Ensuring safe and effective medical devices

Affiliations

Comment

David W Feigal et al. N Engl J Med. 2003.

. 2003 Jan 16;348(3):191-2.

doi: 10.1056/NEJMp020170.

¹ Center for Devices and Radiological Health, Food and Drug Administration, Rockville, Md, USA.

No abstract available

Comment on

Pseudomonas aeruginosa and Serratia marcescens contamination associated with a manufacturing defect in bronchoscopes.
Kirschke DL, Jones TF, Craig AS, Chu PS, Mayernick GG, Patel JA, Schaffner W. Kirschke DL, et al. N Engl J Med. 2003 Jan 16;348(3):214-20. doi: 10.1056/NEJMoa021791. N Engl J Med. 2003. PMID: 12529461
An outbreak of Pseudomonas aeruginosa infections associated with flexible bronchoscopes.
Srinivasan A, Wolfenden LL, Song X, Mackie K, Hartsell TL, Jones HD, Diette GB, Orens JB, Yung RC, Ross TL, Merz W, Scheel PJ, Haponik EF, Perl TM. Srinivasan A, et al. N Engl J Med. 2003 Jan 16;348(3):221-7. doi: 10.1056/NEJMoa021808. N Engl J Med. 2003. PMID: 12529462