Anonymous. The concepts of efficacy and safety. In: Assessing the efficacy and safety of medical technologies. Congress of the United States, Office of Technology Assessment. Ch. 2. Washington, D.C.: U.S. Government Printing Office, Superintendent of Documents, Stock no. 052-003-00593-0, 1978: 22–28.
2.
StokesTLGibbonJHJr. Experimental maintenance of life by a mechanical heart and lung during occlusion of the venae cavae followed by survival. Surg Gynecol Obstet1950; 91: 138–156.
3.
KuruszM. Cardiopulmonary bypass during intracardiac repair of congenital defects. Proc Am Acad Cardiovasc Perfusion1982; 3: 73–78.
4.
DolanAM. Risk management and medical devices. Biomed Instrument Technol1989; 33: 331–333.
5.
BattlesJBKeyesMA. Technology and patient safety: a two-edged sword. Biomed Instrument Technol2002; 36: 84–88.
6.
FeigalDWGardnerSNMcClellanM. Ensuring safe and effective medical devices. N Engl J Med2003; 348: 191–192.
7.
VockleyM. Birth of a standard: achieving consensus on safe and effective healthcare technology. Biomed Instrument Technol2017; 51: 368–379.
8.
AltayyarSS. The essential principles of safety and effectiveness for medical devices and the role of standards. Med Device: Evid Res2020; 13: 49–55.
LowranceWW. Of acceptable risk, science and the determination of safety. Los Altos, CA: Kaufman, 1976.
11.
BeallACJr. Who protects our patients, and from what?Med Instrument1977; 11: 72–73.
12.
21CFR860.7. Title 21-Food and Drug Administration, Dept. Health and Human Services, Subchapter H, Medical Devices, Part 860-Medical Device Classification Procedures, Subpart A-General, Sec. 860.7, Determination of safety and effectiveness. (Accessed 22 November 2021)