20/09/2025
𝗦𝗶𝗻𝗴𝗹𝗲-𝗨𝘀𝗲 𝗗𝗲𝘃𝗶𝗰𝗲𝘀 (𝗦𝗨𝗗𝘀) – 𝗖𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀, 𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 & 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲
Single-Use Devices (SUDs) are intended for one patient, one procedure, one time.
Yet in CSSDs, errors continue to occur - risking patient safety, regulatory compliance, and accreditation.
𝗖𝗼𝗺𝗺𝗼𝗻 𝗘𝘅𝗮𝗺𝗽𝗹𝗲𝘀
Electrosurgical pencils and tips
Staplers & reloads
Laparoscopic trocars & clip appliers
Biopsy forceps, snares, guidewires
Ophthalmic knives, micro-scissors
Endodontic files and burs
𝗖𝗼𝗺𝗺𝗼𝗻 𝗘𝗿𝗿𝗼𝗿𝘀 𝗶𝗻 𝗖𝗦𝗦𝗗
General Surgery – stapler reloads reprocessed; suction tips cleaned as reusable
Laparoscopy – durable trocars mistaken for reusable; opened items returned to stock
Endoscopy – biopsy forceps processed like reusables; catheters rinsed and sent to prep
Cath Lab – Class III catheters/balloons put through EO/plasma cycles without validation
Ophthalmology – knives packed into trays; micro-residues cause infection risks
Dentistry – burs and files reused despite fracture and contamination risk
𝗔𝗱𝘃𝗮𝗻𝗰𝗲𝗱 𝗧𝗲𝗰𝗵𝗻𝗶𝗰𝗮𝗹 𝗥𝗶𝘀𝗸𝘀
Material degradation – plastics, coatings, adhesives fail after heat/chemicals
Bioburden retention – SUDs lack validated cleaning protocols
Sterility Assurance – impossible to guarantee 10⁻⁶ SAL without OEM validation
Traceability gaps – missing UDI & disposal logs violate ISO 13485 and FDA recall requirements
Opened-but-unused items – almost never validated for resterilization; discard is mandatory
𝗦𝘁𝗮𝗻𝗱𝗮𝗿𝗱𝘀 & 𝗚𝘂𝗶𝗱𝗮𝗻𝗰𝗲
FDA (21 CFR 803/806/820): Hospitals reprocessing SUDs are treated as “manufacturers”
AAMI ST79: Clear policy — segregate and do not reprocess unless FDA-cleared
ISO 15223-1: “Do Not Reuse” symbol = 2 with a slash
ISO 17664-1: Defines requirements for reprocessing info; absence = SUD
ISO 13485: Quality management system, traceability, risk-based approach
CDC/WHO: Reuse of SUDs is an infection risk; recommend strict IFU compliance
𝗦𝗮𝗳𝗲 𝗣𝗿𝗮𝗰𝘁𝗶𝗰𝗲 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁
Verify IFU & “Do Not Reuse” symbol at receiving and decon
Segregate SUDs from reusables throughout workflow
Use red bins or dedicated streams for disposal
Record disposal or third-party reprocessing in MMIS/waste logs
Train staff yearly on SUD vs reusable look-alikes
Audit compliance monthly (AAMI ST79, ISO 13485)
Report any attempted reuse as an incident under QMS
𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆
Single-use = one patient, one procedure, one time.
Attempting to reprocess or reuse SUDs in-house is non-compliant, unsafe, and exposes patients to unnecessary harm.
Compliance with FDA, AAMI, ISO, CDC, and WHO is the only acceptable standard.
Which specialty in your hospital presents the toughest challenges with SUD identification, and how does your team ensure compliance?
