Overview
The PSH (Product Summary Header) segment heads a periodic product surveillance report. It identifies the kind of summary being submitted, anchors the report in time, and totals how much product was manufactured, distributed, and remains in use across the interval covered by the report.
PSH appears once per product summary report and is followed by detail segments describing individual product experiences, evaluations, and follow-ups. Regulators, manufacturers, and distributors use the PSH header to reconcile the report against expected periodic filings.
Used In
PSH is the leading header segment of a Product Summary report — a periodic product surveillance summary message used to roll up product experience information over a defined interval. See Product Experience Reporting messages for the surrounding message context.
Field-by-Field Reference
Each field below follows the v2.5.1 definition published in the HAPI javadoc for the PSH segment. Sequence numbers correspond to the field positions encoded in the pipe-delimited segment. Required fields must be present in any conformant instance; optional fields may be omitted. Data type links point to the v2.5.1 data type references on the Vorro HL7 Academy.
| Seq | Name | Data Type | Length | Req | Repeat | Table # | Description |
|---|---|---|---|---|---|---|---|
| PSH-1 | Report Type | st | — | R | — | — | Kind of product summary being reported |
| PSH-2 | Report Form Identifier | st | — | O | — | — | Identifier of the regulatory report form |
| PSH-3 | Report Date | ts | — | O | — | — | Date the summary report was prepared |
| PSH-4 | Report Interval Start Date | ts | — | O | — | — | Start of the reporting interval covered |
| PSH-5 | Report Interval End Date | ts | — | O | — | — | End of the reporting interval covered |
| PSH-6 | Quantity Manufactured | cq | — | O | — | — | Total units manufactured in the interval |
| PSH-7 | Quantity Distributed | cq | — | O | — | — | Total units distributed in the interval |
| PSH-8 | Quantity Distributed Method | id | — | O | — | — | How the distributed quantity was derived |
| PSH-9 | Quantity Distributed Comment | ft | — | O | — | — | Free-text comment on distributed quantity |
| PSH-10 | Quantity in Use | cq | — | O | — | — | Estimated units currently in use |
| PSH-11 | Quantity in Use Method | id | — | O | — | — | How the in-use quantity was derived |
| PSH-12 | Quantity in Use Comment | ft | — | O | — | — | Free-text comment on in-use quantity |
| PSH-13 | Number of Product Experience Reports Filed by Facility | nm | — | O | Y | — | Experience reports filed by reporting facility |
| PSH-14 | Number of Product Experience Reports Filed by Distributor | nm | — | O | Y | — | Experience reports filed by distributor |
Examples
Minimal PSH
PSH|Periodic Distribution Summary
Fully populated PSH
PSH|Periodic Distribution Summary|FORM-3500A-Q2|20260630120000|20260401000000|20260630235959|12450^EA^Each|11820^EA^Each|S|Sampled from production records|9430^EA^Each|E|Estimated from registry returns|14|3
Annotated breakdown
PSH Segment ID
|Periodic Distribution Summary PSH-1 Report Type
|FORM-3500A-Q2 PSH-2 Report Form Identifier
|20260630120000 PSH-3 Report Date (2026-06-30 12:00:00)
|20260401000000 PSH-4 Report Interval Start Date
|20260630235959 PSH-5 Report Interval End Date
|12450^EA^Each PSH-6 Quantity Manufactured (CQ)
|11820^EA^Each PSH-7 Quantity Distributed (CQ)
|S PSH-8 Quantity Distributed Method
|Sampled from production records PSH-9 Quantity Distributed Comment
|9430^EA^Each PSH-10 Quantity in Use (CQ)
|E PSH-11 Quantity in Use Method
|Estimated from registry returns PSH-12 Quantity in Use Comment
|14 PSH-13 Reports Filed by Facility
|3 PSH-14 Reports Filed by Distributor
In-context excerpt — quarterly product summary
MSH|^~&|SURVEILLANCE|VORRO-MFG|REGULATORY|FDA|20260701081500||PGL^PC6^PGL_PC6|MSG00098231|P|2.5.1
PSH|Periodic Distribution Summary|FORM-3500A-Q2|20260630120000|20260401000000|20260630235959|12450^EA^Each|11820^EA^Each|S||9430^EA^Each|E||14|3
PID|1||PAT-44781^^^VORRO^MR||Doe^Jane^A||19720814|F
PEO|N|20260512||AE-2026-00451|Device malfunction during routine use
In-context excerpt — annual safety summary header
MSH|^~&|VIGILANCE|SITE-ATLANTA|REGULATORY|EMA|20260115093000||PGL^PC6^PGL_PC6|MSG00099404|P|2.5.1
PSH|Annual Product Safety Summary|PSUR-2025-ANNUAL|20260115000000|20250101000000|20251231235959|108200^EA^Each|104300^EA^Each|R||87600^EA^Each|S||42|9
PCR|MDL-7745-X^Cardiac Telemetry Patch^MFG^^^^2.1|MFG-ATL||20251020||LOT-FX-991||N
Notes and Best Practices
- PSH-1 must be sent; downstream regulators key the report routing on the Report Type value.
- Report interval fields (PSH-4 and PSH-5) should bracket all detail segments that follow; trading partners commonly reject reports whose detail dates fall outside the interval.
- Quantities are encoded as CQ — pair the numeric value with the unit component so consumers can normalize unit-of-measure across submissions.
- PSH-13 and PSH-14 are the only repeating fields; repeat them when the facility or distributor counts must be stratified by sub-category as agreed with the receiver.
- The Method fields (PSH-8, PSH-11) describe how aggregated quantities were derived (sampled, estimated, reported, etc.) and pair with the matching Comment field for explanatory free text.
