 (en) | 2003-04-03 |
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