Medical device manufacturers are the first to be blamed when a patient complains of injury or harm from the use of a medical device. How does this relate to the medical device supply chain?
In the case of an action for medical device liability due to defects, the lawyer only has to prove that the defect existed at the time immediately after the medical device or tool was manufactured.
But today’s manufacturers outsource most of the inputs and parts of their final manufactured medical devices and products.
Some manufacturers have called for more transparency so that the liability burden is spread across the entire supply chain.
To improve transparency on where they get the inputs and parts of their end products from, companies are looking for preferences for outsourcing medical device manufacturing requirements and should also consider implementing mechanisms.
Here are some of the things manufacturers can do to increase transparency in their medical device supply chain.
1. FDA-mandated Unique Device Identification (UDI)
One of the ways medical device manufacturers and their suppliers can increase transparency in the medical device supply chain is by using the Unique Device Identification (UDI) system.
In order to improve their transparency standards, stakeholders and actors in the manufacture, supply and distribution of medical devices can benefit from it.
It would help improve packaging labeling and tracking of the various medical devices and the parts used to manufacture them.
2. Required by the FDA
The UDI is a system mandated by the US Food and Drug Administration (FDA) as a guide for stakeholders in the medical device industry to identify and trace their products.
It was issued in response to the growing importance of tracking those individuals responsible for the design, manufacture, distribution, and use of these various medical devices. This is important because the device manufacturer is sometimes held liable if a patient is injured or suffers an injury as a result of using the medical device.
The UDI rule was created by the FDA in 2013 to develop regulatory mechanisms, track medical devices, and improve product safety for patients. It outlined specific requirements and standards for labeling medical devices.
The 2014 rule applied to Class III devices. The 2015 rule applied to life support and life support products that can be embedded in patients.
The 2016 rule applied to Class II medical devices. The deadline for enforcing compliance with the requirements for Class III and Class II devices has already passed.
In line with enforcement regulations, these products have been prioritized as they are considered to pose the highest risk to patient safety.
3rd Class I extended to 2022
The deadline for compliance with the enforcement rules for class I medical devices and unclassified devices has been extended to 22 April 2020nd Sep 2022.
Class I medical devices were given last priority as they were judged to pose the lowest risk to patient safety.
Class I includes a wide range of different medical devices. Products in this category include braces, bandages, and smaller surgical tools and instruments.
The FDA maintains a database with a comprehensive list of the different types of medical devices, tools, and instruments. This database is called the Global Unique Device Identification Database (GUDID).
The medical devices included in the list have been classified by the FDA according to type and use.
Medical device manufacturers can use the FDA database to search by type of device and its classification. You can enter the generic name of the medical device to find out the correct classification type of the medical device or instrument.
It is very beneficial to increase transparency in the industry as sometimes even manufacturers cannot agree on the classification of medical instruments and devices.
The FDA’s UDI regulation dictates that UDI should be placed on the labels and packaging of all medical devices, devices, tools, implants, and instruments.
This UDI should consist of two parts, so the first part is the “device identifier” or DI. The second part is the “Production Identifier” or PI. The FDA has also requested a standard format for the date that will appear on the label. The date should be displayed as (YYYY-MM-DD).
In addition, FDA regulation requires that the UDI should be marked in formats that can be read by both humans and machines. There are medical devices, tools and instruments that are used more than once, such as B. surgical clamps, forceps, tweezers and forceps.
The UDI should be marked directly on these instruments and not on their packaging or boxes.
4. Manufacturer’s Product Information Management (PIM).
Another way to address the medical technology challenge of improving supply chain transparency is through the implementation of the Product Information Management (PIM) system and platform in the sourcing, procurement, manufacturing, packaging, sales and distribution Company’s sales workflow processes.
A PIM would require all suppliers and vendors to assign unique marks, barcodes, labels, RFID, QR codes, or other identification methods to each part or product they supply.
The manufacturing company can develop its PIM system with its identification, association, traceability, tracking and monitoring methods. It would be of great help for the manufacturer to instantly identify and recognize the manufacturer or supplier of each part of their medical devices, wearable therapeutics and products.
They can require all their suppliers and service providers to follow the manufacturer’s PIM system if they wish to continue receiving orders. The other possibility is that the manufacturer allows its suppliers and vendors to create their product identification system for all products, parts and consumables that the manufacturer sources from each of them.
The supplier or vendor’s PIM system can be coded and integrated with the manufacturer’s ERP modules and application suites for procurement, production, sales, distribution and logistics.
It would allow the manufacturer to track the usage and location of any part provided by a third party or vendor, even if that manufacturer’s product has already been sold to its eventual user.
Manufacturers can even use their PIM to strengthen their collaboration with their institutional clients as well as with individual buyers. They can upload information about the various parts and products that will be incorporated into their final manufactured medical devices and products.
It would greatly increase the company’s transparency about the input materials and parts of its products. It would also help customers who have questions or complaints about the quality or safety of the manufacturer’s medical devices.
The actual and punitive damages penalties imposed on medical device manufacturers for product defects can sometimes amount to tens or hundreds of millions of dollars.
It can sometimes be unfair when the product failure can be traced back to a failure in a part that has been outsourced to a third party or supplier. This has prompted some manufacturers to advocate greater transparency in the medical device supply chain.
They have called for risk sharing and liability for product defects that cause harm to the general public.