Reprocessing stainless steel accessories: cleaning, disinfection, autoclaving
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Hygiene · Stainless steel accessories
The tube rack and syringe holder from prplab are made of solid stainless steel, autoclavable according to the manufacturer and not medical devices. They do not touch any patient, and there are no validated reprocessing instructions for them of the kind manufacturers provide for medical devices. Your hygiene plan defines the procedure. The sequence used in instrument reprocessing serves as a template: clean promptly, disinfect, rinse with demineralised water, dry, inspect and, if your hygiene plan provides for it, autoclave.
Reading time approx. 7 minutes · Updated: October 2026
Accessories without patient contact
The tube rack holds up to ten tubes during blood collection and preparation. Drawn-up syringes rest on the syringe holder without rolling away. The manufacturer is prpmed Funkner e.K. in Linden. Both items are made of solid stainless steel and are classified by the manufacturer as practice accessories, not as medical devices. You will find more practice accessories in the Accessories category.
Whether a product is a medical device depends on the intended purpose defined by the manufacturer. Our article Centrifuge for PRP: requirements shows how this works for centrifuges. For hygiene, a second question matters: what does the item touch? The tube rack and syringe holder touch the outside of tubes and syringes, gloves and the work surface. They do not come into contact with the patient's skin, mucous membranes or bloodstream.
They still need to be clean. In Germany, the Commission for Hospital Hygiene and Infection Prevention (KRINKO) at the Robert Koch Institute states in its recommendation on punctures and injections that a work surface on which accessories for these procedures are prepared must be wipe-disinfected beforehand.[6] Whatever stands on this surface should meet the same hygiene standard. In addition, blood can adhere to the outside of the tube after collection and thus reach the rack. The article Drawing up PRP from the tube describes how to draw up hygienically at this workstation.
The difference from medical devices with patient contact
In Germany, the reprocessing of medical devices that are used more than once is regulated in detail. The starting point is a risk classification according to the joint recommendation of KRINKO and the Federal Institute for Drugs and Medical Devices (BfArM). The yardstick is the type of use, i.e. the contact with the patient. Design details of the product can further increase the requirements.[1]
Non-critical medical devices are those that only come into contact with intact skin. Semi-critical devices are those in contact with mucous membranes or pathologically altered skin. Critical devices are products that penetrate skin or mucous membranes or are used to apply blood, blood products or sterile medicinal products.[1] The requirements increase with the level: semi-critical products undergo final bactericidal, fungicidal and virucidal disinfection, while critical products are sterilised after thorough cleaning and disinfection.[1]
In Germany, § 8 of the Medizinprodukte-Betreiberverordnung (MPBetreibV, Medical Devices Operator Ordinance) requires suitable validated procedures, taking the manufacturer's information into account, for products that are intended to be used in a low-microbial or sterile state. Single-use products are excluded. If the KRINKO and BfArM recommendation is followed, proper reprocessing is presumed.[2] In other countries, the respective national regulations apply.
The ISO 17664 series of standards governs the information the manufacturer provides for this. Part 1 covers critical and semi-critical medical devices as well as products intended to be sterilised. It ranges from pre-treatment at the point of use through cleaning, disinfection, drying, inspection and packaging to sterilisation and storage.[3] Part 2 applies to non-critical medical devices that are not intended to be sterilised, explicitly including those without direct patient contact.[4] Both parts are addressed to manufacturers of medical devices.
| Feature | Medical device with patient contact | Tube rack and syringe holder |
|---|---|---|
| Classification | non-critical, semi-critical or critical according to KRINKO and BfArM (Germany) | according to the manufacturer, practice accessories without patient contact, not medical devices |
| Manufacturer information | reprocessing instructions, content according to ISO 17664 | material, surface, autoclavable |
| Procedure | validated, machine cleaning and disinfection preferred | defined in your hygiene plan |
| Final step | documented release for use | visual inspection, dry and dust-protected storage |
Simplified presentation based on the KRINKO and BfArM recommendation.[1] Your hygiene plan, the manufacturer's documentation and the national regulations are authoritative.
The steps themselves hardly differ. For practice accessories, the formal framework of classification, validation and manufacturer instructions is missing. A clear rule in your hygiene plan takes its place.
What the product information states
| Feature | Tube rack | Syringe holder |
|---|---|---|
| Material | stainless steel, solid | stainless steel, solid |
| Surface | glass-bead blasted, matt and glare-free | glass-bead blasted, satin matt, non-porous |
| Holds | 10 tubes | various syringe types |
| Reprocessing | fully autoclavable | resistant to disinfectants, autoclavable |
| Sterilisation programme | not stated | not stated |
| Product status | practice and laboratory accessory, not a medical device | practice accessory, not a medical device |
Information from the product documentation of prpmed Funkner e.K., Linden.
Not stated are an autoclave temperature and holding time, a maximum number of cycles, or approved cleaning agents and disinfectants. For the tube rack, information on resistance to disinfectants is also missing. For medical devices, the KRINKO and BfArM recommendation names steam sterilisation at 134 °C as the standard procedure.[1] You therefore define the programme and agents for the two items in your hygiene plan, together with the person responsible for hygiene.
Reprocessing in five steps
The sequence comes from the reprocessing of medical devices.[1] For the tube rack and syringe holder, adopt it in your hygiene plan, adapted to your equipment and agents.
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Start promptly
Gross soiling should be removed immediately after use so that blood does not dry on.[1] If this is not possible straight away, the Arbeitskreis Instrumenten-Aufbereitung (AKI, Working Group Instrument Preparation) considers a waiting time of up to 6 hours with dry storage to be unproblematic.[5] Wear protective gloves while doing so.
-
Clean without fixing
Heat or aldehydes before cleaning fix residues on the surface. The recommendation also lists alcohol, peracetic acid and temperatures above 55 °C as fixing.[1] So never put the tube rack in the autoclave with blood residues on it. Clean with an agent suitable for stainless steel, including inside the holes.
-
Disinfect
Manually with an agent from your hygiene plan: the recommendation requires agents and procedures that are suited to the product and compatible with its material.[1] In a washer-disinfector, thermal disinfection takes place at 80 to 95 °C. The measure used is the A0 value; A0 3,000 corresponds, for example, to 90 °C for 5 minutes.[5]
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Rinse and dry
Finally, rinse with demineralised water. It is recommended to avoid deposits and crystal formation.[1] Then dry immediately: residual moisture promotes corrosion.[5]
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Inspect, autoclave if required, store
Check each item for cleanliness and integrity, including corrosion.[1] If your hygiene plan provides for the autoclave, it comes only now. Then store the items dry and protected from dust, separately from used ones.
Why stainless steel still gets stains
Stainless steel is corrosion-resistant, but not impervious. It protects itself with a passive layer of chromium oxide. This layer forms because the alloy contains at least 12 % chromium, which reacts with the oxygen in the air.[5]
Chloride attacks this layer, depending on its concentration even to the point of pitting corrosion. In practice it comes from blood with 3,200 to 3,550 mg of chloride per litre, from isotonic saline and from water that is not sufficiently demineralised, especially during final rinsing and steam sterilisation.[5] Therefore never soak the items in saline, and do not let blood dry on.
Other stains come from the water. Hardness minerals leave poorly soluble limescale deposits. Silicic acid and silicates cause yellowish-brown to bluish-violet discolouration even at low concentrations. Rust particles from corroded pipes can settle during machine reprocessing. This extraneous rust leaves rust stains and leads to corrosion on the item itself.[5] To prevent water stains, the AKI recommends demineralised water for manual reprocessing too.[5]
Matt or shiny? Both items are glass-bead blasted and therefore matt. According to the AKI, whether a stainless steel surface is matt or shiny has no influence on the formation of the passive layer. The layer becomes thicker with increasing service life, and corrosion attacks decrease as a result.[5]
Which procedure for which practice?
The steps stay the same. How you disinfect and whether the autoclave is added depends on your equipment and your hygiene plan.
Wipe disinfection
You reprocess at the treatment station, without a separate reprocessing room.
Clean, wipe-disinfect with an agent from your hygiene plan, observe the contact time, dry. Check whether the agent is suitable for stainless steel. For the syringe holder, the manufacturer explicitly states resistance to disinfectants.
Autoclave
Your hygiene plan requires racks and holders in the preparation area to be autoclaved.
According to the manufacturer, both items are autoclavable. They only go into the autoclave after cleaning, disinfection and drying. Define the programme in your hygiene plan.
Washer-disinfector
You have a reprocessing room with a washer-disinfector.
Clarify in advance whether the items may go into the washer-disinfector with your instruments. The product information does not state suitability for washer-disinfectors, and a new load configuration may affect your validated procedure. Agree on loading and programme with the person responsible for hygiene and record the result in the hygiene plan.
Second set
You reprocess several times a day.
With a second tube rack and syringe holder, a dry, reprocessed set is always ready while the other is still being reprocessed. That way there is no pressure to cut steps short.
Frequently asked questions
Are the tube rack and syringe holder medical devices?
No. The manufacturer classifies the tube rack as a practice and laboratory accessory and the syringe holder as a practice accessory, both explicitly not as medical devices. As intended, they have no contact with the patient.
Do I have to validate the reprocessing?
In Germany, § 8 MPBetreibV requires validated procedures for products that are intended to be used in a low-microbial or sterile state.[2] The manufacturer does not classify the tube rack and syringe holder as medical devices, and there are no validated manufacturer instructions for them. Nevertheless, record the procedure in writing in your hygiene plan so that everyone in the team works the same way. For facilities outside Germany, the national requirements apply.
Which autoclave programme is the right one?
The product information states “autoclavable” but no specific programme. For medical devices, steam sterilisation at 134 °C is the standard procedure in the KRINKO and BfArM recommendation.[1] Define in your hygiene plan which programme you use for the two items.
May I wipe off traces of blood directly with an alcohol-based disinfectant wipe?
Not as the first step. Like aldehydes and peracetic acid, alcohol has a fixing effect.[1] Clean first and disinfect afterwards.
Do syringes and needles go into reprocessing as well?
No. The syringes and needles at prplab are single-use products. They are not reused, and used needles go into a puncture-resistant sharps container. Only items intended for it are reprocessed, here the tube rack and syringe holder.
The products
- Stainless steel tube rack10 positions, glass-bead blasted, autoclavable
- Stainless steel syringe holderfor various syringe types, autoclavable
- BD Plastipak™ 1 mlDisposable syringe with Luer-Lok™, 100 pieces
- Mediware disposable syringe 5 mlLuer-Lock, 3-part, 100 pieces
Sources
- Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut, Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM). Anforderungen an die Hygiene bei der Aufbereitung von Medizinprodukten. Bundesgesundheitsbl. 2012;55(10):1244-1310. edoc.rki.de (PDF)
- Medizinprodukte-Betreiberverordnung (MPBetreibV) of 14 February 2025, BGBl. 2025 I No. 38, § 8, current version. gesetze-im-internet.de
- ISO 17664-1:2021. Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices. Part 1: Critical and semi-critical medical devices. Catalogue page. iso.org
- ISO 17664-2:2021. Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices. Part 2: Non-critical medical devices. Catalogue page. iso.org
- Arbeitskreis Instrumenten-Aufbereitung (AKI). Traiter les instruments de façon en préservant leur valeur. 10e édition. Mörfelden-Walldorf: AKI; 2012. French edition of the “Red Brochure”, chapters 1.1, 2.1, 5 and 6. pedagogie.ac-lille.fr (PDF)
- Kommission für Krankenhaushygiene und Infektionsprävention (KRINKO) beim Robert Koch-Institut. Anforderungen an die Hygiene bei Punktionen und Injektionen. Bundesgesundheitsbl. 2011;54:1135-1144. edoc.rki.de (PDF)
Product information: product documentation from prpmed Funkner e.K., Linden (tube rack item no. 100314, syringe holder item no. 100315).
Note for professional users: This article gives an overview of hygiene recommendations, standards and manufacturer information on reprocessing stainless steel accessories. It does not replace the instructions for use and labelling, nor professional assessment of the individual case.
Exclusively for medical professionals.