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OCD FY2004 Part 2. Patient and Consumer Protection - CDRH Strategic Goal: Public Health Impact

Postmarket Surveillance Programs

Medical Product Surveillance Network (MedSun)

The FDA Modernization Act of 1997 (FDAMA) directed FDA to change the current MDR regulation pertaining to user facilities from a required universal reporting system to a system comprised of a subset of user facilities. Since February 2002, CDRH has been collecting data about medical devices problems from a sample of hospitals and nursing homes. This data collection initiative, called the Medical Product Surveillance Network (MedSun) is an interactive, internet-based reporting program. CDRH has collaborated with these facilities to determine the effectiveness of various incentives and types of feedback on the quantity and quality of reports sent into the system.

During FY 04, CDRH continued recruitment of reporting facilities from the east coast and mid-west region of the United States, for a total of 180 facilities. Additionally, in FY 04 a pilot project was begun to directly target the submission of reports from laboratories (pathology and in vitro diagnostic tests) in the reporting hospitals. By the end of the fiscal year, 299 sites had been recruited with representation nationwide. The laboratory pilot determined that it was very important for CDRH to receive the type of information that was collected during the pilot. Therefore, special emphasis on increasing the reporting from hospital laboratories will take place in FY 05. Numerous regulatory and non-regulatory initiatives have taken place based on reports received in the MedSun program.

Adverse Event Reports

During FY 04, FDA received approximately 57,600 individual medical device adverse event reports from manufacturers, user facilities, and importers. Additionally, 3,887 voluntary adverse event reports were submitted by health care professionals and consumers. CDRH postmarket staff reviewed and analyzed these reports to determine actual and potential public health risks associated with reported device problems. If the use of a particular product results in unexpected problems or risks, CDRH follow-up is undertaken to determine the etiology of a reported problem and to determine appropriate solution strategies.

This fiscal year, adverse event review and analysis identified significant problems with a number of issues:

  • A patient lift that malfunctioned and fell on a patient resulting in an import alert and recall of the products.
  • Contamination of a sealed blister pack of needles resulted in CDRH working with the firm to improve manufacturing processes to ensure a safe product.
  • Dislodgement of powered toothbrush heads associated with patient injuries resulted in manufacturer recall of the product.
  • Accidental misconnections with intravenous and oxygen tubing resulted in CDRH working with the manufacturer to issue a safety letter to users.
  • Paralysis associated with the use of absorbable hemostatic agents to stop bleeding during surgery resulted in CDRH issuance of a public health notification to healthcare practitioners.
  • Fires involving electrically powered hospital beds resulted in CDRH issuance of a public health notification to healthcare practitioners with safety tips for prevention.
  • The occurrence of thrombosis and hypersensitivity associated with a drug eluting stent resulted in a CDRH public health web notification to physicians.

CDRH also published articles in a device safety column in a peer-reviewed clinical journal alerting healthcare practitioners to identified problems with

  • inappropriate use of patient controlled analgesia infusion pumps resulting in medication overdoses;
  • inadvertent injection of air into intravenous tubing during contrast media injections;
  • the occurrence of peritonitis associated with continuous cyclic peritoneal dialysis therapy by patients in the home;
  • patient use of decorative contact lenses without a prescription or professional fitting resulting in eye injury, vision impairment and blindness;
  • electrical hospital bed fires associated with overheating of bed motors and use of damaged connection plugs; and
  • inadvertent misconnections of intravenous tubing with tubing of other devices resulting in misadministration of medications associated with adverse patient outcomes.

In addition, problems with aortic anastomosis devices used during cardiac surgery were presented at a CDRH cardiovascular panel meeting convened to obtain panel recommendations and guidance for evaluating prospective manufacturer post-market study designs.

Alternative Summary Reporting

CDRH continued to accept more reports into the Alternative Summary Reporting (ASR) program. In this program, manufacturers submit abbreviated reports in a line item, aggregated way. This program is for devices with problems that are well-known and well-documented. Examples of such problems include

  • shearing of central line catheters;
  • endossoeus implants failing to osseointegrate; and
  • breast implant ruptures.

Approximately 58 manufacturers participate in this program for about 50 different types of classified devices. Four manufacturers are currently participating in the electronic version of ASR and twelve firms are using a newly developed CD-ROM based submission process. CDRH received and entered approximately 99,000 line item reports in the summary database in FY 04.

Postmarket Issue Action Teams

The CDRH Issues Management Staff (IMS) is responsible for leading, coordinating, and facilitating the examination of postmarket problems to determine solution strategies for Center actions to protect the public health. The primary vehicle used by IMS to fulfill this responsibility is the interdisciplinary expert working group or Postmarket Issue (PMI) Action Team (formerly known as the Ad Hoc Committee). Postmarket Issue (PMI) Action Teams develop a Center perspective on a safety issue with a marketed medical device or radiation-emitting product and determine the most effective approach to mitigating risk to the public health. A PMI Action Team may be product-specific, or may pertain to a general category of devices. PMI Action Teams, staffed with appropriate clinical, scientific, technical, and regulatory expertise, are convened to:

  • confirm that the issue has potential public health impact, requiring Center-wide participation to manage it;
  • delineate the nature and extent of the issue, if possible; and
  • develop recommendations for solution strategies for Center management decision-making.

In 2004, CDRH PMI Action Teams addressed many diverse issues with marketed medical devices. Some examples include:

  • infection and injury associated with breast pumps;
  • fires with hospital beds and anesthesia gas machines;
  • endotoxin in devices used for LASIK;
  • counterfeit polypropylene surgical mesh;
  • the interaction of medication delivery patches and deep brain stimulators with MRI;
  • potentially life threatening adverse events associated with an aortic connector for anastomosis in cardiac by-pass grafting; and
  • problems with a cerebral aneurysm embolization device.

 International Programs

In FY 04, CDRH developed a plan to help meet the goals of the CDRH portion of the agency’s International Agenda. The plan, which includes a priority list and a schedule of international activities taking into account the public health impact of each activity, helped direct the CDRH International Staff to high priority activities.

Joint Inspection Program

The Joint Inspection Program exists under the United States (US) / European Community (EC) Mutual Recognition Agreement (MRA). During FY 04, CDRH:

  • trained and evaluated the European Union (EU) Conformance Assessment Body (CAB) auditors through the joint inspection program; and
  • established a team to conduct on-site evaluations of US CABs.

International Vigilance Report

The National Competent Authority Report (NCAR) exchange program includes 16 nations, 13 of whom actively initiated reports during FY 04. In FY 04, CDRH issued over 20 and received over 100 NCARs. Providing approximately 16% of the NCARs exchanged in 2004, CDRH remains among the top contributors to the NCAR program. The NCAR subject devices varied in FY 04, though in vitro devices seemed to dominate the reports. Other devices in NCARs included:

  • Breast implants
  • Closure devices
  • Dental implants
  • Disinfection solutions
  • Glucose monitors
  • Hemodialysis
  • Hospital beds
  • Implantable cardio-defibrillators
  • Implantable pumps
  • Incubators
  • Intraocular lenses
  • Lasers
  • Orthopedic implants
  • Umbilical clamps

Global Harmonization Task Force

The Global Harmonization Task Force (GHTF) was formed in 1992. The founding members are the United States, Canada, the European Union, Japan, and Australia. Other nations participate as liaison members and observers.

GHTF encourages convergence of medical device regulatory practices worldwide where possible, while ensuring the safety, effectiveness, and quality of medical devices. Four distinct study groups (SG) develop guidance documents on basic regulatory practices.

Each study group focuses on a different aspect of medical device regulation:

  • Study Group 1: regulatory and premarket requirements;
  • Study Group 2: postmarket vigilance;
  • Study Group 3: quality systems; and
  • Study Group 4: regulatory auditing of quality systems.

The United States, through CDRH, remains a major partner in GHTF. Throughout FY 04, CDRH actively participated in the work of each of the four SGs, as well as the steering committee, which provides oversight to all GHTF activities. GHTF and SG information can be obtained at  http://www.ghtf.org.

CDRH plans to continue full participation in the advancement of the GHTF’s mission and initiatives, such as was demonstrated by the NCAR program, which shares significant global postmarket device information.

Global Medical Device Nomenclature

CDRH continued working towards the eventual adoption of Global Medical Device Nomenclature (GMDN). Staff who represent CDRH in the GMDN Maintenance Agency were also involved in CDRH nomenclature activities. Improvement and expansion of the GMDN was expedited by new web-based computer application that allows the input of hundreds of new device names/definitions from proposals submitted world-wide, and the modification of existing device names/definitions in the ongoing process to accurately link CDRH procodes in the GMDN.

The Emergency Care Research Institute (ECRI) continued to assist CDRH in its work on product codes (procodes) in the GMDN, and in the general improvement of the nomenclature’s structure. Efforts were also made to include the GMDN in the National Library of Medicine’s Unified Medical Language System (UMLS).

The GMDN consists of nearly 19,000 terms, almost 8,000 of which are preferred terms with definitions used for product identification. Within CDRH, a computerized form of device definition elements was developed to accompany new procode requests for the promotion of more informative device definitions, in alignment with those of the GMDN.

Postmarket Collaborations

 Drug-Eluting Stents

CDRH and the American College of Cardiology (ACC) continued to study drug-eluting stents within the ACC’s National Cardiovascular Data Registry (ACC-NCDR). The ACC-NCDR is a confidential quality measurement program for cardiovascular specialists, hospitals, and cardiac catheterizations laboratories for collecting information on practice patterns and outcomes. The registry collects 142 core data elements needed for measuring the clinical management and outcomes of patients undergoing diagnostic cardiac catherizations and percutaneous coronary interventions. The ACC-NCDR consists of over 1.4 million patient records. CDRH currently has a contract with ACC to access data with specific patient- and procedure-level information to examine the prevalence of use and the experience of patients with drug-eluting stents.

Hospital Bed Safety

Death and injury adverse events associated with patient entrapment in hospital beds continue to be reported to CDRH. The Hospital Bed Safety Workgroup (HBSW), under CDRH’s leadership and in partnership with hospital bed manufacturers, national health care organizations, patient advocacy groups, the Department of Veterans Affairs and Health Canada, undertook a series of studies to validate the test methods and various measurement tools to be used to evaluate openings in hospital beds. HBSW will make available the final test methods and tool to the public in FY 05.

During FY 04, CDRH accepted public comment on the draft guidance for industry entitled “Hospital Bed System Dimensional Guidance to Reduce Entrapment.” This guidance, based on HBSW’s expertise, provides recommendations for the manufacturers of hospital beds and hospital bed accessories to reduce life-threatening entrapments associated with hospital bed systems. It identifies the parts of the body at risk for entrapment, the locations of gaps or openings, and recommends dimensional criteria for beds.

CDRH’s website for bed safety provides information and links to clinical information and educational materials to identify and reduce the risk of patient entrapment in hospital beds at http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ MedicalToolsandSupplies/HospitalBeds/default.htm.

Postmarket Epidemiology

CDRH epidemiologists conduct applied epidemiologic research using a variety of methods and databases and provide consultative services to the Office of Device Evaluation (ODE) and other CDRH Offices on issues requiring epidemiological expertise, from systematic reviews of the literature to risk assessments to the design and conduct of observational studies. Major epidemiologic research during the past year that resulted in publications in scientific journals and presentations at national professional meetings include: serious injuries associated with the use of hemostasis devices; the epidemiology of tampon associated toxic shock syndrome; an active surveillance system to detect medical device associated adverse events that are generally undetectable through routine surveillance; breast implant rupture; evaluation of the completeness of studies undertaken by industry as a condition of premarket approval of their products; use of the National Electronic Injury Surveillance System (NEISS) to assess the frequency of injuries due to medical devices; uses and outcomes associated with transmyocardial revascularization; adverse events related to central venous catheters; adverse events related to breast pumps; adverse events related to infusion pumps; adverse events associated with the Smallpox vaccine; adverse events associated with surgical staplers; the public health impact of a continuous glucose monitoring system; and aneurysm-related mortality associated with an endovascular graft.

Conditions of Approval Pilot Project

As part of CDRH’s effort to formalize Total Product Life Cycle (TPLC) precepts within the premarket review process, ODE’s Division of Reproductive, Abdominal, and Radiological Devices (DRARD) continued to refine the cooperative project with the Epidemiology Branch (EB) of the Office of Surveillance and Biometrics. The purpose of this collaboration was to continue EB involvement in the review process of potential postmarket investigations including initiation and evaluation of the product-specific postmarket plans. Over the course of this year, each epidemiologist participated in the review of a PMA being evaluated by DRARD. Four PMAs that were approved during the year had post-approval studies. In all cases, the epidemiology reviewer developed a detailed plan for the postmarket follow-up of the specific device and played a large role in the post-approval study design. For the PMAs that were part of the original DRARD pilot and were approved last year, the epidemiologists continued to follow and monitor the progress of the initiated post-approval studies. There were six follow-up reports completed (one 6-month report, three 12-month reports, and two 18-months reports) on the status of the postmarket experience with the specific devices. Epidemiologists closely collaborated with Product Evaluation Branches analysts to incorporate their analysis of the adverse event reports into the final postmarket follow–up report.

Medical Errors

CDRH met with and educated medical device manufacturers on the importance of implementing human factors engineering (HFE) principles in order to reduce use errors. We worked with manufacturers and informed them about the HFE program and the regulatory status of human factors.

Our primary efforts in FY 04 were as follows:

  • Worked with the Association for Advancement of Medical Instrumentation (AAMI) HFE Standards Committee and AAMI Staff Education Professionals. We participated in 5 teleconferences to plan for the AAMI Human Factors Engineering Conference to be held in Washington, DC in June 2005 and a mirror conference to be held in Germany in March 2005.
  • Presented an overview of the FDA’s HFE program at the Human Factors Personal Medical Device Workshop sponsored by the University of Maryland Department of Computer Sciences.
  • Participated in the Medical Simulators Conference in May 2004 by presenting on the human factors issues of good stimulator design. The conf erence was sponsored by the Center for Telemedicine Law and the Army Medical Materials Command in Ft. Dietrick, MD.
  • Presented a discussion on usability validation issues at the Symposium on the Plug and Play O.R . of the Future – an academia, industry and government organization that discusses what must be done in order to advance the concept of plug and play medical devices and make it possible to integrate devices into one system that maintains a consistent user interface.
  • Assisted in educating the visiting UK Medical Regulators - Presented an overview of the FDA’s HFE program.
  • Presented at the AAMI Conference and Exposition in which patient safety was the theme . The symposium, "Engineering Safety into the Healthcare Process”, included 5 other speakers and was presented by the allied group American College of Clinical Engineers (ACCE).
  • Presented Understanding “No Problem Found” Human Factors in Medical Device Use Error to MEDSUN constituency via audio teleconference.
  • Presented HFE display at FDA/AAMI International Standards and Regulations Conference in March 2004.

Electronic Labeling

During FY 04, CDRH researched optimum ways of presenting electronic labeling on websites. On November 18, 2003, we hosted the "Medical Device Electronic Labeling Conference." The purpose of the conference was to learn about current best practices for conveying medical device information electronically to health care professionals, patients, and consumers. Five experts from the public and private sectors presented information about research-based web design and usability guidelines, user-centered design issues, and writing style and format for web-based applications. The content of the conference is captured in a summary report. Attendees included representatives from all FDA Centers. Next steps include:

  • preparation of electronic labeling prototypes;
  • heuristic assessment of the prototypes of electronic labeling; and
  • usability testing comparing prototypes of electronic labeling to model versions of paper-based labeling presented on the web.