COVID-19 Public Health Emergency – Infusion Pumps

U.S. Food and Drug Administration (FDA) issued this immediately in effect guidance: Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID- 19) Public Health Emergency.  FDA believes the policy set forth in this guidance may help address these urgent public health concerns by helping to expand the availability and remote capabilities of infusion pumps and their accessories during COVID-19 for patients requiring continuous infusion therapy.

SoftwareCPR Comments on FDA Emergency Guidance for Infusion Pumps

This emergency use infusion pump guidance temporarily exempts a wide range of changes to infusion pump hardware and software from premarket review.  It applies to four Class II product codes (FRN, MEA, MRZ, and PHC), and three of which likely could involve software.  The guidance also addresses 22 product codes for accessories to infusion pumps.

Specific areas where FDA believes modifications present low risk include:

  1. Software and/or design modifications implementing the capability for remote monitoring and remote manual adjustment of infusion parameters (i.e., manual adjustment of parameters by trained health care providers from outside an isolation unit to avoid unnecessary exposure). These modifications might include implementing the capability for remote monitoring and remote manual adjustment of infusion parameters via wired or wireless methods.
  2. Modifications to the software to implement remote monitoring and adjustment of infusion parameters for multiple infusion pumps in a central location. This includes new hardware or software accessories for remote monitoring and remote manual adjustment of infusion parameters.
  3. Modifications or additions to the hardware/software architectures to allow for increased remote monitoring and manual setting adjustment capability and availability to support additional indications described above. One example is the addition of wireless and/or Bluetooth capability.
  4. Additional hardware, software, design and material changes to an FDA-cleared infusion pump system accessory or component (e.g., material change to internal tubing) that enables an alternate accessory or component supplier to meet the established performance of the FDA-cleared system.

Note that cybersecurity controls are still expected.

Obviously manufacturers should still ensure adequate (for the current public health emergency) validation to ensure safety for critical changes. While FDA has suspended all routine inspections, we also recommend that manufacturers that use this emergency exemption to later plan for actions to deal with an eventual return to normalcy in clearance requirements and return to use within normal intended use.

Download the guidance here:  Enforcement Policy for Infusion Pumps and Accessories During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff April 2020

About the author

Brian Pate helps medical device companies achieve efficient and FDA regulatory compliant product development to produce higher quality and clinically valued software. He began his career in clinical research in 1985 with the Department of Anesthesiology at UAB developing closed-loop control systems for the automated delivery of gases and control. In 1990, he made the switch from university research to the medical device industry designing control systems, communication interfaces, user interface, and other software for real-time embedded systems and clinical information systems, working for medical device companies including Johnson & Johnson, Baxter Healthcare, and GE Medical. Today, he is a Partner and the General Manager of Crisis Prevention and Recovery LLC (dba SoftwareCPR®), a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software. He has taught the AAMI/FDA course on Software Regulation to FDA Reviewers at FDA and is currently the lead faculty for the public version of that course taught annually along with FDA staff. Brian served on the AAMI/FDA TIR working group that created AAMI TIR32 Guidance on the application of ISO 14971 to Software (later superseded by IEC 80002-1). He later served on the original AAMI/FDA working group that created the AAMI TIR45-2012 TIR Guidance on the use of Agile practices in the development of medical device software and is currently the co-chair leading the creation of the 2nd edition of TIR45. He has served as faculty for all offerings of the AAMI/FDA Compliant Use of Agile Methods public course. Brian also served as an instructor for the AAMI Design Controls course. He is also a member of the Underwriters’ Laboratories Standards Technical Panel 5500, Remote Software Updates. He now serves as a member of the AAMI Software Committee.

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