Sealing Devices for safe Instrument Packaging in Practice and Clinic
The MELAseal Series: Packaging instruments quickly, safely and standard-compliant
Protect patients and practice staff with a safe workflow. Instrument packaging assumes an important place in the decontamination process to prevent the recontamination of the sterilized instruments and medical products.
Our high-performance MELAseal sealing devices perform a reliable and efficient packaging process in a practice and clinic context. The MELAseal series devices seal instruments in film packaging such as MELAfol after cleaning and disinfection and before sterilization in the autoclave.
Find out more about the advantages of the innovative MELAG sealing devices:
How to wrap instruments using a sealing device
International guidelines require that instruments are sterilized wrapped after cleaning and disinfection. Sealing individual instruments in sterilization film packages with a heat sealing device is the ideal measure for realizing sterile instrument storage. The seal seams must fulfil international standards. MELAG provides tips for safe packaging in sterilization film pouches:
✓ The instrument length may only take up max. 75 % of the pouch and a minimum clearance of 3 cm must be maintained between the instrument and the seal seam.
✓ The seal seam should exceed the minimum width of 6 mm.
✓ The overhang behind the seal seam should amount to a standard of 1 cm. The overhang at the operneing side should amount to 3 cm, to enable easy opening of the pouches. Please always comply with the peel direction of the film packaging when opening.
Learn more about the wrapping process with a sealing device:
Rotary sealers and bar sealers
Sealing devices tailored to the needs of your practice and clinic
The MELAseal Pro rotary sealer and the MELAseal 200 bar sealer fulfil the most-demanding requirements placed on reliability and efficiency. Both sealing devices produce standard-compliant and safe seal seams. The sealing devices are validatable and provide legally-compliant documentation of the process-relevant sealing parameters pressure, temperature and time. The difference between them lies in the number of instruments to be wrapped.
The MELAseal Pro rotary sealer is the ideal solution for practices and clinics with large numbers of instruments to be wrapped. The instruments are packaged ergonomically, quickly and safely through automatic feeding of the pouches in the shortest-possible time and without interruption. This ensures efficient operating procedures in the decontamination room. MELAseal Pro provides the additional advantage of a grooved seal seam 14 mm in width. The character of the seal seam guarantees maximum safety in the storage of sterilized instruments and especial ease-of-use when opening.
Frequently Asked Questions
What are the advantages of a validatable sealing device?
Sealing devices enable the contamination-free storage of sterilized instruments until they are needed for the patient treatment. We provide routine tests such as the “seal seam stability test” or MELAink test to check the reliability and safety of the packaging seal seam. These tests should be performed at intervals established by regional authorities.
The hospital sector has long used sealing devices which perform an automatic check during the sealing procedure, documenting the three process parameters temperature, contact pressure and sealing time. The use of such validatable sealing devices in practice-based medicine is currently not mandatory in many countries, but often recommended.
Nevertheless, practices and clinics considering a new purchase should consider to choose a validatable sealing device, guaranteeing reproducible safety through continual monitoring and documentation of all the process parameters.
The MELAG sealing devices MELAseal Pro and MELAseal 200 are fitted with a process-parameter monitoring system as prescribed by international standards. Sealing logs are issued via the documentation interfaces.
Is a sealing device a medical device?
The requirements placed on a medical device are set out in the directive 93/42/EEC. In accordance with article 1 of the directive, a product is a medical device if section 2 of 93/42/EEC is applicable.
Neither section 2a, which describes products which are applied in or on the human body, nor section 2b (medical devices accessories) contains a description of the sealing device and its application. Appendix IX of the classification criteria does not provide a definition of a sealing device as a medical device.
As such, sealing devices are not classed as a medical device. Nevertheless, in developing and producing its sealing devices, MELAG orients itself around the requirements of directive 93/42/EEC.
How long may wrapped instruments be stored after sterilization?
The transport, commissioning and storage of sterile medical devices including the requisite packaging and marking are regulated by international standards. Loss of sterility is dependent less on the length of the storage time as from external influences during storage, transport and application. It is not possible to establish a storage duration for practice and clinic use.
The recommendation pertaining to the storage duration of medical devices is: paper and transparent packaging or another equivalent packaging can be stored in protected storage (in drawers, cupboard etc.) for six months. The storage duration of the instruments may not exceed the individually specified expiry date.
Packaging systems (combination of a sterile barrier system and protective packaging) can be stored for 5 years, as far as the manufacturer has not determined an alternative expiry date.
Unwrapped instruments should be used within 24 and 48 hours. Please always consider your national requirements.
The rooms used for storing medical devices should be dry, dark, cool and easy to clean. They must not be accessible to everyday activity. We recommend protected storage of the instruments in rooms and cupboards which comply with the requirements of international standards.
MELAfol is a transparent sterilization packaging (available as a roll or various size bags) perfectly adapted to MELAG sealing devices and complying with international standards. MELAfol is tear-free, sealed against germs and easy to open. Find out more about our MELAfol products for safe instrument storage after sterilization and approval.
