With Consent Decree, Physio-Control Sees Light at Tunnel's End

The April 28 signing by Physio-Control Inc. and FDA of a consent decree moves the Medtronic, Inc.-owned manufacturer closer to the day when it can again make and ship automated external defibrillators from its Redmond, Wash., plant, company President Brian Webster states in a May 1 letter to customers. Physio voluntarily suspended U.S. shipments from the plant in January 2007 to address quality issues identified by Physio, Medtronic, and FDA, with Medtronic announcing that the suspension interrupted its plan to spin off Physio.

The consent decree bars Physio from manufacturing, distributing, and exporting these AEDs: LIFEPAK 12, LIFEPAK 20, LIFEPAK 500, LIFEPAK 1000, LIFEPAK CR PLUS, and LIFEPAK EXPRESS, and their components and accessories including the LIFENET Systems, until those devices and the Redmond facilities have been shown to be in compliance FDA Good Manufacturing Practice requirements.

Webster's letter says Paragraph 5 of the agreement allows Physio to make a limited selection of product available "to meet the most critical needs of emergency response customers," and he said this exception applies worldwide.

Webster also says Physio has made significant investments and improvements in the past year to its quality system. "We are confident in our ability," he writes, "to make the necessary final improvements and updates to our quality system in a timely manner. We have the right people in the organization to execute to the plan and we are optimistic that these final efforts will be completed in the near future."

FDA said to ensure compliance, an outside expert will conduct yearly audit inspections at the Redmond plant for five years and will submit findings to FDA. Physio and Medtronic are subject to liquidated damages of $15,000 per day if they fail to comply with any of the provisions of the decree and an additional sum of $15,000 for each violation of the consent decree, the Federal Food, Drug, and Cosmetic Act, or FDA regulations. The decree was filed April 25 in a federal court for the Western District of Washington and is subject to court approval.

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Analyze Incident Data

    Collect relevant incident data, analyze trends, and generate accurate regulatory reports, including OSHA 300, 300A, and 301 logs, through IndustrySafe’s extensive incident reporting and investigation module.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We’ve put together a guide on key safety training topics, requirements for certifications, and answers to common training questions.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Industry Safe
comments powered by Disqus

OH&S Digital Edition

  • OHS Magazine Digital Edition - April 2019

    April 2019


      Taking the Guesswork Out of De-Energizing Industrial Equipment 
      Four Simple and Effective Ways to Avoid Digital Eye Strain
      PPE the Automotive Industry Needs to Invest In
      Eliminate 10 Fire Hazards That May Be in Plain Sight
    View This Issue