Expiry dates in the dental practice: FEFO, labels and returns

A cartridge that has just expired, a tube of composite forgotten at the back of the drawer: expired stock turns up in every practice. Usually it comes down to order. The new delivery goes in front, the old one slides to the back. In this article you will find what the rules say about expiry dates, how to apply FEFO, what a supplier will still take back and what to do with expired products. The basics of counting and ordering are in our guide to dental practice inventory management.

What the expiry date means

Most consumables are medical devices and fall under Regulation (EU) 2017/745 (MDR). Under Annex I, section 23.2, the label shows, where relevant, "the time limit for using or implanting the device safely", expressed at least as year and month. Otherwise it shows the date of manufacture.

That date is based on testing: the technical documentation must contain data on "stability, including shelf life" (Annex II). After the expiry date, you are working beyond what the manufacturer has substantiated.

Medicines, such as local anaesthetics, fall under Directive 2001/83/EC. The packaging shows the expiry date in clear terms, month and year (Art. 54), small immediate packaging carries at least that date and the batch number (Art. 55), and the package leaflet warns against using the product after that date (Art. 59).

Reading the label

Manufacturers use the symbols from the ISO 15223-1 standard. The Belgian medicines agency FAMHP explains the most common ones on its symbols page. For dates, these matter most:

• Hourglass: the use-by date.
• Outlined factory: the date of manufacture. A solid factory stands for the manufacturer.
• LOT: the batch code, which you need if a product is recalled.
• Thermometer with limits: the temperature limit.

The FAMHP advises following the storage conditions from purchase until first use, and checking any shelf life after opening.

The data matrix or barcode on the label (the UDI carrier) also contains the expiry date when it appears on the label (MDR, Annex VI, Part C). Software that reads the code can pick up the date without anyone typing it in.

Supplied sterile or sterilised in-house: two different dates

Sterile from the manufacturer. The device stays sterile until you open the packaging at the point of use, as long as the packaging is undamaged and the product was stored as the manufacturer specifies (MDR, Annex I, section 11.4). The sterile packaging carries its own use-by date (section 23.3).

Sterilised in-house. On your own pouches, you set the expiry date. According to Superior Health Council advice SHC 9682, you determine that shelf life through a risk analysis (see our article on sterilisation in the dental practice). Don't forget the pouches themselves: according to the same advice, the manufacturer of the packaging material gives a use-by date after which the packaging may no longer be used. The roll of pouches belongs in your rotation too.

Can you use expired dental materials?

No. The MDR talks about the time limit for using a device safely, the FAMHP advises users to check it before use, and for medicines the leaflet explicitly warns against it. Anything expired no longer goes near a patient, even if it still looks fine.

FEFO: first expired, first out

FEFO means you use first what expires first, not what arrived first. The principle comes from distribution. The European Guidelines on Good Distribution Practice (2013/C 343/01, section 5.5) require medicines wholesalers to rotate stock according to FEFO. The FAMHP guidance for distributors of medical devices (section 4.7) asks the same for devices. These texts are written for distribution, not for practices, but the principle works the same way in your cupboard.

The difference with FIFO (first in, first out) shows as soon as a later delivery expires sooner: if the April box expires before the March box, FEFO has you use the April box first.

FEFO in your practice

1. Check the date on delivery. Under the guidelines, a medicine should still have "an appropriate remaining shelf life" when it is picked for an order (section 5.7). No fixed number of months is given. If you want a minimum, agree it with your supplier.
2. Sort by date, not by arrival. The nearest date goes at the front or on top. A new delivery goes behind, unless it expires sooner.
3. Make the date visible. Write the expiry month in large print on the side of the box.
4. Restock treatment rooms with the nearest date first, not with whichever box happens to be at the front of the storeroom.
5. Order short-life products in smaller quantities. A large pack only pays off if you use it before it expires. To set a tight but safe minimum, read calculating minimum stock.

Implants. The Belgian Law of 22 December 2020 on medical devices (Art. 16, in Dutch and French) requires healthcare professionals to keep the UDI of implantable devices supplied to them, preferably electronically. Note the expiry date on receipt as well.

What will your supplier still take back?

When you buy for your practice, you have no statutory right of withdrawal; what applies are your supplier's terms (see ordering dental supplies online). There is also a practical limit. Under the FAMHP guidance for distributors (section 6.2), a recommendation rather than law, a returned device may only go back into saleable stock if, among other things:

• it is unopened, unused and in good condition;
• it has always been stored correctly;
• it still has an acceptable shelf life;
• its batch number, UDI and expiry date match the delivery.

For medicines, the rules are stricter. Under the European guidelines (section 6.3), a wholesaler may only return medicines to saleable stock if they are unopened, unexpired and not recalled. If the return comes from a customer without a wholesale authorisation, such as a practice, it must happen within an acceptable time limit (the guidelines give ten days as an example) and the customer must show that the storage requirements were met.

Returns are for fixing delivery mistakes, not for offloading surplus that is about to expire. Report a wrong delivery straight away and keep the packaging sealed.

What to do with expired products

Remove them from usable stock immediately, keep them apart and mark them clearly as "do not use". After that they are waste, and how you dispose of it depends on the region:

• Flanders. According to the OVAM healthcare waste manual (2021, in Dutch), old and expired medicines from medical treatment are risk-bearing medical waste (RMA). For expired narcotics and psychotropics, you keep a register. The manual also contains a sorting list.
• Brussels. Brussels Environment (in French and Dutch) asks you never to put expired medicines in the bin or the toilet, but to arrange a collection with your waste collector. Only a very small, occasional quantity may go to a pharmacy.
• Wallonia. Ask your approved medical waste collector how they take back expired medicines and devices.

And in the Netherlands?

The MDR, labels and symbols are the same across the EU. Medical devices are supervised by the Health and Youth Care Inspectorate (IGJ). For instruments sterilised in-house, the KNMT guideline Infectiepreventie in mondzorgpraktijken (2016, under revision) sets a fixed limit: resterilise no later than six months after the sterilisation date and mark the end date of sterility on the packaging. In Belgium, you work with a risk analysis (SHC 9682).

Short-life products in Swyp

FEFO works best when the cupboard isn't overfull. In Swyp you set a minimum and a maximum for each product; for short-life products, keep both tight. When stock drops below the minimum, the product goes on your order list and you order from all your suppliers in one cart. Scout proposes a cheaper split; you approve every change. That way you order small quantities more often, without placing a separate order with each supplier. Try Swyp free.

Sources

• Regulation (EU) 2017/745 (MDR), Annexes I, II and VI
• Directive 2001/83/EC, Art. 54, 55 and 59
• European Commission, Guidelines on Good Distribution Practice of medicinal products for human use (2013/C 343/01)
• FAMHP, Guidance for distributors of medical devices (version 2.1), symbols page and advice on the proper use of devices
• Superior Health Council, SHC 9682 – Sterilisation of reusable medical devices
• Law of 22 December 2020 on medical devices, Art. 16 (Dutch)
• OVAM, Afval in de gezondheidszorg (Dutch); Brussels Environment (French)
• KNMT, Richtlijn Infectiepreventie in mondzorgpraktijken (Dutch)