FDA programs, 38, 114-126, 164-170, 173-177, 229, 235-236

forms, 114-115, 154, 174, 181

by health professional networks, 153, 155, 161-162, 163, 171, 178, 377-378

home health agencies, 126, 156, 157-158, 166, 180

home health care and, 4, 24, 112, 123, 126, 156-157, 159, 162, 178, 181-182, 230

human factors analysis, 127, 160, 169

improvement initiatives, 111, 164-170

inappropriate, 156

and innovation, 163, 310, 321

interactive option, 167

international vigilance reports, 111, 125, 236

investigating, 112-113, 120-126, 151, 158-160, 161-162, 163, 170-171, 172, 173, 175, 178, 180

investigational devices, 91-92

JCAHO program, 171-172

labeling devices, 138, 149, 178

liability concerns and, 132, 155, 156

limitations of programs, 8, 113, 120-121, 125-126, 152-165, 174, 235-236, 330, 338

linkages between programs and databases, 174, 225

mandatory, 9, 24, 37, 39, 40, 86, 87-92, 94, 114, 115, 116-120, 175, 177-178, 321

manufacturer response, 86, 87-92, 93, 94, 98, 100-101, 109-110, 114, 115, 116-119, 120-121, 125, 141-142, 155, 163, 171, 175, 177-178

MAUDE database, 93, 115, 151, 155, 163, 166, 206, 342, 368, 369-374, 412-413

MDR program, 87, 368, 369-370, 411

MedSun program, 8-9, 35, 76, 94, 114, 152, 155 n.3, 159, 165-167, 171, 173, 175-177, 180, 182, 236, 321, 336

MedWatch program, 35, 37, 92, 99 n.16, 164, 171, 174, 178, 181

objectives, 87, 101, 113, 163, 173, 232, 411

online option, 114-115, 167, 174, 181-182

overreporting, 156

oversight responsibility, 74-75, 112-113, 237-238

patient privacy, 91, 93-94, 104, 154, 175

patient safety programs, 154, 156, 157, 165-167, 168, 176-177, 180

private programs, 171-173

problems with, 153-157, 161-162

public availability of information, 93-94, 103, 105, 120

and recalls, 162, 174

recommendations, 8-9, 11-13, 174-175, 176, 177, 178, 179, 180, 182

and redesign of devices, 113

in research vs. patient care, 33

resources for patients and families, 181-182

responding to problems, 58-59, 86, 124, 161-164, 174

review processes, 121-124, 152, 160, 169-170, 172, 173

root-cause analysis, 170, 172, 173

safety advisories and, 124, 153, 206-207

shared responsibility for, 173, 244, 248-249

state programs, 170-171

statutory authority, 38, 39-40, 86, 368

terminology defined, 88-89

trends, 115, 116-119

underreporting, 8, 94, 131, 153-156, 161, 171, 174, 177, 235, 331, 338

by user facilities, 9, 39-40, 87, 88, 91, 93, 94, 114, 115, 116-119, 120, 121, 152-153, 156, 157-158, 165-167, 171, 172, 175, 180, 236, 310, 412

voluntary, 37, 39, 86, 87 n.10, 91, 92-93, 94, 114-115, 116-119, 121, 126, 151, 163, 168, 172, 178-180

Adverse events

“caused or contributed,” 89

to children, 120, 121, 151, 206

close calls or near misses, 32-33, 91, 94, 115, 127-129, 162, 165, 166

“Code Blue” events, 124

computer-based surveillance, 167-169, 182

deaths, 91, 94, 113, 115, 116-119, 122, 146-148, 162

defined, 32-33, 422

design factors, 127-148, 149



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