Device Single Audit Program (MDSAP), was put in place with five participant countries: Australia, Brazil, Canada, Japan, and the United States. The aim of this program was to "develop a process that allows a single audit, or inspection to ensure the medical device regulatory requirements for all five countries are satisfied". In 2017, a study by Dr. Jay Ronquillo and Dr. Diana Zuckerman published in the peer-reviewed policy journal Milbank Quarterly found that electronic health records and other device software were recalled due to life-threatening flaws. The article pointed out the lack of safeguards against hacking and other cybersecurity threats, stating "current regulations are necessary but not sufficient for ensuring patient safety by identifying and eliminating dangerous defects in software currently on the market". They added that legislative changes resulting from the law entitled the 21st Century Cures Act "will further deregulate health IT, reducing safeguards that facilitate the reporting and timely recall of flawed medical software that could harm patients". A study by Dr. Stephanie Fox-Rawlings and colleagues at the National Center for Health Research, published in 2018 in the policy journal Milbank Quarterly, investigated whether studies reviewed by the FDA for high-risk medical devices are proven safe and effective for women, minorities, or patients over 65 years of age. The law encourages patient diversity in clinical trials submitted to the FDA for review, but does not require it. The study determined that most high-risk medical devices are not tested and analyzed to ensure that they are safe and effective for all major demographic groups, particularly racial and ethnic minorities and people over 65. Therefore, they do not provide information about safety or effectiveness that would help patients and physicians make well informed decisions. In 2018, an investigation involving journalists across 36 countries coordinated by the International Consortium of Investigative Journalists (ICIJ) prompted calls for reform in the United States, particularly around the 510(k) substantial equivalence process; the investigation prompted similar calls in the UK and Europe Union. Packaging standards Medical device packaging is highly regulated. Often medical devices and products are sterilized in the package. Sterility must be maintained throughout distribution to allow immediate use by physicians. A series of special packaging tests measure the ability of the package to maintain sterility. Relevant standards include: ASTM F2097 – Standard Guide for Design and Evaluation of Primary Flexible Packaging for Medical Products ASTM F2475-11 – Standard Guide for Biocompatibility