the neuma picc and central line protection clamp€¦ · - search the room for illicit drugs. -...

NEUMA INNOVATIONS LLC :: www.neumainnovations.com :: The Neuma Clamp is Patent Protected :: Copyright © 2018

BACKGROUNDThe use of central lines for medical treatment isaccelerating alongside an epidemic of intravenousdrug abuse and opioid overdoses. Medical facilitiesare experiencing a dramatic need for safe andeffective tools that inhibit the abuse of centrallines by IVDU patients and their associates.

PROBLEMThe risks for central line complications are especiallyhigh in persons who abuse intravenous recreationaldrugs. After discharge from the hospital, thesepatients often use their central line to shoot upharmful drugs. Doctors frequently decide to keeppatients with central lines in the hospital whenthey could otherwise send them home. Providersare unwilling to discharge stable patients becausesome patients will abuse their line, resulting in adangerous infection, damage to the central line,or drug overdose and death. The consequences ofoverdose through an unprotected central line aretragic. Furthermore, the concern about line abuseand the reluctance to discharge patients results inhundreds of millions of dollars in unnecessarymedical expenses as a consequence of keepingpatients with central lines in hospitals when theycould otherwise be receiving their therapy at homeor other care facilities.

SOLUTIONNeuma Innovations has developed a cathetersafety device to deter and detect the purposefulabuse and accidental errors that endanger the millions of patients with central lines insertedannually. The Neuma Clamp is a Class 1 510(k)exempt device registered with the FDA, andmanufactured using medical grade acetyl plastic.

FEATURES AND BENEFITS• Deter and Detect Central Line Abuse• Protect Lines from Contamination• Improve Patient Safety• Discharge Patients with More Confidence• Free up Hospital Beds

THE NEUMA PICC AND CENTRAL LINE PROTECTION CLAMPIntroduction and Frequently Asked Questions

STEP 1Place the linesinto the walledcradle.

(Note the orangehook that will holdthe clamp closed.)

STEP 2Pinch the clampand it will lock shut.

Now the lines areprotected.

STEP 3Turn the blue knobto open the clamp.This action breaksoff the orangehook and theclamp can't beused again.

NEUMA INNOVATIONS :: All Rights Reserved :: Copyright © 2018 Neuma Innovations LLC :: All devices patent protected

Why is the Clamp “tamper-evident” and not“tamper-proof”?

We had 3 primary goals in developing the Clamp:1) Protect for the patient 2) Safeguard the centralline or PICC line and 3) Optimize the use of scarcemedical resources. An intravenous drug use (IVDU)patient can always find a way to use drugs, even ifthe central line is fully protected.

We wanted to help physicians feel more confidentthat the line would remain clean and useful fortreatment. We wanted to minimize danger to pa-tients from line tampering. And we wanted tomake it possible to discharge selected patients toappropriate settings so that they would not remainfor extra unnecessary weeks in the acute hospital.

Tamper-evident sends an important message tothe patient that tampering with the line is dangerous,could lead to death and could jeopardize treat-ment. The initial placement of the tamper-evidentdevice provides an opportunity for the physician tospeak to the patient about the risks and conse-quences of abusing the line. Tamper-evident alsoensures that the care providers know when thepatient has put the line at risk. It’s then up to thetreating team to decide how best to manage thepatient.

Making the line tamper-proof would not preventshooting up in other areas. Tamper-proof wouldrequire a much heavier, more expensive and moreintrusive device. It would also mean that in theevent of an emergency with a line locked off by atamper-proof device, providers might not haveimmediate access to the line.

Can’t the patient just use a needle to shootdirectly into the catheter beyond the Clamp?

The Clamp is applied near the hub leaving littleroom for a needle. In addition, if the patient doesinsert the needle directly into the catheter, leakingwill be immediately apparent.

INTRODUCING THE CENTRAL LINE PROTECTION CLAMPIntroduction and Frequently Asked Questions

What size central venous catheters and howmany lumens can the Clamp handle?

The Clamp can accommodate catheters with 1to 3 lumens and essentially any diameter centralor PICC line other than Quinton catheters orsimilar large bore lines. The Clamp is for shorter,centrally-inserted catheters, PICC lines, mid-linecatheters or even peripheral IVs if you intend toleave them in.

We’re not going to pull the line or stop treat-ment even if the patient tampers with it. Whywould we want to know if the patient is tam-pering with the line?

In many cases, abusing the line is more danger-ous than changing treatment or even endingtreatment. Not knowing that the patient is tam-pering with the line is dangerous for the patientand for your hospital. The Clamp will alert you totampering. An open Clamp is a better alert thana second infection, an air embolism or a deadlyoverdose.

The treatment contract template we recommendspells out what will happen if the patient is dis-covered to have tampered with the line. Thepatient and the treatment team should have adocumented conversation about the rules oftreatment and the consequences for breakingthose rules.

Will use of the Clamp really lead to early andappropriate discharge from the acute hospital?

A survey of 64 hospitals in the UK, Singapore,New Zealand and Australia showed that about50% of those surveyed send IVDU patients tonursing homes with PICC lines and believe thatpractice is safe and effective. Others never do,but there is no evidence that sending patientsto nursing facilities is more dangerous thankeeping them in the hospital with central lines.The decision depends on your patients, your

hospital and your doctors. However, many institutionsdo send patients to skilled facilities.

Surveys of internal medicine hospitalists in Californiaand Kentucky have been conducted. Without theClamp, only about 20% of hospitalists would evenconsider discharging an IVDU patient with a centralline or PICC line. With a device like the Clamp inplace on the line, about 75% of a group of hospitalistssaid they would be willing to send patients whoare stable to a more appropriate level of care.

Outpatient Antibiotic Treatment Centers (OPATs)are a cost-effective site to discharge patients tocomplete antibiotic therapy. They live at home butcome back as outpatients for antibiotics on a dailyor even twice daily basis. The Clamp makes tam-pering evident in OPAT patients. Jennifer Ho* suc-cessfully treated a group of 29 IVDU patients withcentral lines protected by tamper-evident technologyin her OPAT without any excess complications.

What can we do if the patient is found to betampering with the central line?

Here are some recommendations. You and yourstaff may have additional approaches:

- Re-educate the patient about the dangersof tampering with the central line.

- Alert the nursing staff to watch for suspi-cious behavior or to pay special attention tothe patient, perhaps with more frequentchecks.

- Search the room for illicit drugs.

- Engage the patient in a discussion aboutwhy he or she tampered with the line andabout his or her goals for treatment.

- Restate the guidelines and document yourconversation with the patient.

- Implement random drug testing.

- Limit or eliminate visitors.

- Switch to oral or IM antibiotics for the finalweeks of treatment.

- Decrease the treatment duration.

- Switch to a less frequent IV regimen anduse a peripheral line once a day.

- Require the patient to start medical addic-tion treatment with buprenorphine,methadone or even naltrexone.

- Insist on a behavioral health consult.

- Don’t allow the patient to leave the floor.

- Install a sitter or a camera.

- Contact your infectious disease consultantsfor ideas about treatment options.

- Remove the line or let the patient know thatthe next time he tampers with the line, youwill remove it.

- Engage a responsible family member or reli-able friend to be with the patient.

- Beef up your documentation of warnings tothe patient to protect yourself in the eventthat something bad happens.

How can the Clamp be useful when the patient issent home, especially if nurses do not come tothe home for every infusion?

Obviously, there’s no point to having the patientapply and remove his own Clamp. It’s important tohave the patient in a supervised environmentwhen the antibiotics are administered and theClamp is changed under observation. However,some insurance companies and Medicare supple-mental plans will send nurses for every infusion,especially if you can devise a once-daily regimen.Some hospitals may want to create integratedprograms that view the expense of nurse visits asa fair trade-off for discharging the patient to a



more cost-effective environment. Family membersor trusted friends are often recruited to give theantibiotics. These same folks could be in charge ofmonitoring and applying the Clamp. If family mem-bers can handle the infusions, they can also suc-cessfully include the Clamp as part of the treatment.

Should the Clamp be applied for patients still inthe hospital?

Yes. Patients with a history of IVDU often injectwhile in the hospital. Whenever you suspect orknow of IV drug abuse, you should use the Clamp.

What are the legal implications of using theClamp?

You should always consult your own legal counsel.However, the risky activity is the insertion of thecentral line or PICC line, not the application of theClamp to that line. Using the Clamp is a way toprotect the patient from his addiction. The treat-ment contract and documentation of discussionswith the patient about the dangers of abusing theline are an excellent defense against legal actionsif you make the decision to insert a line in any IVDUpatient. We also strongly recommend using atreatment contract.

Is the Clamp FDA approved?

The FDA recognizes several different levels formedical devices. “Class 1 Exempt” applies todevices that are very similar to already existingdevices and are of little or no risk. The Clamp isFDA Class 1 Exempt. However, we took the extrastep of completing an FDA risk analysis of the Clamp,and we registered the device with the FDA.

Is the Clamp sterile?

No. The Clamp is manufactured in a clean roomand packaged in a clean environment. Each Clampis packaged individually, and all lots have uniqueidentification. Since the Clamp is applied to a non-sterile external line and is in touch with the skin,sterility is unnecessary and could not be maintained.

In addition, the Clamp is made of a medical gradeplastic that has been tested for biocompatibilitywith direct skin contact.

Will the Clamp damage the central line?

No. During testing, we kept Clamps on lines con-tinuously for up to 6 months without any damageto the lines. We have also opened and locked up to150 fresh Clamps on the same line without dam-age to that line.

Our institution has an informal policy that wenever discharge IVDU patients with PICC lines. Isit safe to do so?

Many institutions have a never-discharge formal orinformal policy. And there is certainly a rationalcase to be made for that policy. However, the policyis not uniform, and the science, while certainly notcomprehensive or absolutely conclusive, actuallymay lean a bit toward discharging patients underthe right circumstances.

Laura Fanucchi et al at the University of Kentuckyshowed that nearly 40% of all IVDU patients withPICC lines tested positive IN THE HOSPITAL for illicitdrugs (PMID 300332946). So, even hospitalizedIVDU patients with PICCs should have a Clamp todeter and alert to abuse of the line.

Camsari & Libertin showed that given certain criteria,one can predict which patients will do well whendischarged with OPAT follow-up. (PMID 29057191).And Ho successfully treated 29 IVDU outpatientswith PICC lines in an OPAT by using a tamper-evidentapproach (PMID 29864497). In another study, pa-tients discharged to an outpatient OPAT were justas likely to successfully complete treatment aswere those discharged to a SNF (PMID 29766017).The bottom line is that no site, not even the inpatientservice, is immune to line tampering, and, underthe right circumstances, many patients can betreated successfully as outpatients. As with allpatients, one very rational policy is to individualizetreatment to best suit the patient and to always



do what it takes to protect the patient and the line,no matter the venue.

What is a treatment contract?

A “treatment contract” or “treatment agreement”is a document that sets out the rules for treatmentand the relationship between the patient and thetreating team. It also spells out the consequencesof tampering with the central line. The contract is avery useful tool to help educate your patient aboutthe risks and consequences of tampering with thecentral line.

The document also protects you and your institution.The Clamp does not require informed consentsince it is not a procedure and is a routine recom-mended by the manufacturers of central lines. Thecentral line insertion requires informed consent,but that consent does not require mentioning theconsequences of tampering with the line. Thetreatment contract does set those out in detailand documents that you have spoken with yourpatient about them. You do not have to use atreatment contract with a patient, but we stronglyrecommend its use.

You can find a sample treatment contract templatein the “Downloads” section of the Neuma Innovationswebsite:www.neumainnovations.com/neuma_downloads

What is Medical Addiction Treatment?

“Medical Addiction Treatment” is the use of med-ications to control addiction in opioid use disorderpatients. Drugs such as methadone, buprenorphineand naltrexone attach to the opioid brain receptors invarious ways. They decrease craving and controlthe behaviors of addiction. Clinicians skilled andcertified in their use administer them, but thetraining does not need to be extensive. For instance,a licensed physician can be certified to usebuprenorphine through an 8-hour course that isoften offered online and without charge. You can’t

require patients to take these medications. How-ever, if they do so, studies have shown they areseveral times more likely to remain abstinent thanwith behavioral therapy alone.

How can I purchase the Clamp?

The device comes in boxes with 100 individuallywrapped Clamps. Prices and terms are availableon the Neuma Innovations website: www.neumainnovations.com/shop_now.html .

You can also purchase via an invoice or arrange anaccount to submit a purchase order. Contact usdirectly via [email protected] or by thecontact phone number on the website.

How do I learn to use the Clamp?

The Clamp is very simple to use, and we have acomprehensive inservice video on our website.Anyone on your staff can view the video on theirown time, and new staff can be directed to the sitefor training. We also have a post-test document onour website under the Downloads tab that can beused to certify staff.

How much does it cost to add the Clamp to ourtreatment work flow?

You can find a price list on our website under the“Shop Now” tab. We provide volume discounts.The added cost for the treatment of a patientvaries depending upon the number of times perday that you give an infusion. The Clamp is a singleuse device that must be changed with each newinfusion or flush. Multiply the number of dailychanges by the length of anticipated treatment.The average total fee to include the Clamp isbetween $300 and $400 for a 6-week treatment,a small addition compared to the expense of a sitterfor 6 weeks or the treatment of an infection oroverdose. The entire cost for the Clamp for 6weeks of treatment is about 1/10 what it costs tokeep a patient in the hospital for just one day.



the neuma picc and central line protection clamp€¦ · - search the room for illicit drugs. -...

Documents