Authored by: James VanRiper

Medical Device Tracking (MDT) – Background

Implanted medical devices must be tracked by the manufacturer from the point the device enters finished goods, through shipment to a hospital, to implantation in a patient. The device must be then followed by the manufacturer until the device is removed from the patient or the patient is deceased. The device manufacturer will maintain periodic updates on the device after communication with the patient and the patients’ physicians.

All device records must be maintained for the useful life of the device. Failure to comply with the device tracking requirement will result in actions by the US FDA. Records of the device distributor must be provided to the US FDA upon request in 3 working days after a request by the FDA. Within 10 working days of a request, the following must be provided:

• Unique Device Identifier (UDI)
• The device shipment date
• The name, address, telephone number, and social security number (if available) of the patient receiving the device
• The date the device was provided to the patient
• The name, mailing address, and telephone number of the prescribing physician
• The name, mailing address, and telephone number of the physician regularly following the patient (if other than the prescribing physician); and
• If applicable, the date the device was ex-planted and the name, mailing address, and telephone number of the explanting physician; the date of the patient’s death; or the date the device was returned to the manufacturer, permanently retired from use, or otherwise permanently disposed of.

The requirement to track devices is codified by US FDA CFR Part 821. According to the CFR, all Class II and III medical devices must be tracked by the manufacturer:

The Food and Drug Administration (FDA) will require a manufacturer to adopt a method of tracking a Class II/III device, if the device meets one of the following three criteria and FDA issues an order to the manufacturer:

• the failure of the device would be reasonably likely to have serious adverse health consequences; or
• the device is intended to be implanted in the human body for more than 1 year; or
• the device is a life-sustaining or life-supporting device used outside a device user facility.

A “Tracked Device” is the one that meets one of the above criteria and is the subject of an FDA order must comply with this part.

Medical Device Tracking – Necessity

The advancement of medical technology bring along an added responsibility for the healthcare sector towards Patient Safety. They ought to reduce risk and achieve zero harm while providing treatment & care to the patients. The FDA mandates manufacturers, nursing homes, home health agencies, hospitals, and other organizations that implant or distribute medical devices to collect information about certain class of medical devices used in patient care so that the device can be promptly identified and recalled if it presents a serious risk to patients’ health.

FDA’s Medical Device Tracking (MDT) regulations extend from manufacturing facilities to the distributor networks, which can include healthcare providers, and, ultimately, to patients so that patients using the device can be identified, if necessary. The organization needs to designate an individual or department, such as risk management, that is responsible for ensuring compliance.

Krypt Solution

Krypt has been developing a solution to track medical devices from creation to end of use, within SAP S/4HANA to comply with the US FDA CFR Part 821. The solution will be relevant for any device manufacturer who needs to comply with US FDA CFR 821. The medical device tracking solution allows for creating devices and patients and tracking the status of each within SAP S/4HANA. The core functionality is the ability to create a serialized or batched device in Medical Device Tracking, associate the device to a patient and caregivers, and track the device verses reports from the caregivers and the National Death Index.

The Krypt solution combines business partners in roles such as Hospital, Clinic, Physician and Patient that can be associated with a Material Master serialized device. Each entry is date stamped to show implanting physician and each subsequent care provider until the end of the device’s use. The solution includes links to all supporting documents saved on a document management system. Validation of mailing addresses with connections to postal address validation links. As well as support for multiple languages.

How can Krypt help?

Krypt is an SAP preferred partner and has assisted in the success of global businesses across industries & geographies. We have helped businesses through successful integration & implementation of SAP GTS, SAP IBP, SAP TM & SAP EWM.

If you are a medical device manufacturer, and you need to comply with FDA using a successful custom SAP solution deployment, and wish to explore more about our products/services, please request for a DEMO or do Contact Us.

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