Wednesday, December 14, 2011

FDA Recalls Draeger Health IT Device Because "This Product May Cause Serious Adverse Health Consequences, Including Death"

More health IT madness, in the form of an actual FDA recall:

FDA Recall notice

Draeger Medical Inc., Infinity Acute Care System Monitoring Solution (M540)
Recall Class: Class I [the most serious type of recall, see below - ed.]
Date Recall Initiated: October 18, 2011
Product: Infinity Acute Care System Monitoring Solution (M540), Catalog number MS25510
All serial numbers are affected by this recall.

This product was manufactured from March 1, 2011 through September 30, 2011 and distributed only to the Rush University Medical Center (Chicago, Illinois) from July 1, 2011 through September 30, 2011.

Use: This product is a networked solution system used to monitor a patient’s vital signs and therapy, control alarms, review Web-based diagnostic images, and access patient records. The number of monitored vital signs can be increased or decreased based on the patient’s needs.

Recalling Firm: Draeger Medical, Inc. 3135 Quarry Rd., Telford,
Pennsylvania 18969-1042

Manufacturer: Draeger Medical GmbH, Moislinger Allee 53-55_23558, Lubeck, Germany

Reason for Recall: The weight-based drug dosage calculation may indicate incorrect recommended values, including a drug dosage up to ten times the indicated dosage. Additionally, there may be a 5-10 second delay between the electrocardiogram and blood pressure curves (waveforms) at the Infinity Central Station.

This product may cause serious adverse health consequences, including death.

Public Contact: Draeger Medical, Inc. 3135 Quarry Road Telford, Pennsylvania 18969-1042_215-660-2349

FDA District: Philadelphia

FDA Comments: On October 17, 2011, the company sent the Rush University Medical Center a letter stating that users should enter the patient’s weight by way of the admin/demographics screen to ensure the drug dosage is calculated as intended.

Additionally, the company’s letter states that users should follow the instructions for Use of the Infinity Acute Care System Monitoring Solution. The Instructions for Use includes, "For primary monitoring and diagnosis of bedside patients, use the bedside monitor. Use the Infinity Central Station only for remote assessment of a patient's status." [That is, clinicians should work around the device's defects, which would seem to hold the computer's rights over the patients' rights -- rather than taking the device out of service immediately and having the vendor fix it - ed.]

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

I find a software company advising clinicians to make sure to "work around" blatant IT defects in "acute care environments" the height of arrogance and contempt for patient safety. Yes, acute care environments are not unpredictable, chaotic environments often moving a mile a minute. They are precisely the environment where everyone can sit around on their butts and leisurely hold, over pizzas and cokes, a committee meeting where each and every move can be discussed, just like in a software development shop ...

I also find the statement that this medical device was "distributed only to the Rush University Medical Center" remarkable. If true, it raises a number of issues that make me very uncomfortable:

  • How did the company's letter to Rush make its way to FDA? Whistle blower?
  • What testing was done by the manufacturer of this medical device before release to a live-patient environment?
  • Who approved this software "going live?" What due diligence was performed?
  • Was this a software beta test of experimental software on live subjects?
  • Did Rush University Medical Center have some sort of quid pro quo (e.g., financial arrangement) with the software company?
  • Did Rush seek IRB approval of this device?
  • Were patients presented with an informed consent process regarding its use in their care?
  • Were any patients actually injured or did any die as a result of this software?

The answers to these questions need to be sought by FDA.

-- SS


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