News in Brief: October 2020

October 1, 2020

Categories: AAMI News, Clinical, Early Career, Education & Academia, Executive , Government, Health Technology Management, HTM Professionals, Individual Contributor, Information Technology, Manager or Director, Medical Device Manufacturers, Medical Device Manufacturing, Sterilization, Sterilization Professionals

FDA Urges Caution on Spinal Stimulation Devices

The Food and Drug Administration (FDA) released information in early September on risks linked to spinal cord stimulation (SCS) devices. The devices are implanted near the spine to help relieve pain in areas of the body including the back, lower back, and legs by sending electrical pulses to the spinal cord.

About 50,000 of the devices are implanted each year. The agency recently reviewed close to 108,000 SCS device reports received between July 27, 2016, and July 27, 2020. The reports linked 77,937 devices with patient injury; 29,294 with device malfunction; and close to 500 with patient deaths, though, according to the agency, “none of the reports provide enough information to conclude that the device caused or contributed to the death.”

Patient complaints included insufficient pain relief, pain, discomfort, and infection. Device malfunction included charging and battery issues.

As a result of the review, the FDA reminded health providers about the need to conduct a trial with the device before implanting it (the device is inserted near the spine, but not permanently implanted, for several days), as well as other recommendations:

  • Permanent SCS should only be implanted in patients who have undergone and passed a stimulation trial for 3–7 days that shows pain reduction by 50 percent.
  • Risks and benefits of the devices should be discussed with patients.
  • Providers should give patients the name of the device manufacturer, model, and the unique device identifier (UDI) of the implant they received.

According to the FDA, the agency will continue to evaluate information about spinal cord stimulators in Medical Device Reports (MDRs), voluntary reports, current medical literature, information exchanged with other U.S. and international regulators and scientific experts, and from ongoing FDA-mandated postmarket studies.

How Will British Device Registration Work After Brexit?

The United Kingdom (UK) has issued guidance for medical device registration in the period following the UK’s withdrawal from the European Union. From Jan. 1, 2021, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) will handle medical device registration for products to be sold within the UK, to include England, Wales, and Scotland.

The new registration procedures will not apply to Northern Ireland, however. Instead, for EU registration and a CE mark, Northern Ireland will conform with the Republic of Ireland, which remains in the EU, and with which Northern Ireland shares a land border.

Changes to medical device registration and marketing under the UK’s MHRA will include:

  • EU CE marking will be valid until June 30, 2023. After that date, products marketed in the UK will need a UK Conformity Assessment mark (UKCA) conferred by UK Conformity Assessment Bodies.
  • Grace periods for UK registration will apply: four months for Class lll and Class llb implantable devices and all active implantable medical devices; eight months for other Class llb and all Class lla devices; 12 months for Class l devices. The 12-month grace period will not apply to Class l devices and general in vitro diagnostics currently required to register with MHRA.
  • To place a device on the UK market, companies outside the UK will need to establish a UK “Responsible Person” to register the product.

FDA Publishes Enhancements for Reporting Adverse Events

In early September, the Food and Drug Administration (FDA) published eMDR System Enhancements—a guideline describing the changes and updates to Form 3500A, which is used for submitting information regarding medical device–related deaths and adverse events (AEs) to the electronic Medical Device Reporting (eMDR) system. According to the agency, the changes will “enhance usability” of the templates and “improve transparency and analysis” in the eMDR.

FDA’s eMDR Form 3500A involves a system of codes, terms, and definitions used to describe and categorize medical device AEs in the completion of medical device reports (MDRs). The codes are divided into six types, each of which is organized hierarchically. Changes and updates regarding AEs will also apply to the public Manufacturer and User Facility Device Experience (MAUDE) database. Updates to eMDR, eSubmitter, and MAUDE will now be in “real time.”

The list of FDA AE codes accepted in Form 3500A (sections F10 and H6) was updated to harmonize with the International Medical Device Regulators Forum (IMDRF) terminologies for categorized adverse event reporting and affects the Device Problem Codes and Manufacturer Evaluation Codes, which correspond to AE reporting terminologies.

Future updates will harmonize all remaining FDA adverse event codes with IMDRF as more annexes are published. IMDRF codes are not accepted by eMDR, but the new hierarchies include a one-to-one mapping of IMDRF codes to FDA codes.

Call for Healthcare Technology’s ‘Bright Ideas’

AAMI is now accepting nominations for its annual “Bright Ideas” program, which recognizes innovative healthcare technology management (HTM) departments that are implementing creative solutions to challenges.

AAMI’s Technology Management Council (TMC) is seeking specific examples of HTM initiatives that have enhanced patient safety, reduced costs, and/or improved hospital processes.

The TMC will choose six departments to be profiled in AAMI’s publications throughout 2021. Each article will focus on the actions or processes HTM departments have implemented to tackle a specific problem or improve patient care. One of the six profiled departments will be selected to receive an excellence award at the AAMI Exchange 2022, June 3–6, in San Antonio, TX, as well as a $1,000 check and an engraved award.

This year’s Bright Ideas award went to a team led by Donna Marie Dyer, senior director of GE Healthcare’s Healthcare Technology Management Program, for introducing a new organizational system that helped declutter HTM workplaces while streamlining repair and servicing processes.

To submit your nomination, by Oct. 31.