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2025 data FDA MAUDE openFDA FDA Class II

Indicator, Biological Sterilization Process

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA Class II (moderate risk, special controls required), regulated under 21 CFR §880.2800 (General Hospital panel).

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FDA MAUDE casebook

openFDA event book Indicator, Biological Sterilization Process LIGHT-BOOK · MAUDE

#576 of 1000 · 1,469 reports · 1995–2025

  • BOOK 1,469 reports
  • RANK #576 of 1000
  • DEATH 0 death-typed
  • INJ 24 injury-typed
  • MALF 1,346 malfunction
  • SPAN 1995–2025
  • PEAK 2016: 482
  • PHOTO Lift

Nearest event-volume peer: Lift, Patient, Ac-Powered (0 report gap)

Indicator, Biological Sterilization Process sits #576 of 1000 among tracked device types with 1,469 MAUDE reports spanning 1995–2025. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Injury-coded reports sit below the device-type norm

Indicator, Biological Sterilization Process carries 1.6% INJURY-coded reports, 28.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 1.6% corpus 30.3% · below corpus mean (-28.7 pp)
  • MALF 91.6% corpus 64.8% · above corpus mean (+26.8 pp)

Lead product-problem code Appropriate Device Problem Term/Code Not Available is 46% of coded problems · Lead manufacturer ADVANCED STERILIZATION PRODUCTS accounts for 100% of manufacturer-tagged reports · Top event location I is 60% of location-tagged rows .

Indicator, Biological Sterilization Process in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Indicator, Biological Sterilization Process carries 1,469 MAUDE reports, ranked #576 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 1,346 (91.6%)
93 (6.3%)
Injury 24 (1.6%)
Other 6 (0.4%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

1,381 (94.0%)
Other 83 (5.7%)
Required Intervention 3 (0.2%)
Hospitalization 2 (0.1%)

Top Product Problems

Appropriate Device Problem Term/Code Not Available 756
Chemical Problem 307
Other (for use when an appropriate device code cannot be identified) 187
Device Operates Differently Than Expected 181
Use of Device Problem 40
Improper or Incorrect Procedure or Method 18
Device Contamination With Biological Material 17
Insufficient Device Problem Information 14
Break 13
Leak/Splash 13
False Positive Result 12
Adverse Event Without Identified Device or Use Problem 10
Device Issue 10
Incorrect Or Inadequate Test Results 9
Nonstandard Device 9
Unknown (for use when the device problem is not known) 9
Device Disinfection Or Sterilization Issue 8
Incorrect, Inadequate or Imprecise Result or Readings 8
Component Missing 7
Contamination /Decontamination Problem 7

Yearly Trend

95
1995: 2
96
1996: 3
97
1997: 1
98
1998: 2
99
1999: 2
02
2002: 2
03
2003: 4
04
2004: 3
05
2005: 11
06
2006: 20
07
2007: 100
08
2008: 60
09
2009: 45
10
2010: 57
11
2011: 37
12
2012: 46
13
2013: 39
14
2014: 51
15
2015: 182
16
2016: 482
17
2017: 182
18
2018: 22
19
2019: 30
20
2020: 16
21
2021: 10
22
2022: 9
23
2023: 20
24
2024: 22
25
2025: 9

Reports rose to 22 in 2024, up from an average of 15 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Indicator, Biological Sterilization Process

Top Manufacturers

ADVANCED STERILIZATION PRODUCTS 1,134

Event Locations

I 877 (59.7%)
540 (36.8%)
HOSPITAL 45 (3.1%)
NO INFORMATION 4 (0.3%)
AMBULATORY SURGICAL FACILITY 1 (0.1%)
OTHER 1 (0.1%)
OUTPATIENT TREATMENT FACILITY 1 (0.1%)

Nationwide devices with a comparable report-volume footprint

Indicator, Biological Sterilization Process carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (1,469 here).

Lift, Patient, Ac-Powered 1,469 Bed, Air Fluidized 1,460 Radioimmunoassay, Parathyroid Hormone 1,479 Fluid Jet Removal System 1,449

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Indicator, Biological Sterilization Process are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Indicator, Biological Sterilization Process; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.