EtO exposure determination for an overlooked worker population at a medical device company
Anonymized — commercial-stage medical device company
The challenge
The company had a mature EtO sterilization compliance program covering their contract sterilizer — but their own warehouse and shipping/receiving staff, who handled incoming sterilized pallets three times a week, had never been included. No exposure determination, no monitoring, no training, no medical surveillance. An EHS review flagged the gap six weeks before a scheduled Cal/OSHA inspection.
6
Weeks' notice before Cal/OSHA inspection
0
EtO-related citations at inspection
4
SEGs characterized across warehouse operations
12
Employees enrolled in medical surveillance
What we did
- 1
Defined four Similar Exposure Groups across receiving, forklift, QC inspection, and pick/pack operations — none of whom were in the existing EtO compliance program.
- 2
Conducted personal full-shift TWA sampling (OSHA Method 50) and 15-minute STEL samples during pallet arrival and stretch-wrap removal across two sampling days.
- 3
Deployed continuous EtO monitoring at dock, staging zone, and quarantine room throughout each shift to map concentration peaks and decay.
- 4
Built an off-gas decay curve for typical incoming loads to establish a minimum safe quarantine hold time before manual handling.
- 5
Extended the existing EtO compliance program to all warehouse SEGs: regulated area designation, training, medical surveillance enrollment, and a periodic monitoring schedule per §5220(d)(4).
Before & after
Before
- Warehouse and S&R staff had no exposure determination on record
- No monitoring, training, or medical surveillance for downstream EtO handlers
- No quarantine hold time policy — staff handled pallets immediately on arrival
- Company believed their existing EtO program covered all exposed employees
After
- Full exposure determination completed and documented for all 4 warehouse SEGs
- Minimum quarantine hold time established from off-gas decay data
- 12 employees enrolled in medical surveillance; periodic monitoring schedule set
- EtO compliance program formally extended to warehouse operations before Cal/OSHA inspection
The outcome
Cal/OSHA inspection resulted in zero EtO-related citations.
Established a repeatable incoming-load monitoring protocol the safety team could operate independently.
Identified two receiving employees who had been handling freshly-arrived pallets for three-plus years with no monitoring — both enrolled in medical surveillance per §5220 requirements.