4 Questions with Dr. Jackson

Adverse event reporting in orthopedics is beneficial to all

A. Seth Greenwald, D.Phil.(Oxon), answers 4 Questions relating to adverse event reporting and the importance of orthopedic surgeon involvement.

Introduction

This month I have asked a frequent contributor and Orthopedics Today Editorial Board member, Dr. Seth Greenwald, to share with us his insight into the obligations and methods for orthopedic surgeons to define and report adverse events. The Food and Drug Administration has implemented the MedWatch product reporting program for adverse events and it is important for us to understand. Adverse events differ from surgical complications and through surgeons reporting them, we can offer potential to benefit our patients and our specialty.

Douglas W. Jackson, MD
Chief Medical Editor

Douglas W. Jackson, MD: What is a definition of an adverse event in orthopedics that should be reported?

A. Seth Greenwald, D.Phil.(Oxon): The Safe Medical Devices Act (SMDA) of 1990 and its subsequent amendments is a law enacted by Congress to ensure that medical devices entering the market, including those used in orthopedic procedures, are safe and effective, monitored and quickly removed if found defective. To assure this, the Food and Drug Administration (FDA) implemented the MedWatch product reporting program.

4 questions

In this context, an adverse event is defined as death or serious injury potentially caused by a medical device. The latter may require medical or surgical intervention to preclude impairment or damage to the body’s function or structure and can involve observation, medical treatment, device removal or hospitalization.

Events particular to orthopedic devices can result from inadequate design, manufacturing deficiency, device malfunction/failure, technical proficiency and patient use, as well as inappropriate labeling. While exact cause is not always evident; it is the occurrence of the event that must be reported.

Jackson: How does a busy surgeon report these adverse events and how complicated is it to do?

Greenwald: The MedWatch program is threefold in its approach and mandates adverse event reporting for medical device manufacturers and user facilities. The latter is inclusive of hospitals, nursing homes, ambulatory surgical and outpatient treatment facilities. Surgeons are encouraged to file voluntary reports as well as other health care professionals on an individual basis.

The surgeon can go to www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. This web page has the instructions and the link to beginning the forms. Part 5 (Describe Event, Problem or Product Use Error) is the most important for surgeons to provide an interpretation of the event. While most government forms are longwinded, this one is an exception, being brief at only one page.

A. Seth Greenwald
A. Seth Greenwald

Jackson: Why is it the ethical responsibility of an orthopedic surgeon to report adverse events?

Greenwald: Orthopedic surgeons provide the most relevant and useful clinical information regarding the cause and effect of the event. The most important role they play is to differentiate whether the device failed or the disease process or patient biological issues caused the problem. If the United States is to remain a leader of technological advances in orthopedics, the FDA must rely on input from end-product users to determine the safety and effectiveness of manufactured medical devices in the clinical setting. Although this adds to the burden of surgeon responsibility in the care of patients, it is requisite that the most experienced and informed contribute to this aspect of the health care process.

Jackson: What are the most beneficial considerations of a successful reporting system for our patients and colleagues?

Greenwald: While the MedWatch program attempts to serve as a timely tripwire to ensure product safety, it does so in the absence of knowing the total number of the particular product being utilized, making it difficult to gain an indication of its overall safety. This information is vital to both manufacturers and the FDA in determining voluntary or mandated product recalls. Beyond this, the Centers for Medicare & Medicaid Services (CMS) as well as private insurance carriers need to know what works and what doesn’t as they are most often the payers for these technologies.

Oftentimes, the timeline required for publication in peer-reviewed journals of medical devices that have resulted in clinical complications, albeit definitive, does not provide the prompt reporting needed to facilitate removal of defective products from the market. This conundrum may be addressed by ultimately creating a national, mandatory, electronic medical record database with patient-specific protected identifiers that retains all aspects of medical treatments received throughout one’s life. In this regard, The American Joint Replacement Registry (AJRR) may be seen as a demonstration project that not only reports adverse events and population use, but shortens the timeline to identify defective arthroplasty products.

  • A. Seth Greenwald, D Phil.(Oxon), can be reached at Orthopaedic Research Laboratories, 2310 Superior Ave. East, Cleveland, OH 44114; 216-523-7004; e-mail: seth@orl-inc.com.

Introduction

This month I have asked a frequent contributor and Orthopedics Today Editorial Board member, Dr. Seth Greenwald, to share with us his insight into the obligations and methods for orthopedic surgeons to define and report adverse events. The Food and Drug Administration has implemented the MedWatch product reporting program for adverse events and it is important for us to understand. Adverse events differ from surgical complications and through surgeons reporting them, we can offer potential to benefit our patients and our specialty.

Douglas W. Jackson, MD
Chief Medical Editor

Douglas W. Jackson, MD: What is a definition of an adverse event in orthopedics that should be reported?

A. Seth Greenwald, D.Phil.(Oxon): The Safe Medical Devices Act (SMDA) of 1990 and its subsequent amendments is a law enacted by Congress to ensure that medical devices entering the market, including those used in orthopedic procedures, are safe and effective, monitored and quickly removed if found defective. To assure this, the Food and Drug Administration (FDA) implemented the MedWatch product reporting program.

4 questions

In this context, an adverse event is defined as death or serious injury potentially caused by a medical device. The latter may require medical or surgical intervention to preclude impairment or damage to the body’s function or structure and can involve observation, medical treatment, device removal or hospitalization.

Events particular to orthopedic devices can result from inadequate design, manufacturing deficiency, device malfunction/failure, technical proficiency and patient use, as well as inappropriate labeling. While exact cause is not always evident; it is the occurrence of the event that must be reported.

Jackson: How does a busy surgeon report these adverse events and how complicated is it to do?

Greenwald: The MedWatch program is threefold in its approach and mandates adverse event reporting for medical device manufacturers and user facilities. The latter is inclusive of hospitals, nursing homes, ambulatory surgical and outpatient treatment facilities. Surgeons are encouraged to file voluntary reports as well as other health care professionals on an individual basis.

The surgeon can go to www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm. This web page has the instructions and the link to beginning the forms. Part 5 (Describe Event, Problem or Product Use Error) is the most important for surgeons to provide an interpretation of the event. While most government forms are longwinded, this one is an exception, being brief at only one page.

A. Seth Greenwald
A. Seth Greenwald

Jackson: Why is it the ethical responsibility of an orthopedic surgeon to report adverse events?

Greenwald: Orthopedic surgeons provide the most relevant and useful clinical information regarding the cause and effect of the event. The most important role they play is to differentiate whether the device failed or the disease process or patient biological issues caused the problem. If the United States is to remain a leader of technological advances in orthopedics, the FDA must rely on input from end-product users to determine the safety and effectiveness of manufactured medical devices in the clinical setting. Although this adds to the burden of surgeon responsibility in the care of patients, it is requisite that the most experienced and informed contribute to this aspect of the health care process.

Jackson: What are the most beneficial considerations of a successful reporting system for our patients and colleagues?

Greenwald: While the MedWatch program attempts to serve as a timely tripwire to ensure product safety, it does so in the absence of knowing the total number of the particular product being utilized, making it difficult to gain an indication of its overall safety. This information is vital to both manufacturers and the FDA in determining voluntary or mandated product recalls. Beyond this, the Centers for Medicare & Medicaid Services (CMS) as well as private insurance carriers need to know what works and what doesn’t as they are most often the payers for these technologies.

Oftentimes, the timeline required for publication in peer-reviewed journals of medical devices that have resulted in clinical complications, albeit definitive, does not provide the prompt reporting needed to facilitate removal of defective products from the market. This conundrum may be addressed by ultimately creating a national, mandatory, electronic medical record database with patient-specific protected identifiers that retains all aspects of medical treatments received throughout one’s life. In this regard, The American Joint Replacement Registry (AJRR) may be seen as a demonstration project that not only reports adverse events and population use, but shortens the timeline to identify defective arthroplasty products.

  • A. Seth Greenwald, D Phil.(Oxon), can be reached at Orthopaedic Research Laboratories, 2310 Superior Ave. East, Cleveland, OH 44114; 216-523-7004; e-mail: seth@orl-inc.com.