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Jan 24, 2014

Establishing a Master Harms List: Streamlining Risk Management

David Amor

by David Amor, CQA, MS Managing Partner, MEDgineering


Reprinted with permission from MDDI


Risk management is a sore point for a lot of 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 MHA 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 MHA, the engineer should consider the following general steps: 



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

This team should be comprised of medical, quality, development and regulatory personnel at a minimum. Other personnel may be brought in as needed to supplement the team. The goal of this team meeting is to ensure that the technical aspects (product failures, hazards, etc.), typically derived from engineering, aligns with the expectation of the risks to health or harms that arise (clinical adverse events) from the medical experts. Although it may take some hashing out and a bit of back and forth, the product that emerges is a predefined list, specific to a product or suite of products that makes translating hazards into harms much simpler for years to come.


(2)  Identify the scope of applicability of the MHA

The scope of applicability comes down to the following question:  when I create this risk profile (hazards and harms associated with a device), what other products and situations does it apply to? There are cases where an MHA may apply to all of the products that a company makes; this is particularly true if most of the products are in one interventional or clinical space. Different divisions may have different MHAs to account for various indications for use or other clinically relevant disparities. The scope depends on how well you can defend that the identified harms in the document extend to other product lines. This should all be documented within this MHA file!


(3)  Determine the proper template format for the MHA

I’m a huge believer in templates because they provide a systematic way to approach a deliverable. Create an MHA template with some of the guidance provided in this document and ensure that all potential personnel that will use this template are appropriately trained. The template should not be too burdensome- oftentimes, this leads to compliance gaps being created when an engineer decides to create their own version because the original was too difficult to follow.


(4)  Populate the MHA with clinical harms

This is the key step. The team meets to determine what harms are applicable to the device in question. This concept will be expanded further below.


(5)  Update the MHA accordingly

One of the most important considerations for an MHA is continued review and updating of the file. Make sure that you have the proper “triggers” in place that prompt a new harm to be added into the MHA. This should include any field actions or post-market data that is not captured in the pre-existing risk documents. 


An example from the medical device industry in which a MHA 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 (RD) 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 non-technical 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 since 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 MHA

A MHA 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, a MHA 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 MHA 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 both 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

As a guidance document, the MHA should be drafted in a versatile, user-friendly fashion without sacrificing technical efficacy. An appropriate template should include, at minimum, the following:

·       Clinical harms (i.e. Hemorrhage, Vessel Trauma, Prolonged Procedure)

·       Corresponding severity level of harms (for example, an infection treatable with antibiotics may be labeled as Infection – Moderate whereas an infection requiring surgical treatment that may develop into a systemic infection may be labeled as Infection – Catastrophic or Sepsis – Catastrophic)

·       Associated interventional area of harms (i.e. intravascular, urological, neurological)

·       Definition of clinical harm (for example, Hematoma may be defined as: ‘an excess collection of blood outside blood vessels, most commonly associated with severe hemorrhage’)

·       Source of clinical harm information (i.e. where the clinical harm was noted, whether in the instructions for use, customer complaints, a literature search, etc.).    


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 MHA is illustrated below: 




Clinical Effect/Harm

Interventional Area

Definition

Example/Clarification

Source

Delayed Therapy –

Minor

General Procedure

Temporal extension or delay of a procedure

Physician must exchange device; no harm to patient

FMEA/IFU

Pulmonary Embolism - Catastrophic

Intravascular

Blockage of the lung vessels, usually by migratory thrombus.

Lung artery blood flow compromised, leading to myocardial infarction and death

Literature Search, Document #123456

Source: MEDgineering Inc.

Step 4: Populate the MHA 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:



·       Fault Tree Analysis (FTA)

·       Instructions for Use (IFU)

·       Hazards Analyses (new requirement, per ISO 14971:2003)

·       Technical File or other DHF Encompassing Document

·       Intended Use

·       Contraindications

·       Clinical Risk and Benefits Analysis

·       Clinical Evidence Report

·       Clinical Evidence Summary

·       Post Market Surveillance

·       Customer Complaints

·       Literature Search


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

Note: The views expressed in this article are those of the author and do not necessarily represent those of his or her employer, GxP Lifeline, its editor or MasterControl Inc.

David Amor is a medical device consultant, having worked with companies such as Boston Scientific, St. Jude Medical and Hospira in helping 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 named a Top 40 Under 40 Medical Device Innovator in 2012 and founded MEDgineering, a niche quality consulting firm focusing on FDA remediation and remote work solutions (www.medgineering.com). Amor has a strong technical background, having garnered his BS and MS in biomedical engineering from the University of Miami with a focus on innovating around clinical needs.  He is a published speaker, participaing in most major medical device trade shows, including presentations at MD&M East and MD&M West, the two largest medical device conferences in the world. He lectures on topics centering on innovative compliance practices.  He currently serves as chief operating officer of ReMind Technolgoies, a mobile health startup dedicated to tackling medication adherence by using smart device-based medication dispensing units and software applications.









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