Medical errors, infection-control breaches and the use of adulterated and misbranded medical devices

Table 3 Assessed risk of infection associated with nine different confirmed infection-control breaches, the number of patients notified of the breach, and the reference discussing the breach

Assessed risk of infection1	No. of patients notified	Ref.
Negligible2	No patients notified	[1,3,12]
Extremely low	1812	[84]
Small but not zero3	> 10 000	[2,6]
Extremely low	> 500	[85]
Extremely remote	9000	[86]
Minimal to non-existent	360	[87]
Extremely low risk	38	[88]
No increased risk	> 3500	[4,5]
Very low risk	6800	[7,89]

¹Although this table’s nine risk assessments are seemingly without significant clinical differences, the actions associated with each assessment were, at times, notably dissimilar. Whereas breaches assessed to have a “negligible” infection risk did not result in patient notification (Table 3’s first row), other breaches assessed either to have similar infection risks, including “extremely low” and “extremely remote” infection risks, nevertheless resulted in patient notification;

²Some researchers who have studied these breaches have instead concluded that each posed an increased risk of infection warranting the notification of affected patients[1,10,12]. Among other considerations, including to be consistent with the VHA’s policies and procedures[14,15], patient notification is important to transparency and quality improvement;

³These breaches were also assessed to have a “low but significant risk”[2] of infection and a risk of infection that is “substantially less than 1 in 10 000”[2]. The table’s sign “>” denotes “more than”.