People make errors all the time – it’s an aspect of being human. Errors made while using medical devices can lead to hazards which can impact patients, family members, and 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.

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 the Center’s premarket, postmarket, and field-inspection regulatory missions.

We assisted the Center’s Office of Device Evaluation by providing several Human Factors reviews for PMA and 510(k) devices.

• Guidance: In July 2000, we issued a final guidance document, Medical Device Use Safety: Incorporating Human Factors Engineering into Risk Management. This document has receivedpositive feedback from industry representatives. Its content provided the basis for the 2001 teleconference: "Integrating Human Factors Engineering into Medical Device Design and Development." Recent HF guidance efforts include a HF section of the new guidance (being written) for glucose monitors which contains specific considerations for glucose monitors. This effort also included the incorporation of HF perspectives into the software validation component of the glucose monitor guidance document.

• Teleconference: On February 14, 2001, we broadcast a live, interactive satellite teleconference: Integrating Human Factors Engineering (HFE) into Medical Device Design and Development. The audience included risk managers, device manufacturers, and other health care providers. The focus was the role of the medical device industry in reducing errors involving medical device use, a.k.a. "use error". The teleconference included two panels. The first panel was composed of representatives from CDRH who discussed the regulatory implications of HFE and the extent to which human factors is considered as part of the overall review performed by CDRH. The secondpanel was composed of experts on HFE from the medical device industry. This panel discussed integration of HFE into design and development processes for medical devices for the purpose of making devices safe for users. At the end of the teleconference, panelists responded to questions from a nationwide audience. Questions that were not answered at the time of the teleconference are posted on our website (link on previous page).
• 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 fully understand use error with medical devices. In 2000, we completed the first phase in which we interviewed Nurses and other 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 2001, to coincide with the IVD TPLC effort, the next phase of PROUD began with a series of discussion/focus groups consisting of glucose meter users. The results of this undertaking were directly applicable to the recent HF guidance contributions for glucose monitors, and ultimately provided useful information to the public about glucose meter use considerations via a diabetes web site. The next activity will involve discussion groups with clinical engineers regarding use problems with devices used in hospitals.
• National Standards: OHIP played a key role in the development of the American National Standard ANSI/AAMI HE74:2001, Human factors design process for medical devices published in 2001. This standard will be given FDA recognition and will serve as a human factors engineering design guidance for medical devices.
• International Standards: OHIP is leading the development of an international standard (IEC 60601-1-6, collateral standard: Usability: Analysis, test and validation of human factors compatibility) that describes how manufacturers must carryout design activities to address the needs of the device users to minimize dangerous error. The 1st Committee Draft was circulated for national committee comments in the Spring of 2001. This standard serves as the primary basis for the international standard IEC 60601-1-6, collateral standard: Usability: Analysis, test and validation of human factors compatibility which is currently being developed.

• Human Factors Brochure: In FY2001, OHIP updated the Human Factors Brochure and distributed it widely at professional meetings. The brochure briefly introduces Human Factors in medicine, lists CDRH Human Factors activities, and gives other information resources. All of the information from the brochure is available from our webpage.

Labeling

• We review patient labeling for all new Premarket Approval (PMA) submissions and also for non-PMA submissions if CDRH’s Office of Device Evaluation thinks that patient labeling needs review. This was the fifth year that OHIP performed these reviews. In cases where patient labeling is not submitted, OHIP 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 FY2001, we reviewed 141 submissions.

• A Draft Guidance on Medical Device Patient Labeling was issued. In April 2001, we issued a guidance document titled, "Guidance on Medical Device Patient Labeling; Final Guidance for Industry and Reviewers". The guidance can be found at the website to the left of this page. It is designed to assist manufacturers in their development of patient labeling to help make it understandable to and usable by patients (or family members or other lay persons caring for patients). The guidance is also designed to assist Center reviewers in their review and evaluation of medial device patient labeling. This guidance offers:
• A suggested sequence and content for patient labeling;
• Information on readability and writing for increased comprehension;
• Principles to apply to the appearance of text and graphics; and
• Guidelines on pretesting patient labeling with the target audience.

Patient Safety

During 2001, OHIP participated in the Errors Workgroup and the Patient and Consumer Information Working Group of the Quality Interagency Coordinating Committee (QuIC) on patient safety. The QuIC is coordinated by the Agency for Healthcare Research and Quality.

The Patient and Consumer Information Working Group of the QuIC finalized the brochure "5 Steps to Safer Health Care" in English (http://www.ahrq.gov/consumer/5steps.htm) and Spanish (www.ahcpr.gov/consumer/cincorec.htm). This publication is designed to help patients actively participate in their health care. Specifically, the five steps to follow are:

• Speak up if you have questions or concerns.
• Keep a list of all the medicines you take.
• >Make sure you get the results of any test or procedure.
• Talk with your doctor and health care team about your options.
• Make sure you understand what will happen if you need surgery.

The Errors Working Group tracked the progress of the participating QuIC agencies in completing the patient safety action items identified in the Institute of Medicine Report on Medical Errors and coordinated a response to the President on the status of the action items. CDRH prepared summary updates on the CDRH action items related to adverse event reporting, human factors, and patient education.

Additionally, as part of CDRH’s interest in increasing the awareness of medical students about patient safety issues with the use of medical devices, a medical school curriculum content outline was developed and piloted with medical students under a grant to the Cleveland Hospital Foundation. CDRH is pursuing additional partnerships to further develop the curriculum model into an interactive educational program or web-based program that can be utilized in the clinical setting by a variety of healthcare practitioners.