Hello Everyone,
Human Factors study considered users to assess the adequacy of the combination product user interface design to eliminate or mitigate potential use-related hazards. Human factors study is perform to consider the complexity of the combination product and the nature of the safety.
The Human Factor study evaluates
• the ability of the user to perform critical tasks
• the ability of the user to understand the information in the packaging and labeling, such as product labels or instructions for use, that inform the user’s actions and that are critical to the safe and effective use of the combination product.
There are some HF studies such as HF formation and HF validation that evaluate the risk.
HF formation- This type of study process to assess user interaction with the product and identify potential use errors. It also inform the need for user interface changes and inform the content of the HF validation study.
HF validation- This is final finished combination product user interface can be used by intended users without serious damage or errors. This study demonstrate that hazards has been eliminated or the benefit of product use outweigh the residual risk of the product.
Question for all, What are the Human Factors issue relate to combination product? And what other types of HF studies might need to be conducted for the combination product?
The Human Factor Study produces combined devices or products which combine a device, drug or biological element which is totally different from the conventional method. As mentioned by the given link the combined products are formed by three different ways.
1) Physically or chemically combined
2) Co-packaged
3) Separately distributed with specific labeling to combine the products during the use
This leads to the complexity of the product so when the usage of the combined products comes, it must be carefully implemented than the development of the product. This makes even the development and implementation both as a complicated process.
For successful implementation of a combined product certain important things must be considered.
1) Time and sequencing of study in relation to study and combination of product
2) Benefits of Human Factor study related to the product when compared with other normal clinical process
3) Changes of a combined product should be proved by proper human factor study
4) Information provided to the FDA must satisfy the needs for this combined product
- Akshaya Kirithy Baskar
This is an interesting topic and one that goes through considerable research when launching medical products. Personally I have some experience with the human factor research during my time working as a clinical research coordinator for a pain management clinic. The main factor that attributes to errors/misuse of the product is unclear language on packaging. For the most part most clinical trial experiments would run smoothly, however when there were combination products involved some confusion would arise. Even though a specialist is sent in to demonstrate the use of the products, the clinicians would be so busy that when it came time to actually utilizing the product they would have to refer to the packaging instructions and research coordinators for instructions on proper use. This to me represents a design flaw, if the intended user needs to approach external resources for the use of a product. More information on human factors is provided by the FDA in the link attached below.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf
When regarding all the different areas of interest that go into a Human Factor study including HF formation and HF validation, it is especially important to also consider the evaluation of Use-Related risk. The goal of use-related risk analysis will help identify critical tasks that should be further evaluated in a HF study. Two use-risk evaluation methods frequently used are Failure Mode and Effects Analysis (FMEA) and Fault Tree Analysis (FTA).
Critical tasks: these tasks are defined as tasks, which if preformed incorrectly by the user, could lead to adverse medical effects. Therefore, it is crucial to unique considerations for each combination product.
Intended users and use environments: This guideline encompasses who should be qualified to use such a product with minimal risk done to the patient. Depending on the complexity/ sensitivity of the device, it could be used by the patient him/herself or have to be administered by a health care professional. A clean and controlled environment is also desired but not always obtainable so this variable must also be considered in use-related risk analysis.
Training: Trained use of a new product is used as a way to minimize and control risks that were unavoidable in the design of the device. Training for the use of a product can encompass anything from what is involved to use product to how often training session should occur.
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf
You bring up an important point krp76. Both the instructions and training play a pivotal role in ensuring that Human Factor aspect is well considered. Taking into consideration all aspects at play is important in addressing any issues of miscommunication. Well written instructions as mentioned are a great start, but proper labeling also plays a roll. Additionally, these must often be clarified to the point of being poka-yoke or idiot proof. This is the only true way to implement effective human factor practices.
-Romany Botros
Human factors is the study of the interaction of people and technology to ensure that a good compatability exists between the human beings and the device,manufactured to address a disorder or a condition. In addition to that, it provides safety and efficacy to that interaction which includes the user interface, instructions,and training programs to avoid or minimize the errors. In the recent times, more attention is being paid to the assessment of the human factors usability for the combination products by obtaining the acknowledgement by regulators and industry regarding the mechanics of the device about its reliability and its usability.Usually the errors occur when the device is not used as intended or some features of the design are not optimal. Human factors testing, analysis, and validation helps in identifying and eliminating those errors after using appropriate mitigation strategies to ensure the device design provides the optimum use of drug/device combination products.
Combination product development alone is very tricky because of the FDA's rudimentary policies on combination products. Manufacturers are often left scratching their heads as to which regulatory pathway to follow for their combination product even before it is complete; they are asking themselves, which FDA center has responsibility over my product? Is my product a device or is it really a drug? For example, an antibacterial adhesive bandage is both a medical device because it controls minor bleeding but the antibiotic used to prevent infection also makes it a drug. I would rather have my product be considered a device because they are managed by risk classification (more flexibility) while all new drugs must go through pre-market approval and a new drug application. The FDA's current determination criteria is, what is the major mode/purpose of this product? For a device leaning combination product, the manufacturer must then prove that its purpose is not achieved through a chemical reaction.
Now add combine human factor studies into this and the headache becomes bigger. To answer your question, combination products need a combination of human factor studies and nonconventional reliability tests, i.e. a combination of product control and clinical studies. The issue with this is that clinical tests can only be done at the very end, once the product is finished. Combination products may change design after HF validation because of failure during clinical trials for pre-market approval. This means product revision is an arduous time and paperwork consuming process (that also impedes medical innovation). The FDA should rework their policies on combination product development.
References:
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM484345.pdf
http://thehill.com/blogs/pundits-blog/healthcare/250280-fixing-the-fdas-broken-combination-products-policies
Human factor studies for combination devices, as everyone has stated, are essential to the success of the product. There is no benefit of sending a patient home with a product that they are unable to use correctly or safely. The HF validation and formation studies cover a lot of the issues that may arise in combination products. This includes the assembly of the product, the complexity of the interface, and does it get the job done. One of the most important things I think is the directions the device comes with. They should be clearly labeled with images showing step by step use, or clearly written out in multiple languages. Any device that is released for patient use must be "idiot-proof" for the safety of the patients.
