Japan VAD Council,
IMPELLA Committee

Facility qualification

The figure below shows the process from Facility qualification through the start of clinical use of IMPELLA at the Facility.

When medical institutions submit documents for Facility qualification, the documents will be checked, and the Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee, will review the documents. The IMPELLA Committee makes the final decision on Facility qualification based on the overall results of the document review. However, the Committee may conduct an on-site inspection to confirm the details of the application, as necessary.

The committee issues a certificate of Facility qualification which allows the manufacturer to provide the product training. The heart team and staff of the relevant departments of the certified medical institution receive and complete the training programs, after which, the devices are delivered to enable the use of IMPELLA at the Facility.

Fig - Facility Qualification Application Flow
Fig: Facility Qualification Application Flow

1. Application for Facility qualification and document review

Documentation required for Facility qualification application is as follows.

Applicant Facilities fill out all of the application form documents and prepare attachments, submitting them to the Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee.

Application fee: 50,000 yen

Application Documents Package

Necessary documents for IMPELLA Facility qualification application (Excel format, Japanese language)

Applicant Facilities register their contact information, and are then given access to a web page to download the application form for IMPELLA Facility qualification (Excel format, Japanese language).

Attachments

Contact Information for Application Submission

Council for Clinical Use of Ventricular Assist Device Related Academic Societies,
IMPELLA Committee Office
Department of Cardiovascular Surgery,
Osaka University Graduate School of Medicine and Faculty of Medicine
2-2 Yamadagaoka, Suita-shi, Osaka, 565-0871, Japan
N.b.: Submitted documents will not be reviewed if found to be deficient or illicit.

Bank account for payment

MUFG Bank, Ltd. (Bank code: 0005)
Ibaraki Branch (Branch code: 219)
Saving account 0286563
Name: Yoshiki Sawa, The Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee

2. On-site Inspection

If necessary, inspectors selected by the Council for Clinical Use of Ventricular Assist Device Related Academic Societies, IMPELLA committee, will conduct on-site inspections.

Any travel expense related to the inspection (including accommodation fee depending on location/agenda) will be charged to the applying facility (actual fee reimbursement). The IMPELLA Committee Office will separately inform the details of the inspection day and time, after coordinating schedules of applying medical institutions and inspectors.

3. Facility qualification

The IMPELLA Committee makes its decision on Facility qualification based on the overall results of the document review and on-site inspection. To medical institutions that successfully acquire Facility qualification, the IMPELLA Committee informs the medical institutions accordingly, and issues a certificate of IMPELLA Facility qualification.

Certification fee: 100,000 yen

4. Training program

The manufacturer provides the training program.
For details, contact the manufacturer.


Facility Qualification Renewal

Renewal of IMPELLA Facility qualification will be provided separately.