Case 4

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	Federal Food and Drug Administration	Year
4	FDA, Central and Field Office	Case Basics: A medical device company was investigated by the FDA local agency because of clinical reports that their life support device was failing to operate properly. The FDA agents found the manufacturer had violated a number of 21CFR Good Manufacturing Practices for both hardware and software. The central FDA office was considering a court injunction to shut the manufacturer down and at the same time enforce a mandatory recall of the affected medical devices. Consulting Issues: Given the widespread deployment of the affected medical devices connected to patients in many hospitals, outside Biomedical Engineering counsel was sought on several issues: If the subject medical devices were recalled, what options for patient care would the hospitals have? Considering the clinical protocols of the device use, what are the consequences of the device failure, e.g. clinical supervision, hospital backup equipment availability, etc. What is the technical significance of each Engineering Change Order (ECO) related to the device failures? Did the ECO's merit a 510(k) application? What are the consequences of closing the manufacturer down until the technical problems are resolved to FDA satisfaction? BME Work: The work consisted of reviewing the medical device reports related to equipment failures along with the FDA "483" inspection reports where GMP deviations were noted. Additional information was gathered on clinical details related to various medical device failures and patient outcomes. ECO's were reviewed for technical and clinical significance. A summary of the findings, implications, opinions, and recommendations was submitted to the FDA. Outcome: After submission of the BME report the somewhat critical situation resolved. However, this was due to several factors including impending consent decrees authored by the FDA and concessions by the medical device company. The medical devices were upgraded and the manufacturing methods changed to be in compliance with the GMP's. Closure of the manufacturing facility was avoided. Relevance: Although serious problems arose with a life support medical device, the FDA was prudent in assessing their potential actions against the company in a context of patient care implications. Independent counsel on Clinical Engineering factors, helped to resolve the situation equitably.	1994
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No.

Client Type

Federal Food and Drug Administration

Year

FDA, Central and Field Office

Case Basics: A medical device company was investigated by the FDA local agency because of clinical reports that their life support device was failing to operate properly. The FDA agents found the manufacturer had violated a number of 21CFR Good Manufacturing Practices for both hardware and software. The central FDA office was considering a court injunction to shut the manufacturer down and at the same time enforce a mandatory recall of the affected medical devices.

Consulting Issues: Given the widespread deployment of the affected medical devices connected to patients in many hospitals, outside Biomedical Engineering counsel was sought on several issues:

If the subject medical devices were recalled, what options for patient care would the hospitals have?
Considering the clinical protocols of the device use, what are the consequences of the device failure, e.g. clinical supervision, hospital backup equipment availability, etc.
What is the technical significance of each Engineering Change Order (ECO) related to the device failures?
Did the ECO's merit a 510(k) application?
What are the consequences of closing the manufacturer down until the technical problems are resolved to FDA satisfaction?

BME Work: The work consisted of reviewing the medical device reports related to equipment failures along with the FDA "483" inspection reports where GMP deviations were noted. Additional information was gathered on clinical details related to various medical device failures and patient outcomes. ECO's were reviewed for technical and clinical significance. A summary of the findings, implications, opinions, and recommendations was submitted to the FDA.

Outcome: After submission of the BME report the somewhat critical situation resolved. However, this was due to several factors including impending consent decrees authored by the FDA and concessions by the medical device company. The medical devices were upgraded and the manufacturing methods changed to be in compliance with the GMP's. Closure of the manufacturing facility was avoided.

Relevance: Although serious problems arose with a life support medical device, the FDA was prudent in assessing their potential actions against the company in a context of patient care implications. Independent counsel on Clinical Engineering factors, helped to resolve the situation equitably.

1994

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