Standardizing Labels For Arthroplasty Devices

 

By Dave Olson

Vice President, Technical Sales

AdvancedWeb

 

A number of years ago when the FDA proposed nutrition labeling on all food packages, the angst and outcry were tremendous. Artistic directors were horrified that this box would have to be in a prominent place on their packages, operations folks wondered what kind of package modifications would be needed to accommodate this very specific info, and the bean counters lost sleep over the amount of money it would take to modify the thousands of SKUs that had to be managed.

 

In the end the change was implemented, the apocalypse was averted, and consumers have benefited from easy access to the nutritional content of what’s going into their bellies.

 

A similar standardization initiative is in process right now for standardized labeling of orthopedic arthroplasty devices, and the field of battle and debate is Committee F04 Medical and Surgical Materials and Devices, Subcommittee F04.22 Arthroplasty of ASTM International.

 

An Initiative For Patient Safety

The idea came out of the Biomedical Engineering Committee for the AAOS, the American Academy of Orthopedic Surgeons as a patient safety initiative.

The concept would be to have four standard fields with information such as mfg name and implant, material and schematic, a verbal description, and size and body side all in the same place across a company’s offerings and also across the industry. Currently all of the information is there but is located randomly, sometimes even varying between a single company’s closely related products such as tibia or femoral components for total knee replacement.

 

A consistently organized label would allow easy identification of an implant by OR personnel and help streamline and ensure accuracy in the process.

At this point, the arthroplasty labeling initiative has been balloted in ASTM Subcommittee F.04.22 as work item WK27458. There have been two rounds of balloting with negative votes from some stakeholders, particularly large orthopedic device manufacturers.

 

Obstacles of Cost and Label Space

The issues seem strikingly similar to the initial objections to the FDA nutritional labeling standardization project: thousands of SKUs to deal with, real estate issues on the label formats, costs associated with reprogramming and/or replating existing labels, and the general disarray associated with implementing the change in a timely fashion.

 These are all very real issues associated with the project. Between additional languages, more and more ISO symbols, and added label information, label real estate is becoming more and more precious, especially on smaller packages. A set of screws is a lot more limited in label space than a femoral component for a hip replacement package, yet a large percentage of the same information is required on both.

 

Still, the cost/benefit analysis of this standardization, the needs and wishes of OR personnel, and patient safety are all factors that need to be weighed carefully.

 

New Labeling Regs and UDI On The Horizon

The scope of the project at this time is a small piece of the orthopedic market, yet there are those who fear this labeling standardization will ‘go viral’ and result in new regulations for all Class III device labeling.

 

Well folks, that is on the horizon anyway when the Unique Device Identification regulations are published by the FDA sometime next year. If a compromise is reached and an effective arthroplasty standard is agreed upon in the anticipated September balloting, perhaps this change could be implemented at the same time as the mandated UDI changes.

 

Watering down the standard to make it acceptable to everyone would not result in a very effective standard. Like most things that are worth doing, there are opposing views and stakeholders with vital interests in the project. The goal is a worthy one: reducing the possibility of mistakes in the OR and improving patient outcomes.

 

It will be interesting as well as instructive to see what comes out of the next round of balloting in ASTM F.04.22, the third round in the process. Although ASTM standards are and have always been voluntary, standards such as ASTM 4169 tend to take on the status of gospel over time. The three basic camps at this point are the folks that buy in and realize change would be positive but are nervous about implementation, the people that want change now, and the stakeholders that ‘get it’ but don’t want to change. One would hope that a useful yet somewhat flexible standard is the result of the continuing discussions.

 

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