Archived - Notice to Hospitals - Important Safety Information on Pinel Rotating Waist Restraint

Starting date:

March 5, 2007

Posting date:

March 5, 2007

Type of communication:

Notice to Hospitals

Subcategory:

Medical Device

Source of recall:

Health Canada

Audience:

Hospitals

Identification number:

RA-170001670

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This is duplicated text of a letter from PINEL Medical Inc.

Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

Notice to Hospitals - Health Canada Endorsed Important Safety Information on Pinel Rotating Waist Restraint

March 5, 2007

To: Hospital Chief of Medical Staff

Please distribute to the relevant Departments and other involved professional staff and post this ALERT in your institution.

Subject: Possible risk of positional asphyxiation with the PINEL Waist Restraint when used in bed.

Dear Health Care Professional

There have been a number of deaths in Europe with the use of rotating waist belt restraints as applied in bed. These products are similar in design to the Pinel product. These systems permit maximum amount of movement in bed that may prevent deep vein thrombosis, muscle atrophy and increase restful sleep, while ensuring that the patient remains safely in bed. Reasons to restrain may include prevention of falls, entrapment in bed, other patient disruptions and threats to other parties.

Problem Description

The asphyxiation potential is caused when a confused patient pushes the waist belt over his/her thorax (diaphragm) during a bed egress attempt. As the confused patient struggles in the waist belt, his/her actions will tighten the belt. These manoeuvres may result in positions that are increasingly constricting and irreversible due to patient confusion/weakness and may cause increased panic demanding more oxygen. The pressure on the thorax may result in positional asphyxiation and death.

Pinel Recommendations

To reduce these risks, Pinel recommends:

• ensuring that all staff who apply the Waist belt are aware of all Pinel instructions.
• placing all bed rails in the UP position when patient is in the waist belt. If split rails are used, ensure that a gap of 60 mm's or greater between the rails is covered with a non-removable and non-collapsible blocker.
• affixing and maintaining lateral straps (inserted side straps) to ensure that the patient is centred in bed while still permitting rotation.
• using the pelvic strap which prevents upward travel of the waist belt over the thorax for any patient who is restless or at risk of escape attempts.

Rationale

Strict adherence to Pinel instructions and the previous recommendations should prevent any accidents.

The asphyxiations occur by a one-two combination of events. The first is the location of the waist belt over the thorax, followed by a constricting pressure over the thorax. This pressure may be created by the forceful struggling movements by the patient or by gravitational pull as the patient hangs over the edge of the bed/stretcher.

The first problem of upward movement of the waist belt should be prevented by ensuring sufficient tightness around the waist belt. However, total assurance that the waist belt will stay over the waist can be obtained by attachment of the pelvic strap. This pelvic strap is attached to the back of the waist belt, passed between the patient's legs and attached to the front of the waist belt. The pelvic strap should be sufficiently loose to ensure that there is no constant pressure in the groin and permit comfortable rotation the patient, yet still prevent upward movement of the waist belt over the thorax.

Unless there are over riding medical considerations, the bed rails should be in the UP position at all times while the patient is in the Waist belt. This should prevent the patient from falling over the unprotected side of the bed.

The most common asphyxiation problem is an escape attempt through the gap between raised split rails. This tempting exit allows the patient to slide the lower body through the gap and over the edge of the bed forcing the waist belt upward over the thorax. Therefore, if split rails are used, and the gap between the rails is greater than 60 mm, then the gap must be blocked with a non-removable and non-collapsible blocker to close the exit. Other options include adding more restraints, e.g limb restraints or eliminating restraints altogether.

In a situation where the bed rails are down and the waist belt is loosely attached to the bed frame and/or off center, a patient may be able to drift over the edge of the bed and hang over the side of the bed without the ability to return safety. To prevent this, ensure tight and balanced connections of the Waist belt to a non-moveable portion of the bed frame (never the rails - see Figures 1 and 2).

However, to keep the patient centered in bed or stretcher, Pinel strongly recommends the additional attachment of lateral straps (inserted side straps). Both straps should be attached at a sufficient length to permit the patient a complete roll to the side for comfortable sleeping but still hold the patient in the center of the bed/stretcher and prevent sliding over the edge of the bed (Figure 3). Lateral straps are formed by firmly tightening the yellow bordered side straps into the buckles of the Waist belt (Figure 4). Please verify attachment of these lateral straps prior to every use of the waist belt in bed/stretcher unless there are valid over riding medical conditions. The Pinel design allows self tightening as more material is pulled into the buckles (Figure 5) making them very difficult to remove. Connect the lateral straps to the same anchoring post that holds the waist belt to the bed (Figure 6).

Particular caution must be exercised when split rail beds are used. Without a blocker or gap cover in a split rail bed, a patient who is determined to exit the bed may forcefully slide through this gap between the split rails, despite the use of lateral straps.

In addition, staff applying the Pinel equipment should be adequately trained. A proper observation protocol should also be reviewed and maintained. There is no single solution to the complex possibilities created by a confused patient attempting to egress from the bed. Complicating these problems is the objective to keep the patient very comfortable with as few restrictions as possible.

Any cases of risk or unexpected adverse reactions in patients with any Pinel equipment should be faxed immediately to Pinel Medical and/or reported to Health Canada at the following addresses:

Pinel Medical
339 Glenridge Drive,
Waterloo, ON.,
N2J 3W7

Phone: 519-888-0997 or Fax: 519-725-3658
e-mail: pinel@golden.net

Any suspected adverse incident can also be reported to:
Health Products and Food Branch Inspectorate
HEALTH CANADA
Address Locator: 2003D
Ottawa, Ontario K1A 0K9
Tel: The Inspectorate Hotline 1-800-267-9675

The Medical Devices Problem Report Form and Guidelines can be obtained from the Health Canada web site.

For other inquiries related to this communication, please contact Health Canada at:
Medical Devices Bureau Enquiries
Email: mdb_enquiries@hc-sc.gc.ca
Tel: (613) 957-4786
Fax: (613) 957-7318

Pinel reminds you that restraining any patient is a severe procedure that presents risk. Every effort should be made to minimize restraint use. The company recognizes that even within its highly mobile restraints, prolonged restraint increases stress on the patient both mentally and physically. It recommends minimal time within its restraints and restraining only during a patient's normal period of rest.

Original signed by

Ludwig (Lud) Piron
President Pinel Medical Inc.

References:

1. Pinel Instructional Video (Full)
2. Pinel Pelvic Video
3. Pinel Instructions found on Web Site: http://www.pinelmedical.com/instructions.html

Ensuring Central Bed Alignment of Waist Belt.

Anchoring Patient in Centre of Bed.

Figure 3. Allows patient rotation to side but still keep patient anchored in the centre of bed.

Locking Buckles of Side Straps onto Waist Belt.

Figure 4. Pass Side Strap (lateral straps) through buckle of Waist belt and then through the its own buckle. Pull tightly and the V material overlap will ensure an increasing grip as more material enters the lock. This leaves a grip that will make it difficult to remove and should encourage that the Straps remain in place permanently.

Side Straps Fully Locked.

Figure 5. After a tight pull, Side Straps (lateral straps) are now firmly locked together. They must not be removed.

Lateral Straps Attached to Bed.

Figure 6. Side Straps (lateral straps) are attached to the same Pin which holds the Waist belt attachment strap to the bed frame. End of strap is folded over for neatness and to reduce looseness.

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