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zoom RSS 自動輸注ポンプの認可審査を厳格化/FDA 医療機器 インヒュージョンポンプ

<<   作成日時 : 2010/04/27 20:20   >>

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 連邦当局は、自動輸注ポンプ(infusion pump)を含めた医療器具の監督を厳格にするという。
 金曜日(4/23)にFDAは、自動輸注ポンプの認可前により多くのテストを装置の生産者に要求する新たなガイドラインの予備版を出した。最近5年間でこうした装置に関連した患者死亡が710件報告されたというが、実数ははるかに多いだろうとしている。
 過量投与によるものもあり、一部は入力ミスだが装置のソフトウエア誤作動もある。現在約200万個の自動輸注ポンプが使用され、数十万個は患者が自宅で使用している。静脈内にインシュリンや抗ガン剤、栄養剤を注入するなど様々な用途に使用されている。
 自動輸注ポンプについては、2005年から2009年までで、710人の死亡報告を含めて、毎年10,000件以上の不具合報告が出されている。同時期に79件のリコールが出され、医療機器の中では最も多い。
 メーカーはほとんどの問題はデータの誤入力によるとしているが、ソフトの欠陥によりキー入力を2重にしてしまい例えば2の入力を22としてしまうなどの問題があるとFDA役員は言う。
 心臓除細動器のような生命維持装置は認可前に臨床試験が必要である。すでに市場に出回っている製品に類似した機器は臨床試験なしできたが、今後そうした製品の販売は認めない方針という。認可のスピードを落として、装置のソフトウエアの妥当性をテストする。
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FDA内部告発への報復か/米国医療事情 FDA 医療機器
http://kurie.at.webry.info/200901/article_47.html
医療機器の安全性と有効性の検証方法の変革が必要/米国医療事情 FDA
http://kurie.at.webry.info/200901/article_29.html
FDAの科学者が管理体制を批判/米国医療事情 FDA食品医薬品局
http://kurie.at.webry.info/200901/article_20.html
拙速な審査で治療が患者に提供される/米国
http://kurie.at.webry.info/200810/article_65.html
FDAは医薬品の安全性保証はできない
http://kurie.at.webry.info/200711/article_4.html
汚染ヘパリン製剤問題の核心はFDAにある/米国
http://kurie.at.webry.info/200803/article_28.html
FDA「食の安全」計画の失敗/米国
http://kurie.at.webry.info/200806/article_23.html
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F.D.A. Steps Up Oversight of Infusion Pumps
By BARRY MEIER
Published: April 23, 2010
http://www.nytimes.com/2010/04/24/business/24pump.html


画像Daniel Rosenbaum for The New York Times
The preliminary guidelines will require producers of infusion pumps to supply the F.D.A. with more test data on them before they can be approved for sale.


Federal regulators say they are moving to tighten their oversight of medical devices, including one of the most ubiquitous and problematic pieces of medical equipment ― automated pumps that intravenously deliver drugs, food and other solutions to patients.

Jeffrey Shuren, the director of the Center for Devices and Radiological Health at the Food and Drug Administration. From 2005 to 2009, more than 10,000 complaints were received annually by the F.D.A. about the pumps.

On Friday, the Food and Drug Administration issued preliminary guidelines that will require producers of the devices, known as infusion pumps, to supply the agency with more test data on them before they can be approved for sale.

Over the last five years, the agency says it has received reports of 710 patient deaths linked to problems with the devices, though F.D.A. officials say they think the number may be significantly higher. Some of those deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.

An estimated two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes. The pumps use a variety of designs to intravenously deliver food, fluids and drugs like pain medications, insulin and cancer treatments.

The pump-related initiative comes as the Obama administration tries to reinvigorate the F.D.A. after years of criticism by lawmakers and others that it was a rubber stamp for industry. The F.D.A. Center for Devices and Radiological Health, which oversees scores of critical products like heart implants, imaging equipment and infusion pumps, has come under particular scrutiny.

A few years ago, for example, several top scientists at the center contended in letters to lawmakers that their superiors had ignored both their recommendations and policy guidelines in approving the sale of devices. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009. In that same time frame, manufacturers of infusion pumps issued 79 recalls, among the highest for any medical device.

The center’s new director, Dr. Jeffrey E. Shuren, who has headed the center since August, said in an interview this week that pump manufacturers would soon be required to provide more data about their devices before offering them for sale. He added that the agency had determined that pumps could be made far safer.

He also said that the categorywide approach that the agency was taking toward infusion pumps might soon be extended to other types of medical devices, though he declined to elaborate.

“We need to ratchet up the expectations for medical device manufacturers,” Dr. Shuren said.

The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Ill.; Hospira of Lake Forest, Ill.; and CareFusion of San Diego.

Representatives of all three companies said the firms were reviewing of the agency’s initiative and could not comment on the specifics. However, they said their pumps were safe and that they looked forward to cooperating with regulators.

“We are committed to partnering with the agency to advance and complete the process for issuing new guidelines for the enhancement of the device review process,” Eric Floyd, Hospira’s vice president for global regulatory affairs, said in a statement.

Under the infusion pump proposal, which could be completed by the end of the year, producers would be required to provide additional data to support the procedures they used to determine the effectiveness and safety of their devices. In addition, companies would have to conduct limited clinical trials to ensure their pumps were not susceptible to misuse or had design elements that could create errors.

Pump producers now typically conduct “simulated” testing of its devices by users to identify bugs. Dr. Shuren indicated that the agency was seeking real-world testing as well.

Infusion pumps normally use software to automatically control both the rate and volume of a medication’s flow. To set a pump for an individual patient’s needs, a doctor, a nurse or other health care worker enters information by using the buttons on a pump’s keypad, which resembles that of a phone.

Pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong data accidentally. F.D.A. officials said, however, that based on their review of pump complaints they thought many deaths and injuries related to the devices were less the result of user error than of product design and engineering.

For example, agency officials said that some pumps were prone to key bounce, a problem in which defective software interprets a single keystroke as two separate presses of that key. For example, instead of dispensing two units of a drug, a pump would dispense 22 units.

Under F.D.A. rules, life-sustaining devices like heart defibrillators must typically undergo clinical trials before they are approved for sale. But the agency clears the sale of many other critical devices like pumps without clinical testing based on a manufacturer’s claim that a new device is similar to a product already on the market.

Agency officials said Friday that they were sending a letter to all infusion pump makers to inform them of their findings and outline the proposed additional requirements companies were be required to meet.

Dr. Shuren said he expected that the new requirements would initially slow down the rate of the agency’s approval for new pumps that manufacturers are seeking to market.

The agency also said it had developed an open-source software code that manufacturers of pumps can use to test the validity of the software they use in their devices.

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