Streamlining Risk Management in Medical Devices: Establishing a Master Harms List

A master harms list can help ensure consistency across all your company's risk management documents and promote compliance by giving everyone the same starting point.

Editor's note: This is the second installment in David Amor's Med-Dev from Scratch: Compliant Innovation column dedicated to helping entrepreneurs build their medical device companies in a compliant and streamlined way. Read the first and second installments here.

Risk management is a sore point for a lot of medical device start-ups during their product development programs. FMEAs, FTAs, ISO 14971—the sheer number of acronyms alone is staggering! I excitedly introduce you to another one—the MHL, or master harms list. Aligning product failures identified in risk management activities with their corresponding clinical harms sometimes becomes very labor intensive. In attempting to ensure that all relevant harms associated with a product’s component failures are captured, the engineer is presented with an expansive list of possibilities. Consumer risk is a permanent priority: Thorough risk analysis is forever coupled with patient and physician safety. Drawing from multiple sources and inputs—whether from other hazard analyses, customer complaints, instructions for use, or otherwise—the engineer may become overwhelmed with the plethora of available data and overlook some of the simpler and more frequently occurring harms. The preparation of an MHL gives you a leg up on the competition by giving you a “one-stop-shop” for all of your harms and eliminates the difficult task of assembling a coherent list from a multitude of sources.

The design and implementation of an MHL is a useful task that streamlines clinical input from all risk management activities into one source. It is established as a living document that may need revision based on the identification of new harms. In designing an MHL, the engineer should consider the following general steps:

An example from the medical device industry in which a MHL was developed involves the synthesis of clinical harm findings for peripherally inserted central catheters (PICCs) used for delivering chemotherapeutic drugs in a chronic setting. Applying the steps listed above yielded a robust document systematically capable of capturing all harms associated with PICC use.

Step 1: Assemble a qualified team of personnel, including clinical subject matter experts (SMEs).

The assembly of a thorough MESL relies on high-level input from many facets of the organizational framework. Research and development (R&D) engineers are necessary to provide product design considerations that may contribute to foreseeable misuse of the product or product failures. Process engineers provide input on any manufacturing phenomena that may compromise product integrity. Quality engineers should be summoned to ensure that the product performs in a consistent and predictable way. Input from nontechnical personnel is also helpful to offer patient and physician perspective on how the device is performing in the field and to align customer expectations with product output. Finally, a clinical expert is perhaps the most crucial member of this multifunctional team. Ideally, the clinical expert should have product specific knowledge, especially concerning a product’s intended use. In the example started above, an oncologist may offer the most apt clinical outcomes for PICCs because they have intimate product awareness and understand the specific nuances associated with a particular patient population.

Step 2: Identify the scope of applicability of the MHL.

An MHL should generally be used as a guidance document for an organization’s entire product offering. However, should an organization be involved in multiple, distinct clinical areas, as many of the larger corporations are, an MHL may be generated for each product family subset. A medical device company manufacturing PICC devices may have a standalone document for their oncology division and a separate MHL for their urology division. Although some of the clinical effects may be shared, many of the resulting harms will not align in type and/or severity; both a PICC and a ureteral access catheter may fracture (a failure mode) and cause an embolus when lodged within a vessel (a shared clinical effect); however, an embolus closer to the cardiac vasculature in the oncology device is clearly the more severe case. The group of SMEs assembled in step one should decide on the appropriate scope of the MESL and generate each document accordingly.

Step 3: Determine the proper template format for the MESL.

Furthermore, it may be useful to include a clarification and/or example component in the MESL to elucidate particular clinical harm severities, particularly in the case of recurring failure modes and clinical effects. The template should be designed for easy input. I recommend a columnar format for aesthetic and functional reasons. Once the template is decided upon and drafted, it should be included within corporate standard operating procedures to ensure that future clinical effect findings are processed accordingly. A sample from a fictional MHL is illustrated below in Table I.

                        Table I. Shown is a sample from a fictional MHL. Source: Medgineering Inc.

Step 4: Populate the MHL with clinical harms.

The MESL provides comprehensive guidance for clinical input into risk management documents and should consequently encompass any and all clinical effects identified historically. A retrospective analysis should include, but not be limited to, the following features and/or documents:

In summary,  companies spend a lot of time and money directing their efforts at identifying clinical adverse events and harms. Using a systematic approach like an MHL ensures consistency across all risk management documents and promotes compliance by giving everybody the same starting point.
 

David Amor is a medical device consultant who has worked with companies such as Boston Scientific, St. Jude Medical, and Hospira to develop quality management systems and product development infrastructures. A graduate of the Senior Innovation Fellows program at the University of Minnesota Medical Device Center, Amor was one of MD+DI's "40 Under 40" medical device innovators in 2012. He founded MEDgineering, a niche quality consulting firm focusing on FDA remediation, quality staffing and consulting, and med-tech investment due diligence. He holds a BS and MS in biomedical engineering from the University of Miami with a focus on innovating around clinical needs. Amor currently serves as chief operating officer of ReMind Technologies, a mobile health start-up dedicated to tackling medication adherence by using smart-device based medication dispensing units and software applications.