People make errors all the time – it’s a (sometimes unfortunate) aspect of being human. Errors made while using medical devices can lead to hazards which can impact patients, family members, and professional healthcare providers. Hazards associated with device use are a common and serious problem. Evidence from researchers suggests that the frequency and consequence of hazards resulting from medical device use error far exceed those arising from device failures. Therefore, it is essential to ensure safe and effective device use if hazards are to be controlled effectively.

A November 1999 Institute of Medicine report, "To Err is Human – Building a Safer Health System," estimated that as many as 98,000 people die in any given year from medical errors that occur in hospitals, which is more than die from motor vehicle accidents, breast cancer, or AIDS. Though many of these errors are not related directly to medical devices, some are, and it highlights the importance of addressing errors with the use of medical devices.

FDA recognizes that most use errors with medical devices are not "inevitable human error." Rather, they are largely influenced by device design and device labeling. OHIP seeks to promote the safe and effective use of medical devices through our Human Factors program, labeling efforts, and patient safety activities.

Human Factors

Human Factors (HF) is a science devoted to the interaction of people and equipment. "Human Factors," "human engineering," "usability engineering," and "ergonomics" are often used interchangeably. In the field of medicine, the objective of Human Factors is to improve human performance and reduce the likelihood of use error and patient injury.

Human Factors has been used extensively by the military, the transportation industry and in some consumer areas. It is now being applied to address use error problems in medicine. Human Factors analysis and testing should be applied throughout the entire life-cycle of a medical device. Our Human Factors efforts impact on CDRH’s premarket, postmarket, and field-inspection regulatory missions.

• Webpage: We posted a webpage on Reducing Use Error. This page provides CDRH staff, manufacturers and others with comprehensive information on the role that Human Factors and labeling can play in reducing use error.

• Device Reviews: We assisted CDRH’s Office of Device Evaluation by providing Human Factors reviews for selected medical device approval applications.

• Patient Checklist: We developed a one-page checklist, "Make Sure the Medical Device You Choose Is Designed for You." Healthcare professionals and patients can use the checklist to choose a medical device that is best for the patient. It can easily be modified to focus on particular devices for certain patient groups (e.g., patients with arthritis, diabetes, or heart disease). The checklist poses questions in three major categories for patients and healthcare professionals to discuss:

• Do you have limitations that can affect your use of the device?
• Is the device right for the environment where you plan to use it?
• Are there device characteristics that can affect its use?

• Teleconference: On June 21, 2000, we broadcast a live, interactive satellite teleconference for risk managers and other healthcare providers. This video teleconference used a case study format in which a panel of risk managers described actual incidents of medical error. They then analyzed the incident for the audience, including lessons to be learned about preventing and managing errors. The audience also had the opportunity to question the panelists. CDRH’s Office of Surveillance and Biometrics assisted us in co-sponsoring this teleconference with The American Society for Healthcare Risk Management (ASHRM).
• Research – PROUD 2000: The Prioritization and Reduction of Use Error in Devices 2000 project is part of OHIP’s overall strategy to address deaths and injuries resulting from the use of medical devices. There is still much to be learned before we can more fully understand use error in clinical practice. In July 2000, we completed the first phase in which we interviewed Nurses and Risk Managers who are actual device users. We collected information on problematic devices, methods for analyzing device use error, organizational influences on use error, and overall issues that affect use error (i.e., training, staffing, workload issues). During the next phase, we will analyze the results and develop models to help us better understand and prevent use error.

• Human Factors Brochure: In FY2000, we produced a brochure that was distributed widely at professional meetings. The brochure briefly introduces Human Factors in medicine, lists CDRH Human Factors activities, and gives other information resources.

Labeling

Improved patient labeling on medical devices allows the patient or caregiver to better understand both instructions for use and risk-benefit information. Our accomplishments included:

• We review patient labeling for all new Premarket Approval (PMA) submissions and non-PMA submissions where CDRH’s Office of Device Evaluation feels patient labeling needs careful attention. This was the fourth year of an inter-Office agreement for these reviews. Our purpose is to recommend improvements to patient labeling so that the intended patient or caregiver will better understand both the instructions for use and the risk-benefit information provided in the labeling. In cases where patient labeling is not submitted, reviewers determine whether patient labeling will contribute to reducing use error or allow the patient to make a more informed choice concerning their healthcare. During FY2000, we reviewed approximately 90 submissions.

  Out of all reviews, 61 percent of submissions contained patient labeling. Twenty-two percent did not contain patient labeling, but we recommended that patient labeling be written. Seventeen percent did not have patient labeling and did not require labeling for the patient.

• Under a contract with a Duke University expert, Model Patient Labeling for Medical Devices is undergoing Usability Testing. The model patient labeling for medical devices was developed previously and includes recommendations for both risk/benefit information and instructions for use. This contract will compare labeling developed according to our model with the current labeling for a variety of devices. The results will strengthen the scientific foundation for the CDRH policy on labeling.

• A Draft Guidance on Medical Device Patient Labeling was issued. The guidance seeks to assist manufacturers and CDRH reviewers in their review and evaluation of medical device patient labeling. More understandable and usable labeling is essential for patients, family members and other lay persons caring for patients. The draft guidance was issued on March 3, 2000 for public comment. The final guidance will be issued early in 2001. Preparations are underway to provide training for CDRH reviewers on the final guidance.

• A poster presentation entitled "A Patient’s Path to Understanding Medical Devices" was presented at two national meetings of healthcare professionals and stakeholders in promoting patient safety. The presentation details the steps a patient should take to get complete information, including labeling, about a medical device. We developed a brochure based on the poster and are working to make similar information available on our webpage.
• We are working with an FDA-wide Labeling Group to share labeling and advertising/marketing research and policy information. Working with outside experts and stakeholders, the group is also exploring options for leveraging activities in labeling and advertising.

Also during FY2000, OHIP used qualitative research to evaluate labeling-related issues associated with two CDRH programs. Qualitative research attempts to discern a target population’s perceptions, opinions, beliefs and attitudes on a given issue or topic. Focus groups are one of the most familiar tools used in qualitative research. The two CDRH programs were:

• Focus Testing for Tampons: Working with CDRH’s Office of Device Evaluation in November 1999, we coordinated a focus group study consisting of six groups to look at tampon usage and patient labeling. These groups explored:

• how women select tampons and the role of labeling in tampon selection;
• women’s understanding of the tampon label hierarchy and how they interpret the absorbency terms "light" and "ultra"; and
• what women know about Toxic Shock Syndrome (TSS) and the effectiveness of patient labeling in providing TSS information.

• Focus Testing for Latex Gloves: We helped the CDRH Glove Powder Regulation Working Group in identifying and securing a qualitative research contractor and we provided consultation on the preparation and conduct of focus groups to evaluate warning messages for glove labeling.

Patient Safety

In response to the November 1999 Institute of Medicine (IOM) report on medical error, federal agencies including FDA were asked to participate in a Quality Interagency Coordination Task Force (QuIC) to address concerns raised in the IOM report. The goal of QuIC is to ensure that all federal agencies that purchase, provide, study, or regulate healthcare services are working in a coordinated way toward the common goal of improving the quality of healthcare. QuIC prepared a report to the President entitled "Doing What Counts for Patient Safety: Federal Actions to Reduce Medical Errors and Their Impact." The report lists over 100 actions for federal agencies. Staff from OHIP and from CDRH’s Office of Surveillance and Biometrics coordinated CDRH’s responses for inclusion into the QuIC report. As a result, the action list includes several items pertaining to medical devices.

We continue to serve on three QuIC workgroups to ensure implementation of the federal action items addressing patient safety:

• Patient and Consumer Information – addressing barriers to effective communication with patients about quality. This includes providing federal agencies with information to more effectively help people understand quality issues and how their choices influence the quality of the services they receive. It also includes developing a common vocabulary, or set of terms, for federal agencies to use in communicating with patients and consumers about quality.
• Improving Information Systems – exploring how to augment federal efforts to develop a standardized language that will enable computerized comparisons of quality across federal agencies. The workgroup is also examining the potential uses of telemedicine for helping to improve quality of care.
• Errors Workgroup – ensuring the implementation of all action items by federal agencies and, where appropriate, providing a forum for collaborative projects among federal agencies.