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Unclear criteria on reuse of ‘single-use devices’ fuels confusion
  • By Song Soo-youn
  • Published 2017.05.29 15:16
  • Updated 2017.05.29 15:16
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The government has banned disposable needles and other medical devices since the recent mass infection of hepatitis C. However, it has yet to present clear criteria for the management or reuse of “single-use devices” stoking up confusion among medical workers, critics said.

Korean Society for Healthcare-associated Infection Control and Prevention(KOSHIC)대한의료관련감염관리학회 held the 22nd academic conference in Sejong University Thursday and discussed the management system of the single-use devices.

The participants in the conference said in unison that the government’s policy on the devices had been disoriented. The Medical Service Act currently prohibits the recycling of disposable medical supplies for injection but doesn’t provide rules for other disposable products.

The Korean Society for Healthcare-associated Infection Control and Prevention (KOSHIC) holds its 22nd academic conference, on establishing a sustainable infection control system, at Sejong University, Seoul, Thursday.

Nurse Park Hee-yeaon박희연 at the infection control room of Asan Medical Center서울아산병원, while briefing about the domestic and foreign situations regarding the reuse of disposable medical devices, stressed the need for Korea to come up with the related system.

According to the “study on the reuse of diagnostic and treatment devices” by National Evidence-based healthcare Collaborating Agency (NECA)한국보건의료연구원 in 2009, some countries, such as France, Spain, Austria, and Portugal, ban the reuse of disposable devices while others, including Germany, the United States, Australia, Denmark, and Sweden, allow the reuse under qualitative management.

Park presented in detail related U.S. law of 2002, called the “Medical Device User Fee and Modernization Act.” She said the U.S. Food and Drug Administration (FDA) prepared the guideline on single-use devices as early as in August 2000, allowing hospitals and reprocessing companies to reprocess them in the same ways as manufacturing companies do. Later, it enacted the law to allow the reprocessing of devices in facilities registered with FDA and asked them to submit the device list.

“It’s not easy to even know which products are the single-use devices in Korea. The government has to decide the direction -- whether it prohibits the reuse of the devices or sets rules to reprocess them in safe ways,” Park said. “The U.S. has made the process for a long time, but it took us more than a year to know which products were disposable. We, too, have to establish a process with a long-term perspective.”

A doctor agreed. “Currently, we don’t have any legal grounds governing the reuse of devices. So we should start by revising the law,” said Professor Eom Joong-sik엄중식 of the infectious disease division of Gachon University Gil Medical Center가천대 길병원. “The U.S. has rules and standards to examine the used devices and reuse them at prices lower than new products.”

Professor Eom also pointed out the compensation plan for the single-use devices announced by the Ministry of Health and Welfare보건복지부(MOHW) announced in November 2016 was wrong in priorities.

“The insurance coverage for medical supplies is welcome, but it seems to focus operating materials too much. The ministry has to place priority based on occurrence frequency and the level of severity when it gives insurance benefits to treat materials related to infection control,” he said. “For example, ventilator-associated pneumonia (VAP) accounts for more than 60 percent of mortality rate healthcare infection-related deaths, but most items receiving insurance benefits are medical materials related to the infection of surgical sites.”

The ministry said it couldn't help but give insurance benefits by taking fiscal matters into account. “The government should set priority, and move gradually,” said Gu Sung-ja, a section chief at the ministry. “There are many things to consider for the insurance coverage of medical materials, which slow down the processes. We plan to announce some of the 12 products targeted for the coverage in September.”

The ministry announced it would separately compensate 52 products on a phased basis and give insurance coverage to 12 items this year, including disposable surgical drape, disposable sterilization gown, two disposable warming devices, disposable clipper for hair removal, N95 mask, safety syringes, safety butterfly needle set, needless connector, saline prefilled syringe, protective hood, and face shield.


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