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survey takes place and a new accreditation decision has been rendered.


If an onsite survey is not possible in an organization’s area, an account executive will contact the organization to determine whether the survey event can be performed offsite/virtually, with an onsite evaluation taking place for those that meet the follow- up requirement. If there are extenuating circumstances that pose a significant challenge to the organization’s ability to participate in a survey, organizations are asked to contact their account executive.


FDA’s future inspection plans must address COVID-19 backlog The Government Accountability Office (GAO) looked at drug manufacturer inspections after the U.S. Food and Drug Administration (FDA) paused most of those inspections since March 2020 to safeguard its employees. The outbreak of COVID-19 has called greater attention to the United States’ reliance on foreign drug manufacturers. FDA reports that 74% of establishments manufacturing active ingredients and 54% of establish- ments manufacturing finished drugs for the U.S. market were located overseas, as of May 2020. The FDA is responsible for overseeing the safety and effectiveness of all drugs marketed in the U.S., regardless of where they are produced, and it conducts inspections of both foreign and domestic manufacturing establishments. GAO has had long-standing concerns about FDA’s ability to oversee the increas- ingly global pharmaceutical supply chain, an issue highlighted in GAO’s High Risk Series since 2009. The FDA used alternative inspection tools to oversee drug manufacturing qual- ity, such as relying on foreign regulators and sampling and testing drugs. GAO says these are not a comprehensive or long-term substitute for inspections. Fiscal year 205 was the first time that the FDA conducted more inspections of foreign drug manufacturers than domestic manufacturers, with the majority con- ducted in China and India. However, in une 2020, O reported that from fiscal year 206 through fiscal year 20, both for- eign and domestic inspections decreased, in part due to staffing vacancies. While foreign inspections increased in 2019, since March 2020, FDA has largely paused foreign and domestic inspections due to the COVID-19 pandemic, conducting only those deemed mission critical. In January 2021, GAO reported that FDA conducted three foreign inspections in fiscal year 2020 following the pause—significantly less than in recent years.


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FDA has used alternative inspection tools to maintain some oversight of drug manufacturing quality while inspections are paused. These tools include relying on inspections conducted by foreign regula- tors, requesting and reviewing records and other information, and sampling and testing drugs. FDA has determined that inspections conducted by certain European regulators are equivalent to and can be substituted for an FDA inspection. Other tools provide useful information but are not equivalent. In addition, FDA was unable to complete more than 1,000 of its planned fiscal year 2020 inspections and will likely face a backlog of inspections in future years. In January 2021, GAO recom- mended that FDA ensure that inspection plans for future fiscal years respond to the issues presented by the backlog and that FDA fully assess the agency’s alternative inspection tools. FDA concurred with both recommendations.


Even before the COVID-19 pandemic, FDA faced persistent challenges conduct- ing foreign inspections. GAO found in December 2019 that there continued to be vacancies among the investigators who conduct foreign inspections. GAO further found that FDA’s practice of preannounc- ing foreign inspections up to 12 weeks in advance could give manufacturers the opportunity to fix problems ahead of the inspection and raised questions about their equivalence to domestic inspec- tions. In light of COVID-19, FDA is now preannouncing both foreign and domestic inspections for the safety of its staff and manufacturers. GAO also found that lan- guage barriers can create challenges during foreign inspections as FDA generally relies on the establishment for translation services.


AAMI guidance to revamp medical device IFUs Medical device manufacturers, regulators, and healthcare technology management experts recently joined forces to solve a long- standing issue for medical device process- ing: confusing instructions for use (IFUs). These essential instructions explain how to properly clean, disinfect, sterilize and make the device ready for use on the next patient. This updated technical information


report, TIR12:2020, Designing, testing, and labeling medical devices intended for process- ing by healthcare facilities: A guide for device manufacturers, standardizes manufacturer IFUs for the processing of clinically used medical devices and helps manufacturers understand how well the end users compre- hend a device’s instructions and labeling. “Regulators have been pushing the mes- sage that end users need to follow manufac-


April 2021 • HEALTHCARE PURCHASING NEWS • hpnonline.com


turer instructions, saying ‘Don’t make it up yourself.’ But when users look at an IFU, it can be confusing or incomplete,” explained Damien Berg, a regional manager of ster- ile processing at University of Colorado Health and past president of IAHCSMM. Berg co-chaired the AAMI working group that completely revamped TIR12, creating its new 2020 version. The working group determined early on that even though manufacturers and test labs have been vali- dating IFUs all along, the conditions and terminology that they have used were not always an “apples-to-apples” comparison to the rapidly changing environment that is the clinical setting. To create more sensical instructions and labeling, manufacturers would need a way to reference the tools, terminology, and expectations of device users and regulators alike. This is where the new report comes in. “It’s a much cleaner and easier to read reference document for the manufactur- ers,” Berg said. “In turn, the hope is that this will allow them to get their product through the FDA easier and quicker. Then I as an end user get to use their product with clear instructions. It all comes down to pro- actively reducing confusion for my staff.” Initially, sterile processing managers and device manufacturers worked at this prob- lem from different directions, added AAMI working group co-chair Ralph Basile, vice president of marketing and regulatory affairs for Healthmark Industries. “A number of manufacturers were going through the process of rewriting their IFUs alone. They were saying, If we can’t figure this out, how are customers supposed to do it?’ Around that time, the working group had turned its attention towards standardizing IFUs, so the manufacturers shared what they had,” Basile said. “We got end-users, testing labs, and even the FDA involved and that really got this whole effort going.”


An important milestone was the 2017 update of the standard ANSI/AAMI/ISO 17664, Processing of healthcare products— Information to be provided by the medical device manufacturer for the processing of medical devices, which details what information must be provided to healthcare facilities (including instructions for pre- treatment, cleaning, disinfection, drying, inspection, maintenance and functionality testing, and packaging). It also describes the validation testing that needs to be con- ducted to ensure each of these processes is suitable for the device. Three years after ISO 17664 was published, TIR12 now ensures that manufacturers not only know what information they need to provide, but also how to provide it. HPN


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