Case 5

Bruce H. Barkalow, Ph.D., PE, CCE
490 Quarterline SE
Newaygo, MI 49337-9201
Tel: (231) 652-2228
Fax: (231) 652-7912
Email: bhbi@riverview.net
Web page: www.bhbi.com

No.	Client Type	Evaluate a New Medical Device	Year
5	Medical Device Manufacturer	Project Basics: A medical device company planned to add a new medical device to their product line. For the most part, the existing product line included diagnostic or physiological monitoring equipment - FDA Class II. The new device was a life support, FDA Class II device. Consulting Issues: Before implementing the new medical device into selected hospitals for clinical evaluation, it was desired to have the product independently evaluated from a Clinical Engineering and Biomedical Engineering standpoint. Specific issues included review of the: Medical device for systems integration and user features. Current status of the 510(k) application and FDA comments. Device compliance with relevant ASTM, AAMI, and FDA standards. Device labeling including the associated manuals. System physiological monitoring, life support, and related alarms. Operator system verification procedures, maintenance and preventive maintenance procedures. BME Work: The work consisted of off site review of the medical device 510(k) documentation and FDA correspondence, device draft manuals, relevant ASTM, AAMI, and FDA standards, and proposed marketing literature. On site work included operating the device using calibrated patient simulators as well as detailed review of the device and subunit function. Design staff were interviewed and queried regarding various unique features of the device and what distinguished it from competitive devices. Finally, a confidential report was submitted to management with findings, observations, and recommendations. Outcome: After submission of the BME report additional work was accomplished to modify the device, device labeling, and the associated manuals. Further correspondence with the FDA cleared outstanding issues. The device is successfully on the market at the present time. Relevance: Medical liability issues are generally more serious with life support devices than diagnostic devices even if both may be FDA Class II. Outside consultation based on experience with similar life support device accident and incident investigations provided additional insight and appreciation of potential problems. These issues were addressed before the device was implemented in the clinical trials.	1994
Request for details

No.

Client Type

Evaluate a New Medical Device

Year

Medical Device Manufacturer

Project Basics: A medical device company planned to add a new medical device to their product line. For the most part, the existing product line included diagnostic or physiological monitoring equipment - FDA Class II. The new device was a life support, FDA Class II device.

Consulting Issues: Before implementing the new medical device into selected hospitals for clinical evaluation, it was desired to have the product independently evaluated from a Clinical Engineering and Biomedical Engineering standpoint. Specific issues included review of the:

Medical device for systems integration and user features.
Current status of the 510(k) application and FDA comments.
Device compliance with relevant ASTM, AAMI, and FDA standards.
Device labeling including the associated manuals.
System physiological monitoring, life support, and related alarms.
Operator system verification procedures, maintenance and preventive maintenance procedures.

BME Work: The work consisted of off site review of the medical device 510(k) documentation and FDA correspondence, device draft manuals, relevant ASTM, AAMI, and FDA standards, and proposed marketing literature. On site work included operating the device using calibrated patient simulators as well as detailed review of the device and subunit function. Design staff were interviewed and queried regarding various unique features of the device and what distinguished it from competitive devices. Finally, a confidential report was submitted to management with findings, observations, and recommendations.

Outcome: After submission of the BME report additional work was accomplished to modify the device, device labeling, and the associated manuals. Further correspondence with the FDA cleared outstanding issues. The device is successfully on the market at the present time.

Relevance: Medical liability issues are generally more serious with life support devices than diagnostic devices even if both may be FDA Class II. Outside consultation based on experience with similar life support device accident and incident investigations provided additional insight and appreciation of potential problems. These issues were addressed before the device was implemented in the clinical trials.

1994

Request for details