Medical Device Supply Chain article and permission to publish here provided by Claire Glassman.
Manufacturers of medical devices are the first ones to get the blame when a patient complains of suffering injury or harm from using a medical device.
When filing a lawsuit for medical device liability due to defects, the lawyer only has to prove that the defect was present at the time of 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 appealed for higher transparency so the burden of liability would be shared across the supply chain.
To improve the transparency of where they get the inputs and parts of their final products, 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 your medical device supply chain.
1. FDA Mandated Unique Device Identification (UDI)
One of the ways by which medical device manufacturers and their suppliers can increase transparency in the medical device supply chain is by using the Unique Device Identification (UDI) system.
To improve their standards of transparency, stakeholders and players can benefit from it in the medical device manufacturing, supply, and distribution industry.
It would help improve the package labeling and tracking of the various medical devices and the parts used to make them.
2. Mandated By FDA
The UDI is a system mandated by the U.S. Food and Drug Administration (FDA) as guidance for players in the medical device industry on the labeling and tracking of their products.
It was issued in response to the growing importance of tracking people responsible for designing, manufacturing, distributing, and utilizing these various medical devices. It is significant because when a patient gets hurt or suffers injury resulting in the use of the medical device, liability sometimes is imposed on the manufacturer of the device.
The UDI Rule was started by FDA in 2013 to develop regulatory mechanisms, track down medical device products, and enhance product safety for patients. It outlined specific requirements and standards on how medical devices should be labeled.
The 2014 Rule was for class III devices. The 2015 Rule was for life-sustaining and life support products that can be embedded in patients.
The 2016 Rule was for class II medical devices. The deadline for enforcement of acquiescing with the requirements for class III and class II devices has already lapsed.
In compliance with the enforcement regulations of these products was prioritized because they’re considered to have the highest level of risk to patient safety.
3. Class I Extended To 2022
The deadline for complying with the enforcement rules for class I medical devices and unclassified devices was extended till the 22nd of September 2022.
Class I medical devices were made last priority because they have been categorized as having the lowest level of risk to patient safety.
Class I covers a broad scope of various medical device products. Among the products in this category are braces, bandages, and minor surgical tools and instruments.
The FDA has a database containing a comprehensive list of the various kinds of medical devices, tools, and instruments. This database is called the Global Unique Device Identification Database (GUDID).
According to their type and use, the medical devices contained in the list have been classified by the FDA.
Medical device manufacturers can use the FDA database to search for the kind of product and its classification. They can type in the generic name of the medical device to find out the correct classification type of the medical device or instrument.
It is very beneficial in increasing transparency in the industry because even manufacturers sometimes can’t agree on the classification of medical instruments and devices.
The FDA UDI rule mandates that UDI should be placed on the labels and packages of all medical equipment, devices, tools, implants, and instruments.
This UDI should have 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 required a standard format for the date which will appear on the label. The date should appear as (YYYY-MM-DD).
Also, the FDA rule requires that the UDI should be marked in formats that can be read by humans as well as machines. There are medical devices, tools, and instruments used more than once such as surgical clamps, forceps, tweezers, and tongs.
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 meet the medical technology challenge of improving transparency in the supply chain is through the implementation of its Product Information Management (PIM) system and platform across the company’s sourcing, procurement, manufacturing, packaging, sales, and distribution workflows processes.
A PIM would require all suppliers and providers to assign unique markers, bar codes, labels, RFID, QR codes, or other identification methods for every part or product they supply.
The manufacturing company may come up with its PIM system with its identification, attribution, tracing, tracking, and monitoring methods. It would be of great help in enabling the manufacturer to instantly identify and recognize the manufacturer or supplier of each part of their medical devices and products.
They can require all their suppliers and providers to follow the manufacturer’s PIM system if they wish to continue getting contracts. The other way is for the manufacturer to permit their suppliers and providers to come up with their product identification system for all the products, parts, and supplies that the manufacturer sources from each of them.
The supplier or provider’s PIM system may be encoded and integrated into the manufacturer’s ERP modules and applications suites for procurement, production, sales, distribution, and logistics.
It would enable the manufacturer to track the use and location of each part provided by a third-party supplier or provider, even if the specific manufacturer’s product has already been sold to its eventual user.
Manufacturers can even make use of their PIM to increase their engagement with their institutional clients, along with individual buyers. They can upload information about the various parts and products incorporated into their final manufactured medical devices and products.
It would greatly increase the company’s transparency about the input materials and parts to their products. It would also help customers who have inquiries or complaints about the quality or safety of the manufacturer’s medical device products.
The penalties for actual and punitive damages imposed on manufacturers of medical devices for product defects can sometimes amount to tens or hundreds of millions of dollars.
It can be unfair at times if the product defect can be traced to a defect in a part that was outsourced to a third-party supplier or vendor. It has led some manufacturers to appeal for greater transparency in the medical device supply chain.
They’ve asked for distribution of the risks and liability for product defects that cause injuries to the general public.