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September 1, 2006
Bioinstrumentation has a New Location
The Bioinstrumentation Resource Center is moving to new improved and larger facilities, in the MP1 services building. The entrance is at the east side of Maple Avenue across from the new student housing near Mockingbird Lane. Check in at MP1.101 on the southwest corner of the building when you visit. As we are frequently on location in clinics and labs, we recommend that you come by appointment. We are beta testing the new Siemens phone system Our new telephone numbers are: Main x50979; Igor Timakov 50979, Dr. Tibbals 50978. Our mail code is MC9025.
September 1, 2006
New Sources for Mechanical Work
Bioinstrumentation can now provide advanced CAD with three dimensional visualization for physical and mechanical parts, as well as simulation for electromagnetic fields in tissue and other media. We can also provide rapid prototyping with printed three dimensional plastic or metal parts, and/or numerically controlled machine table. This is part of our new program since 2004 of linking the campus with the most advanced sources for design and fabrication of complex and vital medical device prototypes and parts. We are currently working on endoscopy and micro-biopsy tooling, cell perfusion microscopy chambers, calculation of complex interactions between MRI scanning fields and semiconducting nanoforms, wireless implantable and insertable physiology sensors, and other projects.
Some recent projects are described on the web at:
MEDICAL DEVICE CORRECTIONS
September 1, 2006
aBioinstrumentation now has an advanced defibrillator system that can be used to test and calibrate medical defibrllators, and can be set for animal use. The new automatic defibrillators designed for emergency use by non-specialists should be checked for calibration and battery condition, just like the clinical cart defibrillators that are given periodic safety checks. This development is thanks to support from Dr. Garry, Dr. Stromberg, Dr. Idris, and other groups that Bioinstrumentation is working with to develop animal research defibrillation technology.
May 16 2004 - Medtronic Physio-Control LIFEPAK® 12 defibrillator monitors (See link). Medtronic are performing a voluntary correction of LIFEPAK® 12 defibrillator monitors. A Certified Letter notifying UTSW of the correction was received on May 19th 2004. These devices contain a therapy connector or QUICK-COMBO therapy cable that does not meet current durability standards and may not maintain connections sufficient to support ECG monitoring, external pacing, or defibrillation. A poor connection may delay or inhibit therapy delivery.
Engineering evaluation of the therapy connector has identified three issues that Medtronic will correct. Medtronic representatives will be contacting our facility to correct the affected devices, at no charge for this activity.
1) Most of the failures identifed appear to result from strong force or impact damage induced to the cable connection, resulting in a poor connection.
2) The second issue is damaged sockets in the therapy connector or damaged cable therapy pins caused by misalignments.
3) The third issue is worn conductive plating on the sockets or pins affecting the contact resistance.
While Medtronic are correcting defibrillators for the QUIK-COMBO therapy cable and connectors they will also be inspecting the version of the ECG connector. Older versions of the ECG connector have shown a higher than normal connection resistance which results in a noisy or intermittent ECG signal. This occurs primarily in the out-of-hospital, mobile environment. Medtronics are replacing this older version with the latest design to improve durability.
Medtronic continue to recommend routine user testing of the cable as part of the defibrillator checks.
Medtronic recommend you leave your LIFEPAK® 12 defibrillator in use until their service representatives can inspect and correct your devices. Most damage for these issues is visually obvious or readily detected with routine user tests.
Please continue to perform your routine user tests in accordance with the Operating Instructions (see Section 8, Maintaining the Equipment), with special attention to therapy cable defibrillation check to confirm it is working properly. If an issue is found during your inspection and test, call for service immediately.
Medtronic is voluntarily correcting these devices at no charge, as part of their commitment to ensuring highest quality standards and customer support. If you have any questions you may contact Medtronic Technical Support, available at 1-800-442-1142, 6:00 AM to 4:00 PM (Pacific), Monday - Friday.
This notice was received in a certified letter from Michael D. Willingham, Vice President, Regulatory Affairs, Medtronic Physio-Control Corp.. Copies of the letter are available on request from Dr. H. F. Tibbals, Director, Bioinstrumentation Resource Center, MC 9025, Tel. 214-648-3374, email: Harry.Tibbals@UTSouthwestern.edu
FDA "Voluntary" Mandatory Reporting
An informative article regarding FDA incident reports is the LSU Law Center web site on "Voluntary" Mandatory Reporting at: http://biotech.law.lsu.edu/IEEE/ieee14e.htm
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