General Terms and Conditions for Loaner sets BeMedico NV
1. Subject
These general terms and conditions will describe the modalities regarding the provision of loaner sets by the company to the hospital. When placing the order, the hospital agrees to these general terms and conditions.
2. Definitions
The terms below have the following meanings:
Loaner sets: set of medical devices for a specific procedure, which is temporarily made available to the hospital by the company. The cost associated with this provision is determined by mutual agreement (mail) between the company and the hospital.
3. Loaner set principle
The loaner sets are made available to the hospital by the company for a short term. The goods made available remain the property of the company at all times and under all circumstances. The hospital is responsible for monitoring the goods during the time of the loan. The products are stored in a location(s) specified by the hospital, which allows individualization and guarantees complete safety and protection.
The hospital undertakes to strictly comply with the storage conditions and the company’s instructions on the label and in the manual of each product.
The hospital will manage and store the loaner set with due care. The hospital guarantees that the products are sufficiently insured against theft, fire and other damage according to their actual value.
Before the reservation of the loaner set total has been discussed and agreed upon which include materials, transport and service.
In case of urgency, the normal 5 steps procedure , as described under point 4, can be changed after mutual agreement. All additional costs resulting from the adjustment to an emergency procedure will be borne by the hospital.
4. “5 step”- procedure
· 4.1. Step 1 “Reservation”
The reservation by the hospital is made at least 5 working days before the planned procedure by email or through their contact, whereby the following information must be provided:
o the type of material
o the date and time of the procedure
o the name of the surgeon
o the location where the procedure will take place
o the exact details for the place of delivery
o telephone contact details (coordinates of the person who made the reservation)
o indication whether the presence of a technical advisor or external assistant is desired
· 4.2. Step 2 “Confirmation of reservation”
The confirmation of the reservation will be sent by the company to the indicated contact address within the hospital.
The company undertakes that all medical devices included in the set for which the reservation is confirmed are CE marked and that the company and the products concerned comply with all applicable legislation in this regard.
When used for the first time, the company representative contacts the central sterilization service to inform the staff about the maintenance of the new product: disassembly, cleaning, disinfection, packaging, sterilization.
Any additional information about the loaner set in question and its contents, is available at simply request to the company.
· 4.3. Step 3 “Delivery”
The hospital communicates the default place of delivery at the reservation ( Step 1).
The following information accompanies the loaner set in English and or requested language.
o an accurate and updated composition of the loan set, stating the number of packages upon delivery
o photos of the contents of the loan sets supplied
o for implants supplied sterile and non-sterile: a list of reference numbers and quantities and, if possible, supplemented with all important additional information (lot number, expiry date, notification or identification code, etc.)
o instructions regarding sterilization technique and cleaning
o a blank cleaning and decontamination form (see 4.4)
o the contact details of the person within the company to whom problems are reported.
4.4. Fase 4 “Return of the loaner set”
The loaner sets are preferably made available by the hospital 24 hours (with a maximum of 48 hours) after the end of the procedure for return by the company.
If there has been a deviation from the planned date or time of the procedure as stated when booking, the company will be informed as soon as possible.
The hospital will return all material to the company in the same undamaged condition. If material or packaging has been damaged, this must be explicitly stated on the “cleaning and decontamination form” (see below).
For each loaner set supplied, there is a blank “cleaning and decontamination form” available on which the hospital confirms the cleaning and disinfection at the time of return. Any defects in instruments and/or implants must also be noted on this form.
The hospital always adds this completed and signed form to the loaner sets to be returned.
If the hospital does not complete and sign the supplied blank form when it is returned, the costs for cleaning and decontamination of the set in question will be charged to the hospital by the company.
4.5. Step 5 “Invoicing”
Based on the inventory of the loan sets upon return, the hospital pharmacy will draw up an order form that will be sent to the company within (maximum) 5 working days after the procedure or the hospital provides us with an order number.
The order form contains the references, the number used and for sterile Medical Devices, the lot numbers of the Medical Devices used. The statement “order for regularization loaner set” is clearly stated on the order form to distinguish it from a stock order.
Invoicing for any damaged or lost products is done according to the following principle:
o lost goods will be invoiced at cost price
o sterile products whose packaging is damaged or products that are damaged due to incorrect use will be invoiced to the hospital at cost price.
o products that show wear or damage due to “normal” use will not be invoiced.
5. Retention of title
The company remains the owner of the products it makes available to the hospital.
The hospital is obliged to inform the company without delay in the event of:
o third parties assert rights on the loaner sets or the hospital becomes aware that third parties intend to assert rights on them;
o a judicial composition is requested or granted with regard to the hospital or an arrangement is made with the hospital’s creditors;
o bankruptcy of the hospital is filed or the hospital is declared bankrupt or goes into liquidation.
The hospital will inform third parties who wish to seize or otherwise encumber the loaner sets that they are the property of the company.
The hospital undertakes not to remove or alter any markings or other indications on the loaner sets that indicate that they are the property of the company.
6. Liability
To the extent that the company would be held liable to the hospital or the customer for possible damage caused by the goods made available, including the loaner sets, its liability is limited to the amount for which the company is insured under the company liability insurance it has taken. Insurance coverage must be adequate in relation to the risk to which the company exposes itself.
The company cannot be held liable for the consequences for the patient in the event of incomplete delivery, if the hospital has been informed in advance. The hospital must check the delivery before the operation starts.
The company cannot be held responsible for physical harm to the patient if the medical devices are not used according to the instructions for use.
7. Confidentiality
The parties undertake to respect the confidential nature of information they receive from the other party during the process of the loan of a set. They will not make such information public, nor communicate it to any third party or use it for any purpose other than for the execution of this Loan or permitted under applicable law.
8. Dispute settlement – Applicable law
Disputes that may arise fall under the exclusive jurisdiction of the courts of Oudenaarde.
Belgian law applies.