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TJC Releases Safety Alert on Ophthalmology Devices; FDA Modifies Medical Device Reporting Process

By Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS

In May 2019, The Joint Commission (TJC) issued a Quick Safety alert for tonometers and other devices that touch the eye. A tonometer is a device used to determine the intraocular pressure, the fluid pressure inside the eye; this device touches the eye and must be disinfected between uses, along with other medical devices that touch the eye.

At a minimum, items that touch the eye must undergo high-level disinfection and items that contact sterile tissue must be sterilized. The American Academy of Ophthalmology reports that due to a failure to properly disinfect this equipment there have been transmissions of adenovirus and herpes simplex virus, hepatitis C virus, Pseudomonas aeruginosa, methicillin-resistant Staphylococcus aureus, and prions such as Creutzfeldt-Jakob disease.

TJC surveys have identified the following shortcomings of the disinfection process of ophthalmology devices in health care facilities, which have resulted in declarations of immediate threat to health and safety of patients:

  • Lack of awareness with manufacturers’ instructions for use (IFU);
  • Misinterpretation of manufacturers’ IFU;
  • Lack of staff training; and
  • Lack of leadership oversight.

The quick safety alert also provided the following safety actions for health care facilities to take to prevent an infection associated with tonometers and other ophthalmology devices:

  • Review eye instrumentation IFU to ensure the devices are being reprocessed appropriately.
  • Ensure disinfectants are listed as compatible and are FDA-approved as high-level disinfectants. Some products, such as bleach, may be listed for pre-cleaning. If bleach is listed as an option to use, note that it is a disinfectant that does not require clearance through the FDA.
  • Follow manufacturers’ IFU for both the devices used for ophthalmology examinations and procedures, as well as cleaning and disinfection products.
  • There should be an individual knowledgeable about the different types of disinfectants and who reviews the product label and instructions for use.
  • If instructions are unclear, contact the item’s manufacturer (and the manufacturer of any products used for reprocessing) for clarification.

FDA modifies medical device reporting process

The U.S. Food and Drug Administration (FDA) is taking steps to improve its ability to identify and address medical device safety signals and provide patients and health care professionals with important information that can be used to make better-informed health care decisions. This is being accomplished by updating the FDA’s Medical Device Reporting (MDR) Program, which monitors device performance, detects potential device-related safety concerns or signals, and contributes to the benefit-risk assessment of medical devices.

In June, the FDA announced it would be formally ending its Alternative Summary Reporting (ASR) Program. Under this program, manufacturers of some medical devices could request an exemption from the requirement to file individual medical device reports for certain events that were well-known and had well-established risks associated with a particular device and instead submit quarterly summary reports of such events. According to a June 21, 2019, statement from the director of the FDA’s Center for Devices and Radiological Health, the FDA granted 108 such exemptions to individual manufacturers for certain well-known events associated with specific devices, which were often already described in the product labeling available to health care professionals and patients. The ASR Program allowed the FDA to more efficiently review reports of well-known, well-understood adverse events, so it could focus on identifying and taking action on new safety signals and less understood risks.

Beginning in 2017, the FDA took steps to formally sunset the ASR Program and to streamline medical device reporting by implementing the Voluntary Malfunction Summary Reporting (VMSR) Program. The VMSR Program allows the FDA to efficiently detect potential safety signals and free up resources to better address the highest risks, such as deaths and serious injuries, associated with medical devices. As the name suggests, this is a voluntary program that allows manufacturers to report certain device malfunctions in a summary form on a quarterly basis, rather than on an individual basis, for eligible device types. Reports from this voluntary program are publicly available in the Manufacturer and User Facility Device Experience (MAUDE) database. The MAUDE database maintains reports submitted by both mandatory reporters (manufacturers, importers and device user facilities) as well as by voluntary reporters such as health care professionals, patients and consumers. There are exceptions, however; reports of a death or serious injury are not allowed to be submitted via the VMSR Program and the FDA may still require individual malfunction reports instead of summary report for devices that are eligible for the program, such as when individual reports are necessary to address a public health issue.

The MAUDE reporting system will also undergo a change to make it more user friendly over the next few years as part of a broader effort to modernize the medical device program’s information technology systems. The objective of these improvements is to make MDR data more usable and easier to find. This effort is intended to increase transparency in medical device reporting.

Medical device reports submitted to the FDA are only one source used to monitor medical devices in use; however, there are some limitations to these reports. The FDA has identified that some submissions are incomplete, inaccurate, untimely and duplicative, and some include unverified or biased data. The modernized, active surveillance will use real-world data and is a primary focus for the FDA.

In response to these issues and in an effort to improve reporting, the FDA has been developing a new program called the National Evaluation System for health Technology (NEST) to systematically use real-world data to rapidly identify and help address safety signals once devices are in use through active surveillance. Active medical device surveillance will better protect patients by, for example, continuously using analytical software algorithms to evaluate large data sets on device performance and patient safety associated with device use in routine clinical practice.

An important part of this new surveillance system is the establishment of the unique device identification (UDI) system. The UDI requires medical devices are marked on their labels with a unique code that can be used to identify the device through its distribution and use in patients. Device identifiers are stored in a public database; currently, there are more than two million device records, and patients and health care professionals can download information about their devices. The FDA also has engaged in international efforts to facilitate a harmonized approach to adoption of UDI systems worldwide.

– Susan Klacik, BS, CRCST, CIS, CHL, ACE, FCS, is an IAHCSMM Clinical Educator.

A modified version of this article was published in the Sept/Oct 2019 issue of PROCESS, a publication of the International Association of Healthcare Central Service Material Management.



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