New HF Regulatory Requirements Impact Usability Validation Studies on Combo Products

By P.A. Davol, Clinical & Regulatory Project Manager, Ximedica, LLC

The regulatory viewpoints and FDA specific recommendations on current human factor usability testing strategies are constantly evolving – and with these changes come the potential to impact product approvals, particularly for combination products. Why is HF usability testing suddenly being turned upside-down for some medical device manufacturers?

In December 2012, the Division of Medication Error Prevention and Analysis (DMEPA) at the Center for Drug Evaluation and Research (CDER) published the first of its intended three draft guidances directed at applying a human factors approach for reducing medication errors that have the potential to harm patients. This first draft guidance focuses on safety aspects of drug product design for the purpose of reducing such risks. Their second draft guidance published in April 2013 focuses on human factor usability testing considerations for ensuring that drug product container labels, carton labeling, and packaging configurations are effective for reducing or mitigating medication errors. A third draft guidance will address considerations for drug product nomenclature.

Who does the DMEPA draft guidances effect?

The good news is that the HF strategies of device manufactures who only manufacture devices, which do not incorporate a drug or biological constituent, are not likely to be impacted. However, manufacturers of medication (drug or biologic)-delivery devices (i.e. combination products having a medical device constituent) are now being asked to include risk assessment and usability testing to ensure that the product packaging and labeling is effective in mitigating or reducing incidence of use-errors that could result in patient under-treatment, overdosing or otherwise receiving an incorrect treatment (i.e. dispensing of the wrong medication).

What are the key areas of HF testing impacted by DMEPA draft guidances?

These guidances impact the selection of the populations of end-users and the development of relevant use-scenarios for testing.

Here’s an example based on the 2011 CDRH guidance for medical device HF usability testing. If a device is intended to be used by patients or non-professional caregivers in a homecare setting, the study would need to include representative end-users from these intended user populations. It would not necessarily include any professional healthcare providers (HCP), unless one identifies a circumstance where such a professional may be expected to use the device.

By contrast, the new 2012 and 2013 CDER guidances are both more stringent. For example, in the case of combination medication-device products (i.e. inhalers, injectables, drug-patches, nasal sprays, etc.) that will be dispensed through a pharmacy, DMEPA recommends that usability testing include not only the intended end-user but also those who may be considered “intermediate-users”: …”the prescribing physician, nurse, pharmacist, pharmacy technician, and other individuals who are involved in routine procurement, stocking, storage, and administration of medications (e.g. medication technicians)…” (to ensure that they can) … “use the product without making unintentional errors or without being exposed to unnecessary safety risks.”

Accordingly, even if a user is not expected to use the product for direct treatment administration of a patient, DMEPA wants to ensure that the intermediate user can understand the physician prescription or physician clinical order, distinguish the product from other similar products, select the correct dosing strength from within the product line (if applicable), and reconstitute the product correctly (if applicable) before distributing the product for use by the actual end-user. Therefore, each user-group must be tested with a use-scenario that is representative of its respective user-interface. This will vary considerably between each indicated group and from the patient or non-professional caregiver end-user use-scenario; the latter two often do not have significant differences between their task requirements.

Hear more on this topic during our presentation, Usability Evaluations and Regulatory Expectations for Combination Products at the Drug Delivery Partnerships conference, Jan 27-29.